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http://orcid.org/0000-0003-1691-6403 Julian Savulescu 1 , 2 , 3
1 Faculty of Philosophy , University of Oxford , Oxford , UK
2 Murdoch Childrens Research Institute , Parkville , Victoria , Australia
3 Melbourne Law School , University of Melbourne , Melbourne , Victoria , Australia
Correspondence to Professor Julian Savulescu, Faculty of Philosophy, University of Oxford, Oxford, UK; julian.savulescu{at}philosophy.ox.ac.uk

Mandatory vaccination, including for COVID-19, can be ethically justified if the threat to public health is grave, the confidence in safety and effectiveness is high, the expected utility of mandatory vaccination is greater than the alternatives, and the penalties or costs for non-compliance are proportionate. I describe an algorithm for justified mandatory vaccination. Penalties or costs could include withholding of benefits, imposition of fines, provision of community service or loss of freedoms. I argue that under conditions of risk or perceived risk of a novel vaccination, a system of payment for risk in vaccination may be superior. I defend a payment model against various objections, including that it constitutes coercion and undermines solidarity. I argue that payment can be in cash or in kind, and opportunity for altruistic vaccinations can be preserved by offering people who have been vaccinated the opportunity to donate any cash payment back to the health service.

behaviour modification
technology/risk assessment
philosophical ethics
public health ethics

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/ .

https://doi.org/10.1136/medethics-2020-106821

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Introduction

We are in the midst of a global pandemic with COVID-19 and there is a race to develop a vaccine. At the time of writing, there are 53 vaccines in clinical trials on humans (plus five that have bypassed the full trial process) and at least 92 preclinical vaccines under active investigation in animals. There are a number of different approaches: (1) genetic—using mRNA to cause the body to produce viral proteins; (2) viral vector—using genetically modified viruses such as adenovirus to carry sections of coronavirus genetic material; (3) protein—delivering viral proteins (but not genetic material) to provoke an immune response; (4) inactivated or attenuated coronavirus; (5) repurposing existing vaccines, eg, BCG (bacillus Calmette–Guérin). 1

Given the mounting number of deaths globally, and the apparent failure of many countries to contain the pandemic without severely damaging or problematic lockdowns and other measures, there have been calls to make a vaccine, if it were approved, mandatory. 2 Mandatory vaccination has not been ruled out within the UK. 3

The first part of this article asks when, if ever, a vaccine should be mandatory. I will create a set of criteria and a decision algorithm for mandatory vaccination. I will argue that in the case of COVID-19, some of these criteria may not be satisfied. The second part of the article argues that in the case of COVID-19, it may be ethically preferable to incentivise vaccine uptake. I will justify incentivisation and discuss different kinds of incentives.

Ethics of mandatory COVID-19 vaccination

There is a large body of literature on the justification for the use of coercion in public health and infectious disease in particular. Mandatory vaccination is typically justified on Millian grounds: harm to others. According to John Stuart Mill, the sole ground for the use of state coercion (and restriction of liberty) is when one individual risks harming others. 4 The most prominent arguments from bioethicists appeal to preventing harm to others. 5–7 In the case of children, significant risk of harm to the child is also a ground for state protection. Bambery et al 8 give the example of a child taking a box of toxic bleach to school, potentially harming himself and other children. Teachers are entitled to restrain the child and remove the poison both because of risk to the child and to other children. 8 Flanigan uses a similar example of a person shooting a gun into a crowd. 5

The Nuffield Council of Bioethics produced an influential report on public health which considers when coercion and mandatory vaccination might be justified:

When assessing whether more directive policies are acceptable, the following factors should be taken into account: the risks associated with the vaccination and with the disease itself, and the seriousness of the threat of the disease to the population. In the case of incentivised policies, the size of the incentive involved should be appropriate so that it would not unduly compromise the voluntariness of consent. We identified two circumstances in which quasi-mandatory vaccination measures are more likely to be justified. First, for highly contagious and serious diseases, for example with characteristics similar to smallpox. Second, for disease eradication if the disease is serious and if eradication is within reach. 9

I will elaborate on these brief suggestions and provide a novel structured algorithm for when vaccination should be mandatory.

COVID-19 is almost unique because of the gravity of the problem at the global level: not only is there cost in terms of lives from COVID-19, there is also the extraordinary economic, health and well-being consequences of various virus-control measures, including lockdown, which will extend into the future. Probably never before has a vaccine been developed so rapidly and the pressure to use it so great, at least at the global level.

There is a strong case for making any vaccination mandatory (or compulsory) if four conditions are met:

There is a grave threat to public health

The vaccine is safe and effective

Mandatory vaccination has a superior cost/benefit profile compared with other alternatives

The level of coercion is proportionate.

Each of these conditions involves value judgements.

Grave threat to public health

So far, there have been over 1 million deaths attributed to COVID-19 globally (as of 30 September 2020). 10 In the UK alone, it was predicted in influential early modelling that 500 000 would have died if nothing was done to prevent its spread. Even with the subsequent introduction of a range of highly restrictive lockdown measures (measures which could themselves come at a cost of 200 000 non-COVID-19 lives according to a recent UK government report), 11 more than 42 000 (as of 30 September 2020) 12 have died in the UK within 28 days of a positive test.

The case fatality rate was originally estimated to be as high as 11%, but (as is typical with new diseases) this was quickly scaled down to 1.5% or even lower. 13 The infection fatality rate (IFR, which accounts for asymptomatic and undiagnosed cases) is lower still as it has become clear that there are a large number of asymptomatic and mild cases. For example, the Centre for Evidence Based Medicine reports that “In Iceland, where the most testing per capita has occurred, the IFR lies somewhere between 0.03% and 0.28%”. 14

Of course, how you define “grave” is a value judgement. One of the worst-affected countries in the world in terms of COVID-19-attributed deaths per million is Belgium. The mortality is (at the time of writing) around 877 per million population, which is still under 0.1%, and the average age of death is 80. Of course, Belgium and most other countries have taken strict measures to control the virus and so we are not seeing the greatest possible impact the virus could have. Yet others such as Brazil and Sweden have intervened to a much lesser degree, yet (currently) have rates of 687 and 578 deaths per million respectively. Sweden’s April all-cause deaths and death rate at the peak of its pandemic so far, while extremely high, were surpassed by months in 1993 and 2000. 15

The data are complex and difficult to compare with different testing rates, and ways of assigning deaths and collecting data differing from country to country. For example, Belgium counts deaths in care homes where there is a suspicion that COVID-19 was the cause (without the need for a positive test) and, until recently, the UK counted a death which followed any time from a COVID-19 positive test as a COVID-19 death. Moreover, there have been huge behavioural changes even in countries without legally enforced lockdowns. Furthermore, the IFR varies wildly by age-group and other factors. Even among survivors, there is emerging evidence that there may be long-term consequences for those who have been infected but survived. Long COVID-19 health implications may present a grave future public health problem. Nevertheless, some might still argue that this disease has not entered the “grave” range that would warrant mandatory vaccination. The Spanish influenza killed many more (50–100 million), 16 and it afflicted younger rather than older people, meaning even more “life years” were lost. It is not difficult to imagine a Superflu, or bioengineered bug, which killed 10% across all ages. This would certainly be a grave public health emergency where it is likely mandatory vaccination would be employed.

Deciding whether COVID-19 is sufficiently grave requires both more data than we have and also a value judgement over the gravity that would warrant this kind of intervention. But let us grant for the sake of argument that COVID-19 is a grave public health emergency.

Vaccine is safe and effective

There are concerns that testing has been rushed and the vaccine may not be safe or effective. 17

First, although the technology being used in many of these vaccine candidates has been successfully used in other vaccines, no country has ever produced a safe and effective vaccine against a coronavirus. So in one way, we are all in uncharted waters.

Second, any vaccine development will be accelerated in the context of a grave public health emergency.The inherent probabilistic nature of the development of any biologic means that no vaccine could be said to be 100% safe. There will be risks and those risks are likely to be greater than with well-established vaccines.

Thirdly, some side effects may take time to manifest.

This is not to support the anti-vaccination movement. Vaccines are one of the greatest medical accomplishments and a cornerstone of public health. There are robust testing procedures in place in most jurisdictions to ensure that licensed COVID-19 vaccines are both effective and safe. It is only to acknowledge that everything, including vaccination, has risks. Perhaps the biggest challenge in the development of a vaccine for COVID-19 will be to be honest about the extent of those risks and convey the limitations of confidence in safety and efficacy relative to the evidence accrued.

There is an ethical balance to be struck: introducing a vaccine early and saving more lives from COVID-19, but risking side effects or ineffectiveness versus engaging in longer and more rigorous testing, and having more confidence in safety and efficacy, but more people dying of COVID-19 while such testing occurs. There is no magic answer and, given the economic, social and health catastrophe of various anti-COVID-19 measures such as lockdown, there will be considerable pressure to introduce a vaccine earlier.

To be maximally effective, particularly in protecting the most vulnerable in the population, vaccination would need to achieve herd immunity (the exact percentage of the population that would need to be immune for herd immunity to be reached depends on various factors, but current estimates range up to 82% of the population). 18

There are huge logistical issues around finding a vaccine, proving it to be safe, and then producing and administering it to the world’s population. Even if those issues are resolved, the pandemic has come at a time where there is another growing problem in public health: vaccine hesitancy.

US polls “suggest only 3 in 4 people would get vaccinated if a COVID-19 vaccine were available, and only 30% would want to receive the vaccine soon after it becomes available.” 18

Indeed, vaccine refusal appears to be going up. A recent Pew survey suggested 49% of adults in the USA would refuse a COVID-19 vaccine in September 2020. 19

If these results prove accurate then even if a safe and effective vaccine is produced, at best, herd immunity will be significantly delayed by vaccine hesitancy at a cost both to lives and to the resumption of normal life, and at worst, it may never be achieved.

There remain some community concerns about the safety of all pre-existing vaccines, including many that have been rigorously tested and employed for years.

In the case of COVID-19, the hesitancy may be exacerbated by the accelerated testing and approval process which applies not only to Sputnik V (the controversial “Russian vaccine”). Speaking about America’s vaccine programme, Warp Speed, Donald Trump applauded its unprecedented pace:

…my administration cut through every piece of red tape to achieve the fastest-ever, by far, launch of a vaccine trial for this new virus, this very vicious virus. And I want to thank all of the doctors and scientists and researchers involved because they’ve never moved like this, or never even close. 20

The large impact on society means the vaccine will be put to market much more quickly than usual, perhaps employing challenge studies or other innovative designs, or by condensing or running certain non-safety critical parts of the process in parallel (for example, creating candidate vaccines before its approval).

While the speed is welcomed by politicians and some members of the public, the pressure to produce a candidate vaccine, and the speed at which it has been done, may be also perceived (perhaps unfairly) to increase the likelihood of the kind of concerns that lead to vaccine hesitancy: concerns over side-effects that are unexpected or rare, or that take longer to appear than the testing process allows for, or that for another reason may be missed in the testing process.

The job to be done will not only be to prove scientifically that the vaccine is safe and effective, but also to inform and reassure the public, especially the group who are willing to take the vaccine in theory—but only after others have tried it out first.

The question remains of how safe is safe enough to warrant mandatory vaccination. It is vanishingly unlikely that there will be absolutely no risk of harm from any biomedical intervention, and the disease itself has dramatically different risk profiles in different groups of the population. In an ideal world, the vaccine would be proven to be 100% safe. But there will likely be some risk remaining. Any mandatory vaccination programme would therefore need to make a value judgement about what level of safety and what level of certainty are safe and certain enough. Of course, it would need to be very high, but a 0% risk option is very unlikely.

A COVID-19 vaccine may be effective in reducing community spread and/or preventing disease in individuals. Mandatory vaccination is most justifiable when there are benefits to both the individual and in terms of preventing transmission. If the benefits are only to individual adults, it is more difficult to support mandatory vaccination. One justification would be to prevent exhaustion of healthcare services in an emergency (eg, running out of ventilators), which has been used a basis of restriction of liberty (it was the main justification for lockdown). It could also be justified in the case of protection of children and others who cannot decide for themselves, and of other adults who either cannot be vaccinated for medical reasons.

Better than the alternatives

It is a standard principle of decision theory that the expected utility of a proposed option must be compared with the expected utility of relevant alternatives. There are many alternatives to mandatory vaccination. See figure 1 for a summary of the range of strategies for preventing infectious disease.

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Strategies for prevention of infectious disease.

A popular position, especially among medical professionals, 7 is that we don’t need mandatory vaccination because people are self-interested or altruistic enough to come forward for vaccination. We can reach herd immunity without mandatory vaccination.

If this were true, all well and good, but the surveys mentioned above cast doubt on this claim with regard to the future COVID-19 vaccine. Moreover, reaching herd immunity is not good enough.

First, how fast we reach herd immunity is also important. In a pandemic, time is lives. If it takes a year to reach herd immunity, that could be thousands or tens of thousands of lives in one country.

Second, herd immunity is necessary because some people cannot be vaccinated for medical reasons: they have allergies, immune problems, or other illnesses. The elderly often don’t mount a strong immune response (that is why it is better to vaccinate children for influenza because they are the biggest spreaders of that disease 7 —although COVID-19 appears to be different on the current evidence). And immunity wanes over time—so even people previously vaccinated may become vulnerable.

Even when national herd immunity is achieved, local areas can fall below that level over time, causing outbreaks, as happened with measles recently. This is especially likely to happen where people opposed to vaccines tend to cluster toghether—for example, in the case of certain religious communities. So ideally we need better than herd immunity to ensure that people are protected both over time and in every place.

These are thus reasons to doubt whether a policy of voluntary vaccination will be good enough, though it remains to be seen.

There are other policies that might obviate the need for mandatory vaccination. South Korea has kept deaths down to about 300 (at the time of writing) with a population of 60 000 000 with a vigorous track and trace programme (although it was criticised for exposing extra-marital affairs and other stigmatised behaviours). 21 Other countries have enforced quarantine with tracking devices. There could be selective lockdown of certain groups, 22 or for intermittent periods of time.

The long-term costs and benefits of such policies would have to be evaluated. That is, we should calculate the expected utility of mandatory vaccination (in combination with other policies) and compare it to alternative strategies (or some other combination of these). How utility should be evaluated is an ethical question. Should we count deaths averted (no matter how old), life years lost or lost well-being (perhaps measured by quality adjusted life years)? 23 Should we count loss of liberty or privacy into the other side the equation?

It may be that a one-off mandatory vaccination is a significantly smaller loss of well-being or liberty than these other complex resource intensive strategies.

So we cannot say whether a mandatory policy of COVID-19 vaccination is ethically justified until we can assess the nature of the vaccine, the gravity of the problem and the likely costs/benefit of alternatives. But it is certainly feasible that it could be justified.

It is important to recognise that coercive vaccination can be justified. This is easy to see by comparing it to other coercive interventions in the public interest.

Conscription in war

In the gravest emergencies, where the existence and freedom of the whole population is at stake, people are conscripted to serve their country, often with high risk of death or permanent injury. We often analogise the pandemic to a war: we are fighting the virus. If people can be sent to war against their will, in certain circumstances some levels of coercion are justified in the war on the virus. Notably, in conditions of extreme emergency in past wars (graver than currently exist for COVID-19), imprisonment or compulsion have even been employed. 24

A more mundane example is the payment of taxes. Taxes benefit individuals because tax revenue allows the preservation of public goods. But if sufficient numbers of others are paying their taxes, it is in a person’s self-interest to free ride and avoid taxes. Indeed, paying taxes may result in harm in some circumstances. 24 In the USA, where there is a large private healthcare sector, paying your taxes may mean you cannot pay for lifesaving medical care that you would otherwise have been able to afford. Still, taxes are mandatory based on considerations of fairness and utility.

Seat belts are mandatory in the UK and many other countries, whereas they were previously voluntary. Interestingly, 50% or so of Americans initially opposed making seat belts mandatory, but now 70% believe mandatory laws are justified. 25

Seat belts reduce the chance of death if you are involved in a car accident by 50%. They are very safe and effective. Notably, they do cause injuries (seat belt syndrome) and even, very occasionally, death. But the chances of being benefitted by wearing them vastly outweigh these risks, so they are mandatory, with enforcement through fines . I have previously likened vaccination to wearing a seat belt. 25

Pre-existing mandatory vaccination

Mandatory vaccination policies are already in place in different parts of the world. Mandatory vaccination policies are those that include a non-voluntary element to vaccine consent and impose a penalty or cost for unjustified refusal (justified refusal includes those who have a contraindicating medical condition, or those who already have natural immunity). There are a range of possible penalties or costs which can coerce people. Australia has the “No Jab, No Pay” scheme which withholds child benefits if the child is not vaccinated, and a “No Jab, No Play” scheme which withholds kindergarten childcare benefits. Italy introduced fines for unvaccinated children who attend school. In the USA, state regulations mandate that children cannot attend school if they are not vaccinated, and healthcare workers are required to vaccinate. Some US states (eg, Michigan) make exemptions difficult to obtain by requiring parents to attend immunisation education courses 26 (see also 27 28 ).

Figure 2 summarises the range of coercive policies that can constitute mandatory vaccination.

Cost of mandatory/coercive vaccination.

Coercion is proportionate

In public health ethics, there is a familiar concept of the “least restrictive alternative”. 28 The least restrictive alternative is the option which achieves a given outcome with the least coercion (and least restriction of liberty).

This is a very weak principle: it uses liberty as tie breaker between options with the same expected utility. More commonly, however, we need to weigh utility against liberty. That is, a more restrictive policy will achieve more expected utility—but is it justified?

According to a principle of proportionality, the additional coercion or infringement in liberty is justified if it is proportionate to the gain in expected utility of the more coercive intervention compared with next best option. That is, additional coercion is justified when the restriction of liberty is both minimised and proportionate to the expected advantages offered by the more coercive policy.

As we can see from the previous section and figure 2, there are a variety of coercive measures. (The Nuffield Council has created a related “Intervention Ladder”, 29 though this includes education and incentives, as well as coercive measures.) Penalties can be high. In war, those who conscientiously objected to fighting went to jail or were forced to perform community service (or participate in medical research). In France, parents were given a suspended prison sentence for refusing to vaccinate their child. 30

While there are legitimate concerns that the effectiveness of these policies in different contexts has been inadequately investigated, a number of these policies have been shown to increase vaccination rates. 31

Notably, the fine or punishment for avoiding taxes varies according to the gravity of the offence. The fine for not wearing a seat belt is typically small. A modest penalty for not being vaccinated in a grave public health emergency could be justifiable. For example, a fine or restriction of movement might be justified.

Figure 3 combines these four factors into an algorithm for justified mandatory vaccination.

Algorithm for mandatory vaccination.

These four factors can be justified in several ways. They represent a distillation and development of existing principles in public health ethics, for example, the least restrictive alternative. They can also be justified by the four principles of biomedical ethics.

For example, justice is about the distribution of benefits and burdens across a population in a fair manner. Justice and beneficence, in the context of vaccination policies, both require that the problem addressed is significant and vaccination is an effective means of addressing it. Non-maleficence requires that the risk imposed on individuals be small. Respect for autonomy and justice both require that coercion be applied only if necessary and that it be proportionate to additional utility of mandatory vaccination (and that such coercion be minimised, which is a feature of proportionality).

It is important to recognise that vaccines may have benefits both to the individual and to others (the community). If the vaccine has an overall net expected utility for the individual, beneficence supports its administration.

How great a sacrifice (loss of liberty or risk) can be justified? The most plausible account is provided by a duty of easy rescue: when the cost to an individual is small of some act, but the benefit or harm to another is large, then there is a moral obligation to perform that act. I have elsewhere argued for a collective duty of easy rescue: where the cost of some act to an individual is small, and the benefit of everyone doing that act to the collective is large, there is a collective duty of easy rescue. 32 Such a principle appropriately balances respect for autonomy with justice.

Whether mandatory vaccination for any disease can be justified will depend on precise facts around the magnitude of the problem, the nature of the disease and vaccination, the availability and effectiveness of alternative strategies and the level of coercion. Elsewhere I compare mandatory vaccination for influenza and COVID-19 in more detail. 27

Better than coercion? Payment for risk

Given the risks, or perceived risks, of a novel COVID-19 vaccine, it would be practically and perhaps ethically problematic to introduce a mandatory policy, at least initially (when uncertainty around safety will be greater). Is there a more attractive alternative?

The arguments in favour of vaccination, particularly for those at lower risk (children, young people and those previously infected) can be based on a principle of solidarity. After all, “We are in this together” has been a recurrent slogan supporting pandemic measures in different countries. Those at low risk are asked to do their duty to their fellow citizens, which is a kind of community service. Yet they have little to personally gain from vaccination. The risk/benefit profile looms large for those at lowest risk.

However, another way of looking at this is that those at low risk are being asked to do a job which entails some risk., so they should be paid for the risk they are taking for the sake of providing a public good. And although it may be unlikely to influence so-called 'anti-vaxxers', it may influence a good portion of the 60% of American adults who responded in a March 2020 poll that they would either delay vaccination or didn’t know about vaccination. 33

I have previously argued that we should reconceive live organ donation and participation in risky research, including challenge studies, 34 as jobs where risk should be remunerated, much like we pay construction workers and other dangerous professions both for the job and for the risk involved. 35 36 While the risk profile for approved vaccinations means that it differs from these examples, it could be compared to a job such as social work as a further argument in favour of payment. People may legitimately be incentivised to take on risks, as the Nuffield Council recognises in its Intervention Ladder. 29

The advantage of payment for risk is that people are choosing voluntarily to take it on. As long as we are accurate in conveying the limitations in our confidence about the risks and benefits of a vaccine, then it is up to individuals to judge whether they are worth payment.

Of course, that is a big ask. It would require government to be transparent, explicit and comprehensive in disclosure of data, what should be inferred and the limitations on the data and confidence. This has often not been the case—one only has to remember the denial of the risks of bovine spongiform encephalopathy (BSE) at the height of the crisis by the British government, when in 1990 the Minister for Agriculture, Fisheries and Food, John Gummer proudly fed his 4-year-old daughter, Cordelia, a hamburger in front of the world’s media, declaring British beef safe. (Gummer was awarded a peerage in 2010 and is now Lord Deben.) 37

There is also a danger that payment might signal lack of confidence in safety. That is a real risk and one that I will address in the “payment in kind” section below.

But the basic ethical point (public acceptability aside) is that, if a vaccine is judged to be safe enough to be used without payment, then it is safe enough to be used with payment. 36 Payment itself does not make a vaccine riskier. If a vaccine is considered too risky to be administered to the population, then it should not be administered, no matter whether coercively, through incentives, or through some other policy.

A standard objection to payment for risk (whether it is risky research or live organ donation) is that it is coercive: it forces people to take risks against their better judgement. In Macklin’s words:

The reason for holding that it is ethically inappropriate to pay patients to be research subjects is that it is likely to be coercive, violating the ethical requirement that participation in research should be fully voluntary. 38

As I have previously argued, 39 this demonstrates deep conceptual confusion. Coercion exists when an option which is either desired or good is removed or made very unappealing. The standard example is a robber who demands “Your money or your life”. This removes the most desired and best option: your money and your life. The Australian “No Jab, No Pay”scheme arguably does constitute coercion as it removes an option that one is entitled to, that is, non-vaccination with the “Pay”. So too is the Italian scheme of fines coercive.

However, paying people is not coercive. Adding an option, like payment, without affecting the status quo is not coercive. If a person chooses that option, it is because they believe that overall their life will go better with it, in this case, with the vaccination and the payment. The gamble may not pay off: some risk might eventuate and then it wasn’t worth it. But that is life—and probability.

It is true that the value of the option might exercise force over our rational capacities, but that is no different from offering a lot of money to attract a favoured job applicant.

What can be problematic about offers is exploitation. Exploitation exists where one offers less than a fair deal and a person only accepts it because of vulnerability from background injustice.

There are two ways to prevent exploitation. First, we can correct any background injustice that might cause it. In this case, the person would have little reason to accept the offer. Second, we can pay a fair minimum price for risk, as when we pay construction workers danger money. Paradoxically, this requires paying more, rather than less. 40

But there is an important additional feature of vaccination. If a vaccine were deemed to be safe enough to offer on a voluntary basis without payment, it must be safe enough to incentivise with payment because the risks are reasonable. It may be that those who are poorer may be more inclined to take the money and the risk, but this applies to all risky or unpleasant jobs in a market economy. It is not necessarily exploitation if there are protections in place such as a minimum wage or a fair price is paid to take on risk.

So payment for vaccination which passes independent safety standards (and could reasonably be offered without payment) is not exploitation, if the payment is adequate.

Undue influence?

A related concern is undue influence. Undue influence means that because of the attractiveness of the offer, I can’t autonomously and rationally weigh up the risks and benefits. It is sometimes understood as “were it not for the money, he would not do it”.

But that formulation is too broad—were it not for the money, many people would not go to work. Rather what the concept of ‘undue influence’ intends to capture is that the offer, usually money, bedazzles a person so that he or she makes a mistake in weighing up the risks and benefits. Someone offers Jones a million dollars to take on a risk of 99.99% of dying in a dangerous experiment. He just focuses on the money and takes a deal which is unfair and unreasonable. However, taking such an offer might be rational. If Jones’ daughter is about to die without a million dollars and he values her life more than his own, it might be both autonomous and rational to take the deal.

Because we cannot get into people’s minds, it is difficult in practice to unravel whether undue influence is occurring—how can you differentiate it from a rational decision? In practice, if it would be acceptable to be vaccinated for nothing, it is acceptable to do it for money. Concerns about undue influence are best met by implementing procedures to minimise bias and irrational decision making, such as cooling off periods, information reframing, and so on.

There remains a lurking concern that a decision where payment is involved may not be fully autonomous or authentic. For example, racial and ethnic minorities are among the groups most gravely affected by COVID-19, but given concerns about systemic racism in research and medicine, these communities may have good reason to distrust the medical machine. Is it acceptable to use payment to get over those concerns?

All we can do practically to address concerns about autonomy and authenticity is to redouble efforts: to ensure we do know the risks and they are reasonable (and that the underpinning research is not itself subject to concerns about systemic racism), and try to foster trust with such public education campaigns. This can work alongside a payment scheme. People still need to understand what the facts are. They still need to make as autonomous and authentic a decision as possible.

Practical advantages

A payment model could also be superior to a mandatory model from a practical point of view. There may be considerable resistance to a mandatory model which may make it difficult, expensive and time-consuming to implement, with considerable invasion of liberty. In a payment model, people are doing what they want to do.

A payment model could also be very cheap, compared with the alternatives. The cost of the UK’s furlough scheme is estimated to reach £60 billion by its planned end in October, 41 and the economic shut down is likely to cost many billions more, as well as the estimated 200 000 lives expected to be lost as a result. 11 It would make economic sense to pay people quite a lot to incentivise them to vaccinate sooner rather than later—which, for example, would speed up their full return to work.

It may be that payment is only required to incentivise certain groups. For example, it may be that young people require incentivising because they are at lower risk from the disease itself. On the other hand, justice might require payment for all taking the risk. Although the elderly and those at higher risk have more to gain personally, they are also providing a service by being vaccinated and not using limited health resources. (There is an enormous backlog of patients in the NHS—another grave threat to public health.)

One particularly difficult case is paying parents to vaccinate their children. It is one thing to pay people to take on risk for themselves; it is quite another to pay them to enable their children to take on risks, particularly when the children have little to gain as they are at lowest risk. In part, the answer to this issue is determined by how safe the vaccine is and how confident we can be in that assessment. If it were safe, to a level that even a mandatory programme would be justified, it may be appropriate to instead incentivise parents to volunteer their children for vaccination. If safety is less certain, payment for risk in this group is the most problematic.

It is true that some mandatory vaccination programmes already fine parents for failure to vaccinate their children. However, in those cases vaccination is clearly in the child’s best interest, as the child receives the benefit of immunity to diseases such as measles, that pose a greater risk to that child than we currently believe COVID-19 does. Moreover, they are for vaccines that have been in place for many years and have a well-established safety profile.

A standard objection to paying people to do their duty, particularly civic duty, is that it undermines solidarity, trust, reciprocity and other community values. This is the argument given by Richard Titmuss for a voluntary blood donation scheme. 42

The UK does not pay donors for blood or blood products, but does purchase blood products from other countries, including Austria where donors are paid a “travel allowance” for plasma donation. In Australia, which runs a donor system, more than 50% of the plasma comes from paid donors in the USA. 43 Altruism is insufficient. Germany recently moved to paying for plasma donors. It does not appear to have undermined German society.

In the end, the policy we should adopt towards COVID-19 vaccination will depend on the precise risks and benefits of the vaccine (and our confidence in them), the state of the pandemic, the nature of the alternatives, and particularly the public appetite for a vaccine.

In the right circumstances, mandatory vaccination could be ethically justified, if the penalty is suitably proportionate.

Payment for vaccination, perhaps, has even more to be said for it.

For those attached to the gift of altruism, the vaccinated could be offered the opportunity to donate their fee back to the NHS (or similar health service provider). This combined “payment-donation” model would be a happy marriage of ethics and economics. It would give altruists a double chance to be altruistic: first by vaccinating and second by donating the fee. It would also couple self-interest with morality for free-riders (as they would have greater self-interest to do what is moral), and it would give those who face obstacles to vaccination an additional reason to overcome these.

Payment in kind

Of course, benefits can come in cash or kind. An alternative “payment” model is to pay those who vaccinate in kind. This could take the form of greater freedom to travel, opportunity to work or socialise. With some colleagues, I have given similar arguments in favour of immunity passports. 44

One attractive benefit would be the freedom to not wear a mask in public places if you carried a vaccination certificate, and not to socially distance. Currently, everyone has to wear a mask and practise social distancing. Relaxing this requirement for those who have been vaccinated (or otherwise have immunity) would be an attractive benefit. Moreover, it would help ameliorate the risks the unvaccinated would pose to others.

Payment in kind has one advantage over cash in that it might not send the signal that vaccination is perceived to be unsafe. A cash payment may paradoxically undermine vaccination uptake by introducing unwarranted suspicion (though this is an intuition that may need to be tested). Benefits in kind are less susceptible to this concern because they are directly linked to the benefit provided by the vaccine itself: the vaccinated person is no longer a threat to others.

Some might object that this represents a form of shaming the non-vaccinators (some of whom might be excluded from vaccination for health reasons), just as presenting those who evaded conscription with a white feather was a method of shaming perceived free-riders. But this could be managed through an education campaign about the justification for face covering requirements. There is a good reason to require the non-vaccinated to continue to wear masks and practice social distancing, regardless of whether their refusal is justified—they do represent a greater direct threat to others.

It is quite possible that some mixture of altruism, financial and non-financial benefits will obviate the need to introduce mandatory vaccination. It is better that people voluntarily choose on the basis of reasons to act well, rather than being forced to do so. Structuring the rewards and punishments in a just and fair way is one way of giving people reasons for action.

Mandatory vaccination can be ethically justified (see figure 3), but when risks are more uncertain, payment for vaccination (whether in cash or kind) may be an ethically superior option.

Acknowledgments

This piece builds on a previous piece I published on the JME blog, Good Reasons to Vaccinate: COVID19 Vaccine, Mandatory or Payment Model? [ https://blogs.bmj.com/medical-ethics/2020/07/29/good-reasons-to-vaccinate-covid19-vaccine-mandatory-or-payment-model/ ]. I would like to thank an anonymous reviewer for very many helpful and constructive comments. I would also like to thank Alberto Giubilini for his help.

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Supplementary materials

Press release

Contributors Sole authorship.

Funding JS is supported by the Uehiro Foundation on Ethics and Education. He received funding from the Wellcome Trust WT104848 and WT203132. Through his involvement with the Murdoch Children’s Research Institute, he has received funding through from the Victorian State Government through the Operational Infrastructure Support (OIS) Program.

Competing interests None declared.

Patient consent for publication Not required.

Provenance and peer review Not commissioned; externally peer reviewed.

Data availability statement No data are available.

Linked Articles

Response Persuasion, not coercion or incentivisation, is the best means of promoting COVID-19 vaccination Susan Pennings Xavier Symons Journal of Medical Ethics 2021; 47 709-711 Published Online First: 27 Jan 2021. doi: 10.1136/medethics-2020-107076

Read the full text or download the PDF:

Honor Scholar Theses

Attitudes towards covid-19 vaccination: literature review and attitudes of individuals who delayed vaccination.

Sydney Hornberger '22 , DePauw University

Date of Award

Document type, first advisor.

Dr. Ted Bitner

Second Advisor

Dr. Alicia Suarez

Third Advisor

Dr. Jeffrey Jones

This thesis examines attitudes towards and ethics of receiving one of the fastest vaccines ever developed— the COVID-19 vaccine. The Food and Drug Administrations (FDA) in the U.S. has granted either Emergency Use Authorization or full approval to three vaccines: the Pfizer-BioNTech, Johnson & Johnson, and Moderna-NIAID vaccines. However, although the FDA approved and the Center for Disease Control and Prevention (CDC) recommends getting the vaccines, that does not necessarily mean people have an ethical responsibility or a positive attitude towards getting vaccinated against COVID-19; this current paper explores both of these ideas as related to COVID-19 vaccination. First, it surveys sources highlighting the utility of vaccines to control infectious diseases and pandemics. Next, it questions whether getting vaccinated against any disease, and specifically COVID-19, is the ethical action to take. Then, there is a literature review of research into attitudes towards the COVID-19 vaccine, determining the most prevalent attitudes across all people and within specific demographics such as women, people belonging to certain political and religious groups, racial and ethnic minorities, and children. Finally, the results of a study conducted at DePauw University to investigate attitudes, attitude changes, and motivations of recently vaccinated individuals are reported in order to elucidate certain factors that may be useful to understand vaccine decision making.

Recommended Citation

Hornberger, Sydney '22, "Attitudes Towards COVID-19 Vaccination: Literature Review and Attitudes of Individuals Who Delayed Vaccination" (2022). Honor Scholar Theses . 201, Scholarly and Creative Work from DePauw University. https://scholarship.depauw.edu/studentresearch/201

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Five people lined up wearing facemasks and flexing their arm with a bandaid on the bicep

The first line of vaccines was highly effective at restricting COVID-19 ’s damage

Postdoctoral Research Fellow, Department of Health, Kinesiology, and Applied Physiology, Concordia University

Postdoctoral Fellow, Department of Health, Kinesiology, and Applied Physiology, Concordia University

Professor of Behavioural Medicine, Concordia University

Disclosure statement

Nana Wu receives funding from the Canadian Institutes of Health Research (CIHR).

Keven Joyal-Desmarais receives funding from the Fonds de recherche du Québec (FRQ) and the Canadian Institutes of Health Research (CIHR).

Simon Bacon receives funding from Fonds de recherche du Québec (FRQ), Canadian Institutes of Health Research (CIHR), Canadian Foundation for Innovation (CFI), Public Health Agency of Canada (PHAC), Weston Family Foundation, Canadian Cancer Society (CCS), Heart and Stroke Foundation of Canada (HSFC), Quebec Ministère de l’économie et de l’innovation (MEI), Canadian Partnership Against Cancer (CPAC), Canadian Statistical Sciences Institute (CANSSI), The Auger Foundation, Concordia University, CIUSSS-NIM.

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Universitié Concordia provides funding as a founding partner of The Conversation CA-FR.

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After more than three years of COVID-19, the World Health Organization (WHO) reports that over 763 million infections, and nearly seven million deaths, have been attributed to SARS-CoV-2.

COVID-19 vaccination was deemed crucial to prevent the continued spread of the disease, protect those infected from experiencing severe effects, counter the rise of new variants, and ultimately end the pandemic.

The WHO has lifted the Public Health Emergency of International Concern , but ending the ongoing threat of COVID-19 still depends on vaccination and other protective behaviours. Understanding the effectiveness of vaccines remains crucial.

Primary doses and boosters

Today, more than 5.5 billion people (72.3 per cent of the world’s population) have received at least one dose of a COVID-19 vaccine. A total of 5.09 billion people have completed a primary COVID-19 vaccination series (i.e., two doses of a two-dose vaccine or one dose of a one-dose vaccine).

At the end of 2021, several countries began offering booster doses in response to research indicating that the effectiveness of the vaccines may diminish over time, especially against the Omicron variant, which emerged in late 2021, and has become the dominant circulating variant .

A lineup of people in face masks behind a sign for a COVID-19 vaccination clinic.

With this in mind, we sought to answer two questions. First, how well does the primary series of COVID-19 vaccines protect people (against infections, hospitalizations and deaths) four months or more after completing vaccination? Second, how well does the first booster dose protect people three months or more after receiving it?

Answering these questions will provide invaluable information for policymakers to make evidence-based decisions, such as the timing of administering COVID-19 vaccine booster doses.

To answer these questions we sought to identify all studies that:

Compared people who were vaccinated (either with the primary series or a booster) to people who were unvaccinated;

Followed people for at least 112 days after a primary series, or 84 days after a booster dose, and;

Looked at who got infected, was hospitalized or died due to COVID-19.

In total, we identified 68 studies that met these criteria, representing 23 countries. We then combined all the data to better understand how the vaccines’ protection changes over time. The results were published in Lancet Respiratory Medicine .

Protection against COVID-19, in general

The WHO has set standards to define whether a vaccine offers adequate protection. Specifically, vaccines should show at least 70 per cent protection against infections and 90 per cent protection against hospitalizations and deaths.

We found that the primary series offered excellent protection against hospitalizations and deaths in the short term, showing over 90 per cent protection against both outcomes within 42 days after vaccination. This protection waned over time, going below the WHO recommendation, but stayed relatively high, at around 80 per cent against hospitalizations at eight months post-vaccination, and around 85 per cent against deaths at six months post-vaccination.

Close-up of a person's shoulder in yellow T-shirt getting an injection in the upper arm.

The primary series also offered good protection against infections in the short term (over 80 per cent within the first 42 days), but that protection fell to around 60 per cent after four months, and 50 per cent after nine months.

The initial protection of a booster dose was around 70 per cent against infections and 90 per cent against hospitalizations within the first month after vaccinations. Protection then fell to around 45 per cent against infections and to around 70 per cent against hospitalizations after four months had passed. Too little data was available to track the long-term effects against deaths.

Overall, the vaccines work at preventing infections, hospitalizations and deaths related to COVID-19, but their effectiveness does decline over time, particularly against infections. Boosters restore protection lost, but may need additional boosting over time.

Protection against the Omicron variant

Vaccines were generally less effective against the Omicron variant, which emerged in fall 2021 , about a year after COVID-19 vaccines were introduced .

Within 42 days after vaccination with the original COVID-19 vaccine formulations, the primary series only reached around 60 per cent protection against Omicron-based infections, and this dropped to around 30 per cent after five months.

The primary series’ protection against hospitalization for Omicron infections reached around 70 per cent within the first 42 days, but also dropped over time, reaching closer to 50 per cent after six months. None of these reached the levels recommended by the WHO.

The boosters did fare better in protecting against Omicron. Within the first 28 days after the booster, protection hovered close to the 70 per cent threshold against infections and 90 per cent threshold against hospitalizations recommended by the WHO.

For context, if individuals delayed the administration of the booster by six months after completing the primary series, their protection levels would be around 20 per cent against Omicron infections and around 50 per cent against hospitalizations right before receiving the booster.

Yet, booster protection also waned over time, falling to about 40 per cent against Omicron infections and 70 per cent against hospitalizations after four months post-booster. Too little data was available to comment on long-term effects against deaths.

Syringes lined up in front of two vials of vaccine

With Omicron, boosters are particularly needed to maintain adequate protection, but this protection also needs additional boosting as it wanes over time.

New formulations of mRNA COVID-19 vaccines that target the Omicron variant were introduced in fall 2022, and are recommended for booster shots by Canada’s National Advisory Commission on Immunization . The Public Health Agency of Canada recommended in March 2023 that people at high risk of severe COVID-19 get an additional booster shot.

In May, the WHO recommended that new formulations of COVID-19 vaccines should target Omicron XBB variants, which are the dominant variants currently circulating.

Behaviour-based prevention measures remain necessary

While vaccines provide reasonable protection against COVID-19 infections, hospitalizations and deaths, their effectiveness is imperfect and wanes over time, particularly against the now-dominant Omicron variant for people vaccinated with the original vaccines.

Notably, waning is especially pronounced against infections. This means that although being vaccinated is likely to protect most people against becoming severely ill, vaccinated people are still at risk of catching the virus and transmitting it to others — some of whom will be at higher risk of severe complications from the disease.

That means measures like wearing a mask, washing one’s hands, and staying at home when sick remain essential complements to vaccination. Contrary to vaccines, these measures do not decline in effectiveness over time and are particularly well suited to protect people against infections.

Eliminating the threat of new COVID-19 infections will continue to rely heavily on a combination of vaccination and behaviours, whereas new vaccine doses will continue to protect those who are infected from severe complications like hospitalizations and deaths.

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COVID-19 prevention
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Research Article

Attitudes on voluntary and mandatory vaccination against COVID-19: Evidence from Germany

Roles Conceptualization, Formal analysis, Writing – original draft, Writing – review & editing

Affiliation DIW Berlin / SOEP, Berlin, Germany

* E-mail: [email protected] (CSP); [email protected] (CS)

Affiliation Karlsruhe Institute of Technology, Karlsruhe, Germany

Affiliations DIW Berlin / SOEP, Berlin, Germany, Freie Universität Berlin, Berlin, Germany

Daniel Graeber,
Christoph Schmidt-Petri,
Carsten Schröder

Published: May 10, 2021
https://doi.org/10.1371/journal.pone.0248372
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Several vaccines against COVID-19 have now been developed and are already being rolled out around the world. The decision whether or not to get vaccinated has so far been left to the individual citizens. However, there are good reasons, both in theory as well as in practice, to believe that the willingness to get vaccinated might not be sufficiently high to achieve herd immunity. A policy of mandatory vaccination could ensure high levels of vaccination coverage, but its legitimacy is doubtful. We investigate the willingness to get vaccinated and the reasons for an acceptance (or rejection) of a policy of mandatory vaccination against COVID-19 in June and July 2020 in Germany based on a representative real time survey, a random sub-sample (SOEP-CoV) of the German Socio-Economic Panel (SOEP). Our results show that about 70 percent of adults in Germany would voluntarily get vaccinated against the coronavirus if a vaccine without side effects was available. About half of residents of Germany are in favor, and half against, a policy of mandatory vaccination. The approval rate for mandatory vaccination is significantly higher among those who would get vaccinated voluntarily (around 60 percent) than among those who would not get vaccinated voluntarily (27 percent). The individual willingness to get vaccinated and acceptance of a policy of mandatory vaccination correlates systematically with socio-demographic and psychological characteristics of the respondents. We conclude that as far as people’s declared intentions are concerned, herd immunity could be reached without a policy of mandatory vaccination, but that such a policy might be found acceptable too, were it to become necessary.

Citation: Graeber D, Schmidt-Petri C, Schröder C (2021) Attitudes on voluntary and mandatory vaccination against COVID-19: Evidence from Germany. PLoS ONE 16(5): e0248372. https://doi.org/10.1371/journal.pone.0248372

Editor: Valerio Capraro, Middlesex University, UNITED KINGDOM

Received: October 19, 2020; Accepted: February 25, 2021; Published: May 10, 2021

Copyright: © 2021 Graeber et al. This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Data Availability: Our analyses rely on the German Socio-Economic Panel (SOEP), an independent scientific data infrastructure established in 1984. We, as users, cannot send the data to the journal and make them publicly available, as this is against SOEP's statutes (and most likely against the statutes of all providers of micro data). However, this should not be a hurdle, as researchers from scientific institutions around the globe can access the data (free of costs) once they have signed a user contract. The scientific use file of the SOEP with anonymous microdata is made available free of charge to universities and research institutes for research and teaching purposes. The direct use of SOEP data is subject to the provisions of German data protection law. Therefore, signing a data distribution contract is the single precondition for working with SOEP data. The data distribution contract can be requested with a form which can be downloaded from: http://www.diw.de/documents/dokumentenarchiv/17/diw_01.c.88926.de/soep_application_contract.pdf .

Funding: The data collection of the SOEP-CoV Study was financially supported by the German Federal Ministry of Education and Research. We acknowledge support by the KIT-Publication Fund of the Karlsruhe Institute of Technology. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Competing interests: The authors have declared that no competing interests exist.

Introduction

Great efforts have been made worldwide to develop a vaccine against COVID-19. When we first drafted this article, in October 2020, 35 different potential vaccines were in clinical trials and 145 were still in the pre-clinical stage. In February 2021, several vaccines have been approved in many countries and are being rolled out, 74 are in clinical trials, and 182 are in the pre-clinical stage [ 1 ].

These developments are very encouraging, as a wide availability of vaccines is seen by many as a prerequisite for a return to a “normal” pre-COVID-19 type of social and economic life. With the growing availability of vaccines comes the hope that coercive measures such as restrictions on international trade, contact restrictions, and travel bans, etc., which cause enormous economic and social costs, may soon be removed and will not need to be reimplemented.

Of course, any vaccine is only an effective contribution to a return to normal life if a sufficiently high number of people are actually vaccinated, yielding herd immunity. If so, vaccination secures a public good: protection from COVID-19 for everyone. From a microeconomic perspective, this raises a well-known problem, free-riding: If the vaccination is freely available but not obligatory, then citizens’ individual decisions determine the extent to which this public good is made available. In order to make that decision, they will weigh their own costs and benefits. These costs include the time sacrificed, physical unpleasantness, possible side effects of a vaccination, etc. The benefits to a particular individual are primarily, but not necessarily exclusively, the reduction in risk to that person’s own health or material well-being. From a welfare perspective, if individuals do not take into account the positive externalities on third parties that their own vaccination triggers, there will be an undersupply of the public good. Following [ 2 , 3 ], individuals’ utility function may also include other-regarding preferences and hence yield a direct benefit from contributions to a public good. In our context, people could therefore benefit from a ‘warm glow of vaccinating’, because by vaccinating themselves they also reduce the risks of others. But even so there is certainly no guarantee that the social optimum will be reached [ 4 ] or that a sufficiently high number of people will freely choose to get vaccinated.

It is frequently argued that vaccination should be made mandatory because of the free-rider problem [ 5 ]: While vaccinated individuals have incurred private costs in terms of discomfort or money and receive the private benefit of a reduced risk of getting the disease, the major collective benefit, the reduced incidence of disease, is public. If enough other people produce the public benefit, and the circulation of the virus decreases accordingly, an individual might rationally decide to free-ride on others’ decisions. A policy of mandatory vaccination would prevent this.

[ 6 ] argue that such a policy would not be necessary: “If vaccinations are perfect, then if one is vaccinated he or she does not care whether others are vaccinated, so there is no longer any public good problem” ([ 6 ], p. 70). Hence there would not be a case in favor of mandatory vaccination, as under such a policy, individuals who would have favored not to be vaccinated are made worse off, while those who anyway would get vaccinated are not better off.

However, by definition, ‘perfect’ vaccination means that everyone vaccinated is perfectly immune [ 6 ]. In the current situation, it can neither be taken for granted that a perfect vaccination is being or will be provided soon, nor that everyone who wants to also will have the possibility to be vaccinated (both financially and in terms of health). If perfect vaccination is not feasible, however, mandatory vaccination is not dominated by a laissez faire solution [ 6 ].

Extensions of this theoretical public good analysis emphasize the relevance of behavioral aspects not typically considered in classical models. The empirical literature also highlights a number of factors that matter for vaccine uptake. For instance [ 7 ], show that social norms matter for an individual’s willingness to get a vaccination and that such norms can suppress vaccine uptake even in the presence of frequent disease outbreaks. Further [ 8 ], show that the design of public vaccination policies should also take intergroup interactions into account. Other-regarding preferences can explain voluntary vaccination uptake, as argued by [ 9 ]. For example [ 10 ], show that the presence of individuals who cannot get vaccinated, like babies and the elderly, increases the willingness to get vaccinated. The static model in [ 6 ] also does not reflect interactive processes [ 9 , 11 ]. show that vaccination is the individually best response until a certain vaccination rate is reached in the population and becomes a social dilemma only from this vaccination rate until herd immunity is maximized. Communicating the social benefits of vaccination can have positive effects, particularly when this protects vulnerable groups, but it can also invite free-riding [ 12 ]. Those people who cannot get vaccinated themselves for medical reasons are particularly vulnerable: they cannot protect themselves even if they wanted to and, hence, depend on their fellow citizens to protect them by preventing the spread of the virus through their vaccination. Children, too, need to be considered separately. Since they cannot give informed consent to a voluntary vaccination themselves, they might have to be protected from their parents (who might be unwilling to get them vaccinated) in case of particularly serious diseases (see [ 13 , 14 ]).

There is, in summary, hope that the public goods problem may be overcome, as social and behavioral science offers a wide array of potential policy options to influence people’s perceptions and reactions to the pandemic (for an extensive up-to-date overview, see [ 15 ]). It is not clear, however, how the research on well-established vaccines carries over to the current pandemic, and recent developments seem to indicate that the willingness to get vaccinated against the novel coronavirus is currently rather low. We therefore chose to investigate two fundamental questions at the opposite extremes of the spectrum of policy options: would a sufficient number of people voluntarily undergo vaccination to achieve herd immunity? Or would a mandatory vaccination against COVID-19 be acceptable to achieve herd immunity?

A legal duty to be vaccinated against COVID-19 could be an alternative to other coercive measures if one assumes that a high-risk, unregulated, laissez faire approach is not a realistic policy option: it seems irresponsible to lift all restrictions because the virus would soon spread through the entire population. Coercive measures of some kind therefore seem inevitable. Mandatory vaccination could be preferable to other coercive measures, provided the interference with bodily integrity would be considered less socially costly in the long run than the effects of prolonged lockdowns. Emotions run high where vaccination policies are concerned, but because mandatory vaccination might become a realistic scenario, it is worth investigating what the general population thinks about such a policy.

It is important to emphasize that a legal duty to vaccinate against COVID-19 would not imply a legal (or even moral) duty to vaccinate against other diseases. The novel coronavirus is a special case in many respects: In contrast to influenza, for example, the population does not have a background immunity from past infections. In addition, many infected people do not show symptoms (a recent meta-study estimates this to be one in six infected [ 16 ]) and, hence, cannot protect others from being infected through voluntary self-quarantining. Thus, people with COVID-19 represent a much higher risk of infection for others than, for example, people who come down with influenza, assuming that these would normally stay at home. Therefore, a vaccination against COVID-19 is much more important from the social perspective than e.g. a vaccination against influenza: not for self-protection, but to protect other people from unintentional infection. Although classic liberal positions (cf. [ 17 ]) would reject a paternalist legal obligation to protect oneself through vaccination, they plausibly would favor a policy of mandatory vaccination in the case of COVID-19 to protect others from being harmed. In modern philosophical discussions, even some libertarians are in favor of mandatory vaccination against serious diseases for similar reasons (see [ 18 ] and for an overview [ 19 ]).

Though there are philosophical reasons supporting a policy of mandatory vaccination, we want to emphasize that we are not advocating it as a concrete policy option for Germany at this moment. Our aim is to understand whether the general public would consider such a policy acceptable, or which sections of the population, and why. To this end, we study the willingness to get vaccinated and the acceptance of a policy of mandatory vaccination against COVID-19 in June and July 2020 in Germany. We use unique real time survey data from a sub-sample (SOEP-CoV) of the German Socio-Economic Panel (SOEP, see [ 20 ]). A set of questions about vaccination was part of the later stages of SOEP-CoV, an ongoing research project initiated in April 2020. This so-called ‘vaccination module’ included questions on the willingness to get vaccinated voluntarily and the acceptance of a policy of mandatory vaccination against COVID-19. In addition, individuals could indicate reasons for their preference regarding the second question. Using the rich data of the SOEP, pre-pandemic income, education, household context, personality, political preferences etc., which can be directly linked with SOEP-CoV, we are able to provide a detailed picture on who intends to get vaccinated and who does not.

The most important result of our study is that about 70 percent of adults in Germany would get vaccinated voluntarily against COVID-19 if a vaccine without significant side effects was available. Further, about half of adults in Germany are in favor, and half against, a policy of mandatory vaccination against COVID-19. The approval rate for mandatory vaccination is significantly higher among those who would get vaccinated voluntarily (around 60 percent) than among those who would not get vaccinated voluntarily (27 percent). However, 22 percent of the individuals would disapprove of both a voluntary and a mandatory vaccination and 8 percent can be characterized as ‘passengers’ (they are not willing to get vaccinated but do support a policy of mandatory vaccination, but they might not all be ‘free-riders’ in the standard sense). In this group, surprisingly, 86 percent state that, without a mandatory vaccination, too few individuals would get vaccinated and about 87 percent indicate that most people underestimate how dangerous COVID-19 is. In general, the willingness to get vaccinated is significantly lower for female, younger, and less educated respondents as well as those with lower income. A policy of mandatory vaccination is rejected with higher probability by women and favored by older people and those living in the eastern federal states.

Data, measures, and methods

Data: soep and soep-cov.

The German Socio-economic Panel (SOEP) is among the largest and longest-running representative panel surveys worldwide and is recognized for maintaining the highest standards of data quality and research ethics [ 20 ]. In 2020, the survey covers about 30,000 adults in 20,000 households. Since the same individuals and households participate in the study every year, life courses of the respondents can be tracked and intertemporal analyses can be carried out at the individual and at the household level. The data contain information on the respondents’ household situation, education, labor market outcomes, and health, among others (see [ 20 , 21 ]).

To better understand the effects of the corona pandemic, a special survey called SOEP-CoV was conducted within the framework of the SOEP, which consisted of a random sample of about 6,700 SOEP respondents, (see [ 21 , 22 ]). SOEP-CoV was surveyed in nine staggered tranches from early April to the end of July 2020 and collected data on the following topics: a) Prevalence, health behavior, and health inequality; b) Labor market and gainful employment; c) Social life, networks, and mobility; d) Mental health and well-being; and e) Social cohesion. Over time, some new question modules were introduced within these five thematic complexes. These included the ‘vaccination module’ (see questionnaires available under www.soep-cov.de/Methodik/ ).

Measures: Preferences toward vaccination against COVID-19

The ‘vaccination module’ went into the field with tranches 7 to 9, in June and July 2020, and covered a total of 851 persons aged 19 years and older. At that moment, major research efforts were being undertaken, but it was not clear whether any vaccine would actually be found. The module hence starts with a question on the hypothetical willingness to get vaccinated against COVID-19:

“Let us assume that a vaccine against the novel coronavirus that is shown to have no significant side effects is found. Would you get vaccinated?” The response categories are ’Yes’, ’No’, and ‘no answer’. The module contains a further question about mandatory vaccination with the same response categories:
“Would you be in favor of a policy of mandatory vaccination against the coronavirus?” In addition, the interviewees were asked about their reasons for or against a policy of mandatory vaccination. For this purpose, a filter was used to adapt the arguments according to the respondents’ answers to question (B). The arguments given were as follows:

Argument 1: Others’ willingness to get vaccinated without mandatory vaccination

Against mandatory vaccination: “Enough people would get vaccinated even without a policy of mandatory vaccination.”
In favor of mandatory vaccination: “Only with a policy of mandatory vaccination would enough people get vaccinated.”

Argument 2: Misperception of risks

Against mandatory vaccination: “Most people overestimate the dangerousness of the virus.”
In favor of mandatory vaccination: “Most people underestimate the dangerousness of the virus.”

Argument 3: Legitimacy of a policy of mandatory vaccinations in general

Against mandatory vaccination: “A policy of mandatory vaccination is never permissible, even in the case of very dangerous diseases.”
In favor of mandatory vaccination: “A policy of mandatory vaccinations would make sense also for less dangerous diseases.”

Argument 4: Other reasons (without listing these reasons explicitly)

The first three arguments are of particular relevance for political decision-making. Although there is quite a lot of research on the reasons people have not to get vaccinated themselves, there is much less research on what people think about policies of mandatory vaccinations, and up to present–at least to our knowledge–none on the application to the special case of the novel coronavirus. As the reasons for the individual decision need not carry over to the policy assessment, and given the previously discussed particularities of the coronavirus, we focused on factors that are both of theoretical importance and under discussion in the general public. It would be interesting, for instance, if many people did not have the intention to get vaccinated themselves, yet believed that enough other people would get vaccinated so that mandatory vaccination would not be required. Similarly, it would be surprising if people wanted to get vaccinated yet believed that others overestimated the dangerousness of the virus. Finally, we wanted to see whether people considered mandatory vaccinations potentially legitimate at all.

Sample selection, weighting, and item non-response

Since SOEP-CoV is a random sample from the SOEP population, the SOEP-CoV data 2020 can be linked with the regular SOEP data of previous years. Thus, attitudes toward vaccination against COVID-19 that were collected during the pandemic can be linked to the characteristics of the respondents before the outbreak of the pandemic (e.g., income or educational level). Since these characteristics were collected before the pandemic, they can be considered unaffected by the pandemic event and, hence, exogenous ( S1 File provides definitions of all dependent and independent variables used in the empirical analyses).

The response rate in the vaccination module was high. Altogether, only 4.58 percent of the 851 respondents did not answer the question about voluntary vaccination and 3.41 percent did not answer the question about mandatory vaccination. Of those who supported (objected to) mandatory vaccination, 0.26 (1.82) percent did not provide at least one motive in the follow-up question. Hence, bias from item non-response should be small and we did not correct for it. As the focal variables are coded dichotomously (yes = 1; no = 0), there was no need to remove outliers in them from the database.

To derive population-wide estimates, the SOEP-CoV data is equipped with frequency weights. The weighting of SOEP-CoV follows the standard weighting used in SOEP [ 23 , 24 ]. Based on the SOEP household weights, weights for all persons in the participating households were generated via a marginal adjustment step and corrected for selection effects. Furthermore, the data were corrected for the fact that some SOEP subsamples were excluded from the SOEP-CoV study from the outset. To address potential selection effects and adjust frequency weights accordingly, we followed the two-step procedure recommended in [ 25 ]:

Step 1: Estimation of a logistic regression model where the dependent variable is a dummy variable indicating whether respondents belong to the working sample of tranches 7 to 9 (dummy is equal to one) or not (dummy is zero). All variables included in the following analyses serve as explanatory variables.
Step 2: If at least one analysis variable shows a significant (i.e., p -value below 0.05) and at the same time meaningful effect (i.e., coefficient above 0.01) with respect to the assignment to the analysis population, a correction of the SOEP-CoV weights is performed by multiplying the frequency weights by the inverse estimated probability. In other words, multiplying the SOEP-CoV weights belonging to the analysis set by the inverse predicted probability yields the sought adjusted weight that can be used to calculate population statistics. In the present case, an adjustment using the following variables is indicated: Extraversion and whether respondents live in a household in which at least one household member was tested for COVID-19. Overall, selection on observables is very minor. Unless otherwise stated, our results are weighted with the adjusted probability weights.

Statistical framework

Since the vaccination questions are answered once by each respondent, our empirical strategy is between-person. Uni- and bivariate results for our focal variable, attitudes toward vaccination, are presented as weighted means or percentages. Assessments of differences in attitudes or characteristics between-groups rely on two-tailed t-tests, with statistical significance evaluated at p <0.01, p <0.05, and p <0.10 using the survey weights explained above. Our empirical strategy involves multiple between-group tests. This raises the question of whether a correction is necessary for multiple hypotheses testing. We do not implement such a correction because we seek to compare a certain attitude or characteristic between groups and not to draw, at the end of the test series, a concluding summary of all tests results.

Willingness to get vaccinated and attitudes toward a policy of mandatory vaccination

For the questions on voluntary vaccination (A) and mandatory vaccination (B), four groups in the population may be distinguished:

Anti-vaccination: interviewees who would not get vaccinated voluntarily against the coronavirus and who also oppose a policy of mandatory vaccination.
Anti-duty: interviewees who would get vaccinated voluntarily but oppose a policy of mandatory vaccination.
Passengers: interviewees who would not get vaccinated voluntarily but are in favor of mandatory vaccination. We refer to this group as ‘passengers’ because they apparently want to see the public good of herd immunity provided by mandatory vaccination, yet would not voluntarily contribute to this good. Some of these passengers might be free-riders in the standard sense, trying to benefit from the decisions of others while not voluntarily contributing themselves, while others might not be able to get vaccinated for medical reasons. If mandatory vaccination were introduced, the first group, but not the second, would also get vaccinated, of course. Neither group would actually free-ride, but the first might initially have wanted to.
Pro-vaccination: interviewees who would get vaccinated voluntarily and are also in favor of mandatory vaccination.

Overall, 70 percent of adults in Germany would voluntarily get vaccinated against the coronavirus, provided a vaccine without significant side effects was available ( Table 1 : groups 2 and 4). This value corresponds exactly to the results of [ 26 ]. From May till September 2020, the COVID-19 snapshot monitoring (COSMO) at the University of Erfurt showed relatively constant values of between 60 and 66 percent; it was only in April that it showed an exceptionally high value of 79 percent, and it has now decreased further (cf. [ 27 ], p. 76; an overview of previous studies on the willingness to get vaccinated in Germany is provided in S2 File .). Overall, these studies paint a consistent picture, with a slight decline in the willingness in the second half of 2020.

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https://doi.org/10.1371/journal.pone.0248372.t001

Approximately half of the interviewees are against, and half are in favor of, a policy of mandatory vaccination (against: 51%, groups 1 and 2, in favor: 49%, groups 3 and 4). These values, too, coincide almost exactly with those of the COSMO monitoring since May 2020 (cf. [ 27 ], p. 78), which in April showed an approval rate for mandatory vaccination of 73 percent, but later discontinued this question (till July 2020, and it has been decreasing since; see S2 File ). The agreement with a policy of mandatory vaccination is clearly higher, namely almost 60 percent (41/(41+29) = 0.59) among those who would get vaccinated voluntarily than with those who would not let themselves be vaccinated voluntarily, i.e. approximately 27 percent (8/(8+22) = 0.27).

Attitudes toward a policy of mandatory vaccination

The four groups differ noticeably in how they assess the arguments presented to them. This is shown in Table 2 , which gives the group-specific approval rate for each argument in combination with the p-values of t-tests in S3.1 Table in S3 File .

https://doi.org/10.1371/journal.pone.0248372.t002

Argument 1.

The groups differ markedly in how likely they think it is that others will get vaccinated. Among the two groups that are against a policy of mandatory vaccination, 56 percent of the ‘anti-vaccination’ group (who would not get vaccinated voluntarily) think that their fellow citizens would get vaccinated sufficiently frequently such that mandatory vaccinations would not be necessary. Almost 80 percent of the ‘anti-duty’ group (the members of which would get vaccinated voluntarily) think the same. Among the two groups that are in favor of mandatory vaccination, 85 percent of the ‘passengers’ (who would not voluntarily get vaccinated) think that the others would not voluntarily get vaccinated either, as do slightly more than 90 percent of the ‘pro-vaccination’ group (who would also get vaccinated voluntarily).

Argument 2.

These results run in parallel with the assessment of the dangerousness of the virus. Even though the analysis is not causal, we can see that about 50 percent of the ‘anti-vaccination’ group and 30 percent of the ‘anti-duty’ group think that most people overestimate the dangerousness of SARS-CoV-2. Exactly the opposite, that most people underestimate the dangerousness, is believed by nearly 90 percent of the ‘passenger’ group and by slightly more than 80 percent of the ‘pro-vaccination’ group. Summarizing the numbers differently, one could say that groups 2 and 4, who would voluntarily get vaccinated, probably have similar opinions about whether their fellow citizens correctly assess the danger posed by the virus. About 80 percent of the members of the ‘pro-vaccination’ group think that most people underestimate the danger. Of the members of the ‘anti-duty’ group, we only know with certainty that 30 percent of them believe that most people overestimate the danger–we do not know, however, how the remaining 70 percent are divided between ’underestimate’ and ’correctly estimate’. The difference between the corresponding values for groups 1 and 3 is significantly higher.

Looking at arguments 1 and 2, we may conclude that there is a high level of disagreement among the population about the dangerousness of the virus. This disagreement probably explains why people have such different attitudes toward getting vaccinated and toward the necessity (or not) of a policy of mandatory vaccination.

The position of the group of the ‘passengers’ is hard to understand. On the one hand, they favor a policy of mandatory vaccination, presumably because, as they do believe, the dangerousness of the virus is often underestimated. On the other hand, they probably assume that they themselves do not underestimate that dangerousness, but nevertheless would not get vaccinated voluntarily. One reason for this could be their medical condition: they might be willing but unable to get vaccinated for medical reasons. If so, they would not be trying to free-ride. It is unclear, however, how much weight the appeal to such a hypothetical medical contraindication should have, given that at the time of the interviews, no vaccine was even available. Some, but not all, of the ‘passengers’ are probably free-riders in the standard sense.

Argument 3.

Approximately 40 percent of both the ‘anti-vaccination’ group and the ‘anti-duty’ group agree with the statement that a mandatory vaccination is never permissible, not even with very dangerous diseases. Since these two groups reject mandatory vaccination against COVID-19, this means that for the remaining 60 percent of the group, mandatory vaccination may well be permissible–but apparently only for diseases that they would have to consider as even more dangerous than COVID-19. Conversely, well over 60 percent of the ‘passenger’ group and just over 70 percent of the ‘pro-vaccination’ group agree with the statement that a policy of mandatory vaccination would also make sense for less dangerous diseases. In combination with the results for argument 2, these two groups could therefore believe that their fellow citizens also underestimate the danger of such other diseases. It is interesting to note that, overall, people in Germany estimate the probability that the novel coronavirus will cause a life-threatening disease within the next twelve months to be high (cf. [ 20 ]). This probability is around 25 percent across our four groups. In group 1 it is 20 percent, in group 2 around 27 percent, in group 3 it is 30 percent and in group 4 it is 25 percent (see Table 3 ).

https://doi.org/10.1371/journal.pone.0248372.t003

Other reasons (which were not further broken down in the questionnaire for capacity reasons) are important primarily among those respondents who would not themselves get vaccinated and also oppose mandatory vaccination. Although questions (A) and (B) explicitly assume that a vaccine would not have any significant side effects, this could be due to a deeper skepticism about vaccination, which we hope to be able to explore in future research (on ’vaccine denialism’ see [ 28 ]).

Characteristics of the ‘anti-vaccination’, ‘anti-duty’, ‘passenger’, and ‘pro-vaccination’ groups

Description of the individual characteristics of the groups..

We would like to know in more detail who is in favor of a policy of mandatory vaccination against COVID-19 and who is opposing it, as well as what the socio-economic characteristics of those who would get vaccinated and of those who would not are. Table 3 shows how the four groups defined above differ across various socio-demographic characteristics (measured before the pandemic), personality (measured before the pandemic), health (before and during the pandemic), and political orientation (measured before the pandemic). Statistical t-tests for the significance of differences in characteristics between groups are shown in S3.2 Table in S3 File assuming equal variances across groups. S3.3 Table in S3 File provides supporting evidence: tests for equality of variance across groups provides support for this assumption in about 90% of the cases, and as S3.4 Table in S3 File . shows, relaxing the equality of variances assumption does not change our conclusions.

Socio-demographic characteristics . Almost 60 percent of the ‘anti-vaccination’ group are female, they are on average 48 years old, 12 percent of them have a university degree and their monthly net household income in 2019 averaged just under EUR 2,800. Around 27 percent have children under 16 and around 17 percent live in the eastern German states. ‘Passengers’ do not differ in their characteristics statistically significantly from this group. The members of the ‘anti-duty’ group, by contrast, are much more likely to be male and more often have a university degree. In comparison to the ‘anti-vaccination’ group, the members of the ‘pro-vaccination’ group are also more often male and older, and are also more likely to have a university degree. In particular, older interviewees are more likely to be in groups that favor mandatory vaccination and persons with a university education in groups comprising those who would get vaccinated voluntarily.

Personality traits . SOEP collects the personality traits of the respondents using a battery of questions that measure the five dimensions of the so-called ’Big Five’ [ 29 ]. The Big Five are the five most important groups of character traits in personality research: ’openness’, ’conscientiousness’, ’extraversion (sociability)’, ’tolerance’, and ’neuroticism’. Furthermore, risk attitude is surveyed. We see that members of the ‘anti-vaccination’ group tend to be more sociable but less open than the other groups. Their willingness to take risks is similar to that of the members of the ‘anti-duty’ and of the ‘pro-vaccination’ groups, but is significantly higher than that of ‘passengers’. Members of the ‘anti-duty’ group are particularly unsociable compared to the other groups, but open to new experiences. The ‘passengers’ are, like the members of the ‘pro-vaccination’ group, less neurotic. They are particularly tolerable and the least willing to take risks of the four groups.

Health . As far as the health of those surveyed is concerned, statistically significant differences are only evident in the number of illnesses: Members of the ‘anti-vaccination’ group have significantly fewer risk diseases than ‘passengers’ and members of the ‘pro-vaccination’ group. ‘Anti-duty’ members, on the other hand, have significantly fewer diseases than the ‘passengers’. Thus, overall, it may be said that those who refuse a policy of mandatory vaccination have fewer risk diseases at the time of the survey. There are no differences between the groups in terms of whether a member of the respondent’s household has already undergone a test for an infection with corona. It should be noted, however, that the number of cases of those tested for an infection is comparatively small.

Political orientation . As far as the political orientation of the respondents is concerned, no systematic significant differences between the four groups are identified. Only the members of the ‘anti-vaccination’ group seem to be positioned somewhat more to the right in the party spectrum than the members of the ‘anti-duty’ group.

Multivariate description of the characteristics of the four groups.

The differences and similarities with regard to group composition described above always refer to a single characteristic, i.e. they are univariate. Additionally, the relationships between individual characteristics of the respondents–after taking other characteristics into account–and their attitude toward mandatory or voluntary vaccination are explained below using a multivariate model (logistic estimation; see Eq ( 1 )). The dependent variable is either an indicator that describes the respondent’s own willingness to get vaccinated voluntarily (value 1 = yes; 0 = no; Table 4 ) or an indicator (value 1 = yes; 0 = no) that describes whether the respondents favors a policy of mandatory vaccination ( Table 5 ). As our interest is the explanation of data structures, we do not use survey weights in the multivariate analysis.

https://doi.org/10.1371/journal.pone.0248372.t004

https://doi.org/10.1371/journal.pone.0248372.t005

With regard to the willingness to voluntarily get vaccinated ( Table 4 ), some significant differences in socio-demographic characteristics are observed. If all other characteristics are kept constant, the willingness to vaccinate is about 10 percentage points lower in women than in men. It is positively associated with age (0.4 percentage points per year of life), education (13 percentage points if respondents have a university degree compared to the other education categories), and household income (2.5 percentage points per 1,000 euros). The personality traits of the Big Five do not correlate with the respondents’ willingness to vaccinate; only openness is slightly positively associated with the willingness to vaccinate. In the health block, there is also only one significant variable that correlates with the willingness to get vaccinated: The higher the respondents estimate the probability that the virus could trigger a life-threatening disease in them, the more willing they are to be vaccinated.

A policy of mandatory vaccination ( Table 5 ) is also rejected with higher probability by women, but favored by older people and those living in the eastern federal states, ceteris paribus . Approval is negatively associated with neuroticism, i.e. emotional instability, and positively associated with the subjective probability of contracting life-threatening COVID-19.

The tables presenting the logit estimations include an initial model diagnostic: the Pseudo- R 2 . In S4 File , we present two additional model diagnostics: First, the linktest for both logit models does not find any evidence for model misspecifications. Second, a receiver operator characteristic (ROC) analysis provides evidence that the predictive power of our two models is acceptable. In addition, to assess multicollinearity, we have computed variance inflation factors (VIF) in S5 File . As a rule of thumb, a variable whose VIF values exceeds 10 may merit further investigation. In both regressions, the VIF of none of the explanatory variable exceeds 7.7 and the average VIF over all variables is below 2.1. It should also be noted that the two separate logit models do not model correlation and heteroscedasticity between the two outcomes (vaccinate voluntarily or obligatorily). Hence, in S6 File , as a robustness check, we have estimated a multivariate probit model using Stata’s mvprobit command that relies on simulated maximum likelihood [ 30 ]. S6.1-S6.6 Tables in S6 File compare the coefficients of the multivariate probit with the two separate models. Overall, there are some changes in the magnitude of the coefficients, but no changes in the signs of the regression coefficients or significance levels.

It is possible that respondents who did not give an answer about their vaccination preferences–for example, because they are still undecided–would decide to vaccinate or support mandatory vaccination after an adequate vaccination campaign. In a robustness check, we followed this argument by assigning respondents who refused to answer the question about voluntary or mandatory vaccination to the ‘yes’ category and repeated the logit estimation. This does not change our results (see S7.1 and S7.2 Tables in S7 File , S8 File provides our Stata code, which prepares the data and conducts all the statistical analyses, as well as the outputs of the multivariate estimations).

Finally, Table 6 provides a statistical comparison of the marginal effects from the model on willingness to get vaccinated ( Table 4 ) and attitudes toward mandatory vaccinations ( Table 5 ). We find no significant differences in marginal effects between the two models except for two variables: tertiary education and eastern federal states. The marginal effect for tertiary education is significantly larger for the willingness to get vaccinated model while the opposite is true for eastern federal states.

https://doi.org/10.1371/journal.pone.0248372.t006

Politicians must make decisions which are based on incomplete information yet have far-reaching consequences for public health, personal freedom, and economic prosperity. It seems that many citizens are prepared to behave responsibly in the sense that they are prepared to endure a ‘little sting’ for the good of all: a vast majority of the German population (70 percent) state that they would get vaccinated as soon as a vaccine against COVID-19 was available. This means that under favorable conditions, a legal duty to get vaccinated to achieve herd immunity might not be necessary. It should, however, be noted that the question was asked in a stylized context: Potential side effects or ineffectiveness of the then hypothetical vaccine were assumed away. Though there is no reason to believe the vaccines currently being administered are more problematic in this respect than any other vaccines in use, neither can strictly be guaranteed in reality. In addition, the time required for a vaccination, the process of the vaccination itself (i.e. the injection), bureaucratic administration (e.g. making an appointment with the family doctor) or any necessary co-payment should de facto reduce the willingness to get vaccinated. Furthermore, at the time of writing, not only is it still unclear how quickly a vaccine can even be produced in the quantity required and administered to enough people, it is also unclear how long its effect will last. It is not even clear what percentage of the population would have to be vaccinated to achieve herd immunity, as this also depends on individual behavior and legal (or ethical) norms which are likely to continue to change (e.g. an explicit or implicit obligation to wear a mask of a specific variety in public transport or a testing obligation for people returning from trips abroad) [ 31 , 32 ]. Hence, a sufficiently high willingness to get vaccinated in the ‘best case’ scenario investigated here is an idealization and in any case only one relevant factor among many.

We observed there to be gender differences in the willingness to get vaccinated: women are less willing to get vaccinated, and also less willing to support a policy of mandatory vaccination. This is surprising, given that men are generally less likely to engage in preventive behavior [ 33 ] and women have been shown to be more willing to engage in preventive behavior in the pandemic, for instance by wearing face masks when recommended [ 34 ], and they also seem to be more compliant with other measures in general [ 35 ]. However, men are also more severely affected by the coronavirus [ 36 ] and women generally more skeptical about vaccinations, especially against COVID-19 [ 37 ]. We don’t know whether our interviewees frame their decision to get vaccinated or not as a situation of a social dilemma, but if so, previous results on gender differences in cooperation suggest men and women might have to be addressed differently to influence their decisions [ 38 , 39 ]. We also observed that income and education increase the willingness to get vaccinated voluntarily. It has also been shown recently that the willingness to pay for a vaccine against Covid-19 is positively impacted by, among other variables, income [ 40 ].

A mandatory vaccination would almost certainly achieve herd immunity against COVID-19, since all those for whom there is no medical contraindication would also get vaccinated. About half of the respondents approve and disapprove, respectively, of such a mandatory vaccination policy. In this context, the strong disagreement among the participants of the study regarding the dangerousness of the virus is particularly striking. Many of those who reject a policy of mandatory vaccination assume the dangerousness of the virus is being overestimated by others, while those who approve of a policy of mandatory vaccination seem to believe the exact opposite. This is highly problematic: at most one of the two groups can be right. Plausibly, the interviewees themselves differ in how dangerous they think the virus is. This yields a concrete and important policy recommendation (see also [ 40 , 41 ]): we need more reliable data on the dangerousness of SARS-CoV-2 and to communicate this data more clearly to the general public. Though the ‘knowledge-deficit’ explanation of low vaccine uptake might not work for well-established vaccines [ 42 ], we have found evidence that this might be different for COVID-19.

We are not recommending a policy of mandatory vaccination in this paper, but merely investigating the attitudes of people towards it. A policy of mandatory vaccination would be an extreme solution to solve the potential problem of low vaccine uptake, and a lot may be said in favor of less extreme policies (as outlined in [ 15 ], for instance). Vaccination could also be made mandatory only for certain groups of people (e.g. nurses, physicians, physiotherapists, people working in confined spaces, people travelling on public transport etc.), or only after time has conclusively shown that not enough people actually get vaccinated. It might also turn out that people are unwilling to take the second dose of a two-dose vaccine, or not accept refresher doses, which would further complicate the situation and might require subtle intertemporal strategy choice. Before making any vaccination mandatory, people could also be paid or incentivized in other ways to accept it [ 43 ]. If, as we hope, people take the external effects of their action into account, and a sufficiently high number of people get vaccinated as a result, mandatory vaccination won’t be necessary.

This article investigates the willingness to get vaccinated and the acceptance of a policy of mandatory vaccination against COVID-19 in June and July 2020 in Germany. Our first main result is that a large majority of about 70 percent of adults in Germany would voluntarily get vaccinated against the novel coronavirus if a vaccine without side effects was available. Our second result is that about half of this population is in favor of, and half against, a policy of mandatory vaccination. Our third main result is that the individual willingness to get vaccinated and acceptance of a policy of mandatory vaccination correlates systematically with several socio-demographics (gender, age, education, income) but, overall, not with psychological characteristics of the respondents.

When interpreting the results from our survey, it should be noted that preferences were elicited in an ideal-typical situation: a vaccine which is effective and free of side effects is immediately available for the entire population at zero cost. Future research will have to show how actual vaccination behavior differs in real-life situations that deviate from this ideal-typical situation.

Supporting information

S1 file. variable definitions..

https://doi.org/10.1371/journal.pone.0248372.s001

S2 File. Comparison with further studies in Germany.

https://doi.org/10.1371/journal.pone.0248372.s002

S3 File. Complementary estimation results.

https://doi.org/10.1371/journal.pone.0248372.s003

S4 File. Additional diagnostics for the logit models.

https://doi.org/10.1371/journal.pone.0248372.s004

S5 File. Multicollinearity across explanatory variables.

https://doi.org/10.1371/journal.pone.0248372.s005

S6 File. Functional form assumptions and simultaneity.

https://doi.org/10.1371/journal.pone.0248372.s006

S7 File. Imputation.

https://doi.org/10.1371/journal.pone.0248372.s007

S8 File. Stata code.

https://doi.org/10.1371/journal.pone.0248372.s008

Acknowledgments

We thank Thomas Rieger for his outstanding research assistance.

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Open access
Published: 20 October 2020

A qualitative analysis of vaccine decision makers’ conceptualization and fostering of ‘community engagement’ in India

Tapati Dutta ORCID: orcid.org/0000-0002-3272-1115 1 ,
Beth E. Meyerson 2 ,
Jon Agley 3 ,
Priscilla A. Barnes 4 ,
Catherine Sherwood-Laughlin 5 &
Jill Nicholson-Crotty 6

International Journal for Equity in Health volume 19 , Article number: 185 ( 2020 ) Cite this article

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Globally, and in India, research has highlighted the importance of community engagement in achieving national vaccination goals and in promoting health equity. However, community engagement is not well-defined and remains an underutilized approach. There is also paucity of literature on community engagement’s effectiveness in achieving vaccination outcomes. To address that gap, this study interviewed Indian vaccination decision makers to derive a shared understanding of the evolving conceptualization of community engagement, and how it has been fostered during India’s Decade of Vaccines (2010-2020).

Semi-structured interviews were conducted with 25 purposefully sampled national-level vaccine decision makers in India, including policymakers, immunization program heads, and vaccine technical committee leads. Participants were identified by their ‘elite’ status among decisionmakers in the Indian vaccination space. Schutz’ Social Phenomenological Theory guided development of an a priori framework derived from the Social Ecological Model. The framework helped organize participants’ conceptualizations of communities, community engagement, and related themes. Inter-rater reliability was computed for a subsample of coded interviews, and findings were validated in a one-day member check-in meeting with study participants and teams.

The interviews successfully elucidated participants’ understanding of key terminology (“community”) and approaches to community engagement propagated by the vaccine decision makers. Participants conceptualized ‘communities’ as vaccine-eligible children, their parents, frontline healthcare workers, and vaccination influencers. Engagement with those communities was understood to mean vaccine outreach, capacity-building of healthcare workers, and information dissemination. However, participants indicated that there were neither explicit policy guidelines defining community engagement nor pertinent evaluation metrics, despite awareness that community engagement is complex and under-researched. Examples of different approaches to community engagement ranged from vaccine imposition to empowered community vaccination decision-making. Finally, participants proposed an operational definition of community engagement and discussed concerns related to implementing it.

Conclusions

Although decision makers had different perceptions about what constitutes a community, and how community engagement should optimally function, the combined group articulated its importance to ensure vaccination equity and reiterated the need for concerted political will to build trust with communities. At the same time, work remains to be done both in terms of research on community engagement as well as development of appropriate implementation and outcome metrics.

The Global Vaccine Action Plan 2011–2020 lists equity as one of its six guiding principles [ 1 ]. Resonating this ethos, various national vaccination policies and programs have acknowledged vaccines’ contribution to preventing high-cost treatments and averting medical impoverishment, while striving to extend the benefits of immunization to all [ 2 , 3 ]. Correspondingly, community engagement (CE) for vaccinations has increasingly been recognized by decision makers [ 4 ] as a core component of working toward health equity, with a focus on community-based participatory research [ 5 , 6 , 7 ]. CE has been lauded for its facilitation of research translation [ 8 ] and for fostering positive perceptions of vaccines and immunization-related interventions [ 9 ], while decreasing the likelihood of therapeutic misconception [ 10 ]. CE also has been recognized for its assertion that research and interventions with people but without their input is unethical [ 11 ]. Further, recurring incidents of vaccine backlash by communities, as demonstrated by skepticism, resistance, and lack of vaccine support, are often attributed to ‘inappropriate CE’ [ 12 ]. Despite this salutogenic understanding of CE, which has been hypothesized to be a pathway through which population health goals related to public health equity can be met [ 13 ], several studies have suggested that CE has not been clearly defined or explicated in the context of vaccination programs [ 14 , 15 ]. It is important to understand how CE may be utilized to ensure that vaccines are translated into affordable and globally accessible public health solutions, which are acceptable by all communities [ 16 , 17 , 18 ].

To do so, this study examined CE in the context of India’s Universal Immunization Program. India has made tremendous progress during the “Decade of Vaccines” (2010-2020) by introducing multiple new vaccines along with striving to increase access to new and underused vaccines in the country [ 19 ]. The National Vaccine Policy of India mentions ethical use and equitable access as its basic mantra (Ch 5, p 28). However, vaccine decisionmakers are increasingly concerned with the 62% vaccination uptake prevalence among vaccine-eligible children (12-23 months), compared to the 90% target set under government’s Universal Immunization Program, to be achieved by the end of 2020 [ 20 ].

Vaccine studies also indicate the need to embed CE within India’s immunization programs [ 19 , 21 , 22 ]. This growing sensitization about CE among Indian vaccine decision makers has been bolstered by the Supreme Court advisory which recommends meaningful dialogue with communities to accelerate vaccination uptake [ 21 ]. CE is also perceived to be an important step in addressing communities’ vaccine resistance, which leads to delays that inhibit timely vaccination. For example, the cervical cancer-preventing human papilloma virus vaccine was suspended by the Supreme Court of India in 2010. Later, the country's right-wing groups wrote to the Prime Minister expressing concerns about pharmaco-governance and asserting that foreign companies were pushing the vaccine onto an unsuspecting public. Through July 2020, despite advice by the National Technical Advisory Group on Immunization, the Federation of Obstetric & Gynecological Societies of India, and the Indian Academy of Pediatrics for its inclusion in the Universal Immunization Program, substantial community resistance remains. As a result, the vaccine has been sporadically rolled out in three (Sikkim, Punjab and Delhi) out of 36 states and Union Territories [ 23 , 24 ].

Community skepticism about vaccines has a long history in India, evidenced by covert and overt vaccine resistance. As early as the mid 1800’s, some Hindus resisted the smallpox vaccine on religious grounds, because the material used for vaccines was drawn from the lymph of a cow, which is considered a sacred animal by the community [ 25 ]. During the National Polio Surveillance Program, community resistance ranged from people closing their doors and windows when they heard vaccinators approaching their houses, to vaccine backlash such as physical conflict between vaccinators and communities [ 26 ]. Recently, in 2017, there was decreased uptake of measles-rubella vaccination in certain Indian states amidst community uproar following social media rumors of political conspiracy and safety concerns about the vaccine [ 27 , 28 ]. Thus, work to articulate a shared conceptualization of CE is critical at this juncture to establish concerted and strategic CE that can facilitate transparent vaccine communication between communities and decisionmakers and build on existing technology, interventions, and healthcare systems to address inequities in vaccination coverage, especially among under-reached and underserved populations. This may be especially useful in overcoming communities’ myths and fears about new vaccines, which are often considerably more expensive than existing ones, and target relatively ‘hidden’ diseases [ 21 , 23 ]. However, current CE evidence is limited to a few systematic examinations focused on community counselling and vaccination campaigns, often in pockets of high vaccine resistance and low vaccination coverage [ 29 , 30 ]. These reviews have also focused on public opposition rather than involvement, and no data have been collected to indicate ‘if’ and ‘how’ communities are engaged beyond individuals’ decisions to vaccinate themselves and their children [ 31 , 32 , 33 ]. The wider body of academic literature attributes this dearth of CE related studies to the variously premised and sometimes conflicting definitions of and rationales for CE [ 34 ] and the absence of CE metrics [ 35 ]. Other studies mention that evaluating CE is challenging, as such activities often occur in the context of ongoing work and throughout the process of adopting more collaborative engagement approaches [ 36 , 37 ].

It is our perception that typifying an understanding of CE may lead to contextual and ethical application of CE within a complex system of relationships among researchers, policymakers, implementation scientists, and vaccine users. It may also prevent erroneous assumptions about its value and utility, or lack thereof, and inform research and data needs related to CE. This may, in turn, trigger a policy dialogue focused on robust measures to assess what works, how it works, and, over time, if CE efforts have improved vaccination rates and thereby bolstered national efforts to reach out to every vaccine eligible child and adult. Therefore, this study aimed to examine elite Indian vaccine decision makers’ individual perspectives and collective understanding about CE, the circumstances in which CE has been implemented, and how they have fostered CE for effective vaccination.

Schutz’s Social Phenomenology Theory was used as an underlying approach because it is consistent with the belief that ‘conceptualizations’ are socially constructed and appropriated to explore participatory action [ 38 ]. This theory also helped direct attention toward considering the dynamic contexts in which CE was conceived and operationalized [ 39 ]. Social Phenomenology further helped to treat CE conceptualization and its fostering as intersubjective, integral to institutions and systems, all embedded in history, time, and space [ 40 ]. The lead author’s (TD) professional role was that of a translational researcher, supporting evidence-based programs and policy through examination of ecological frameworks using a community-based participatory approach. Her a priori assumption was that community engagement can foster social, relational, and ethical progress toward health equity [ 41 ]. However, few assumptions were made about how decisionmakers would conceptualize CE and community, as these issues infrequently are described in formal, written documents and must instead be intuited from distally related activities.

In preparing for this study, the lead author (TD) purposefully identified 30 individuals who had authoritative roles related to vaccine discovery, development and delivery, such as national-level vaccine decision makers who were policymakers, program heads and/or associates in the government, private sector, non-governmental organizations, and country-offices of international donor and UN agencies. Thus, these individuals, by virtue of their knowledge and positions, were the ‘elites’ [ 42 ] and were able to provide a unique ‘big-picture perspective’ [ 43 ] about CE strategizing and implementation during India’s Decade of Vaccines. Interviewees were approached with this status differential in mind [ 44 ]. In keeping with the assumptions and beliefs of social phenomenology, a two-step participatory approach for data collection was used: (1) semi-structured elite interviews followed by (2) a member check-in meeting [ 42 ]. All interactions used a community-engaged approach, including emphasis on mutual respect and recognition of the knowledge and expertise of study participants. This included adhering to participants’ preferred meeting dates on December 25 and January 1, even though these were national holidays. Further, the member check-in meeting was democratically conducted rather than using the researcher as a moderator. In addition, the researcher was sensitive that issues related to vaccine resistance were occurring in real time, wherein trust building with the study participants was necessary to obtain ‘good data’ and completion of the project.

Access to participants (distinct from identification of the sample) was obtained using a snowball methodology, beginning from the professional network of the principal investigator (TD). Recruitment emails were sent by TD in December 2017 to each of the 30 potential participants, followed up with phone calls to identify interest and availability for an in-person interview. Interviews were conducted by TD with 25 individuals who agreed to participate in the study from December 2017 to February 2018. Each interview lasted for 50 to 90 minutes, was carried out in English, and conducted in the country-offices of the respective agencies, institutions, and organizations located in or around New Delhi, the capital city of India. Interviews were audio recorded and transcribed verbatim. All personalized information was anonymized. Data also included field-notes written within 24 hours of each interview. The interview topics drew from earlier studies focusing on CE as a strategic tool for vaccine research and rollout [ 45 , 46 ]. Accordingly, the inquiries explored participants’: (i) conceptualization of community and CE, (ii) evolution of CE, (iii) fostering support for CE, (iv) resources available for CE, (v) partnerships for CE, (vi) enablers to CE, and (vii) barriers to actualize CE. The interview guide used for this study, including questions and probes, is available as a digital supplement ( 1 ) to this article.

Once a preliminary analysis of the interview data was completed, TD presented the findings in a one-day member check-in meeting among the study participants and their teams (who held second-line leadership positions) in January 2018. Study participants and their team members who participated in the member check-in meeting were knowledgeable about the issue and were comfortable validating and candidly critiquing the primary findings. All study participants and their teams were nationally known; thus, in order to maintain confidentiality, identities, names, and organizational affiliations were not used in reporting the findings. Therefore, although participants in the follow-up meeting knew each other, no specific responses were linked to any individual or organization. This meeting ensured that the overall summation and meaning making of the findings prepared by TD and the research team conformed with what the study participants had mentioned in their interviews and made sense to both the vaccine decision makers and their teams in India (e.g., validity). This was a participatory way to verify both data saturation and completeness of the findings, as well as archival document review (part of the overall project, but not of this study). The study was approved by Indiana University’s Institutional Review Board.

Data analysis

First, all data were transcribed verbatim and entered in NVivo12 (QSR International, Melbourne, Australia) for qualitative data management.

An a priori coding structure was used to categorize individual participants’ conceptualization of CE, how their interests in CE for vaccination evolved by overcoming barriers and optimizing facilitators, while integrating 'policy push for vaccine uptake' and 'generating vaccination demand pull' approaches for different vaccines under the UIP. Based on the interpretive analysis used in social phenomenology, first-level broad construction of CE was done, followed by second-level typical constructs, deliberated through critical events or performance of CE ‘duties’ and ‘responsibilities’ throughout the tenure of the decision makers [ 47 ]. Categories conceptually corresponded with the Social Ecological Model, which has been used to study vaccination uptake and health disparities [ 41 ]. Given this loose pre-existing framework, a general inductive approach was used [ 46 ]. To reach intercoder-reliability (>90%), two coders joined TD, iteratively reviewed, and re-reviewed data for existing and emerging themes and/or patterns, and ultimately crystallized a holistic interpretation through multiple coding conferences. Thereafter the three coders independently coded five interviews to test, reject, accept, or refine the codes [ 43 ]. The final coding structure contained 7 multi-dimensional CE themes with 42 nodes. Exemplar interview excerpts illustrate the findings, although the analysis drew from the entire dataset. The coding structure is available in full as a digital supplemental ( 2 ) file.

All study participants held national and multi-regional leadership roles in vaccine policymaking, financing, and/or program planning and management across vaccine research, development, and roll-out stages for at least ten years in India. In addition to their roles in India, five participants reported managing programs in multiple countries in Asia, Africa, and Latin America. Table 1 describes the study participants.

This section sequentially shares results organized by the following categories and subcategories. Because the results are extensive, we list many of the key themes in brief here as well.

conceptualization of community, and how stakeholders define community;

community was typically understood to be one or more of the following: vaccine-eligible children and their parents and vaccine-eligible adults, frontline healthcare providers, local-level stakeholders, vaccine gatekeepers, and local-level implementing organizations.

conceptualization of CE, with particular attention to analyzing extant efforts, which generally fell into three categories:

capacity building of frontline stakeholders as CE;

capacity building most often was expressed as training, training-of-trainers, and course offerings;

vaccine-related information dissemination as CE;

participants described a wide variety of different communication methods, as well as perceived benefits and disadvantages to each;

targeted community interventions as CE;

participants provided examples of ways in which community

interventions had been carried out;

different tangible ways in which CE might be fostered;

fostering CE was viewed on a broad spectrum that ranged from highly participatory approaches to direct imposition of vaccination services;

evolution and transformation of CE;

all participants acknowledged the need for a better understanding of CE and, in the member check-in meeting, came to a consensus on a definition of CE.

Conceptualization of community

Most participants defined communities as ‘beneficiaries of the UIP,’ with a notion of transactional exchange of vaccine related information between the providers and the communities, always with the aim of vaccination uptake. Communities consisted of the following categories of people: (1) vaccine-eligible children, vaccine-eligible young adults, and their parents and guardians who make vaccination-decisions for the former; (2) healthcare providers who deliver vaccines and sensitize vaccine-eligible populations and their guardians for improved vaccination rates and herd immunity; (3) local-level stakeholders who disseminate information to encourage vaccination uptake; (4) gatekeepers who resist a particular vaccine or vaccination per se , and; (5) local-level implementing organizations of community health workers, groups that includes what are known in India as the 3As. These are Auxiliary Nurse Midwifes who are based at a sub-center and are multipurpose workers responsible for administering vaccines among communities of < 5000 people; Accredited Social Health Activists, who are local women trained to act as health educators in their communities, catering to 700 people in tribal areas and 1000 in rural villages; and Anganwadi Workers, resident workers in the village rural child care centers in India who are responsible for promoting maternal and child health, including interpersonal communication for full immunization coverage, among communities of <1000 people. A few participants took a broader perspective: “ It is the whole communities in which those individuals were living.”

Most of the participants acknowledged their distance from the community, mentioning “if I went to the community nobody will accept me,” while comparing the sense of community with local organizations because they “help raise community demand for routine immunization. ” These organizations included grassroots non-profit organizations (NPOs), community-based organizations (CBOs) like women’s self-help groups, local-level representatives of occupational groups like brick-kiln workers and barbers, and the local-chapters of technical and youth organizations such as the Indian Association of Pediatricians and Nehru Yuva Kendras Sangathan (autonomous organization for youth development under the Government of India, Ministry of Youth Affairs and Sports). Several NGO heads identified themselves as ‘communities’ for their people-centric approach, though, in most of these expressions, fractious relationships and issues of incompatibility between decision makers [mostly government or donors] and NPOs were evident.

“ … .they [Government or donors] want to clip our wings. This is very sad because we [NPOs] bring up issues [local issues of the communities] , which you [Government or donors because of being at the national-level] might never know.”

Some participants identified vaccine-gatekeepers, people who were suspicious that vaccination is a political agenda against minority groups, as communities. Interventions targeting their positive vaccination decisions came across as an area of CE.

“ … in Mallapuram the mother generally said ‘no’ to vaccination because their husband lived in the Middle East [who was proxy decision-makers for their child’s vaccination] .”

Finally, it was unclear whether the media was part of the community, or a driver of communities’ vaccination decisions. Most participants indicated that the media spread misinformation and promulgated negative sentiments among vaccine priority populations about vaccines, and thus expressed the need “to stop negative media so that they [media] do not “blindly publish” , or “ over-sensationalize when it is not an Adverse Event Following Immunization.”

Conceptualization of CE

The participants perceived CE both as a strategy and tool in implementation terms, and variously defined CE as segments of processes comprising of: (1) vaccine policy and program formulation; (2) capacity-building of frontline stakeholders; (3) vaccine information dissemination among communities to promote vaccination uptake, and; (4) targeted community-level interventions to curtail the recurring incidents of vaccine-related community backlash. There was evidence of relational goals of CE, like “longer-term trust building” [between the vaccine decision makers and the communities], and “ … .understand what is going on in people’s minds [regarding vaccinations] ” .

Intuitively, all the participants proposed ongoing and early instantiation of CE for better vaccination outcomes:

“We always go to the communities earlier and have media campaigns, and interpersonal communications to sensitize people on what [vaccine] we would give to their children.”

However, several participants critiqued that CE interventions came in waves, mostly during vaccine introductions, before and during vaccine trials, and in response to a disease outbreak. They also noted that there were no tools or metrics to measure its impact. They speculated that these deficits may be because:

“The Immunization Technical Unit was not built with a CE model [CE frame] for immunization. Like, you [Government] compensate Accredited Social Health Activists for fully immunizing children and trainings attended, but not for doing CE.”

Participants described a top-down and decentralized vaccine governance structure where vaccine policy formulation and vaccine introductions were conducted at the Ministry, considering disease burden, vaccine cost, cold-chain, and supply chain issues. These efforts were completely funded by the Ministry of Health and Family Welfare (MoHFW) and international donors.

“ … . [CE is like] a chandelier, the [MoHFW] is the hook. The different lights are the different partners, they are held at right distances in the right manner. In immunization, the roles and partnerships [of national level decisionmakers] are clearly defined .”

The development of vaccine policies and operational guidelines in English and Hindi (one of the 22 scheduled languages of the Republic of India, and also one of the official languages of India which is understood, spoken, and read by more people than English) by the technical bodies of MoHFW, such as the Immunization Technical Support Unit, and the Mission Steering Group, was conceptualized as CE too. Participants mentioned that the “ state translated and modified [these documents] if they think that something is to be added or deleted,” though no such example of any such revisions incorporated based on communities’ recommendations was cited.

Except the Vaccine Policy (2011), which recommended enhancing communities’ vaccination acceptance and confidence, and vaccine-specific Operational Guidelines, which recommended community-facing strategies, participants did not identify any sub-population-based CE-specific policy. Almost half of the participants cited the Communication Strategy for Polio Eradication , published by the UNICEF and USAID CORE Group, detailing intensive outreach for polio vaccination, as nearest to any CE guideline. Three participants, considering India’s diversity where “every mile the language changes, the culture changes” suggested having a “village-level communication strategy.” Participants noted strategic programs like Mission Indradhanush and Intensified Mission Indradhanush to achieve 90% immunization “to the last child” as CE.

The heads of organizations and technical bodies often criticized chasms in this one-way, top-down approach as “ working in silos” and “not real CE,” and feared that it would ultimately “hinder an integrated approach.” A few participants identified CE as activities occurring in spaces like Village Nutrition and Sanitation Days, which are organized monthly at rural childcare centers. There, communities can ask questions about vaccines and vaccination strategies. However, these participants were doubtful that communities possessed any emancipated voice beyond seeking or resisting vaccines.

Capacity building of frontline stakeholders

Some participants mentioned ‘cascade training of trainers’ for the 3As and local Master Trainers as CE, since the goal is to motivate communities for full immunization. Notably, the CE roles of the 3As and other local stakeholders were different. The Auxiliary Nurse Midwives and Anganwadi Workers are salaried staff for vaccine administration among communities and the Accredited Social Health Activists receive honoraria for counselling and escorting the communities to vaccinations. However, the local NPOs and CBOs appeared to be instrumental in carrying out community-based activities to motivate each community’s vaccination decisions, and, in the case of vaccine trial conducting organizations, act as conduits between researchers and vaccine clinical trial participants.

Participants conceptualized the 18 months training for ANMs, and 3–4 weeks trainings for AWWs and ASHA workers respectively, with additional trainings such as the 3-day Boosting Routine Immunization Demand Generation course for the 3As, and vaccination sensitization trainings for the local-level vaccine-champions (community advisory boards, local religious leaders, barbers, and CBO members), as CE. In these instances, it appeared that some interpersonal tactics were imparted to frontline stakeholders, and tasks were later delegated to them. However, a few participants questioned the ‘quality of CE outcomes’ from these trainings:

“So, you [Government] piggy back everything on the Community Healthcare Worker, who talks to communities about everything: immunization, family planning, maternal health, school health, adolescent health, non-communicable diseases, and cancer … [but] you are not actually engaging or doing CE.”

Vaccine-related information dissemination

Most respondents mentioned “ bilateral information transfer [interpersonal and behavior change communication] sent down to communities” as CE. In the same vein, most participants denoted the Communications Officer as the CE human resource. In fact, one participant said, “The role of communication, I mean CE, sorry using the wrong word again.”

Some participants highlighted the need to be creative and explore web-based media, considering its ease of use, cost-effectiveness, and penetration to interior locations:

“Nobody is interested to read your mobile texts. So, use GIF messaging.”

There were a few examples where bottom-up information, going from the community to the government which facilitated realizing the vaccine program goals, was acknowledged:

“In a construction site we [participant’s organization] did the mapping. But when we reached the community after a fortnight, they [community] have already migrated. The local person would tell us the whereabouts of the mobile community and we could then reach them through the Accredited Social Health Activist network.”

Some participants highlighted campaign-related booklets like the area-based ‘ Underserved Strategy,’ developed after a polio outbreak in Uttar Pradesh in 2002 among the Muslim populations, the ‘ Social Mobilization Network’ formed in 2001 to sensitize families to polio immunization, ‘ My Village my Home’ , a pictographic vaccination tracking method in the shape of a hut, where each column of the hut contains vaccination details of each new-born in the village, and media trainings of “State Immunization Officers on how to handle the media and stop negative media,” as CE.

Vaccine champion engagement and celebrity engagement to motivate communities’ vaccination decisions came across as another form of CE, though there were mixed reactions regarding this strategy.

“Our communication campaigns are pathetic. What is the point in having [a film star in his 70s ] there? We have no way of measuring CE. Does he convey safety of the product? To sell a toothpaste or a phone we spend hundreds of millions of dollars. How much is going into selling something far more important as vaccines?”

Targeted community interventions

Some participants perceived CE as a [right of the communities], “communities want the leadership to come to them. … just sit with them [communities], work with them and that is CE. The leader needs to go to the community at least once or twice. It really increases the communities’ motivation and trust.”

Others suggested a more emancipatory understanding of CE:

“[Vaccine] demand generation is another thing [than CE] . It means that you [government/vaccine providers] are giving and we [vaccine-eligible community] are accepting. Policy influencing is that where the [empowered] community thinks that certain things needs to be changed [and advocates for that] .”

Intervention programs reflected a range, between vaccine imposition and respectful engagement with community stakeholders, where participants’ responses reflected balanced trade-offs between CE’s time and resource investments and feasibility, emphasizing that it is a “ marathon, and not a sprint,” “an expensive process” and “took 20 years to learn about community and how to do CE.”

“In XXXX district community was very resistant and started beating the vaccination team. Then we had to contact a local muscleman, briefed him that this [carrying on with the vaccination drive] is important, and then told him to make an announcement that vaccination is not a bad thing.”

“We engaged with the staff of Aligarh Muslim University, Jamia Milia Islamia and Jamia Hamdard [institutions of higher education that were created to manifest indigenous ethos and spirit of diversity in India] , who went to the field. That helped to address the issue of vaccine hesitancy among religious leaders [especially the Muslim religious leaders] .”

Later, in the member check-in meeting, participants reiterated that effective CE conceptualization and conduct will require developing CE performance and outcome indicators and advocating for their incorporation in immunization surveillance instruments in India. Herein, all the participants emphasized the need to document CE effectiveness and its relational gains:

“ … as a country, I will be ashamed … ., very poor in documentation. You will hardly see any papers from the learnings of polio eradication. This is so because the people who are doing CE do not have the time to document.”

Range of approaches to fostering CE

Though a strict categorization of responses by organizations would not be accurate, participants endorsed a wide variety of types of approaches to fostering CE. These methods generally fell on a spectrum ranging from empowered (‘1’) to disempowered (‘7’). Table 2 provides exemplar quotes illustrating efforts or actions that might be categorized into these different levels.

All participants acknowledged “ decision makers’ good intention for CE but they were not matched with recipes of successful CE models.” Most of the CE interventions reported occurred during the National Polio Surveillance Program (a campaign of the World Health Organization and MoHFW initiated in 1995 to ensure polio eradication through house-to-house poliovirus vaccine delivery), with minimal evidence of institutionalization, replication, or scale-up of these during introduction of other vaccines.

Evolution and transformation of CE

All participants indicated that CE was still a “very poorly understood space,” “complex,” and there were “several gaps to understand this puzzle.” Three participants from NPOs critiqued that it is “ offhand,” “ad-hoc practices to douse the fire,” “firefight,” or “control big chaos and help put things back to normal” and recommended “real community engagement” and a “scientific approach to CE.” Recollecting CE’s evolution, participants noted that the earlier paternalistic prevention impositions has built a negative community memory, and jeopardized communities’ trust on vaccine authorities:

“..the vaccine fear was connected to the family planning program wherein women were forcibly sterilized.”

There was some evidence of pragmatic pressures by global provider/donor organizations (e.g., “GAVI funding went partly for community mobilization” ) that reinforced renewed systems-thinking and inclusive bottom-up- models, like:

“We were not really very serious and formed a small community group. [Initially, the community group ] came, had some snacks and went off. CE really didn’t go beyond that. But by then the NIH and USAID wanted Community Advisory Boards or CABs … and then we learnt how necessary it was.”

Consequently, several participants described recent and direct interactions between vaccine decisionmakers and communities while referring to “ The Prime Minister’s Office invites suggestion from the public” and “ Health Minister issues letters to each Accredited Social Health Activist and Auxiliary Nurse Midwife encouraging them to vaccinate every child.”

In the day-long member check-in meeting, the summary of analysis from the interviews was presented. Study participants and their teams agreed with the findings, and jointly came up with a robust definition of CE, which can be summarized as:

“CE is an upstream policy imperative rather than downstream interventions to build trustworthy relationships between vaccine decisionmakers and communities. It involves demystifying vaccine science and transparent communication for empowered community agency. This would enable communities to critically analyze vaccine related myths and misinformation and enable knowledge co-production in building community sensitive vaccine policies and programs. [CE] is incumbent to sustained political-will and resources to ensure evidence-informed, tailored, vaccine policies and programs, providing equitable, quality, and tangible vaccination and capacity building benefits to community members.”

Meeting participants recognized the need to carry out interventions in ways such that trustworthy relationships between communities and decision makers are established. There were comments reflecting realizations like “If we [decisionmakers] close the doors once again to the community, we might lose their trust, and not get the communities back, ever again.” They also recommended creating more opportunities for relationship-building and group discussions between community healthcare workers and vaccine decision makers. Meeting participants were especially interested in addressing inequities in vaccination coverage by building on the existing range of interventions while innovating newer mechanisms such as community mobilization for vaccination, strategic interventions with vaccine gatekeepers, providing immunization information using traditional, digital, and social media, and dispelling vaccine misinformation and disinformation while formulating rumor management strategies.

This study was able to identify elite decision makers’ core conceptualizations of community, CE, and both extant and aspirational approaches to CE related to vaccination programs in India. In reviewing these findings with study participants, a core definition of CE emerged, focused on upstream relationships (bidirectional), fostering trust, transparent communication, capacity building, and political will to ensure such approaches. Participants indicated that much of the extant work being conceptualized as CE is primarily downstream delivery and even imposition of services for vaccination uptake. While such things can be beneficial (e.g., vaccination), it likely matters to whom they done, in what way, and with what level of community voice (e.g., changing “to whom” to “with whom”). Given that direct imposition has resulted in community backlash against vaccination campaigns both in India and other parts of the world, including violence and hiding children from vaccinators, achieving national policy goals and fostering equitable distribution of public health outcomes may be difficult without a revised approach to CE. Concomitant to this must be an increased focus on CE metrics to promote greater understanding of processes and goals. Importantly, each of the different approaches to CE, including direct imposition, appeared to have been done with the primary goal of increasing equitable access to vaccinations (e.g., supporting community immunization). Thus, the underlying question discussed in this study did not focus on whether individuals should have equitable access to vaccinations, but rather on how such an outcome might best be achieved – that is, the degree to which a revised understanding of CE can support bilateral improvements in both vaccination dissemination by the government and vaccine confidence among communities.

Notably, being an Indian but performing the research at an American university, mitigated reflexivity issues and gave TD the identity of an 'informed outsider,' which allowed her to gain increased access to elites [ 43 ]. Being an implementation researcher allowed TD to deeply engage in analyzing the data while utilizing NVivo predominately as a data management tool. The member check-in meeting facilitated a participatory approach to the interviews, providing considerable interpretive latitude, and probing opportunities. It also allowed participants to critically review CE in UIP with a diversity-equity-inclusion focus. This was particularly important because studies on ‘elite interviewing’ mention that such access can be rare, because such people are hard to reach, surrounded by gatekeepers, and have power and ability to protect themselves from intrusion and criticism [ 44 , 48 ].

This study also benefited from the fact that none of the CE strategies/interventions were ranked as ‘best practice’ over another by institutional mandate or leadership, unlike the traditional ranking of engagement models in Holland Matrix (1997) [ 49 ], or Arnestein’s Ladder [ 50 ]. This helped reduce social desirability issues among the participants, who would not be perceived as ignoring a best-practice approach when answering honestly about CE.

In most cases, decision makers did not identify themselves or their families as ‘community’, and in some cases only a section of the public was perceived as ‘community’. Ensuring full immunization to communities under UIP was considered the most important CE goal and a step toward equitable health outcomes. However, as noted in other literature [ 35 , 51 ], a non-immersive and reductionist approach to conceptualizing communities may inhibit formation of trusted collaborations with the communities, ultimately compromising the creation of communities’ agency [ 52 ]. Some authors have described this as ‘conservative corporatism’ which, contrary to the ‘whole community approach’ [ 53 ], can lead to fragmented health governance, introduce barriers to building comprehensive people-centered vaccine policy reform [ 36 ], and risk defining communities as internally homogenous entities, which is unlikely to be the case given the diversities prevalent in India [ 54 ]. This may also undermine tailored CE strategies for particular sub-populations, leading to reductions in their trust of vaccinators and empowered vaccination decision making, especially among those for whom vaccine hesitancies are high, and/or vaccination uptake is low [ 55 , 56 ].

While findings supported current iterations of CE in making substantive contributions to vaccine demand generation and disease eradication, communities were often seen as offering ‘passive demand.’ Ideally, communities would actively seek vaccines and there would be community demand reflecting social support for vaccination as a norm [ 11 ]. Head’s research goes so far as to suggest that utilitarian CE may foster health inequities [ 57 ]. Gopichandran’s work looks at the relational gains (more intrinsic in nature, rather than transactional relationship building) from CE and posits development of trust between vaccine decision makers and communities as a result of shared CE goals integrated into vaccination targets [ 56 ]. Accordingly, doing empowered CE may require a paradigm-shift to perceive communities as integral parts of the policy and delivery systems, incorporate CE metrics into vaccine surveillance, and create new roles with a focused responsibility to coordinate CE.

It appears that many facets of the national-level CE response were an equilibrating reaction to appease community outrage rather than an integral approach set in place a priori . Adhikari et. al. has defined such CE as 'short-hand' [ 31 ], often resulting in wasted resources, with the potential to create mistrust rather than enhance benefits, create legitimacy, or share responsibility [ 31 , 56 ]. Other authors have envisaged that such CE can eventually give rise to communities as agents of the government, and CE becoming an ‘involvement industry’ ‘procured from external organizations’ [ 57 , 58 ]. To alleviate this, Folayan et. al. (2019) have recommended memoranda signed between the government and local partner organizations at the study design stage [ 54 ]. That noted, Webber seems to doubt whether national government-based public health initiatives might ever be able to stray too far from a top-down approach, postulated as the ‘two-community thesis’ [ 58 ]. Other authors suggest that deviation from this paradigm will require transformative leadership which is difficult to achieve in the public service sector with the prevailing traditional organizational thinking, policies, and management techniques [ 59 ].

While frontline local stakeholders played a role in Indian vaccination efforts as two-way conduits between decision makers and the community, more studies are recommended to examine complex issues derived thereof, such as internal chasms and accountability mechanisms between the 3As, and motivational erosion when CE work is not compensated financially (adequately). Prior research would not suggest, though, that social media could replace this in-person work. Ramsbottom’s et al.’s study found that, although social-media messaging is a cost-effective mechanism for vaccine information dissemination, it might not be the best approach for India, and could leave out social media illiterate populations, those with erratic and sporadic internet connectivity, and areas where vaccine communication needs to be translated to local dialects [ 53 ].

Limitations

Ensuring open discussion with vaccine decision makers and their team members on a potentially controversial topic like CE for vaccination was not always easy; it took time to convince the potential participants to participate. Some of the elites were difficult to access because of the ongoing community uproars around Measles-Rubella and HPV vaccines which were playing out in real time in the country during the study’s time period [ 60 , 61 ]. Despite these structural impediments, theoretical saturation was ensured by virtue of interviewing nearly the entire group of elite vaccine decision makers in the country. This was achieved by utilizing TD’s professional networking and familiarity with some of the study participants, use of a sensitive mix of knowledge and intercultural humility, flexibility to re-schedule appointments after office hours or on national holidays, and use appropriately persuasive multiple communication channels like Facebook Messenger, or WhatsApp [ 43 ], in addition to emails and phone calls. Nonetheless, the study findings were limited by the inherent limitations of a qualitative study design. However, generalizability within India might be more strongly inferred than would be typical given the high percentage of decision makers who provided data. In addition, all the study participants were interviewed in or around New Delhi. While the individuals who were interviewed each had a national or international scope to their decision making, this centrality may have influenced the findings in some way. Finally, some of the findings related to intended actions in the future rather than things that had already been completed; this hampered the ability to ascribe definite actions in some cases. However, existing literature demonstrates that intentions are moderately good predictors of future behavior [ 62 , 63 ].

The results from this study can be used both to understand past CE challenges and successes and to prospectively plan community-led, tailored CE initiatives for better vaccination outcomes. Of note, there appears to be conceptual tension between multiple vaccination-related goals, such that each can be perceived as CE for health equity; namely, top-down vaccination programs may be successful in achieving some short-term immunization, but there may be backlash, and longer-term increases in immunization rates may suffer as a result. At this stage, it will be critical to devise CE process and outcome indicators for vaccination programs in India, and to advocate for their incorporation in vaccination surveillance datasets. As of now, the suggestions herein are theoretical – and evaluation metrics would allow for demonstrations of how CE impacts a variety of important outcomes, and, ultimately, foster replicability of successful efforts within India and internationally.

Availability of data and materials

All twenty-five qualitative interviews (audio recording and transcripts) are available from the lead author (TD) and can be shared on request.

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Acknowledgements

We thank all the study participants and their teams for providing the information and data used in this study and for hosting the member check-in in meeting in New Delhi, India.

The lead author (TD) received a scholarship from Dhar India Studies Program, Indiana University, to undertake travel to India for the member check-in meeting.

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As the first and corresponding author, TD was primarily responsible for conceptualizing the study, conducting the data collection and analysis, coordinating and facilitating the check-in validation meetings, writing the manuscript, and adding the revisions addressing the reviewer comments in this version of the manuscript. Other authors (dissertation committee members) offered extensive input at the proposal and study design stages and throughout the dissertation (BEM, JA, PB, CSL, JNC). JA additionally contributed intensively to revisions and preparation of this manuscript for publication, and revisions addressing reviewer comments. The author(s) read and approved the final manuscript.

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This manuscript is one of the papers from the lead author’s (TD) doctoral dissertation. That study, and all related manuscripts, were reviewed and approved under the 'Exempt' category by the Indiana University's Institutional Review Board (protocol 1710654732). Consent to participate was obtained from all study participants via email.

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Dutta, T., Meyerson, B.E., Agley, J. et al. A qualitative analysis of vaccine decision makers’ conceptualization and fostering of ‘community engagement’ in India. Int J Equity Health 19 , 185 (2020). https://doi.org/10.1186/s12939-020-01290-5

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A Top Vaccine Expert Answers Important Questions About a COVID-19 Vaccine

The covid-19 vaccine is on track to become the fastest-developed vaccine in history. that doesn’t mean the process is skipping any critical steps..

Understanding what we know—and still don’t—about a vaccine for COVID-19 can help shed light on its safety and efficacy.

Ruth Karron, MD , is one of the top vaccine experts in the world, serving on vaccine committees for the CDC, the WHO, and the FDA. Karron, who leads the Center for Immunization Research at the Johns Hopkins Bloomberg School of Public Health, recently spoke with Josh Sharfstein and answered a list of important questions about the COVID-19 vaccine.

How close are we to a vaccine?

There are some very encouraging developments. We have a few vaccines now that will go into Phase 3 clinical trials, also known as efficacy trials. That means that those vaccines have passed certain goalposts in terms of initial evaluations of safety and immune response such that they can be evaluated in larger trials.

We know that these vaccines are promising, but we don’t yet know if they are going to work. That’s what the purpose of an efficacy trial is—as well as to provide a broader assessment of safety of the vaccine in a large number of people.

Tell me more about these efficacy trials. What do they actually entail?

They involve large numbers of people: In these particular trials for COVID vaccines, there are going to be about 30,000 people enrolled per trial. Individuals are given a vaccine, and then they are followed both to make sure that the side effects from the vaccine are acceptable and to see whether they develop a SARS-CoV-2 infection along with some symptoms.

These are placebo-controlled trials, meaning that some individuals will get a COVID vaccine and some will get a placebo. Then, the rates of disease will be compared in the people who got placebo and the people who got the vaccine to determine the efficacy of the vaccine.

How successful does a vaccine have to be in one of these studies for it to be considered effective?

Recently, the FDA issued guidance about the development of COVID vaccines. The guidance that they issued to vaccine manufacturers— this is a document that is available to the general public —is that a vaccine would need to be at least 50% effective. This means that an individual who was vaccinated would be 50% less likely to get COVID disease—or whatever the particular endpoint is that’s measured in the trial—than individuals that weren’t vaccinated.

This is a reasonable goal for a number of reasons. Typically, the more severe a disease is, the better chance a vaccine has of preventing that disease. So, a vaccine that’s 50% effective against mild COVID disease—which might be the endpoint that’s measured in a clinical trial, or any evidence of COVID infection with any symptom, which is how a lot of trials are designed—might be more effective against severe disease.

When you have a disease that’s as prevalent as COVID—and if we think about what the U.S. has experienced in the past several months in terms of severe disease and death—even if we were only able to cut those numbers in half, that would be a major achievement.

How long would a vaccine be effective for? If you get 50% effectiveness or more, that’s good news. But if it’s only effective for a few months, that’s not such good news.

Time will tell for that. The short answer is that we don’t yet know. Even for the data we have on the vaccine so far in smaller studies, we haven’t yet had the opportunity to follow individuals for very long. The very first people who got the very first vaccine were immunized in March and it’s only July. So, we don’t know very much about the durability of the immune response in people.

Our hope would be [that protection would last] at least a year or more and then people might need boosters.

It’s also possible that a vaccine might not entirely protect against mild disease. So you might actually experience mild disease and then have a boost in your immune response and not suffer severe disease. From a public health perspective, that would be completely acceptable. If we turned a severe disease not into “ no disease ” but into mild disease, that would be a real victory.

Let’s talk about safety. What are they looking for in a 30,000-person study to figure out whether a vaccine is considered safe enough to use?

Every person who is enrolled in the trial will complete information about the kinds of acute symptoms that you might expect following an infection. People will need to provide information about swelling, redness, tenderness around the injection site, fever, and any other symptoms they might experience in the three to seven days following vaccination.

More long term, people will be looking to make sure that when COVID disease is experienced, there’s not any evidence of more severe disease with vaccination [which is known as disease enhancement].

There was a lot of discussion as these vaccines were being developed of a concern about disease enhancement. This is based on some animal models—not with SARS-CoV-2 but with other coronaviruses. We haven’t seen any evidence of enhanced disease thus far and there are a number of scientific reasons why we don’t think it should occur with these vaccines. But, of course, it’s something we would still watch for very carefully just as with any other safety signal.

How should we think about the possibility of adverse effects that might come up after the period of the vaccine trial?

There are a couple of things to mention about that, and one is that individuals with these trials will be followed for a year or longer. It may be that a vaccine is either approved for emergency use or licensed before all of that long-term follow up is completed. Nevertheless, companies will be obligated to complete that follow up and report those results back to the FDA.

It’s important to enroll older adults in these studies. All of these large efficacy trials will be stratified so there will be some younger adults and some older adults enrolled.

In addition, it’s very likely—and this would not just happen with COVID vaccines, but whenever the FDA licenses vaccines—that there is an obligation for post-licensure assessments. If a COVID vaccine is licensed, the companies will work with the FDA to determine exactly what kind of post-licensure safety assessments will need to be done.

COVID affects certain populations more than others—particularly older adults and people with chronic illnesses. What do these studies need [in order] to address the question of whether a vaccine will be protective for them?

I also think it will be important to enroll older adults across an age span. A 65-year-old is not the same as an 85-year-old. Also, a healthy older adult is not the same as a frail older adult who might be living in a care facility.

We’ll need some information about diverse elderly populations in order to think about how to allocate vaccines. There may also be other alternatives for older adults if they don’t respond well to vaccines. There’s a lot of work going on on development of monoclonal antibodies [ learn more about lab-produced antibodies in a recent podcast episode with Arturo Casadevall ] as an alternative for groups that don’t respond well to vaccines such as elderly, frail adults.

Let’s say there are 30,000 patients in the study and only a few hundred who are over 80 years old. What can you learn about a relatively small population of much older adults that would be informative about that group?

We may not have a large enough number of people in that subgroup to directly look at efficacy of a vaccine. But we might have enough to look at the immune response—the antibody response, for example, of a vaccine.

If, in the course of these trials, we can determine a correlative protection—for example, a laboratory measure like a level of a particular kind of antibody that correlates with protection against COVID disease—we can at least look at the immune responses in that subset of very elderly and decide if they are the same or different than the younger groups’. If they are the same, we may be more comfortable making the leap to say that it’s likely those individuals will also be protected by the vaccine.

So, we will learn more from a vaccine trial than just whether or not a vaccine works. We’re going to find out, perhaps, what predicts whether the vaccine works. That information might help us understand—without having to do a whole new trial—who might be protected by a vaccine.

It’s certainly a hope.

The majority of vaccines that we use today don’t have such a marker of protection and they’re very effective. Just because we can’t detect a marker doesn’t mean that a vaccine is not effective. It means that we’re not smart enough to figure out what that marker should be.

We really hope that there will be such a marker of protection because then we can link that—and, in FDA speak, that’s called “bridging”—to another population where we can just look at that marker of immunity rather than doing a whole efficacy trial.

How should we think about the need for racial and ethnic diversity in these clinical trials?

It’s critically important that we have racial and ethnic diversity.

We know that COVID causes increased rates of severe disease in Latinx and Black populations and in Native American populations. We will certainly want to be able to offer these COVID vaccines to these high-risk populations and encourage their use. But we need to know how well these vaccines work in these populations—if different vaccines work differently—so that we can offer the most effective vaccines.

It would not be an understatement to say that there can be a measure of distrust from some communities that have experienced discrimination from the health care system. How does that play into vaccine research?

It’s really important to engage those communities in a number of ways. One way is to engage local leaders early in the process. Lay leaders and leaders of faith communities can have focus groups to find out what their concerns are and how those can be allayed.

I think a very important issue that has been raised by some people who might potentially volunteer for some of these trials has to do with eventual access. People want to have some sense that if they participate in a trial, not only might they have access to the vaccine at the end of that trial, but their families and their communities would, too. Ensuring access among these high risk and vulnerable communities is really critical.

A clear policy decision to make sure that a vaccine is widely available without charge might actually help with the studies to prove whether or not that vaccine is safe and effective?

That’s absolutely the case. It’s great that you brought up the “without charge” piece, too, because a vaccine that’s made available but costs something to the individual may not be used. Particularly for people who don’t have health insurance or people who are undocumented. It has to be broadly and freely available.

Let’s talk about other specific populations. One of those is pregnant women. We know that they can certainly get COVID-19 and that there are some signs that they can have a more severe course. How do you think about the issue of pregnant women in vaccine studies?

I’ve done some work in this area —particularly with Ruth Faden and Carleigh Krubiner in the Berman Institute of Bioethics —specifically related to ensuring that pregnant women are considered and included in vaccine development and implementation for vaccines against epidemic and pandemic diseases.

When thinking about trials, there needs to be a justification for excluding pregnant women from trials rather than a justification for including them. The justification often is—and certainly is the case with these early COVID vaccines—that we don’t know enough yet about the vaccine or the vaccine platform or the safety of the vaccine to do a study in pregnant people.

With the mRNA vaccine, for example, [the type of vaccine being considered for COVID-19] we don’t currently have a licensed mRNA vaccine. It’s a new platform and we’re just learning about the safety of that platform so it wouldn’t have been appropriate to include pregnant women in the early stage trials.

But these 30,000-person studies are going to be really big studies. They will certainly enroll people of child-bearing potential. And even though there’s what we call an exclusion criterion—women are not supposed to be pregnant at the time they are enrolled, and usually women of child-bearing potential will take a pregnancy test prior to enrollment and immunization—we know from previous experience that it’s quite likely that some women will become pregnant in the months immediately following immunization. It happens quite frequently. So, it’s important for companies and the government to anticipate that this will be the case and to think about how they will systematically collect data from women who do become pregnant during these trials.

It’s not that the data needs to be interpreted cautiously—because pregnant women aren’t being formally randomized and we don’t have that kind of trial design—but there are things that could be learned and it’s important to think now about how to collect those data. It’s also important to think about how pregnant women could be directly included in both trials and deployment later down the road.

What about young children who are less likely to get severe disease? Would your approach to clinical trials be different?

Yes. I think we need to learn a bit more about the epidemiology in children. Fortunately, children don’t seem to suffer from acute COVID disease at the rates that adults do. But we need to learn more about that and we also need to learn from our trials in adults before we make decisions about how and whether children will be included in vaccine trials.

Once we have a vaccine that has made it through these various stages and we’re ready to start immunizing people outside of a pure clinical trial, how close are we to really getting the benefit of the vaccine? How does all the work it takes to develop a vaccine compare to what comes next?

The best vaccine in the world won’t work if it isn’t used.

Use has two parts to it: One is availability and access, and the other part is acceptance.

We need to think about what kind of infrastructure we should be planning now for what we’re going to need to deliver this vaccine. We’ll set priorities; certainly not everyone is going to get a vaccine all at once. But certainly, over time we will expect that all adults will receive the vaccine and perhaps children. So we’ll need to have systems in place that can deliver the vaccine. At the same time, we need to make sure that the vaccine is acceptable. We need to communicate the importance of vaccination to the public and address their concerns so that we can not only be able to deliver vaccines, but have those be accepted by the public.

So, there’s a lot of work to be done. But this isn’t science fiction: We are really on a path to a vaccine for a brand new infectious disease.

Yes. If you think back to the fact that in January, we barely knew what this virus was, and here we are, seven months later, embarking on efficacy trials, it’s really a remarkable accomplishment. We have a lot to do yet, but in the time that we’re assessing the efficacy of these vaccines and making sure that they can be delivered to the public, people really need to stay safe and to do all the things we’ve been encouraging them to do all along.

But we are well on our way to developing vaccines not only for people in the U.S., but for people all over the world.

Public Health On Call

This conversation is excerpted from the July 31 episode of Public Health On Call.

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What vaccines are recommended for adults?

Nationally recognized pharmacist and vcu professor explains what vaccines adults should consider to better protect themselves from severe illnesses as they age..

8/28/2024 12:00:00 AM

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What vaccinations do we get as children that wear off as adults? Do we need to get new shots for these immunizations? 

You will need to get boosted or new doses of certain vaccines over time. For example, tetanus-diphtheria-pertussis vaccine (Tdap) requires a booster every 10 years to maintain protection against these illnesses. Other vaccines, including influenza (flu) and COVID-19 , are recommended every year because the viruses they offer protection from mutate and an updated vaccine is needed to fight off newer variants. It's also important to check with your primary care provider to make sure you have received all the necessary doses for the several vaccines that you may have received when you were younger, such as measles, mumps, rubella (MMR) , varicella (chickenpox) and Hepatitis B .

Are there certain times in adulthood when we are more susceptible to certain illnesses?

Adults are more at risk for certain illnesses, and risk may be increased based on age, job, health conditions or travel plans, so adults might need additional vaccines to protect themselves or their loved ones. Immunization protects a person from getting sick and from spreading infections. Getting vaccinated can help you stay healthy and save your life.

What vaccinations should adults consider getting as part of preventive care?

Besides making sure you are up to date on the vaccines mentioned above, there are several other immunizations and health concerns to take into consideration. Talk to your health care provider about what vaccines you might need at your next visit to the office or pharmacy.

Here are vaccine recommendations based on age:

18 to 26 years old:

Human papillomavirus (HPV) vaccine if you are not already vaccinated
Hepatitis B vaccine if you have not already received the recommended number of vaccine doses (2 to 3 based on the vaccine brand)

27 to 49 years old:

50 to 64 years old:

Shingles vaccine
If you are under 60, check with your doctor to make sure you have received all the recommended doses for the Hepatitis B vaccine
If you are 60 and older, you may be at increased risk for respiratory syncytial virus (RSV ) and are recommended to receive the RSV vaccine. Those at increased risk include adults with chronic illnesses, weakened immune systems, severe obesity and diabetes, or those who are living in a nursing home or other long-term care facility. Ask your primary care provider if you are at increased risk for RSV. If you have already received an RSV vaccine, you do not need another dose at this time.

65 years and older:

Pneumococcal conjugate vaccine

75 years and older:

Respiratory syncytial virus (RSV) vaccine. If you have already received an RSV vaccine you do not need another one at this time.
Check with your primary care provider to make sure you have received all the necessary doses of zoster (or shingles) vaccine

What vaccines should adults consider when they are around infants or small children? 

Adults should be up to date with all the recommended vaccines to protect themselves and to prevent spreading illness to infants and children. Surrounding infants and children with individuals who are protected against viruses is called “cocooning.” Adults and adolescents can be spread pertussis (whooping cough) which can be deadly for an unvaccinated or partially vaccinated infant. If an adult will be in contact with infants, the adult is recommended to have received:

Tdap vaccine within in the last 10 years. If an adult has not received a Tdap vaccine, it is recommended that they receive the vaccine 2 weeks before meeting the infant.
Annual flu vaccine at least 2 weeks before meeting the infant

Pregnant individuals are recommended to receive certain vaccines to protect the infant during early months of life. These include:

Tdap vaccine at 27 to 36 weeks of gestation in each pregnancy
COVID-19 vaccine
Flu for pregnancies during influenza vaccine season generally September through as late as April
RSV vaccine (only Abrysvo) for during gestational weeks 32 to 36 during the RSV season, which is from September to January in most of the U.S. If you have received an RSV vaccine during one pregnancy, you do not need another dose at this time. Check with your pediatrician or primary care provider for how to protect your infant against RSV disease.

Where can people find more information about adult immunizations?

You will need to find your vaccination record, which is the history of all the vaccines you have received during your lifetime. Ask your parents, contact your current or previous primary care providers or the state health department. If you can’t find your record, ask your primary care provider if you should get some vaccines again. Here are other resources used by primary care providers and pharmacists:

Centers for Disease Control and Prevention: Adult vaccines
National Foundation for Infectious Diseases
Immunize.org
If you are not sure if you need a vaccine, you can take the CDC's adult immunizations quiz

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Accelerating a safe and effective COVID-19 vaccine

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Global research on coronavirus disease (COVID-19)
WHO COVID-19 Solidarity Therapeutics Trial
"Solidarity II" global serologic study for COVID-19
Solidarity Trial Vaccines

Information on this page is not up to date. Please go to our latest information on COVID-19 vaccines.

The availability of a safe and effective vaccine for COVID-19 is well-recognized as an additional tool to contribute to the control of the pandemic. At the same time, the challenges and efforts needed to rapidly develop, evaluate and produce this at scale are enormous. It is vital that we evaluate as many vaccines as possible as we cannot predict how many will turn out to be viable.

To increase the chances of success (given the high level of attrition during vaccine development), we must test all candidate vaccines until they fail. WHO is working to ensure that all of them have the chance of being tested at the initial stage of development.

This is a major and extraordinary global research undertaking: WHO is facilitating collaboration and accelerated efforts on a scale not seen before; it is convening vital communications across the research community and beyond.

R&D Roadmap for COVID-19

Highlights of WHO actions so far

Harnessing a broad global coalition to develop and evaluate candidate vaccines as quickly and safely as possible by convening and coordinating multiple public and private partners and using the best scientific and public health evidence and ethical principles.
Mapping candidate vaccines and their progress across the world and fostering regular open dialogue between researchers and vaccine developers to expedite the exchange of scientific results, debate concerns and propose rapid and robust methods for vaccine evaluation.
Defining the desired characteristics of safe and effective vaccines to drive and focus research that is public health and needs oriented.
Coordinating clinical trials across the world to accelerate multiple actions with the aim of providing a safe and effective vaccine as early as possible.

The 4 critical elements of WHO global R&D efforts in detail

1. Harnessing a broad global coalition to develop and evaluate candidate vaccines as quickly and safely as possible

WHO’s core function is to direct and coordinate international efforts through:

Global collaboration and cooperation;
Development of robust methods;
Working to accelerate progress and avoid duplication of research efforts;
Coordinating an unparalleled effort to rapidly and simultaneously assess many vaccines.

WHO is facilitating interactions between scientists, developers and funders to support coordination, and/or provide common platforms for working together. It is combining the relative strengths of different stakeholders. It has used its global mandate to rapidly convene 300 scientists, developers and funders to increase the likelihood that one or more safe and effective vaccines will soon be available to all. Activities are being delivered at extremely high speed with many steps executed simultaneously.

2. Mapping candidate vaccines and their progress across the world

Over 210 candidate vaccines are at some stage of development. Of these, at least 48 candidate vaccines are in human trial. About 10 are in phase III trials. There are several others currently in phase I/II, which will enter phase III in the coming months.

WHO is fostering regular open dialogue between researchers and vaccine developers to expedite the exchange of scientific results, debate concerns and propose rapid and robust methods for vaccine evaluation.

3. Defining the desired characteristics of safe and effective vaccines to combat the pandemic

To guide the efforts of vaccine developers, WHO has drawn up a Global Target Product Profile target product profiles (TPPs) for COVID-19.

This document outlines the minimum and desired attributes of safe and effective vaccines. The TPPs cover two types of vaccines: vaccines for the long-term protection of people at higher risk of COVID-19 such as healthcare workers; and vaccines for use in response to outbreaks with rapid onset of immunity.

WHO has also coordinated expert consultations to identify the potential role of different animal models and laboratory assays to evaluate and screen candidate vaccines before their evaluation in humans. We are devising an unprecedented effort for rapid assessment of many candidates simultaneously before they are tested in humans.

4. Coordinating clinical trials across the world – giving humanity the best chance of safe and effective vaccines for all

WHO is proposing to massively accelerate the evaluation of vaccines. Its expert group has designed a large international randomized controlled clinical trial to enable the simultaneous evaluation of the benefits and risks of different vaccines at sites with sufficiently high rates of the disease. This will ensure a faster turnaround of results.

The power of the vaccine Solidarity trial is its global ambition, and the potential to rapidly deploy and assess vaccines in areas with high transmission. The results for the efficacy of each vaccine are expected within three to six months and this evidence, combined with data on safety, will inform decisions about whether it can be used on a wider scale in those countries or regions where the vaccines are being tested.

WHO expert groups are also considering:

Key criteria to help prioritize which vaccines should go into Phase II and III clinical trials;
A Phase 2b/3 protocol that can be used by all vaccine developers to shape their trial, which will enable real-time evaluation of the benefits and risks of each promising candidate vaccine

Once a safe and effective vaccine becomes available, it will be vital that it is accessible to everyone who needs it. WHO will continue to work to align R&D, fast-track regulatory approvals and manufacturing so that all populations in all countries can access a vaccine as early as possible.

The centre-piece of the world’s research response is a globally agreed scientific R&D Roadmap for COVID-19, which details steps for current and future work.

COVID-19 vaccine tracker and landscape COVID-19 vaccine tracker and landscape

WHO R&D actions for COVID-19

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FDA Approves and Authorizes Updated mRNA COVID-19 Vaccines to Better Protect Against Currently Circulating Variants

FDA News Release

Today, the U.S. Food and Drug Administration approved and granted emergency use authorization (EUA) for updated mRNA COVID-19 vaccines (2024-2025 formula) to include a monovalent (single) component that corresponds to the Omicron variant KP.2 strain of SARS-CoV-2. The mRNA COVID-19 vaccines have been updated with this formula to more closely target currently circulating variants and provide better protection against serious consequences of COVID-19, including hospitalization and death. Today’s actions relate to updated mRNA COVID-19 vaccines manufactured by ModernaTX Inc. and Pfizer Inc.

In early June, the FDA advised manufacturers of licensed and authorized COVID-19 vaccines that the COVID-19 vaccines (2024-2025 formula) should be monovalent JN.1 vaccines. Based on the further evolution of SARS-CoV-2 and a rise in cases of COVID-19, the agency subsequently determined and advised manufacturers that the preferred JN.1-lineage for the COVID-19 vaccines (2024-2025 formula) is the KP.2 strain, if feasible.

“Vaccination continues to be the cornerstone of COVID-19 prevention,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “These updated vaccines meet the agency’s rigorous, scientific standards for safety, effectiveness, and manufacturing quality. Given waning immunity of the population from previous exposure to the virus and from prior vaccination, we strongly encourage those who are eligible to consider receiving an updated COVID-19 vaccine to provide better protection against currently circulating variants.”

The updated mRNA COVID-19 vaccines include Comirnaty and Spikevax, both of which are approved for individuals 12 years of age and older, and the Moderna COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine, both of which are authorized for emergency use for individuals 6 months through 11 years of age.

What You Need to Know

Unvaccinated individuals 6 months through 4 years of age are eligible to receive three doses of the updated, authorized Pfizer-BioNTech COVID-19 Vaccine or two doses of the updated, authorized Moderna COVID-19 Vaccine.
Individuals 6 months through 4 years of age who have previously been vaccinated against COVID-19 are eligible to receive one or two doses of the updated, authorized Moderna or Pfizer-BioNTech COVID-19 vaccines (timing and number of doses to administer depends on the previous COVID-19 vaccine received).
Individuals 5 years through 11 years of age regardless of previous vaccination are eligible to receive a single dose of the updated, authorized Moderna or Pfizer-BioNTech COVID-19 vaccines; if previously vaccinated, the dose is administered at least 2 months after the last dose of any COVID-19 vaccine.
Individuals 12 years of age and older are eligible to receive a single dose of the updated, approved Comirnaty or the updated, approved Spikevax; if previously vaccinated, the dose is administered at least 2 months since the last dose of any COVID-19 vaccine.
Additional doses are authorized for certain immunocompromised individuals ages 6 months through 11 years of age as described in the Moderna COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine fact sheets.

Individuals who receive an updated mRNA COVID-19 vaccine may experience similar side effects as those reported by individuals who previously received mRNA COVID-19 vaccines and as described in the respective prescribing information or fact sheets. The updated vaccines are expected to provide protection against COVID-19 caused by the currently circulating variants. Barring the emergence of a markedly more infectious variant of SARS-CoV-2, the FDA anticipates that the composition of COVID-19 vaccines will need to be assessed annually, as occurs for seasonal influenza vaccines.

For today’s approvals and authorizations of the mRNA COVID-19 vaccines, the FDA assessed manufacturing and nonclinical data to support the change to include the 2024-2025 formula in the mRNA COVID-19 vaccines. The updated mRNA vaccines are manufactured using a similar process as previous formulas of these vaccines. The mRNA COVID-19 vaccines have been administered to hundreds of millions of people in the U.S., and the benefits of these vaccines continue to outweigh their risks.

On an ongoing basis, the FDA will review any additional COVID-19 vaccine applications submitted to the agency and take appropriate regulatory action.

The approval of Comirnaty (COVID-19 Vaccine, mRNA) (2024-2025 Formula) was granted to BioNTech Manufacturing GmbH. The EUA amendment for the Pfizer-BioNTech COVID-19 Vaccine (2024-2025 Formula) was issued to Pfizer Inc.

The approval of Spikevax (COVID-19 Vaccine, mRNA) (2024-2025 Formula) was granted to ModernaTX Inc. and the EUA amendment for the Moderna COVID-19 Vaccine (2024-2025 Formula) was issued to ModernaTX Inc.

Related Information

Comirnaty (COVID-19 Vaccine, mRNA) (2024-2025 Formula)
Spikevax (COVID-19 Vaccine, mRNA) (2024-2025 Formula)
Moderna COVID-19 Vaccine (2024-2025 Formula)
Pfizer-BioNTech COVID-19 Vaccine (2024-2025 Formula)
FDA Resources for the Fall Respiratory Illness Season
Updated COVID-19 Vaccines for Use in the United States Beginning in Fall 2024
June 5, 2024, Meeting of the Vaccines and Related Biological Products Advisory Committee

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products.

The Queensland Cabinet and Ministerial Directory

Urgent call as whooping cough cases surge.

Published Thursday, 22 August, 2024 at 02:32 PM

Minister for Health, Mental Health and Ambulance Services and Minister for Women The Honourable Shannon Fentiman

Pregnant people are being encouraged to protect themselves and their unborn baby by getting a free whooping cough vaccine.
This year there have been more than 7,000 cases reported compared to just over 100 cases in the same period last year.
A whooping cough vaccination during pregnancy is the best way to protect your baby from the disease.

Queensland is currently experiencing a significant surge in whooping cough cases, posing a health risk to the community, particularly vulnerable infants.

In babies and infants this highly contagious respiratory infection, also known as pertussis, can lead to severe complications, including hospitalisation and even death.

From 1 January to 11 August 2024, there were 7,010 cases reported, compared to just 104 cases in the same period last year, representing a staggering 70-fold increase in cases.

Whooping cough is a cyclical disease which peaks every three to five years. During the last peak in 2019, there were only 937 cases of whooping cough reported for the same period.

Vaccination is the most effective way to reduce the risk of whooping cough and pregnant people are recommended to receive a whooping cough vaccine each pregnancy to reduce the risk of their baby becoming seriously ill with whooping cough.

Immunisation between weeks 20 and 32 of every pregnancy, offers crucial protection in the critical early months of life before babies can be vaccinated themselves, and is provided free under the national immunisation program.

According to the most recent Queensland Health data only 70.7 per cent of pregnant people in Queensland received a whooping cough vaccine in 2023.

Since 2020 when vaccination rates were 77.2 per cent, there has been a downward trend of pregnant women receiving a whooping cough vaccine.

The whooping cough vaccine is available for free under the National Immunisation Program during pregnancy, for children aged 2, 4, 6, and 18 months, and 4 years old, and for adolescents aged 11-13 years as part of the free Queensland School Immunisation Program.

Anyone under 20 who missed a childhood whooping cough vaccine can also access one for free.

In 2023, vaccination coverage for children was strong, with 92.72 per cent of one-year-olds, 91.47 per cent of two-year-olds, and 93.10 per cent of five-year-olds protected against whooping cough.

While these numbers are encouraging, it’s important to note that overall childhood vaccination rates have declined over the last few years. This decrease is also being seen nationally.

For more information and advice, please consult with your healthcare provider.

Quotes attributable to the Minister for Health, Mental Health and Ambulance Services and Minister for Women Shannon Fentiman:

“Whooping cases are soaring across the country, posing a serious threat to our youngest and most vulnerable Queenslanders.

“We know vaccinations save lives.

“The whooping cough vaccine is the best defense against this disease which can be life-threatening for young children.

“Vaccination during pregnancy is an effective way to protect babies until they are old enough to be vaccinated.

“This single action can dramatically reduce the risk of their baby contracting the potentially fatal disease.

“I want to urge all pregnant people to shield their babies by taking advantage of the free whooping cough vaccine during their pregnancy.”

Quotes attributable to Chief Health Officer Dr John Gerrard:

“Whooping cough is particularly severe in infants under 6 months of age and can be life-threatening.

“While we encourage all Queenslanders to ensure their vaccinations are up to date, it is especially crucial for pregnant women to be immunised to protect themselves and their babies.

“Remarkably, vaccinating pregnant women reduces the risk of babies contracting whooping cough by 75 per cent.

“We are committed working closely with healthcare providers and expectant mothers to achieve high vaccination rates in this vulnerable group.”

Quotes attributable to AMA Queensland President Dr Nick Yim

“Anyone who has seen a baby struggling to breathe with whooping cough will never forget that sight.

“Newborns cannot be vaccinated, which is why it is so important that everyone around them who can be vaccinated is.

“Vaccination during pregnancy gives newborns the greatest protection.

“We encourage all expecting parents to talk to their GP about vaccination.”

Quotes attributable to RACGP Queensland Chair Dr Cathryn Hester:

“Whooping cough is extremely contagious and babies under six months are at-risk of severe complications, and usually need to go to hospital.

“Thankfully, whooping cough can be prevented by vaccination, and the vaccine is recommended for people in contact with babies, and for those who are pregnant – having a vaccine while pregnant is the best way to protect you baby.

“I urge anyone who’s pregnant or has a baby to book an appointment with your GP and get vaccinated as soon as you can.”

Media contact: [email protected]

Background:

Whooping cough cases


<2months	<10	<10	<10	<10	<10	16
2m to <6months	25	<10	<10	<10	19	49
6m to <12months	28	<10	<10	<10	17	90
1 to 4	148	30	17	<10	71	470
5 to 9	442	104	10	<10	182	1496
10 to 19	478	118	27	13	394	3152
20 to 29	109	35	<10	<10	48	387
30 to 39	125	40	11	<10	53	300
40 to 49	156	52	<10	<10	59	399
50 to 64	160	60	<10	<10	51	395
65+	89	44	<10	12	31	256

Whooping cough vaccination rates for pregnant women

2020	77.2%
2021	74.5%
2022	70.9%
2023	70.7%

Whooping cough cases according to Hospital and Health Service


Cairns and Hinterland	317
Central Queensland	119
Central West	10
Darling Downs	755
Gold Coast	1249
Mackay	65
Metro North	1400
Metro South	1564
North West	25
South West	17
Sunshine Coast	865
Torres and Cape	77
Townsville	174
West Moreton	476
Wide Bay	233

For more information on notifiable conditions annual reporting please visit the Queensland Health website.

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The Anti-vaccination Movement: A Regression in Modern Medicine

Azhar hussain.

1 Medicine, Xavier University School of Medicine, Oranjestad, ABW

2 Psychology, Stony Brook University, Stony Brook, USA

Madiha Ahmed

3 Medicine, Touro College of Osteopathic Medicine, New York, USA

Sheharyar Hussain

4 Clinical Psychology, Teachers College, Columbia University, New York, USA

There have been recent trends of parents in Western countries refusing to vaccinate their children due to numerous reasons and perceived fears. While opposition to vaccines is as old as the vaccines themselves, there has been a recent surge in the opposition to vaccines in general, specifically against the MMR (measles, mumps, and rubella) vaccine, most notably since the rise in prominence of the notorious British ex-physician, Andrew Wakefield, and his works. This has caused multiple measles outbreaks in Western countries where the measles virus was previously considered eliminated. This paper evaluates and reviews the origins of the anti-vaccination movement, the reasons behind the recent strengthening of the movement, role of the internet in the spread of anti-vaccination ideas, and the repercussions in terms of public health and safety.

Introduction and background

Vaccines are one of the most important measures of preventative medicine to protect the population from diseases and infections. They have contributed to decreasing rates of common childhood diseases and, in some cases, have even wiped out some diseases that were common in years past, such as smallpox, rinderpest, and have nearly eradicated malaria and polio [ 1 ]. In fact, according to the World Health Organization’s Polio Global Eradication Initiative, the inactivated polio vaccine (IPV) will be used as a backbone for eradicating poliovirus in the next decade. However, there has been a recent rise in anti-vaccination sentiments surrounding beliefs that vaccines cause more harm than benefits to the health of the children who receive them. The premise of the anti-vaccination movement can also be contributed to the demonization of vaccinations by news and entertainment outlets. Voices such as Jenny McCarthy’s have proven to be influential, sweeping fear and distrust into parents’ minds by parading as “autism experts”. Social media and television talk show hosts, such as Oprah Winfrey, played a big role in this miseducation by giving credence to the campaign. This has caused vaccination rates to sustain a surprising drop in some Western countries [ 2 ]. The decrease in vaccinations has led to recent outbreaks of diseases that were thought to be “eliminated”, such as measles. Still, other reasons for the anti-vaccination movement can be due to personal reasons, such as religious or secular views. A drop in immunizations poses a threat to the herd immunity the medical world has worked hard to achieve. Global communities are now more connected than ever, which translates to a higher probability of the transmission of pathogens. The only thing that can protect populations against a rapidly spreading disease is the disease's resistance created by herd immunity when the majority are immune after vaccinations. Given the highly contagious nature of diseases like measles, vaccination rates of 96% to 99% are necessary to preserve herd immunity and prevent future outbreaks [ 3 ].

Origins of the anti-vaccination movement

Fear of vaccines and myths against them are not a new phenomenon. Opposition to vaccines goes as far back as the 18th century when, for example, Reverend Edmund Massey in England called the vaccines “diabolical operations” in his 1772 sermon, “The Dangerous and Sinful Practice of Inoculation” [ 4 ]. He decried these vaccines as an attempt to oppose God’s punishments upon man for his sins [ 5 ]. Similar religious opposition was seen in the “New World” even earlier, such as in the writings of Reverend John Williams in Massachusetts, who also cited similar reasons for his opposition to vaccines claiming that they were the devil’s work [ 6 ]. However, opposition against vaccines was not only manifested in theological arguments; many also objected to them for political and legal reasons. After the passage of laws in Britain in the mid-19th century making it mandatory for parents to vaccinate their children, anti-vaccine activists formed the Anti-Vaccination League in London. The league emphasized that its mission was to protect the liberties of the people which were being “invaded” by Parliament and its compulsory vaccination laws [ 7 ]. Eventually, the pressure exerted by the league and its supporters compelled the British Parliament to pass an act in 1898, which removed penalties for not abiding by vaccination laws and allowed parents who did not believe vaccination was beneficial or safe to not have their children vaccinated [ 8 ]. Since the rise and spread of the use of vaccines, opposition to vaccines has never completely gone away, vocalized intermittently in different parts of the world due to arguments based in theology, skepticism, and legal obstacles [ 9 ].

Anti-vaccination propaganda

While pushback against the measles vaccine due to fears of its connection to autism is the most recent example that comes to mind, there have been other instances of outbreaks of previously “extinct” diseases in modern times. One example is the refusal of some British parents to vaccinate their children in the 1970s and 1980s against pertussis in response to the publication of a report in 1974 that credited 36 negative neurological reactions to the whole-cell pertussis vaccine [ 10 ]. This caused a decrease in the pertussis vaccine uptake in the United Kingdom (UK) from 81% in 1974 to 31% in 1980, eventually resulting in a pertussis outbreak in the UK, putting severe strain and pressure on the National Health System [ 11 - 12 ]. Vaccine uptake levels were elevated to normal levels after the publication of a national reassessment of vaccine efficacy that reaffirmed the vaccine’s benefits, as well as financial incentives for general practitioners who achieved the target of vaccine coverage [ 13 ]. Disease incidence declined dramatically as a result.

The anti-vaccination movement was most strongly rejuvenated in recent years by the publication of a paper in The Lancet by a former British doctor and researcher, Andrew Wakefield, which suggested credence to the debunked-claim of a connection between the measles, mumps, and rubella (MMR) vaccine and development of autism in young children [ 14 ]. Several studies published later disproved a causal association between the MMR vaccine and autism [ 15 - 18 ]. Wakefield drew severe criticism for his flawed and unethical research methods, which he used to draw his data and conclusions [ 19 ]. A journalistic investigation also revealed that there was a conflict of interest with regard to Wakefield’s publication because he had received funding from litigants against vaccine manufacturers, which he obviously did not disclose to either his co-workers nor medical authorities [ 20 ]. For all of the aforementioned reasons, The Lancet retracted the study, and its editor declared it “utterly false” [ 21 ]. As a result, three months later, he was also struck off the UK Medical Registry, barring him from practicing medicine in the UK. The verdict declared that he had "abused his position of trust" and "brought the medical profession into disrepute" in the studies he carried out [ 22 ].

Repercussions of declining vaccination rates

The damage, however, was already done and the myth was spread to many different parts of the world, especially Western Europe and North America. In the UK, for example, the MMR vaccination rate dropped from 92% in 1996 to 84% in 2002. In 2003, the rate was as low as 61% in some parts of London, far below the rate needed to avoid an epidemic of measles [ 23 ]. In Ireland, in 1999-2000, the national immunization level had fallen below 80%, and in part of North Dublin, the level was around 60% [ 24 ]. In the US, the controversy following the publication of the study led to a decline of about 2% in terms of parents obtaining the MMR vaccine for their children in 1999 and 2000. Even after later studies explicitly and thoroughly debunked the alleged MMR-autism link, the drop in vaccination rates persisted [ 25 ].

As a result, multiple breakouts of measles have occurred throughout different parts of the Western world, infecting dozens of patients and even causing deaths. In the UK in 1998, 56 people contracted measles; in 2006, this number increased to 449 in the first five months of the year, with the first death since 1992 [ 26 ]. In 2008, measles was declared endemic in the UK for the first time in 14 years [ 27 ]. In Ireland, an outbreak occurred in 2000 and 1,500 cases and three deaths were reported. The outbreak was reported to have occurred as a direct result of a drop in vaccination rates following the MMR controversy [ 28 ]. In France, more than 22,000 cases of measles were reported from 2008 - 2011 [ 29 ]. The United States has not been an exception, with outbreaks occurring most recently in 2008, 2011, and 2013 [ 30 - 32 ].

Perhaps the most infamous example of a measles outbreak in the United States occurred in 2014-2015. The outbreak was believed to originate from the Disneyland Resort in Anaheim, California and resulted in an estimated 125 people contracting the disease [ 33 ]. It was estimated that MMR vaccination rates among the exposed population in which secondary cases have occurred might be as low as 50% and likely no higher than 86% [ 34 ]. Physicians in the region were criticized for deviating from the CDC's (Center for Disease Control and Prevention) recommended vaccination schedule and/or discouraging vaccination. As a result, California passed Senate Bill 277, a mandatory vaccination law in June 2015, banning personal and religious exemptions to abstain from vaccinations [ 35 ].

Technology and its effects on anti-vaccination movement

Access to medical information online has dramatically changed the dynamics of the healthcare industry and patient-physician interactions. Medical knowledge that was previously bound to textbooks and journals, or held primarily by medical professionals, is now accessible to the layman, which has shifted the power from doctors as exclusive managers of a patient's care to the patients themselves [ 36 ]. This has led to the recent establishment of shared decision-making between patients and healthcare physicians [ 37 ]. While this is beneficial in some ways, the dissemination of false and misleading information found on the internet can also lead to negative consequences, such as parents not giving consent to having their children vaccinated. When it comes to vaccines, the false information is plentiful and easy to find. An analysis of YouTube videos about immunization found that 32% opposed vaccination and that these had higher ratings and more views than pro-vaccine videos [ 38 ]. An analysis of MySpace blogs about HPV immunization found that 43% portrayed the immunization in a negative light; these blogs referenced vaccine-critical organizations and cited inaccurate data [ 39 ]. A similar study of Canadian internet users tracked the sharing of influenza vaccine information on social media networks, such as Facebook, Twitter, YouTube, and Digg. Of the top search results during the study period, 60% promoted anti-vaccination sentiments [ 40 ]. A study that examined the content of the first 100 anti-vaccination sites found after searching for “vaccination” and “immunization” on Google concluded that 43% of websites were anti-vaccination (including all of the first 10) [ 41 ].

Online anti-vaccination authors use numerous tactics to further their agendas. These tactics include, but are not limited to, skewing science, shifting hypotheses, censoring opposition, attacking critics, claiming to be “pro-safe vaccines”, and not “anti-vaccine”, claiming that vaccines are toxic or unnatural, and more [ 42 ]. Not only are these tactics deceitful and dishonest, they are also effective on many parents. A study that evaluated how effectively users assessed the accuracy of medical information about vaccines online concluded that 59% of student participants thought retrieved sites were entirely accurate; however, out of the 40 sites they were given, only 18 were actually accurate, while 22 were inaccurate. These sites were not evidence-based and argued vaccines were inherently dangerous without any merit-based argument. More than half of participants (53%) left the exercise with significant misconceptions about vaccines [ 43 ]. Research has also shown that viewing an anti-vaccine website for merely 5 - 10 minutes increased perceptions of vaccination risks and decreased perceptions of the risks of vaccine omission, compared to visiting a control site [ 44 ]. The study also found that the anti-vaccine sentiments obtained from viewing the websites still persisted five months later, causing the children of these parents to obtain fewer vaccinations than recommended [ 45 ]. The role of the online access to false anti-vaccination information just cannot be understated in examining the rise and spread of the anti-vaccination movement.

Ethical and legal issues regarding vaccination

Opposition to the MMR vaccine among parents leads to an ethical dilemma that can be analyzed using both medical ethics and moral principles. Medical ethics call for health professionals to abide by a code of bioethics upholding autonomy, non-maleficence, beneficence, and justice. The most relevant in mandating vaccinations are autonomy and non-maleficence [ 46 ]. Patients are entitled to the right to refuse vaccination using “our children, our choice” based on their autonomy, while health care providers are morally obligated to treat everyone with non-maleficence and avoiding harm to society at all costs.

At the individual level, religion is a common reason to refuse vaccination. The MMR vaccine specifically has been the cause of instigating debate among the Hindu, Protestant, Orthodox Jewish, and Jehovah’s Witness communities. Specific religious views on vaccines in general, however, are not normally the cause for debate but instead the components of the MMR vaccine [ 47 ]. The MMR vaccine, combined with the rubella vaccine, was originally derived from the cells of aborted fetal tissue. Hindu, Protestant, Muslim, and Jewish communities are generally opposed to abortion for moral reasons based on religious teachings; thus, individuals from these beliefs may cite religious reasons for filing vaccine exemptions. Further, the MMR vaccine contains porcine gelatin as a stabilizer, a means for ensuring effective storage. The porcine ingredients are unlike gelatins used for oral consumption and purified down to small peptides, commonly used in medicine capsules as well [ 48 ]. As there is a wide range of practice preferences in every religion, some individuals belonging to religions, such as Judaism, Islam, and Hinduism (to name a few), may be opposed to injecting a porcine product into their body along with the vaccine [ 47 ]. Further, other religious views, such as the ones held by Dutch-Protestant Christian congregations, consider vaccinations “inappropriate meddling in the work of God”. These groups, therefore, believe that we should not change the predestined fate of someone who becomes ill [ 49 ].

While exercising autonomy and refusing vaccination is valid for sensitive personal issues, it will cause more harm than good if a certain percentage of the population does not get vaccines causing the immunization rate to fall below the herd immunity threshold. This threshold varies in every disease. The development of vaccines is considered one of the greatest strides made in medicine due to the enormous benefits to an entire population. From an ethics perspective, achieving herd immunity and minimizing the amount of “freeloaders” is in the best interest of society as a whole [ 48 - 49 ].

Further, studies liken the decision to object to vaccinations to military service drafts. For the conscientious objectors, military duty and receiving a vaccine hold the same costs: liberty, personal risk, and utility in terms of time [ 41 ]. Naturally, the costs of military duty are more taxing and demand more from an individual than receiving a vaccine. In terms of herd immunity and depending on the severity of impending diseases, these costs are ones that they should incur for the benefit of themselves as well as society.

At the forefront of the legal complications lies the state-regulated vaccinations for all children attending school. Anti-vaccination proponents argue that this is an infringement upon autonomy; however, public health policymakers justify their actions using rule utilitarianism. Rule utilitarianism is the ideology that a rule for society should be established that has the best outcome for the greatest amount of people in the society. In addition to this, John Stuart Mill’s essay, “On Liberty”, explains the Harm Principle that is often used to justify mandated infectious disease control methods, including vaccines [ 50 ]. The Harm Principle justifies interfering with autonomy and individual liberties, against their will, if it is done so as to prevent harm to others. An example of this was seen in California in 2014-2015 after an outbreak of measles led to the passing of Senate Bill 277 calling for state-mandated vaccinations for everyone - no personal exemptions. The root of the problem, however, was most likely to be contributed to Wakefield’s fraudulent findings striking the fear of a vaccination-autism link in parents, which led to an all-time low rate of people receiving the MMR vaccine. The hoax has been called the most damaging medical hoax in 100 years after bringing about outbreaks of diseases otherwise eradicated [ 8 - 9 , 11 ].

In the times that we have achieved herd immunity, there remain two questions then. Can legal exemptions still be justified? And should these exemptions be limited to religious reasons or should they include secular reasoning as well [ 21 , 25 ]? Most scientists and medical experts suggest that exemptions should only even be considered if society is well within the limits for herd immunity. As for the religious versus secular debate, it is difficult to ignore secular objections as most of them are rooted in spiritual or holistic personal views [ 6 , 47 ]. Since herd immunity is cumulative, the ability to waive immunizations is concluded to be difficult but not impossible. If the waivers are given to a small number of individuals who sincerely need them rather than ones who are inconvenienced by them, waivers may be ethically and legally sound.

Conclusions

The rise of anti-vaccination movements in parts of the Western world poses a dire threat to people’s health and the collective herd immunity. People of all ages have fallen victim to recent outbreaks of measles, one of the most notable “eliminated” diseases that made a comeback as a direct consequence of not reaching the immunization threshold for MMR vaccines. These outbreaks not only put a strain on national healthcare systems but also cause fatal casualties. Therefore, it is of the utmost importance that all stakeholders in the medical world - physicians, researchers, educators, and governments - unite to curb the influence of the anti-vaccination movement targeting parents. Research has shown that even parents favorable to vaccination can be confused by the ongoing debate, leading them to question their choices. Many parents lack basic knowledge of how vaccines work, as well as access to accurate information explaining the importance of the process. Furthermore, those with the greatest need for knowledge about vaccination seem most vulnerable to this information. Further, we must effectively combat the wrongful demonization of vaccinations through social media and news media platforms. A qualitative study that explored how parents respond to competing media messages about vaccine safety concluded that personal experiences, value systems, and level of trust in health professionals are essential to parental decision making about immunization. Therefore, to combat the anti-vaccination movement, there must be a strong emphasis on helping parents develop trust in health professionals and relevant authorities, educating them on the facts and figures, debunking the myths peddled by the anti-vaccination movements, and even introducing legislation that promotes vaccination, if not mandating it.

Acknowledgments

We would like to thank Dr. Alice Anne Brunn, Ph.D., Associate Professor of Psychiatry and Ethics, and Chairman of Behavioral Sciences and Ethics Department, as well as Dr. Xenia Sotiriou, Ph.D., Assistant Professor of Behavior Science and Ethics at St. Matthew’s University School of Medicine.

The content published in Cureus is the result of clinical experience and/or research by independent individuals or organizations. Cureus is not responsible for the scientific accuracy or reliability of data or conclusions published herein. All content published within Cureus is intended only for educational, research and reference purposes. Additionally, articles published within Cureus should not be deemed a suitable substitute for the advice of a qualified health care professional. Do not disregard or avoid professional medical advice due to content published within Cureus.

The authors have declared that no competing interests exist.

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Published: 28 August 2024

Health and economic impacts of Lassa vaccination campaigns in West Africa

David R. M. Smith ORCID: orcid.org/0000-0002-7330-4262 1 na1 ,
Joanne Turner ORCID: orcid.org/0000-0002-0258-2353 2 , 3 na1 ,
Patrick Fahr 4 ,
Lauren A. Attfield 5 , 6 ,
Paul R. Bessell 7 ,
Christl A. Donnelly ORCID: orcid.org/0000-0002-0195-2463 6 , 8 , 9 ,
Rory Gibb 5 ,
Kate E. Jones 5 ,
David W. Redding 10 ,
Danny Asogun 11 ,
Oladele Oluwafemi Ayodeji 12 ,
Benedict N. Azuogu 13 ,
William A. Fischer II ORCID: orcid.org/0000-0002-4900-098X 14 ,
Kamji Jan 15 ,
Adebola T. Olayinka 15 ,
David A. Wohl 14 ,
Andrew A. Torkelson ORCID: orcid.org/0009-0009-4126-1374 16 ,
Katelyn A. Dinkel ORCID: orcid.org/0009-0003-1445-8565 16 ,
Emily J. Nixon 2 ,
Koen B. Pouwels ORCID: orcid.org/0000-0001-7097-8950 1 &
T. Déirdre Hollingsworth 17 , 18

Nature Medicine ( 2024 ) Cite this article

Metrics details

Epidemiology
Health care economics
Outcomes research
Viral infection

Lassa fever is a zoonotic disease identified by the World Health Organization (WHO) as having pandemic potential. This study estimates the health-economic burden of Lassa fever throughout West Africa and projects impacts of a series of vaccination campaigns. We also model the emergence of ‘Lassa-X’—a hypothetical pandemic Lassa virus variant—and project impacts of achieving 100 Days Mission vaccination targets. Our model predicted 2.7 million (95% uncertainty interval: 2.1–3.4 million) Lassa virus infections annually, resulting over 10 years in 2.0 million (793,800–3.9 million) disability-adjusted life years (DALYs). The most effective vaccination strategy was a population-wide preventive campaign primarily targeting WHO-classified ‘endemic’ districts. Under conservative vaccine efficacy assumptions, this campaign averted $20.1 million ($8.2–$39.0 million) in lost DALY value and $128.2 million ($67.2–$231.9 million) in societal costs (2021 international dollars ($)). Reactive vaccination in response to local outbreaks averted just one-tenth the health-economic burden of preventive campaigns. In the event of Lassa-X emerging, spreading throughout West Africa and causing approximately 1.2 million DALYs within 2 years, 100 Days Mission vaccination averted 22% of DALYs given a vaccine 70% effective against disease and 74% of DALYs given a vaccine 70% effective against both infection and disease. These findings suggest how vaccination could alleviate Lassa fever’s burden and assist in pandemic preparedness.

Lassa fever is a viral hemorrhagic disease endemic to West Africa, where infections are common but widely undetected. Lassa fever is caused by Lassa mammarenavirus (LASV), and several lines of evidence, including detailed genomic analyses, suggest that the vast majority of human LASV infections are caused by zoonotic transmission from the Natal multimammate mouse ( Mastomys natalensis ) 1 , 2 . The virus can also spread through human-to-human contact, although this has predominantly been observed in healthcare settings with inadequate infection prevention and control practices 3 .

Most LASV infections are thought to be asymptomatic or cause only mild febrile illness 4 , but Lassa fever nonetheless has a large negative impact on population health and economies. Among patients presenting to hospital, the case–fatality ratio is estimated to be approximately 15%, and long-term sequelae, such as bilateral sensorineural hearing loss, are common in survivors of Lassa fever 5 , 6 . Monetary costs per hospitalization are estimated to be high and are often paid (partly) out of pocket by patients 7 . For example, a study from Nigeria found that the average patient’s out-of-pocket expenditure on Lassa fever treatment was approximately 480% of the monthly minimum wage in 2011 (ref. 8 ).

No licensed vaccines against Lassa fever are currently available, although several candidates are under development. A recent phase 1 randomized trial of a measles-vectored Lassa vaccine showed an acceptable safety and tolerability profile, a substantial increase in LASV-specific non-neutralizing IgG concentrations and a moderate T cell response 9 , in line with the response observed in non-human primates 10 . Several other vaccines are currently at early stages of development, with five phase 1 trials and one phase 2 trial registered by October 2022 (ref. 11 ).

Lassa fever is listed by the World Health Organization (WHO) as one of the diseases posing the greatest risk to public health due to its epidemic potential and the absence of effective countermeasures 12 . In response to such concerns, in 2022, the Group of Seven forum, the Group of Twenty forum and various international governments endorsed the 100 Days Mission, a pandemic response roadmap aiming at the delivery of vaccines within 100 d of the emergence of novel pathogens with pandemic potential 13 .

In anticipation of one or more Lassa vaccine candidates being licensed in the near future, in the present study, we estimate the current health-economic burden of Lassa fever in West Africa and project the potential impacts of different reactive and preventive vaccination campaigns. We also project potential impacts of vaccination in line with the 100 Days Mission in response to the emergence of ‘Lassa-X’, a hypothetical future variant of LASV with pandemic potential. Table 1 summarizes our main findings and their implications for public policy.

Model overview

We developed an epidemiological model projecting human Lassa fever burden over a 10-year time horizon across the 15 countries of continental West Africa (Benin, Burkina Faso, Côte d’Ivoire, The Gambia, Ghana, Guinea, Guinea-Bissau, Liberia, Mali, Mauritania, Niger, Nigeria, Senegal, Sierra Leone and Togo) and their 183 level 1 subnational administrative units. These units have different names in different countries (for example, regions in Guinea, counties in Liberia and departments in Benin) but herein are collectively referred to as ‘districts’. Due to large gaps in Lassa fever surveillance and limited case reporting throughout much of its endemic range 3 , we favored a bottom-up modeling approach, synthesizing best available ecological, epidemiological, clinical and economic data to project the cumulative health and economic burden of disease.

Our model consists of six main components (see model schematic in Extended Data Fig. 1 ). First, a previously published geospatial risk map was used to predict the risk of zoonotic LASV transmission from M. natalensis to humans (‘spillover’) at the level of 0.05° × 0.05° spatial pixels throughout West Africa 14 . Second, modeled spillover risk estimates were used as inputs in a generalized linear model (GLM) to predict human LASV seroprevalence. Third, modeled human LASV seroprevalence estimates were used as inputs in a serocatalytic model including country-level population projections to predict spillover infection incidence. Fourth, spillover infections were aggregated at the district level, and a stochastic branching process model was used to simulate onward human-to-human LASV transmission. Fifth, a computational algorithm was applied retrospectively to spillover infections and ensuing transmission chains to simulate a range of reactive and preventive vaccination campaigns and to project the number of infections averted by vaccination. (Separate model components used to simulate Lassa-X transmission and vaccination are described below.) Sixth, modeled estimates of LASV infection, and of infections averted due to vaccination or occurring in vaccinated individuals, were used as inputs in a probabilistic decision-analytic model used to project the health burden of Lassa fever and associated economic costs and the health and economic burden averted due to vaccination over 10 years.

Lassa fever burden

Our model predicts a heterogeneous distribution of zoonotic LASV infection throughout West Africa (Fig. 1 ). In the absence of vaccination, the mean annual number of LASV infections throughout the region was estimated at 2.7 million (95% uncertainty interval (UI): 2.1–3.4 million) or 27.2 million (20.9–34.0 million) over the full 10-year simulation period (Extended Data Table 1 ). Just over half of all infections occurred in Nigeria (mean, 52.9%), and the vast majority (mean, 93.7%) resulted from zoonotic spillover as opposed to human-to-human transmission, due to LASV’s low estimated basic reproduction number ( R 0 ). At the district level, annual LASV infection incidence was highest in Margibi, Liberia (1,198 (943–1,475) infections per 100,000 population), followed by Denguélé, Côte d’Ivoire (1,032 (880–1,200) per 100,000 population) and Nasarawa, Nigeria (978 (803–1,162) per 100,000 population). Over 10 years, LASV infection throughout West Africa led to an estimated 5.4 million (2.7–9.9 million) mild/moderate symptomatic cases, 237,000 (148,600–345,600) hospitalizations and 39,300 (12,900–83,300) deaths, resulting in 2.0 million (793,800–3.9 million) disability-adjusted life years (DALYs). See Supplementary Appendix E for more detailed estimates of Lassa fever burden.

Top, map showing the classification of Lassa fever endemicity for different countries and ‘districts’, as defined by the US CDC and the WHO (Supplementary Appendix C.2 ). Middle, the median annual incidence of zoonotic LASV infection per 100,000 population as estimated by our model at the level of 5-km grid cells. Bottom, the median total annual number of zoonotic LASV infections as estimated by our model at the level of 5-km grid cells.

Over 10 years, Lassa fever treatment was projected to incur $338.9 million ($206.6–$506.3 million) in government-reimbursed treatment costs and $166.9 million ($116.0–$289.3 million) in out-of-pocket medical costs, resulting in catastrophic expenditures for 232,300 (145,600–338,700) individuals and pushing 167,000 (104,700–243,600) individuals below the international poverty line (Supplementary Tables E.3 and E.4 ). Missed work due to illness totaled $1.1 billion ($380.5 million–$2.2 billion) in productivity losses, primarily due to mortality in actively employed adults. Productivity losses outranked treatment costs in driving an estimated $1.6 billion ($805.1 million–$2.8 billion) in total cumulative societal costs. Hospitalization costs, not outpatient costs, were the main driver of treatment costs, but mild to moderate disease in the community resulted in greater productivity losses than severe disease in hospital (Supplementary Fig. E.2 ). Lassa fever DALYs were valued at $287.7 million ($115.4–$562.9 million) using country-specific cost-effectiveness thresholds. Finally, an alternative measure of Lassa fever’s economic burden, the value of statistical life (VSL) lost due to Lassa fever mortality, was projected at $15.3 billion ($5.0–$32.4 billion). Uncertainty in health-economic outcomes was primarily driven by uncertainty in risks of hospitalization and death (Supplementary Fig. D.2 )

Simulating Lassa vaccination campaigns

Vaccination is introduced into the population via a series of six scenarios designed to reflect realistic assumptions about vaccine stockpile, administration and efficacy (Extended Data Table 2 ). In all six scenarios, we include reactive vaccination, in which Lassa fever outbreaks trigger the local deployment of a limited vaccine stockpile in affected districts. In scenarios 2–6, we also include preventive vaccination in the form of mass, population-wide campaigns rolled out over 3 years and focusing primarily on regions classified as Lassa fever ‘endemic’. The 15 countries included in our model are categorized as high endemic, medium endemic or low endemic according to classifications published by the US Centers for Disease Control and Prevention (CDC), and districts within high-endemic countries are further classified as endemic or non-endemic according to classifications published by the WHO (Fig. 1 and Supplementary Appendix C.2 ). Two main mechanisms of vaccine efficacy are considered: protection against infection prevents individuals from acquiring LASV infection from either M. natalensis or other humans, and protection against disease prevents vaccinated individuals who become infected from progressing to disease, thus averting outpatient consultation, hospitalization, chronic sequelae and death. In our simulations, we project impacts of a vaccine that is 70% or 90% effective only against disease or 70% or 90% effective against both infection and disease. We do not consider other potential mechanistic impacts of vaccination, such as reduced infectiousness or altered behavior among vaccinated individuals, as such factors are less relevant given low estimated rates of human-to-human LASV transmission.

Health-economic impacts of vaccination against Lassa fever

The considered vaccination scenarios varied considerably in their projected impacts, with scenario 4 leading to the greatest reductions in Lassa fever burden over 10 years (Extended Data Fig. 2 and Table 2 ). In this scenario, in addition to reactive vaccination triggered in districts experiencing local outbreaks, preventive vaccination was administered to 80% of the population in WHO-classified endemic districts as well as to 5% of the population in all other districts throughout West Africa. For a vaccine 70% effective against disease with no impact on infection, over 10 years this strategy averted a mean 456,000 (226,400–822,700) mild/moderate symptomatic cases, 19,900 (12,700–28,800) hospitalizations, 3,300 (1,100–7,000) deaths and 164,100 (66,700–317,700) DALYs. Over this period, this strategy further prevented 19,800 (12,600–28,500) and 14,200 (9,000–20,500) individuals, respectively, from experiencing catastrophic or impoverishing out-of-pocket healthcare expenditures and averted $128.2 million ($67.2–$231.9 million) in societal costs, or $1.3 billion ($436.8 million–$2.8 billion) in VSL lost.

Other vaccination scenarios used fewer doses of vaccine and, in turn, averted less of Lassa fever’s health-economic burden. Scenario 3, which limited preventive vaccination to high-endemic countries, was the scenario resulting in the second greatest health-economic benefits, including the aversion of 141,400 (57,600–273,200) DALYs and $112.8 million ($59.2–$203.8 million) in societal costs. Scenarios 2, 5 and 6 varied considerably in terms of which individuals were vaccinated but ultimately resulted in similar cumulative health-economic benefits across the region, because the overall number of doses delivered under each scenario was essentially the same. By contrast, scenario 1 included only reactive and not preventive vaccination, averting just 13,700 (5,500–26,800) DALYs and $10.3 million ($5.3–$18.8 million) in societal costs, thus having approximately one-tenth the overall health-economic benefits of scenario 4.

A vaccine effective against infection in addition to disease was found to have moderately increased impact. In scenario 4, for instance, $20.1 million ($8.2–$39.0 million) in DALY value was averted by a vaccine 70% effective only against disease, whereas $27.1 million ($11.0–$52.5 million) was averted when also 70% effective against infection (Table 2 ). By comparison, a vaccine 90% effective only against disease averted $25.8 million ($10.5–$50.1 million) in DALY value (Supplementary Table E.9 ), having similar impact to a vaccine 70% effective against both infection and disease. In the best-case scenario of a vaccine 90% effective against both infection and disease, scenario 4 averted up to 3.1 million (2.4–3.7 million) infections, 240,100 (97,500–464,900) DALYs valued at $29.5 million ($12.0–$57.2 million) and $1.9 billion ($638.5 million–$4.1 billion) in VSL lost.

Geographic variation in vaccine impact depended primarily on which districts were classified as endemic and, hence, targeted for vaccination (Extended Data Fig. 2 ). Overall impacts of vaccination were greatest in Nigeria, but impacts per 100,000 population were greatest in other endemic countries (Guinea, Liberia and Sierra Leone), because Nigeria had a larger number of individuals but a smaller share of its total population living in districts classified as endemic. In turn, approximately 16% of the total population of Nigeria and 33% of the combined population of Guinea, Liberia and Sierra Leone were vaccinated by 10 years under scenarios 3 and 4 (Fig. 2 ). Given a vaccine 70% effective only against disease, these scenarios averted 10.5% of DALYs in Nigeria, 20.3% of DALYs in Liberia, 23.6% of DALYs in Guinea and 28.1% of DALYs in Sierra Leone. For a vaccine 90% effective against infection and disease, these scenarios averted 15.3% of DALYs in Nigeria, 29.4% of DALYs in Liberia, 34.1% of DALYs in Guinea and 40.7% of DALYs in Sierra Leone.

a , Share of the total population vaccinated by 10 years in each vaccination scenario ( x axis) and aggregated across three geographic levels ( y axis). b , Share of cumulative DALYs due to Lassa fever averted over 10 years by vaccination. Impacts vary greatly depending on the vaccination scenario ( x axis), the assumed vaccine efficacy ( y axis) and the geographic location (panels).

Threshold vaccine costs

Projected economic benefits of Lassa vaccination were used to calculate the threshold vaccine cost (TVC). This can be interpreted as the maximum cost per dose at which vaccination has a benefit-to-cost ratio above 1, in the specific context of our modeled vaccination campaigns and corresponding dosage assumptions (that is, a single-dose primary series followed by a single-dose booster after 5 years, with 10% dose wastage). TVCs were similar across all five preventive campaigns (scenarios 2–6) but lower for reactive vaccination (scenario 1) (Supplementary Table E.12 ). Estimated TVCs ranged from $0.51 ($0.30–$0.80) to $21.15 ($7.28–$43.97) depending on the economic perspective considered, the vaccination campaign evaluated and the vaccine’s efficacy against infection and disease. TVCs were lowest from the perspective considering only healthcare costs and monetized DALYs (range of means, $0.51–$0.91) but more than doubled given a perspective considering all societal costs (healthcare costs and productivity losses) in addition to monetized DALYs ($1.18–$2.20) and increased by more than 20-fold when considering healthcare costs and VSL ($10.54–$21.15).

Modeling ‘Lassa-X’

In addition to our analysis of Lassa fever, we modeled the emergence of ‘Lassa-X’, a hypothetical future variant of LASV with pandemic potential due to both elevated clinical severity and increased propensity for human-to-human transmission. In this analysis, Lassa-X was assumed to emerge in humans after a single spillover event, where the probability of emergence in each district is directly proportional to the estimated share of all zoonotic LASV infections occurring in each district. We assumed that prior LASV immunity, whether natural or vaccine derived, offers no protection against Lassa-X. We conceptualized Lassa-X as having Ebola-like transmission characteristics and, under baseline assumptions, a 10-fold increase in hospitalization risk relative to Lassa fever. Lassa-X transmission parameters were quantified using Ebola case data from the 2013/2016 West Africa epidemic, resulting in simulated Lassa-X outbreaks lasting for approximately 2 years before subsiding. A range of reactive 100 Days Mission vaccination scenarios were then evaluated, considering different delays to vaccine initiation, rates of vaccine uptake and degrees of efficacy against infection and disease. Finally, as for Lassa fever, we used a probabilistic decision-analytic model to project the health and economic burden of Lassa-X and burden averted as a result of vaccination.

Projected burden of Lassa-X

Under our modeling assumptions, the emergence of Lassa-X led to explosive outbreaks throughout West Africa (Fig. 3 ), spreading to 88.3% (63.9%–94.0%) of the 183 districts included in our model (Supplementary Fig. F.1 ). In total, there were 1.7 million (230,100–4.2 million) Lassa-X infections, and Nigeria accounted for by far the greatest share of infections, followed by Niger and Ghana (Supplementary Tables G.1 and G.2 ). The projected burden of Lassa-X infection was associated with a high degree of uncertainty, driven predominantly by the highly stochastic nature of simulated outbreaks (Supplementary Fig. G.2 ).

a – c , Maps of West Africa showing, for each district: the population size ( a ), the probability of Lassa-X spillover ( b ) and the mean cumulative number of Lassa-X infections over the entire outbreak (approximately 2 years) ( c ). d , e , The second row depicts the median cumulative incidence of Lassa-X infection over the entire outbreak ( d ) and the median cumulative incidence over the entire outbreak per 100,000 population in the absence of vaccination ( e ). Interquartile ranges are indicated by error bars ( n = 10,000). f , The total number of Lassa-X infections over time in six selected countries in one randomly selected outbreak simulation in which the initial Lassa-X spillover event occurred in Niger (the red dot highlights the initial detection of the epidemic at time 0). Lines show how a vaccine with 70% efficacy against infection and disease influences infection dynamics, where line color represents the delay to vaccine rollout, and line dashing represents the rate of vaccination (the proportion of the population vaccinated over a 1-year period). g , The mean cumulative number of deaths averted due to vaccination over the entire outbreak and across all countries, depending on vaccine efficacy (panels), the rate of vaccination ( x axis) and the delay to vaccine rollout (colors). Interquartile ranges are indicated by error bars ( n = 10,000). yr, year.

In our baseline analysis, Lassa-X resulted in 149,700 (19,700–374,400) hospitalizations and 24,800 (2,400–76,000) deaths, causing 1.2 million (132,500–3.7 million) DALYs valued at $191.1 million ($18.4–$575.2 million). Out-of-pocket treatment costs were estimated at $118.5 million ($12.2–$317.3 million), resulting in catastrophic healthcare expenditures for 147,400 (18,500–372,500) individuals and pushing 103,100 (13,600–254,300) individuals below the poverty line. Lassa-X also resulted in $737.2 million ($56.4 million–$2.4 billion) in productivity losses to the greater economy and $10.1 billion ($625.9 million–$34.1 billion) in VSL lost. In alternative scenarios where Lassa-X infection was just as likely or one-tenth as likely to result in hospitalization as LASV infection, estimates of the health-economic burden were approximately one and two orders of magnitude lower, respectively (Supplementary Table G.4 ).

Vaccination to slow the spread of Lassa-X

Impacts of vaccination on the health-economic burden of Lassa-X depend on the delay until vaccination initiation, the rate of vaccine uptake in the population and the efficacy of vaccination against infection and/or disease (Table 3 ). In the most ambitious vaccination scenario considered, vaccine administration began 100 d after initial detection of the first hospitalized case of Lassa-X at a rate equivalent to 40% of the population per year across all countries in West Africa. Assuming a vaccine 70% effective only against disease, this vaccination scenario averted 276,600 (38,000–755,900) DALYs. However, in contrast to LASV vaccination, vaccine impact was more than three-fold greater when effective against infection as well as disease. For a vaccine 70% effective against both, this most ambitious vaccination scenario averted 1.2 million (201,300–2.7 million) infections and 916,400 (108,000–2.6 million) DALYs, representing approximately 74% of the DALY burden imposed by Lassa-X. Vaccinating at half the rate (20% of the population per year) averted approximately 55% of the DALYs imposed by Lassa-X, whereas vaccinating at a low rate (2.5% of the population per year) averted just 11% of DALYs (Supplementary Tables G.5 – G.8 ). Benefits of delivering vaccines at a higher rate outweighed benefits of initiating vaccination earlier (100 d versus 160 d from outbreak detection), which, in turn, outweighed benefits of a vaccine with greater efficacy against infection and disease (90% versus 70%).

This is, to our knowledge, the first burden of disease study for Lassa fever and the first to project impacts of Lassa vaccination campaigns on population health and economies 15 . We estimated that 2.1–3.4 million human LASV infections occur annually throughout West Africa, resulting in 15,000–35,000 hospitalizations and 1,300–8,300 deaths. These figures are consistent with recent modeling work estimating 900,000–4.4 million human LASV infections per year 14 and an annual 5,000 deaths reported elsewhere 3 , 16 . We further estimated that Lassa fever causes 2.0 million DALYs, $1.6 billion in societal costs and $15.3 billion in lost VSL over 10 years. Our modeling suggests that administering Lassa vaccines preventively to districts of Nigeria, Guinea, Liberia and Sierra Leone that are currently classified as ‘endemic’ by the WHO would avert a substantial share of the burden of disease in those areas. In our most expansive rollout scenario, in which vaccine reaches approximately 80% of individuals in endemic districts and 5% of individuals elsewhere over a 3-year period, a vaccine 70% effective against disease is projected to avert 164,000 DALYs, $128 million in societal costs and $1.3 billion in VSL lost over 10 years. This corresponds to a 10.5% reduction in Lassa fever DALYs in Nigeria given vaccination among 16.1% of the population and a 24.4% reduction in DALYs across Guinea, Liberia and Sierra Leone given vaccination among 33.3% of the population. However, for the same rollout scenario, a vaccine 90% effective against both infection and disease could avert 240,000 DALYs, $188 million in societal costs and $1.9 billion in VSL lost, corresponding to a 15.3% reduction in Lassa fever DALYs in Nigeria and a 35.3% reduction across Guinea, Liberia and Sierra Leone.

Impacts of the Lassa vaccination campaigns included in our analysis were modest in countries other than Nigeria, Guinea, Liberia and Sierra Leone. This is due primarily to these simulated campaigns reflecting a constrained global vaccine stockpile (<20 million doses annually) and, hence, limited allocation to districts not currently classified as endemic by the WHO. Although our most optimistic vaccination scenario was projected to prevent as many as 1.9 million (62%) infections in endemic-classified districts (Supplementary Fig. E.4 ), these areas cover just shy of 10% of the approximately 400 million individuals living in West Africa. However, our model predicts high Lassa fever incidence and disease burden in several ‘non-endemic’ areas. This is consistent with seroprevalence data highlighting extensive underreporting of LASV infection across the region, particularly in Ghana, Côte d’Ivoire, Burkina Faso, Mali, Togo and Benin 14 , 17 , 18 , 19 . Underreporting of Lassa fever is likely due to a combination of limited surveillance resources in affected countries, the mild and non-specific symptom presentation of most cases, seasonal fluctuations in infection incidence coincident with other febrile illnesses (malaria in particular) and stigma associated with infection, making robust estimation of Lassa fever burden a great challenge 20 . Conversely, low case numbers in some areas estimated to be suitable for transmission 21 may reflect truly limited burden, driven, in part, by significant spatiotemporal heterogeneity in LASV infection prevalence and the low dispersal rate of M. natalensis 22 .

It is important to put Lassa fever’s projected health-economic burden and impacts of vaccination in context, in particular given limited economic resources available for investment in infectious disease prevention in West Africa and, hence, opportunity costs to investing in Lassa vaccination in lieu of other interventions. In Nigeria in 2021, we estimated an annual 48 (95% UI: 19–93) Lassa fever DALYs per 100,000 population. This compares to previous estimates for various emerging, neglected and vaccine-preventable diseases, including trachoma (22 DALYs per 100,000 population in Nigeria in 2019), yellow fever (25), rabies (34), lymphatic filariasis (54), intestinal nematode infections (63), diphtheria (80) and typhoid fever (93) 23 . We further predicted mean TVCs up to $2.20 per dose for preventive campaigns when considering societal costs and monetized DALYs. A global costing analysis across 18 common vaccines estimated a per-dose cost of $2.63 in low-income countries from 2011 to 2020, including supply chain and service delivery costs 24 , suggesting that it may be feasible to achieve a maximum price per dose in line with our TVC estimates. However, real-world costs for any potential forthcoming vaccines are not yet known, and it is important to consider that vaccines currently undergoing clinical trials have distinct dosage regimens 11 and that our TVC estimates are specific to our model assumptions: a single-dose primary series with a booster dose after 5 years and 10% dose wastage. All else being equal, undiscounted TVC estimates for preventive campaigns would be roughly doubled or reduced by one-third, respectively, for a vaccine not requiring a booster dose or one requiring a two-dose primary series.

The real-world cost-effectiveness of any forthcoming Lassa vaccine will depend not only on its dosage, price and clinical efficacy, estimates of which are not yet available, but also on the alternative interventions available. Novel small-molecule antivirals and monoclonal antibodies are in various stages of development 25 , 26 and may represent promising alternatives for prevention of severe Lassa fever. Our results further highlight how the choice of perspective can lead to divergent conclusions regarding vaccine cost-effectiveness 27 . For instance, TVCs were roughly one order of magnitude greater when considering VSL instead of societal costs and monetized DALYs, up to $21.15 from $2.20 per dose. This disparity is consistent with a comparative analysis of health risk valuation, highlighting greatest TVC estimation when using VSL 28 . Although our estimates of vaccine-averted DALYs, societal costs and lost VSL may complement one another to inform priority setting and decision-making 29 , caution is needed when comparing and potentially combining distinct economic metrics (and, hence, perspectives). In particular, the value inherent to VSL may encapsulate both economic productivity and health-related quality of life, so VSL must be considered independently of productivity losses and monetized life-years. Ultimately, defining the full value of vaccination in endemic areas will require ongoing engagement and priority setting across stakeholders 30 and may benefit from considering broader macroeconomic impacts of vaccination not included in our analysis 31 . However, even if a particular vaccine is identified as a priority by local stakeholders and is predicted to be cost-effective using context-specific willingness-to-pay thresholds and an appropriate perspective, investment will be possible only if vaccination is affordable—that is, if sufficient economic resources are available to cover vaccine program costs.

One major potential benefit to present investment in Lassa vaccination is increased readiness to rapidly develop and deploy vaccines against future LASV variants with pandemic potential. The coronavirus disease 2019 (COVID-19) pandemic demonstrated that prior research on coronaviruses and genetic vaccine technologies gave researchers an important head start on COVID-19 vaccine development in early 2020 (ref. 32 ). In this context, we projected impacts of ambitious vaccination campaigns in response to the emergence of a hypothetical novel LASV variant with pandemic potential. Although it is impossible to predict whether ‘Lassa-X’ will evolve and exactly which characteristics it would have, this modeling represents a plausible scenario for its emergence and spread, totaling, on average, 1.7 million infections, 150,000 hospitalizations and 25,000 deaths over roughly 2 years, resulting in 1.2 million DALYs, $1.1 billion in societal costs and $10.1 billion in VSL lost. We estimate that a vaccine 70% effective against infection and disease, with delivery starting 100 d from the first detected case, could avert roughly one-tenth of Lassa-X’s health-economic burden assuming delivery of approximately 10 million doses per year, or up to three-quarters of its burden given 160 million doses per year. Such ambitious vaccination scenarios are in keeping with the stated goals of the 100 Days Mission 13 , representing an expansive global effort to rapidly respond to emerging pandemic threats. In contrast to LASV, vaccination against Lassa-X was more than three-fold more impactful when blocking infection in addition to disease, due to indirect vaccine protection successfully slowing its explosive outbreak dynamics.

This work has several limitations. First, our projections of Lassa fever burden build upon recent estimates of spillover risk and viral transmissibility but do not account for the potential evolution of these parameters over time, for instance, due to projected impacts of climate change 22 . Second, our model appears to overestimate the magnitude of seasonal fluctuations in incidence, potentially biasing not the total number of infections but, rather, how they are distributed through time. Although peaks in Lassa fever risk during the dry season are well observed, including five-fold greater risk estimated in Nigeria 33 , a large outbreak in Liberia during the rainy season in 2019/2020 highlights that LASV nonetheless circulates year-round 34 . Third, in assuming no LASV seroreversion among previously infected people, our model potentially underestimates the number of infections occurring annually. However, fitting the infection–hospitalization ratio to hospital case data from Nigeria limits the sensitivity of model outcomes to this assumption. Fourth, our evaluation of the economic consequences of Lassa-X is conservative, as we do not account for the exportation of cases outside of West Africa nor potential externalities of such a large epidemic, including negative impacts on tourism and trade, and the oversaturation and potential collapse of healthcare services. Fifth, because poor Lassa fever knowledge has been reported among both healthcare workers and the general population in several endemic areas 35 , 36 , increased awareness resulting from vaccination campaigns could have positive externalities not considered in our analysis, including the adoption of infection prevention behaviors and timelier care-seeking. Conversely, poor Lassa fever knowledge could limit vaccine uptake, posing challenges to reaching the vaccine coverage targets considered here.

Finally, for both LASV and Lassa-X, we do not stratify risks of infection, hospitalization or death by sex or age, and infections in each country are assumed to be representative of the general population in terms of age, sex, employment and income. Seroepidemiological data from Sierra Leone show no clear association between antibodies to LASV and age, sex or occupation 37 , and studies from hospitalized patients in Sierra Leone and Nigeria show conflicting relationships between age and mortality 3 , 38 , 39 . Prospective epidemiological cohort studies, such as the ongoing Enable program, will help to better characterize Lassa fever epidemiology—including the spectrum of illness, extent of seroreversion and risk factors for infection and disease—in turn informing future modeling, vaccine trial design and intervention investment 40 . In particular, better quantification of risk in groups thought to be at high risk of infection (for example, healthcare workers) and severe disease (for example, pregnant women) will help to inform targeted vaccination strategies, which are likely to be more cost-effective than the population-wide campaigns considered in our analysis. Nevertheless, a recent stakeholder survey highlights that the preferred vaccination strategy among Lassa fever experts in West Africa is consistent with the vaccine scenarios considered here—that is, mass, proactive campaigns immunizing a wide range of people in high-risk areas—with corresponding demand forecasts reaching up to 100 million doses 41 .

Our analysis suggests that vaccination campaigns targeting known Lassa fever hotspots will help to alleviate the large health-economic burden caused by this disease. However, expanding vaccination beyond WHO-classified ‘endemic’ districts will be necessary to prevent the large burden of disease estimated to occur in neighboring areas not currently classified as endemic. Improved surveillance is greatly needed to better characterize the epidemiology of Lassa fever across West Africa, helping to inform the design of vaccination campaigns that maximize population health by better targeting those at greatest risk of infection and severe outcomes. In the hypothetical event of a novel, highly pathogenic pandemic variant emerging and devastating the region, our modeling also suggests that the ambitious vaccination targets of the 100 Days Mission could have critical impact, helping to prevent up to three-quarters of associated health-economic burden. The probability of such a variant evolving is exceedingly difficult to predict, but investment in Lassa vaccination now could nonetheless have great additional health-economic value if facilitating a more rapid vaccine response in the event of a pandemic Lassa-related virus emerging.

Inclusion and ethics

This modeling study did not involve the collection or use of any primary individual-level patient data; thus, ethics approval was not necessary. This study included local researchers throughout the research process, including stakeholder meetings, expert feedback and manuscript revision from Lassa fever researchers in regions where Lassa fever is endemic. These researchers are included as co-authors.

Zoonotic LASV transmission

The incidence of LASV spillover was estimated by extending a previously published geospatial risk model by Basinski et al. 14 (details in Supplementary Appendix A ). In brief, this model synthesizes environmental features, M. natalensis occurrence data and LASV seroprevalence data from both rodents and humans to predict rates of zoonotic LASV infection across West Africa. Environmental features were obtained as classification rasters from the Moderate Resolution Imaging Spectroradiometer dataset, including 11 landcover features and seasonally adjusted measures of temperature, rainfall and vegetation. Occurrence data include historical captures of M. natalensis confirmed with genetic methods or skull morphology across 167 locations in 13 countries from 1977 to 2017. Rodent seropositivity data cover 13 studies testing M. natalensis for LASV across six countries from 1972 to 2014, and human seropositivity data cover 94 community-based serosurveys across five countries from 1970 to 2015.

Consistent with Basinski et al. 14 , we used a GLM to predict human seroprevalence from modeled estimates of spillover risk at the level of 0.05° × 0.05° spatial pixels. To estimate incidence rates, a Susceptible–Infected–Recovered model was used to model transitions among susceptible (seronegative), infected (seropositive) and recovered (seropositive) states. To account for change in human population size over time, this model was augmented with data on per-capita human birth and death rates for each country for each year from 1960 to 2019. Using a forward Euler model with 4-week timesteps, we estimated the number of new infections in each timestep that reproduced modeled seroprevalence estimates in 2015 and stepped this forward to estimate infections in 2019, dividing by the 2019 population size to give the 2019 incidence rate in each pixel 42 . Uncertainty in human LASV seroprevalence from the GLM was propagated forward to generate uncertainty in spillover incidence. Final non-aggregated estimates of spillover incidence from our model (at the pixel level) are shown in Fig. 1 , and aggregated estimates at the district level are shown in Supplementary Fig. B.1 . Estimates of spillover incidence in endemic districts are shown in Supplementary Figs. B.2 and B.3 .

Human-to-human transmission

We developed a stochastic branching process model to simulate infections arising from human-to-human transmission after spillover infection (Supplementary Appendix C.1 ). To account for uncertainty in estimated annual spillover incidence, 99 distinct transmission simulations were run, with each one using as inputs a set of LASV spillover estimates corresponding to a particular centile. Each set contains 183 values (one for each district), and the same values are used for each of the 10 years of simulation.

To account for seasonality observed in Lassa fever case reports, annual incidence estimates are distributed across each epidemiological year according to a beta distribution, as considered previously in Lerch et al. 43 . An outbreak tree was generated for each spillover event using an estimate of LASV’s basic reproduction number from the literature ( R 0 = 0.063) 43 , estimated from case data from a Lassa fever ward in Kenema Government Hospital, Sierra Leone, from 2010 to 2012 (ref. 44 ). Infections in each outbreak tree are distributed stochastically through time following estimates of LASV’s incubation and infectious periods 43 , and final outbreak trees are combined to generate the daily incidence of human-source infection in each district in the absence of vaccination. See Supplementary Table C.1 for LASV infection and transmission parameters.

Lassa vaccination campaigns

We included six vaccination scenarios in which limited doses of vaccine are allocated across specific subpopulations of West Africa (see Extended Data Table 2 and Supplementary Appendix C.2 for more details). Vaccine doses are allocated preferentially to populations perceived to be at greatest risk of Lassa fever—that is, those living in districts classified as Lassa fever endemic by the WHO 45 . In some scenarios, a small number of additional doses are allocated to non-endemic districts. In ‘constrained’ scenarios, the total number of vaccine doses is constrained to reflect limited capacity to produce, stockpile and deliver vaccine. For these scenarios, cholera is used as a proxy disease for assumptions relating to vaccine stockpile and target coverage based on recent campaigns in West Africa.

In our vaccination scenarios developed with these constraints in mind, we considered both reactive vaccination (targeting specific districts in response to local outbreaks) and preventive vaccination (mass vaccinating across entire countries or districts regardless of local transmission patterns). Vaccination was assumed to confer immunity for 5 years after a single-dose primary series, with a single-dose booster administered 5 years after the initial dose. Vaccination was applied in the model by ‘pruning’ zoonotic infections and ensuing person-to-person transmission chains—that is, by retrospectively removing infections directly and indirectly averted as a result of vaccination (see Supplementary Appendix C.3 for more details). We did not consider potential side effects of vaccination.

Health-economic burden of Lassa fever

A decision-analytic model describing the clinical progression of Lassa fever was developed to project the health and economic burden of disease and impacts of vaccination (Supplementary Appendix D.1 ). Inputs into this model from our spillover risk map and branching process transmission model include, for each year, district and vaccination scenario: the total number of LASV infections, the number of infections averted due to vaccination and the number of infections occurring in vaccinated individuals. The latter is included to account for vaccine preventing progression from infection to disease (Supplementary Appendix D.2 ). Probability distributions for model parameters were estimated using data from the literature and are described in detail in Supplementary Appendix D.3 . In brief, probabilities of hospitalization and death were estimated from reported hospital case data in Edo and Ondo, Nigeria, from 2018 to 2021; durations of illness before and during hospitalization were estimated from a prospective cohort study in a hospital in Ondo from 2018 to 2020; and hospital treatment costs were estimated from patients attending a specialist teaching hospital in Edo from 2015 to 2016 (Supplementary Table D.1 ) 5 , 8 , 38 .

Model outcomes

Lassa fever health outcomes estimated by our model include mild/moderate symptomatic cases, hospitalized cases, deaths, cases of chronic sequelae (sensorineural hearing loss) after hospital discharge and DALYs. Economic outcomes include direct healthcare costs paid out of pocket or reimbursed by the government, instances of catastrophic or impoverishing out-of-pocket healthcare expenditures, productivity losses, monetized DALYs and the VSL lost (a population-aggregate measure of individuals’ willingness to pay for a reduction in the probability of dying) 46 . We report societal costs as the sum of healthcare costs and productivity losses. All monetary costs are reported in 2021 international dollars ($), and future monetary costs are discounted at 3% per year. Impacts of vaccination are quantified from outputs of the health-economic model as the difference in projected outcomes across parameter-matched runs of the model with and without vaccination.

To calculate the TVC, we first summed relevant monetary costs for each simulation according to the economic perspective considered: healthcare costs and monetized DALYs, societal costs and monetized DALYs or healthcare costs and VSL. The TVC is then calculated as the monetary costs averted due to vaccination divided by the number of vaccine doses allocated, including booster doses and wasted doses, and discounting future vaccine doses at 3% per year.

In addition to our analysis of Lassa fever, we consider the emergence of ‘Lassa-X’, a hypothetical future variant of LASV with pandemic potential due to both elevated clinical severity and increased propensity for human-to-human transmission. We assume that the clinical characteristics of Lassa-X are identical to Lassa fever (including sequelae risk and hospital case–fatality ratio), except that Lassa-X is accompanied by a 10-fold increase in risk of hospitalization relative to Lassa fever. Then, to conceive plausible scenarios of Lassa-X transmission informed by empirical data, we assume that the inherent transmissibility of Lassa-X resembles that of Ebola virus during the 2013/2016 West Africa outbreak 47 , 48 . Ebola virus transmission was chosen as a surrogate for Lassa-X transmission because, like LASV, Ebola virus is a single-stranded RNA virus known to cause outbreaks in West Africa, results in frequent zoonotic spillover to humans from its animal reservoir, causes viral hemorrhagic fever and spreads from human to human primarily through contact with infectious bodily fluids. Based on this conceptualization of Lassa-X, we use a five-step approach to model its emergence and subsequent geospatial spread across West Africa and to estimate the health-economic impacts of reactive ‘100 Days Mission’ vaccination campaigns (described in detail in Supplementary Appendix F ).

Simulation and statistical reporting

For each of 99 runs of the LASV transmission model and 100 runs of the Lassa-X transmission model, health-economic outcomes were calculated via 100 Monte Carlo simulations, in which input parameters for the health-economic model were drawn probabilistically from their distributions (Supplementary Table D.1 ). In our base case, we assumed that the vaccine is 70% effective only against disease. However, we also included scenarios with vaccine that is 90% effective against disease, 70% effective against both infection and disease and 90% effective against both infection and disease. Final health and economic outcomes, as well as outcomes averted by vaccination, are reported as means and 95% UIs across all simulations over the 10-year time horizon of the model. In sensitivity analysis, we considered a 0% discounting rate, a lower risk of developing chronic sequelae subsequent to hospital discharge and either the same or lower hospitalization risk for Lassa-X relative to LASV. We also conducted a univariate sensitivity analysis to identify the parameters driving outcome uncertainty (see Supplementary Appendix D.4 for more details). Estimates of Lassa fever burden are reported in accordance with the Guidelines for Accurate and Transparent Health Estimates Reporting (GATHER) statement. A GATHER checklist is provided in Supplementary Appendix H .

Role of the funder

The Coalition for Epidemic Preparedness Innovations (CEPI) commissioned this analysis, and CEPI internal Lassa fever experts were involved in study design by providing knowledge on input parameters and fine-tuning realistic scenarios for vaccine rollout. An earlier version of this work was provided as a report to CEPI.

Reporting summary

Further information on research design is available in the Nature Portfolio Reporting Summary linked to this article.

Data availability

The minimum dataset required to run our code and reproduce results is available at https://doi.org/10.5281/zenodo.12751191 (ref. 49 ).

Code availability

The code underlying our model is available at https://doi.org/10.5281/zenodo.12751191 (ref. 49 ). Data were collected, compiled, analyzed and simulated using R version 4.3.3. Simulations were dispatched using HTCondor version 10.0.4.

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Acknowledgements

This work was conducted by the OxLiv Consortium and funded by the Coalition for Epidemic Preparedness Innovations (CEPI) through Vaccine Impact Assessment project funding. We acknowledge the CEPI project team (project lead: A. Deol and project co-lead: C. Mukandavire) for their continuous support and helpful discussions and the project’s external advisory team for their invaluable feedback. T.D.H. thanks the Li Ka Shing Foundation for institutional funding. K.B.P. is supported by the Medical Research Foundation (MRF-160-0017-ELP-POUW-C0909). C.A.D. is funded by the National Institute for Health Research (NIHR) Health Protection Research Unit (HPRU) in Emerging and Zoonotic Infections (200907), a partnership among the United Kingdom Health Security Agency (UKHSA), the University of Liverpool, the University of Oxford and the Liverpool School of Tropical Medicine. D.W.R. is supported by a Medical Research Council (MRC) UK Research and Innovation (UKRI)/Rutherford Fellowship (MR/R02491X/1 and MR/R02491X/2) and a Sir Henry Dale Research Fellowship (funded by the Wellcome Trust and the Royal Society) (220179/Z/20/Z and 220179/A/20/Z). This research was supported by the Quantitative and Modelling Skills in Ecology and Evolution (QMEE) Centre for Doctoral Training (CDT), funded by Natural Environment Research Council (NERC) grant NE/P012345/1 (L.A.A.); the MRC Centre for Global Infectious Disease Analysis (L.A.A. and C.A.D.); the HPRU in Emerging and Zoonotic Infections (C.A.D.) and the Trinity Challenge (the Sentinel Forecasting project) (K.E.J., R.G. and D.W.R.). D.A.W. is funded by the National Institutes of Health (National Institute of Allergy and Infectious Diseases: R01AI135105). We would like to thank A. Lerch for personal communications and for providing code that inspired our LASV transmission model. We thank M. Todd from Dreaming Spires for assisting in optimizing the speed of our stochastic branching process model for Lassa. We acknowledge I. Smith, Head of Research Software Engineering at University of Liverpool IT Services, for his help running simulations using HTCondor. We thank A. Desjardins and A. Borlase for early discussions on Lassa dynamics, N. Salant for beta testing our code and C. Nunes-Alves for providing helpful comments on an earlier draft. The views expressed are those of the authors and not necessarily those of the institutions with which they are affiliated.

Author information

These authors contributed equally: David R. M. Smith, Joanne Turner.

Authors and Affiliations

Nuffield Department of Population Health, Health Economics Research Centre, University of Oxford, Oxford, UK

David R. M. Smith & Koen B. Pouwels

Department of Mathematical Sciences, University of Liverpool, Liverpool, UK

Joanne Turner & Emily J. Nixon

Department of Livestock and One Health, Institute of Infection, Veterinary and Ecological Sciences, University of Liverpool, Liverpool, UK

Joanne Turner

Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK

Patrick Fahr

Department of Genetics, Evolution and Environment, Centre for Biodiversity and Environment Research, University College London, London, UK

Lauren A. Attfield, Rory Gibb & Kate E. Jones

Department of Infectious Disease Epidemiology, Imperial College London, London, UK

Lauren A. Attfield & Christl A. Donnelly

Independent consultant, Edinburgh, UK

Paul R. Bessell

Department of Statistics, University of Oxford, Oxford, UK

Christl A. Donnelly

Pandemic Sciences Institute, University of Oxford, Oxford, UK

Science Department, The Natural History Museum, London, UK

David W. Redding

Irrua Specialist Teaching Hospital, Irrua, Nigeria

Danny Asogun

Federal Medical Centre, Owo, Nigeria

Oladele Oluwafemi Ayodeji

Alex Ekwueme Federal University Teaching Hospital Abakaliki, Abakaliki, Nigeria

Benedict N. Azuogu

Institute for Global Health and Infectious Diseases, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, NC, USA

William A. Fischer II & David A. Wohl

Nigeria Centre for Disease Control and Prevention, Abuja, Nigeria

Kamji Jan & Adebola T. Olayinka

Linksbridge SPC, Seattle, WA, USA

Andrew A. Torkelson & Katelyn A. Dinkel

Big Data Institute, Li Ka Shing Centre for Health Information and Discovery, University of Oxford, Oxford, UK

T. Déirdre Hollingsworth

Nuffield Department of Medicine, NDM Centre for Global Health Research, University of Oxford, Oxford, UK

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Contributions

D.R.M.S. and J.T. contributed equally to this work and share first authorship, and E.J.N., K.B.P. and T.D.H. contributed equally to this work and share senior authorship. E.J.N., K.B.P. and T.D.H. conceived of the study and acquired funding. A.A.T. administered the project. D.A., O.O.A., B.N.A., W.A.F., K.J., A.T.O. and D.A.W. provided expert input on Lassa fever epidemiology. L.A.A. and D.W.R. developed the methods to estimate zoonosis incidence, which C.A.D., R.G. and K.E.J. supervised. E.J.N., K.B.P. and T.D.H. supervised all other aspects of the study. J.T. developed the branching process model and pruning algorithm, with support from D.R.M.S. D.R.M.S. developed the health-economic model, with support from P.F., developed the Lassa-X model and prepared final results, figures and tables, with support from J.T. and P.R.B. The original draft was written by D.R.M.S., J.T., P.F., C.A.D., A.A.T., E.J.N., K.B.P. and T.D.H. All authors reviewed, edited and approved the final draft.

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Extended data

Extended data fig. 1 model schematic..

See Methods for details and Supplementary figure D.1 for a schematic of the decision-analytic model describing disease progression. Pruning in step 5a refers to retrospectively removing infections averted due to vaccination from simulated transmission chains. LASV = Lassa virus .

Extended Data Fig. 2 Impacts of a Lassa vaccine effective against infection and disease.

( A ) The mean cumulative number of LASV infections averted due to vaccination across the 15 countries included in the model, comparing vaccine efficacy against infection and disease of 70% (blue) versus 90% (red) across the six considered vaccination scenarios (panels). 95% uncertainty intervals are indicated by shading. ( B ) The mean cumulative number of infections averted over ten years under each vaccination scenario in the four countries classified as high-endemic (Guinea, Liberia, Nigeria and Sierra Leone). 95% uncertainty intervals are indicated by error bars (n = 9,900). ( C ) The mean cumulative incidence of infections averted over ten years per 100,000 population under each vaccination scenario in the same four countries. 95% uncertainty intervals are indicated by error bars (n = 9,900). ( D ) The mean daily number of infections averted by a vaccine with 70% efficacy against infection and disease over the first three years of vaccine rollout, in three distinct districts under four selected vaccination scenarios. 95% uncertainty intervals are indicated by shading.

Supplementary information

Supplementary appendices a–i, figs. b and d–g and tables c–e, g and h., reporting summary, rights and permissions.

Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ .

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Smith, D.R.M., Turner, J., Fahr, P. et al. Health and economic impacts of Lassa vaccination campaigns in West Africa. Nat Med (2024). https://doi.org/10.1038/s41591-024-03232-y

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DOI : https://doi.org/10.1038/s41591-024-03232-y

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Ethics of mandatory COVID-19 vaccination

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Attitudes on voluntary and mandatory vaccination against COVID-19: Evidence from Germany

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Measures: Preferences toward vaccination against COVID-19

Sample selection, weighting, and item non-response

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Willingness to get vaccinated and attitudes toward a policy of mandatory vaccination

Attitudes toward a policy of mandatory vaccination

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