The prospect of safe and effective vaccines against COVID-19 is good news for everyone towards the end of a grim year. Of course, caution is still advisable with as yet no certainty as to how long the vaccine might work or whether there might be adverse side effects for certain groups. There are also a host of ethical issues that need to be addressed.
This blog was jointly written by Dave Archard, Chair of the Nuffield Council on Bioethics, and Susan Tansey, Council member and independent Consultant Pharmaceutical Physician.
One of these is whether there is a case for making vaccination mandatory. It might be thought that the biggest risk in the roll out of a vaccine would be a tumultuous rush to the vaccination centres. Yet a significant number of people are distrustful of vaccines in general and the prospective COVID-19 ones in particular. In the USA nearly half of the population would refuse to have the jab. In the UK vaccine hesitancy is not as widespread but it is significant and may be growing. Given that any vaccine has less than 100% efficacy and that a certain level of population immunity is needed to secure the health of everyone, it is important to be sure that enough people will be prepared to have the vaccine. Should we use measures to compel vaccination compliance?
The recently published joint statement of the Standing Committee on Vaccination (STIKO), the German Ethics Council, and the National Academy of Sciences Leopoldina on the ethical and legal framework for administration of a COVID-19 vaccine is absolutely clear that ‘undifferentiated, general compulsory vaccination can be ruled out.’ That is because it is incompatible with a requirement of informed individual consent that derives from the key principle of self-determination. This view seems generally to be shared by other guidelines on access to a vaccine. Yet if the vaccine is safe and effective, and if we can agree that the loss of life and the suffering caused by the pandemic is huge, then why wouldn’t we strive by any practicable means to ensure people do get vaccinated? Why wouldn’t be it ok to balance the loss of individual freedom against the enormous gains in public health?
The 2007 Nuffield Council on Bioethics report on public health argued for a ‘stewardship’ model of the duty any government has to provide conditions that allow people to be healthy. This goes beyond a simple liberal harm principle that allows limitations of individual liberty only to prevent harms to others, but, nevertheless, it would seek to minimise such interventions. In the case of vaccination, the report argues that what it calls quasi-mandatory measures (ones that attach penalties of some form to non-compliance) might be justified in two circumstances: ‘First, for highly contagious and serious diseases, for example, with characteristics similar to smallpox. Secondly, for disease eradication if the disease is serious and if eradication is within reach.’ From what we know, COVID-19 is less serious (in the general population) and less contagious than measles, which we certainly do not think of as requiring mandatory vaccination. But with a general presumption in favour of individual liberty, the onus of justification falls on those who would favour mandatory measures. At the very least it has to be shown that the costs of the interventions that limit freedom are outweighed by the gains of using such measures over merely relying on voluntary compliance.
Care here is needed in appealing to examples that are argued to be ones where we already allow coercive measures to serve the public good. Liberal societies have introduced conscription to fight wars that threaten their future. But conscientious objection is normally allowed, and we can easily imagine individuals who could give convincing reasons for their objection to being vaccinated. It is also not clear how far we can compare COVID-19 to an aggressive war by an enemy who threatens the continued existence of your society. Taxation is enforced for what is sometimes called ‘fair play’ reasons, that is to prevent people from unfairly free riding, namely enjoying the public benefits tax revenue secures without paying their own contribution. I might be happy to pay my share of the costs of a health service but not undergo a vaccination.
So why should we not go for an incentivisation scheme? It might be more effective than relying on people freely agreeing to vaccination but not have the worrying moral costs of mandatory measures. Indeed, Julian Savulescu has argued in a recent article in the Journal of Medical Ethics in favour of making payments to individuals to encourage uptake of the vaccine. It is an interesting argument not least because it does help us to see some of the problems with such an approach. One such problem is indicated in the public health report. Incentives of modest value might be ineffective, but ‘higher-value incentives might lead people to take risks they might not wish to take had no incentive been provided.’ There is a huge and fascinating philosophical literature on what are called ‘coercive offers.’ Threats (‘Your money or your life’) do coerce, but so perhaps do some offers whose terms appear to leave the other person with as little choice as the victim of the highway robber. A much-discussed example is that of a prison governor who offers prisoners a commuting of their life sentences if they agree to take part in a medical experiment of unknown risks. Might a very high payment similarly coerce agreement to be vaccinated? Would those in desperate economic circumstances see the offer as ‘Have the jab and get enough for you and your family to eat?’ The fact that some people are in such circumstances may be down to unjustified social and economic inequality. But we cannot simply wish this context away.
We also need to know what justifies the payment. Is it that it is owed to anyone who takes the risks associated with the vaccine, or is that it simply incentivises taking the vaccine? How we answer makes a difference to how much we pay: enough to induce compliance or proportionate to the risk. And it would differ across individuals according to their attitude to vaccination, their susceptibility to certain risks, and their economic situation. How much do we pay a rich individual who is ill-disposed to vaccines and how much to a poor person who is already willing to be vaccinated? Or to someone desperate enough to gamble on the risks they think they are taking? Hard bargains can easily be negotiated by those who can exaggerate their vaccine hesitancy. Unreasonable agreements may be made by those in bad circumstances.
Crucially, we should only think about non-voluntary vaccination schemes when we have addressed the reasons there might be for vaccine hesitancy. For instance, there is evidence of what has been called a ‘pandemic of social media panic’ that travels faster than COVID-19. If we can effectively prevent the transmission of false information, at the same time as we provide people with trustworthy, clear and comprehensive information about COVID-19 and the vaccines, then we may ensure the degree of public confidence in vaccination that is needed. The public health report uses the example of the 1998 Lancet article on the alleged links between the MMR vaccine and autism that led to a significant loss of confidence in the vaccine. The report enjoins those who report research to do so responsibly. Yet that might not be enough when irresponsibility lies with those who use social media. It would be a significant move to use the law to block fake vaccination news, as has been proposed. Yet the threats to freedom envisaged are surely far less those of mandatory measures to secure vaccination compliance and have none of the possible costs of an incentivisation scheme.
We want people freely to have the jab and to do so for the right reasons. That is just as important as ensuring that the jab they take is safe and effective.
Banning false information about vaccines is likely to be counterproductive. A sense that information is being suppressed will lead to less trust, not more. It will play into narratives that there is a secret agenda.
Moreover, to present this as the solution assumes that people who currently have concerns are clearly factually wrong. But most likely for many people, their concerns currently are quite reasonable- this is a different situation to measles or other vaccines, as even if the data is bulletproof, it is undeniably limited in the number of people tested on, and the length of time tested. It is a novel vaccine. The vaccine hesitant are as likely to have different values, risk assessment, or personal circumstances as they are to be misinformed (a recent CDC survey said nearly 40% of US healthcare workers are themselves hesitant for example). A 20 year old, who lives with other 20 year olds, and who has already had COVID, might reasonably think that any risk, however small, is not worth it.
As for your concerns about payment, the original article puts this in the context where the alternative is to offer it for free. That is, we are already so convinced of its safety that we are happy for everyone to take it. In that light the highway robbery analogy is a little hysterical. The risks they 'think' they are taking is really irrelevant- it is the risks they actually are taking that count.
The final conclusion- that the reasons for taking the vaccine are as important as its safety and efficacy is rhetorically nice, but hopefully meaningless. Personally, I would much rather be held down and given a safe vaccine than I would joyfully consent to a vaccine that it turns out ultimately destroys my health.
However, I think everyone is wrong here. For me as a pro-vaccine, but COVID vaccine hesitant person, I think the relevant issue here is compensation for any harms that do arise. Those who got narcolepsy from Swine Flu faced a years long battle to get it recognised and approved for compensation. No doubt the same would be true for this were any issues to arise. (however unlikely it is that they will)
Trust has been eroded over many decades. if you want to get it back , treat patients better. Don't dismiss hesitancy as victims of fake news. Don't assume that side effects are unrelated until the victims have been forced to spend years fighting for recognition.
Many thanks for this thoughtful comment. Vaccine hesitancy might for some be reasonable. But if significant numbers refuse the vaccine on unreasonable grounds it is worth asking what might be done. Of course, trust is crucial and there is much more that can and should be done to promote it. We must also be wary of increasing suspicion of official policy. But in a public health emergency the spread of false rumours can have awful consequences. We think that if the banning of dangerously false views is what is needed, then the loss of freedom of speech is certainly no more morally costly than resorting to mandatory measures of vaccination.
The highway robbery example but more relevantly the converse offer example was intended to show that payment for something with risks may be accepted by people desperate to avoid the consequences of having little or no money. And we know that the pandemic has dramatically worsened the situation of many already badly off groups.
Of course, no-one consents to something that has terrible consequences. But then we should only consent with full information of what is involved. And not everyone would be happy to be tied down for their own good!
Quite incredible that ‘compulsory’ is even in the debate. Even more incredible.... less than a handful of comments to this noteworthy article.
What it means for individuals to give fully informed voluntary consent to participate in challenge trials is an important issue and is certainly worth considering. It goes beyond the question of voluntarily agreeing to be vaccinated with a vaccine that has been approved as safe and effective. However, when we don't as yet know the long-term effects of the new vaccines - which have been developed very fast - it is worth emphasising that agreement to be vaccinated cannot be done with the same degree of knowledge as is the case with other established vaccines. There will be a lot of data on short-term safety since the size of studies for the COVID vaccines are very much larger than similar studies in the past carried out with new vaccines and submitted for approval.
As a former Council member, I am pleased to see you addressing these issues.
As an immunologist I am very much in favour of vaccination. From what has been shown so far the C19 vaccines are effective and safe. However, the safety can only be shown after treating much greater numbers of recipients over a longer time.
Experience with side-effects of Flu vaccines in past years show is that it is not possible to give any assurance and risk-benefit analysis has to be weighed.
Also when compulsion was used in the UK for smallpox in the 19th century it was counter productive and uptake was improved by allowing fee choice.
Therefore I would argue strongly against compulsory vaccination and especially with any new vaccine.
Widespread and well informed PR is essential to achieving maximum uptake.
It is not vaccination per se that is bothering some, it is the speed at which mRNA vaccines have been developed, having been on the pharma shelf for 25+ years.
mRNA vaccines have never received Regulatory approval for use in humans, never ever. Therefore, no track record for regulators to go off.
It is a theory still to be proven. The theory suggests the patient's body (host) can manufacture the virus itself from the virus's genetic code in the vaccine, which then prompts an immune response - it is a kind of immunotherapy, where it is very difficult to predict the effect of foreign DNA in a patient's body.
Then there is the fact the vaccine is a biologic - sensitive to changes in tempature, processing methods and sources of supply.
They are the same as biosimilars (generic drug equivalent - copy of the original) and very few are being approved in the prescription drug world. Those that are typically take 5+ years to get approved.
The mega ethical question is, IMHO, should drug developers be allowed to test their own products behind closed doors?
Interesting issue of safety first to voluntariness but what about volonteers...in vaccine trials...