There is no vaccine against SARS-CoV-2 – the virus causing the global COVID-19 pandemic. However, dozens of potential vaccines are in the early stages of development. While there may be a long road ahead, many have pinned their hopes on an effective vaccine as a way to end the crisis.
The search for a coronavirus vaccine poses a host of bioethical dilemmas – who should be included in clinical trials? Should volunteers be deliberately exposed to the virus to accelerate vaccine testing? Who should be prioritised if vaccine stocks are limited? Could it ever be mandatory?
We spoke to leading bioethics expert, Dr Arthur Caplan of the New York University Langone Medical Center, about the moral dilemmas that lie ahead.
Is it ethical to expose volunteers to coronavirus during a research study?
There are a lot of promises about how soon a vaccine could be ready. I don’t think it’s doable unless we find some way to speed up the normal process of demonstrating safety and efficacy. Usually, there are animal studies, then small safety trials and eventually studies with 20,000 – maybe 40,000 – people. Researchers wait for nature to show whether the vaccine gives a sufficient response when people encounter the virus.
That can take years, especially with coronavirus because there is not so much of it in the community right now. The alternative is challenge trials: volunteers can be given the virus in known doses to determine the response. You get an answer within months rather than years.
Should researchers conduct challenge trials of coronavirus vaccines?
I favour doing them [challenge trials]. It’s important that participants are observed closely and are near a hospital where they could receive the best possible care if needed. This can be justified if they are volunteers who are competent and understand the risks.
You would take younger people with lower risk of consequences – even though we don’t know the long-term impact. If a vaccine is safe and effective, it might become morally justifiable to include higher risk groups, such as older people.
Is it acceptable to include children in research trials?
For coronavirus vaccines, I wouldn’t recruit children right now until I had demonstrated efficacy in 20 to 50 year olds. Then you might work your way down, but I wouldn’t expect to see newborns or pregnant women until the end when we know a lot about the vaccine and more about the disease. It made sense to include kids and pregnant women in Zika trials with long term follow-up because they were the at-risk group. It’s not the same for children and coronavirus.
A case can be made for recruiting older people. There is a worry that they won’t build an immune response or that they might need more than the standard dose.
How might coronavirus vaccine development shape public trust in science?
Speed is important in a highly infectious pandemic. However, if you’re seen as cutting corners, or something goes wrong in manufacturing – there will be trouble. People might turn away from other vaccines. Vaccines are very safe. But there is always a risk of manufacturing glitches when producing huge volumes of a new vaccine. We saw it in the US with a swine flu vaccine in 1976 – it was a disaster, nobody would take it. So, it’s not just a question of getting the research right, manufacturing also has to be scaled up with great care.
Then there’s the complex communication problem. We don’t know how effective a vaccine needs to be to roll it out. I’m a bit nervous about some of the hype around how quickly a vaccine will be available and how effective it will be for those who need it. It might not be 100% effective but could still be well worth rolling out – communicating this and preserving public trust is vital.
From a global perspective, who should get the first batches of coronavirus vaccine?
When we had the H1N1 pandemic, a lot of samples used to develop vaccines were in Indonesia. The government felt they might not get the vaccine or that might have to wait in line behind the US and Europe where a lot of the manufacturing capacity was. They decided not to send samples to the WHO and others until they had a commitment that they’d get vaccines when they arrived.
Today, we already see politicians – including in the US and the UK – making noise about getting first shot at the vaccine. It doesn’t necessarily make sense to prioritise your own population, but that’s probably what will happen. It should go where the need is greatest. In some cases it might even be wiser to have a ring of protection around countries with major outbreaks – helping to contain a new global wave of cases – but that takes coordination.
Could this be organised or agreed at a global level?
It could, but I fear we’re going to see a lot of nationalism driving the international distribution. There’s nobody with the authority to enforce a global approach.
Within each country, who should be prioritised?
There will be an initial shortage – nobody will unveil 2 billion doses overnight. It will come in a trickle, then a stream. For me, the fairer distribution is to try to save the most lives and to control the spread.
Healthcare workers and first responders, and those in healthcare – including cleaners and truckers working in distribution – are essential. You need a health system, and to protect food supplies. The elderly are most at risk and should be high on the list. So too are teachers and daycare staff because they are essential to getting people back to work. Some politicians will argue that the political elite are essential.
At the peak of the pandemic, difficult ethical decisions were made about access to ventilators, does that same thinking apply to vaccination?
For access to ventilators or dialysis, we had a lot of difficult conversations and age was a factor. I always stressed that we need to use resources effectively and efficiently – there’s no point using a ventilator for someone who can’t respond.
It’s a bit different for preventative measures (such as vaccines). A vaccine might keep nursing home residents alive – you are likely to get a much better impact by vaccinating vulnerable people.
What if the vaccine is more effective in younger people?
It depends how big the difference is; the algorithm can become very complex. To complicate matters further, the vaccine might require two or three shots. This poses a huge manufacturing challenge but also raises questions about fairness – would one person receive three doses and another person receive none? The answer might depend on how effective a single dose is. This is already playing out with HPV vaccines where more than one dose is required but vaccines are scarce in low-resource countries.
If there were sufficient vaccines, would mandates be justifiable – or even necessary?
It will depend on what’s required to reach herd immunity. Let’s say it’s 80% – I can’t imagine achieving that level of herd immunity without a mandate. I think we’ll see disparities around the world, depending on current approaches to mandatory vaccination. It’s not hard to imagine a mandate in Singapore, for example, but there would be resistance in the UK where no other vaccines are compulsory.
What’s more likely in the US and Europe is that it will become effectively mandatory for some populations – the military and those working in hospitals, for example. I suspect some employers will mandate vaccination. We might get to herd immunity not by government mandate but by a patchwork of private requirements.
Will this pose civil liberties dilemmas?
People get nervous about mandates – and about tracing apps – if they view it as giving up some of their freedoms. It has to be pointed out that if you carry a smartphone you’re getting traced anyway. I’m not sure there’s much left to give up.
The other way to view is that by opting in to vaccination or tracing apps, you gain freedoms in terms of mobility. Freedom is not unlimited: you’re not free to infect someone or knowingly put them at risk. So we need to talk about how to behave ethically. This is not what science does best. Throwing facts won’t work: we need an ethics argument.
