Europe discovers that vaccine caution is risky

It may have served its purpose in environmental policy, but proven downright dangerous when applied during a pandemic


THE prime ministers of the UK and France rolled up their sleeves last Friday and took the AstraZeneca plc Covid-19 vaccine. But that didn’t happen in Denmark, Norway and Sweden, where all AstraZeneca vaccinations remain suspended.

If that wasn’t confusing enough, France announced that the vaccine was only for those over 55. Until two weeks ago, both Germany and France had said it was only for those under 65, even as the European Union (EU) permitted it for all adults.

Most countries in Europe had stopped the use of the AstraZeneca vaccine to investigate fears that it might cause potentially fatal blood clots. All of this was happening as a third wave of the pandemic takes hold in continental Europe. And AstraZeneca has yet even to apply for clearance in the US.

In short, the AstraZeneca vaccine has divided the world. It has also confronted everyone with unique moral issues that can no longer be avoided.

The shot revealed a serious flaw in the way EU countries balance risks and benefits, and laid bare the unexpected moral issues raised by the availability for the first time of several different vaccines for the same disease. The lessons are relevant everywhere.

Vaccinations were halted due to the “precautionary principle” promulgated in the 1970s to help set environmental standards for the growing European Economic Community. It holds that “if an action or policy has a suspected risk of causing harm to the public or to the environment, and there is no scientific consensus, the burden of proof that it is not harmful falls on those taking the action”.

This sounds attractive. It helped France and Germany build large nuclear power programmes with public support, and it echoes the Hippocratic Oath of doctors to “first do no harm”.

Europe’s shutdown came after reports of women, some under 55, dying of blood clots after taking the vaccine. Under the precautionary principle, this was enough to justify the stoppage, while awaiting a scientific consensus establishing or disproving a causal connection.

But ethical risk management requires balancing risks with benefits. All vaccines have risks, and the precautionary principle takes no account of benefits — even when the benefit could be to eradicate a pandemic that has been the scourge of our lifetimes.

Each day’s delay allows more infections and deaths, and a longer wait for immunity to spread through the population.

Looking only at the side effects of a vaccine is the equivalent of a pension fund deciding to keep all its money in cash under mattresses because of the possibility of losses in stocks and bonds.

The principle virtually requires scientists to prove a negative, an impossible hurdle, notes David Salisbury, former head of immunisation at the UK Department of Health. All vaccines have risks, but the blood-clot cases are not as alarming as they appear.

According to a ruling last week by the European Medicines Agency (EMA), around 20 million people in the UK and EU had received the vaccine as of March 16, and only 25 cases of potentially fatal thromboses had been identified. The total number of all thrombosis cases recorded, according to the EMA, was “lower than that expected in the general population”, confirming that the vaccine caused “no increase in overall risk of blood clots”.

European officials may have been encouraged to err on the side of caution by the competition between different viable vaccines. There are no precedents or protocols for dealing with such a situation. During 2020, it became clear that this year’s global vaccination campaign would rely on several vaccines, but nobody dealt with the problems of public trust this could create.

“It’s unprecedented, and we’ve never figured out how to manage it,” said Arthur Caplan, head of bioethics at the New York University (NYU) Langone Medical Centre.

Now, the problem has arrived. As different companies announced the results of their clinical trials at the end 2020, they gave percentage figures for “efficacy”, referring to their success at preventing infection.

The Pfizer Inc-BioNTech SE and Moderna Inc vaccines, now on offer in the US boasted efficacy of 95% after two doses. AstraZeneca came in at 76% and a one-shot vaccine from Johnson & Johnson at 66%.

As with the blood clots, these statistics could be misleading. AstraZeneca’s vaccine appears to be just as effective as the others in preventing death or hospitalisation from Covid; all have scored 100% so far in that life and death test. But publicity surrounding the initial test results created a lasting impression that some vaccines were better than others.

Who gets to have which? Should people be given a choice? If other vaccines exist, does that make it easier for a regulator to err on the side of caution when doubts are raised?

Vaccination is a public good, from which everyone benefits, but compulsory shots should be a last resort; people have autonomy over what goes into their body. If we are free to choose not to be vaccinated, can’t we also refuse one particular brand of vaccine, and demand another instead?

It’s a difficult question, but the best theoretical answer appears to be “No”. “People lack the fundamental ethical right to receive any scarce resource they fancy the most,” says Nir Eyal, professor of bioethics at Rutgers University. “Even if there are vast differences in quality between these vaccines, there’s no fundamental right for individuals to pick their place in the queue.”

But even if the authorities are justified in saying “take it or leave it”, many in the real world may choose to wait. That is a problem because time is of the essence; if people exercise their right to wait for a “better” vaccine, new and potentially deadlier variants of the virus have more time to take hold. But if public trust in any one vaccine is lost, there may be no alternative.

That raises more troubling issues of international and social justice. AstraZeneca’s shots can save lives. It would be an obscenity for any of them to remain unused. But if they are now perceived as a bargain-basement alternative, who takes them?

Many now advocate donating Europe’s unwanted shots to the emerging world. But can anybody be expected to take a vaccine which is only available because richer people didn’t think it was good enough? Even if the richer people are wrong?

“Are you kidding me?” says Caplan of NYU. “You’re going to be accused of exploitation.” Similar arguments apply to proposals for donations to minority communities in the US.

The issue will only grow more acute. More vaccines, each with slightly different underlying technologies, are in the pipeline. Johnson & Johnson’s is the cheapest of the three authorised for use in the US, and there should be plentiful supply as Merck & Co Inc is helping with production. It stands to be a linchpin of vaccination efforts. But what happens if people don’t want to take it?

The US doesn’t use Europe’s extreme precautionary principle, and need not overreact to the first hint of bad news.

But AstraZeneca’s European agonies are still relevant. In a competitive environment, confidence in any vaccine that appears inferior will be especially fragile. If bad news stories shake confidence in any vaccine, regulators must be able to explain clearly why its benefits still justify the risks.

Meanwhile, Europe’s nations need to find a way to retreat from the precautionary principle. It may have served its purpose in environmental policy, but it has proven downright dangerous when applied in the middle of a pandemic. — Bloomberg

  • This column does not necessarily reflect the opinion of the editorial board or Bloomberg LP and its owners.