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LONDON – Several European countries this week halted the deployment of the world’s leading Oxford-AstraZenaca Covid-19 vaccine due to reports that some patients have suffered from blood clots.
However, according to some experts and regulators, not only were these decisions based on poorly understood evidence, but they also risked increasing anxiety in one of the most vaccine-reluctant regions of the world.
“We have to be extremely careful – but now it is too careful,” said Mukesh Kapila, former adviser to the director-general of the World Health Organization, who has held senior positions in many other UN agencies. United.
“We have real world information on tens of millions of vaccinated patients, and if it was a serious problem it would have happened,” added Kapila, now professor emeritus of global health and humanitarian affairs at the University of Manchester in the United Kingdom.
On Thursday, Denmark announced that it was suspending the deployment of the vaccine developed by the University of Oxford and the Anglo-Swedish pharmaceutical giant AstraZeneca. This follows reports of dozens of people with blood clots after receiving the injections, including at least one person who has died in the Nordic country.
Norway, Bulgaria and Iceland followed suit, while other countries, including Estonia, Lithuania, Luxembourg, Latvia, Italy and Austria, stopped specific lots which, according to them, could be associated with diseases.
These countries stressed that no link had been confirmed and that the decision was a temporary measure until they could gather more evidence. Denmark has said it uses the “precautionary principle” – the idea that until you have more evidence, it’s better to be safe than sorry.
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However, according to some experts, this seems to be a classic case of confusion between causation and correlation: Just because someone got sick after being vaccinated doesn’t mean the vaccine caused it, they say.
The European Medicines Agency, the continent’s main drug regulatory body, said as of Thursday 30 blood clots were reported in 5 million vaccinated patients – about the same number expected in the unvaccinated population.
Britain, which has vaccinated more than 20 million people, most with the AstraZeneca vaccine, has said much the same. The European Medicines Agency and WHO have said they will investigate the cases, but stressed that for them this vaccine is safe and effective.
AstraZeneca said in an emailed statement that its own data from more than 10 million patient records showed that the incidence of blood clots was in fact lower than the rate in the general population.
Europe is the most vaccine-reluctant continent in the world, according to a survey by British charity The Wellcome Trust. In particular, AstraZeneca fell victim to public relations after several European regulators and leaders, including French President Emmanuel Macron, suggested there was not enough data to prove its effectiveness in people over 65. .
Real-world evidence suggests this is not true, but the damage to public trust was already done. At one point last month, millions of AstraZeneca vaccines went unused in countries like Germany and France, in part because people were reluctant to take them, officials said.
German Health Minister Jens Spahn said on Friday he “regretted” seeing neighboring Denmark withhold injections despite what he described as a lack of evidence.
The United States has pledged some $ 1.2 billion for the development of the AstraZeneca vaccine and ordered 300 million doses. But it has yet to be approved in the United States amid questions about the transparency of data from the initial Phase 3 trial and a delay in the ongoing study in the United States.
At the heart of this debate is the delicate balance that must be struck by public health officials and governments: vigilance against possible side effects, transparency to maintain public confidence, but also not giving credit to fragile assertions that could unduly harm confidence in them. vaccines.
“This is a somewhat delicate question because there is also a danger in minimizing these concerns,” said Hajo Zeeb, professor at the Leibniz Institute for Preventive Research and Epidemiology in Germany. “Are you saying you stay on the cautious side, or are you saying, ‘No, we don’t see anything out of the ordinary’, and continue to vaccinate as we are in Germany?”
One such debate took place in the UK in 2009 after a 14-year-old high school student died hours after being vaccinated against the human papillomavirus, also known as HPV, which can cause cancer.
David Salisbury, the UK government’s director of immunization at the time, said they decided to withdraw this batch of vaccine but never stopped the vaccination campaign.
Importantly, he said, his team declined to comment to the media until the cause of death was known, which turned out the next day to be a malignant tumor and unrelated to the stroke. fire.
“The story got out of the news pretty quickly after that,” Salisbury told NBC News on Friday. Now he fears that stopping AstraZeneca’s firing on the basis of fuzzy evidence will mean “the story will spread, and of course it won’t help” overcome vaccine reluctance.
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