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The European Union's medical regulator concluded Wednesday that unusual and potentially fatal blood clots should be listed as a very rare side effect of the AstraZeneca coronavirus vaccine.
The findings of the weeks-long review into the safety of the jab could fuel vaccine skepticism in Europe, where several governments have paused their rollouts of the jab amid rising safety doubts.
Officials at the European Medicines Agency, or EMA, emphasized that the benefits of AstraZeneca overall outweigh the risks and that the vaccine is saving lives. The side effects are extremely rare, they stressed during a news conference in Amsterdam.
"The EMA is reminding health care professionals and people receiving the vaccine to remain aware of the possibility of very rare cases of blood clots combined with low levels of blood platelets occurring within two weeks of vaccination," the officials said. "So far, most of the cases reported have occurred in women under 60 years of age within two weeks of vaccination," the EMA officials added.
Emer Cooke, head of the EMA, said, "This vaccine has proven to be highly effective, it prevents severe disease and hospitalization and it saves lives." Rare blood clots have been associated with the deaths of at least 14 people across Europe.
The announcement about the link between the vaccine and a clotting disorder marks a dramatic shift in the EMA's position on the AstraZeneca vaccine. For two months the agency had insisted there were no reasons for EU countries to restrict or stop using the shot.
Several European countries ignored the reassurances over the jab and have been restricting the use of the vaccine amid mounting worries about links with the clotting disorder. Germany last week said the vaccine should not be given to those under 60 years of age.
Britain's medicines regulator separately also has found a causal link between the vaccine and the rare clotting disorder, which has been associated with the deaths of seven vaccinated people in Britain. It is advising that Britons under 30 should be offered the Pfizer or Moderna vaccine instead.
June Raine, chief executive of Britain's Medicines and Healthcare Regulatory Agency, (MHRA) said at a press conference in London that more than 20 million doses of the AstraZeneca jab have been administered in Britain, but no effective medicine is "without risks." She said a link between rare blood clots, that prevent blood draining from the brain, and the AstraZeneca vaccine are a "strong possibility," but that more work needs to be done to "establish beyond all doubt" that the jab can cause the rare side effect.
Raine too, emphasized that the vaccine's "benefits continue to outweigh the risks." She said, "This is extremely rare and with the proven effectiveness against a disease that is still a huge risk to our population, the balance of benefits is still very favorable for the vast majority of people."
Up to March 31, Britain's MHRA received 79 reports of blood clots accompanied by low blood platelet count, in people who had their first dose of the vaccine. Of these 79, 19 people have died. The 79 cases occurred in 51 women and 28 men, ages 18 to 79. Of the 19 who died, three were under the age of 30, the MHRA said.
While the medicines regulators highlighted how rare the side effects are with less than one death per one million jabs administered, European Union officials fear the findings of the reviews will knock confidence not only in the AstraZeneca jab but in other COVID vaccines.
They warned the health ministers of the bloc's 27 member states that the announcements on both sides of the English Channel would have an "immediate impact on vaccination plans" and "vaccine confidence," according to an official EU document seen by the Reuters news agency.
According to pollsters, Europe is already the most vaccine-skeptic continent in the world.
Doubts about the jab's safety have mounted in recent weeks, leading to Europeans in growing numbers declining the chance of being inoculated with the AstraZeneca vaccine. British officials reacted angrily to doubts cast recently about the vaccine by French President Emmanuel Macron and German Chancellor Angela Merkel.
AstraZeneca has been the key vaccine in Britain's exceptionally speedy inoculation campaign, which has outpaced significantly the vaccination rates in the rest of Europe. British officials say restricting the use of AstraZeneca will not have a major impact on the country's inoculation program with other vaccines coming on stream.
The vaccine is critical also to Europe's immunization campaign and crucial in the global strategy to supply vaccines to poorer countries. The vaccine is cheaper and easier to use than rival vaccines from Pfizer-BioNTech and Moderna.
Independent medical experts backed the conclusions of the medicines regulators and also said only a very small number of people could have serious side effects from AstraZeneca but that the vaccine is clearly saving tens of thousands of people from dying of COVID-19, the illness caused by the coronavirus.
"If you are currently being offered a dose of Oxford-AstraZeneca vaccine, your chances of remaining alive and well will go up if you take the vaccine and will go down if you don't," Adam Finn, a professor of pediatrics at Britain's University of Bristol, wrote in a press release.