AMSTERDAM (Reuters) – The EU drug watchdog said Thursday that it is still convinced that the benefits of AstraZeneca’s COVID-19 vaccine outweigh its risks following an investigation into reports of blood clots that have led to more than one dozen countries have discontinued its use.
Emer Cooke, director of the European Medicines Agency (EMA), said the watchdog could not definitively rule out a link between blood clot incidents and the vaccine in its study of 30 cases of a rare blood clotting condition.
But she said the study’s “clear” conclusion was that the benefits of protecting people from the risk of death or hospitalization outweigh the potential risks. The matter deserves further analysis, the EMA said.
“This is a safe and effective vaccine,” Cooke told a briefing.
However, the agency will update its guidelines with an explanation for the patient about the potential risks and in information for healthcare professionals, she said.
“If it was me, I’d be vaccinated tomorrow,” Cooke said.
The EMA is under increasing pressure to address safety concerns after a small number of reports of bleeding, blood clots and low platelet counts in people who received the injection in recent weeks.
At least 13 European countries, including France, Germany, and Italy, have stopped administering the shot pending the review.
The suspensions were the final blow to the European Union’s vaccination campaign, which was left behind by the United States and former EU member Great Britain.
The Spanish government met to discuss whether vaccinations should resume after the EMA ruling.
Many governments have said that the decision to interrupt the vaccinations was out of an excess of caution. But experts have said political interference could undermine public confidence in vaccinations as governments struggle to tame more contagious variants.
Some scientists said the agency’s approval should be enough to address concerns of EU governments.
“I hope any concerns about possible links between the Oxford-AstraZeneca COVID-19 vaccine can now be discarded, given the positive statements from the EMA, WHO and MHRA,” said Professor Gino Martini, chief scientist of the Royal Pharmaceutical Society .
The AstraZeneca shot was co-developed with the University of Oxford, and the Oxford vaccine research chief welcomed statements from European and UK medical regulators that the vaccine should be rolled out further.
Even before the fear of blood clots, a YouGov poll published on March 7 found perceptions of the safety of the AstraZeneca vaccine in France and Germany lower than those developed by Pfizer and its partner BioNTech and Moderna.
In Germany and France, the reputation of the AstraZeneca injection was tarnished by a decision to initially only allow the vaccine to people under 65 years of age due to a lack of data on efficacy in the elderly.
News reports of strong side effects among front-line workers also slowed uptake in Germany, leaving doses unused.
20 MILLION PEOPLE
The EMA review, which covers 20 million people in the UK and the European Economic Area (EEA), connecting 30 European countries, included seven cases of blood clots in multiple blood vessels and 18 cases of a rare condition that is difficult called cerebral venous sinus thrombosis (CVST), it said.
Overall, the number of thromboembolic events reported after vaccination, both in pre-licensing studies and in post-deployment reports, was lower than expected in the general population, the report said.
That means there is no increase in the overall risk of blood clots. However, some concerns remain in younger patients, particularly in connection with these rare cases, he said.
The UK drug regulator said Thursday that it was investigating five cases of CVST in people who received the AstraZeneca vaccine, but it also reiterated that the benefits far outweigh the potential risks.
The World Health Organization also confirmed its support for the shot this week.
AstraZeneca has said that a review of more than 17 million people who received its injections in the EU and Britain found no evidence of an increased risk of blood clots.
VACCINE FOR THE WORLD
The fear of safety is the latest challenge facing AstraZeneca in its ambition to produce a “vaccine for the world”.
The shot was one of the first and cheapest to be widely developed and launched since the coronavirus was first identified in central China in late 2019, and it will become the mainstay of vaccination programs in much of the developing world.
But questions have been raised about the vaccine since the results of human trials released in December revealed a dosing error.
They have continued to raise concerns about its efficacy in the elderly and against the variant identified in South Africa.
Political drama has also engulfed the Swedish drug company after it drastically cut its supplies to the European Union due to manufacturing problems.
Reporting by Anthony Deutsch and Toby Sterling in Amsterdam, Ludwig Burger in Frankfurt and Kate Kelland in London; Additional reporting by Matthias Blamont in Paris; Written by Josephine Mason in London; Adaptation by Elaine Hardcastle and Frances Kerry