AMSTERDAM (Reuters) – The EU anti-drug agency said on Thursday that it is still convinced that the benefits of AstraZeneca’s COVID-19 vaccine outweigh the risks after an investigation into blood clot reports that led more than a dozen nations to suspend its use.
The director of the European Medicines Agency (EMA), Emer Cooke, said the watchdog cannot definitively rule out a link between blood clot incidents and the vaccine in its investigation of 30 cases of a rare blood clotting condition.
But she said the review’s “clear” conclusion was that the benefits of protecting people from the risk of death or hospitalization outweigh the possible risks. The issue deserves further analysis, said the EMA.
“This is a safe and effective vaccine,” said Cooke at a briefing.
The agency will, however, update its guidelines to include an explanation to the patient about the potential risks and information for healthcare professionals, she said.
“If it were me, I would be vaccinated tomorrow,” said Cooke.
EMA has been under increasing pressure to address safety concerns after a small number of reports in the past few weeks of bleeding, blood clots and low platelet counts in people who received the injection.
At least 13 European countries, including France, Germany and Italy, have stopped administering the injection pending review.
The suspensions were the final blow to the European Union’s vaccination campaign, which lagged behind the United States and the former EU member, Britain.
The Spanish government was meeting to discuss whether to resume vaccination after the EMA verdict.
Many governments said the decision to stop vaccinations was over-cautious. But experts say that political interference can undermine public confidence in vaccines as governments struggle to tame more infectious variants.
Some scientists said the agency’s endorsement should be sufficient to allay the concerns of EU governments.
“I hope that any concerns about possible links between the Oxford-AstraZeneca COVID-19 vaccine can now be ruled out, given the positive verdicts given by EMA, WHO and MHRA,” said Royal Pharmaceutical Society chief scientist, Professor Gino Martini .
The AstraZeneca injection was developed with the University of Oxford, and the head of Oxford vaccine testing praised the statements by European and British medical regulators that the vaccine should continue to be launched.
Even before the blood clot scare, a YouGov survey published on March 7 showed that safety perceptions for the AstraZeneca vaccine in France and Germany were lower than for those developed by Pfizer and its partner BioNTech and Moderna.
In Germany and France, the reputation of the AstraZeneca injection was undermined by the decision to initially authorize the vaccine only for people under the age of 65, due to a lack of data on its effectiveness in older people.
News of strong side effects among frontline workers has also delayed acceptance in Germany, preventing doses from being used.
20 MILLION PEOPLE
The EMA review covering 20 million people in the UK and the European Economic Area (EEA), which links 30 European countries, included seven cases of blood clots in various blood vessels and 18 cases of a rare, difficult-to-treat condition called cerebral venous. sinus thrombosis (CVST) said.
Overall, the number of thromboembolic events reported after vaccination, both in studies before licensing and in reports after implantation, was less than expected in the general population, the study said.
This means that there is no increase in the overall risk of blood clots. However, in younger patients, some concerns remain, related in particular to these rare cases, he said.
Britain’s drug regulator said on Thursday that it was investigating five cases of CVST among people who received the AstraZeneca vaccine, but also reiterated that the benefits far outweigh any possible risk.
The World Health Organization also reaffirmed its support for the injection this week.
AstraZeneca said that an analysis covering more than 17 million people who received their vaccines in the EU and Britain did not find evidence of an increased risk of blood clots.
VACCINE FOR THE WORLD
The security scare is the latest challenge for AstraZeneca in its ambition to produce a “vaccine for the world”.
His vaccine was one of the first and cheapest to be developed and launched in large volume since the coronavirus was first identified in central China in late 2019 and is expected to be the mainstay of vaccination programs in much of the developing world.
But the vaccine has been haunted by doubts since the results of human tests released in December revealed a dosing accident.
They continued to worry about its effectiveness in older people and against the variant identified in South Africa.
The political drama also involved the Swedish pharmaceutical company after it reduced its deliveries to the European Union due to production 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; Editing by Elaine Hardcastle and Frances Kerry