AMSTERDAM (Reuters) – The EU Drug Enforcement Agency said on Thursday it was still convinced that the benefits of the AstraZeneca COVID-19 vaccine outweigh the risks of a blood clot investigation that has led more than a dozen countries to and suspend use.
The director of the European Medicines Agency (EMA), Emer Cooke, said the watchdog could not definitively rule out a link between blood clot and vaccine incidents in his investigation of 30 cases of rare blood clotting disorders.
However, she said the “clear” conclusion of the review was that the benefits in protecting people from the risk of death or hospitalization outweigh the possible risks. The issue deserves further analysis, the EMA said.
“This is a safe and effective vaccine,” Cooke said in a briefing.
However, the agency will update its guidelines to include an explanation for the patient about the potential risks and in information for health professionals, she said.
“If it was me, I’d be vaccinated tomorrow,” Cooke said.
The EMA has come under increasing pressure to clarify safety concerns after a small number of reports in recent weeks of bleeding, blood clots and low platelet counts in people receiving the vaccine.
At least 13 European countries, including France, Germany and Italy, have stopped firing pending the review.
The suspensions were the latest blow to the European Union’s inoculation campaign, which has delayed the United States and former EU member Britain.
The Spanish government has met to discuss whether to resume vaccinations following the EMA verdict.
Many governments said the decision to discontinue vaccinations was prudent. But experts say political interference could undermine public confidence in vaccinations as governments struggle to tame more infectious variants.
Some scientists said the agency’s approval should be enough to alleviate EU governments’ concerns.
“I hope that any concerns about the potential links between the Oxford-AstraZeneca COVID-19 vaccine can now be removed, given the positive verdicts issued by the EMA, WHO and MHRA,” said Gino Martini, chief scientist at the Royal Pharmaceutical Society. .
The AstraZeneca shot was developed in conjunction with Oxford University, and the head of the Oxford vaccine study welcomed the statements by European and British medical regulators that the vaccine should continue to be launched.
Just before the blood clot scare, a March 7 poll published by YouGov showed that safety perceptions for the AstraZeneca vaccine in France and Germany were lower than those developed by Pfizer and its partner BioNTech and Moderna.
In Germany and France, the reputation of the AstraZeneca shot was affected 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 the elderly.
News of strong side effects among front-line workers has also slowed take-up in Germany, leaving doses unused.
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 several blood vessels and 18 cases of rare diseases, which is difficult to treat, called cerebral venous sinus thrombosis (CVST), it was said.
In general, the number of thromboembolic events reported after vaccination, both in pre-licensing studies and in post-release reports, was lower than expected in the general population, he said.
This means that there is no increase in the general risk of blood clots. However, in younger patients some concerns remain, especially related to these rare cases, he said.
The UK drug regulator said on Thursday it was investigating five cases of CVST among people receiving the AstraZeneca vaccine, but also reiterated that the benefits far outweigh the possible risks.
The World Health Organization reaffirmed its support for the shooting this week.
AstraZeneca said a review covering more than 17 million people who received fires in the EU and the UK found no evidence of an increased risk of blood clots.
VACCINE FOR THE WORLD
Fear of safety is the last challenge for AstraZeneca in its ambition to produce a “vaccine for the world”.
Its image has been among the first and cheapest developed and released in volume since the coronavirus was first identified in central China in late 2019 and will be the main vaccination program in much of the developing world.
But the vaccine has been hampered by questions, as the results of human studies launched in December showed a dosing accident.
They continued to be concerned about its effectiveness in the elderly and against the variant identified in South Africa.
Political drama has also engulfed the Swedish drug maker after cutting supplies 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; Edited by Elaine Hardcastle and Frances Kerry