AMSTERDAM (Reuters) – EU drug watchdog said on Thursday it was still convinced that the benefits of AstraZeneca’s COVID-19 vaccine outweigh the risks following an investigation into reports of blood clots. that more than a dozen countries would suspend its use.
The director of the European Medicines Agency (EMA), Emer Cooke, said the watchdog could not definitively rule out a link between blood clot incidents and the vaccine in his investigation into 30 cases of a disease rare coagulation.
But he said the “clear” conclusion of the review was that the benefits of protecting people from the risk of death or hospitalization outweigh the potential 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 possible risks and in information for health professionals, he said.
“If it was me, I’d be vaccinated tomorrow,” Cooke said.
The EMA has come under increasing pressure to clear up safety concerns following a reduced number of reports in recent weeks of bleeding, blood clots and low platelet counts in people who have received the onset.
At least 13 European countries, including France, Germany and Italy, have stopped administering the firing pending 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 was meeting to discuss whether vaccinations would resume after the EMA verdict.
Many governments have said the decision to pause inoculations was out of great prudence. But experts have said political interference could undermine public confidence in vaccines as governments struggle to domesticate more infectious variants.
Some scientists said the agency’s support should be enough to allay concerns from EU governments.
“I hope that any concerns about possible links between the COVID-19 Oxford-AstraZeneca vaccine can now be ruled out given the positive verdicts issued by the EMA, the WHO and the MHRA,” said the Royal’s chief scientific professor. Pharmaceutical Society, Gino Martini.
The shooting of AstraZeneca was developed with the University of Oxford, and the head of the Oxford vaccine trial welcomed the statements of European and British medical regulators that the vaccine should continue to be deployed. .
Even before the blood clot scare, a YouGov poll published on March 7 showed that the safety perceptions of 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 AstraZeneca shooting was affected by the decision to initially authorize the vaccine only for people under 65 due to a lack of data on its effectiveness in the elderly.
News reports of strong side effects among front-line workers also slowed adoption in Germany, causing the doses to go unused.
20 MILLION PEOPLE
The EMA review, which included 20 million people in the UK and the European Economic Area (EEA), which brings together 30 European countries, included seven cases of blood clots in several blood vessels and 18 cases of a Rare and difficult to treat condition called cerebral venous sinus thrombosis (CVST), he said.
Overall, the number of thromboembolic events reported after vaccination, both in pre-license studies and in post-deployment reports, was lower than expected in the general population, he said.
This means that there is no increase in the overall risk of blood clots. However, in younger patients there are still some concerns, particularly related to these rare cases, he said.
The British drug regulator said on Thursday it was investigating five cases of CVST among people who received the AstraZeneca vaccine, but also reiterated that the benefits far outweighed the possible risks.
The World Health Organization has also reaffirmed its support for the shooting this week.
AstraZeneca said a review of more than 17 million people who had been shot in the EU and Britain found no evidence of an increased risk of blood clots.
VACCINE FOR THE WORLD
The security scare is AstraZeneca’s latest challenge in its ambition to produce a “vaccine for the world”.
Its shot was one of the first and cheapest to be developed and launched at high volume since the coronavirus was first identified in central China in late 2019 and is considered to be the mainstay of the vaccination programs in much of the developing world.
But the vaccine has been in question since the results of human trials published in December revealed a dosing setback.
They have continued to be concerned about its effectiveness in the elderly and against the variant identified in South Africa.
The political drama has also surrounded the Swedish pharmacist after reducing his shipments to the European Union due to production problems.
Reports by Anthony Deutsch and Toby Sterling in Amsterdam, Ludwig Burger in Frankfurt and Kate Kelland in London; Additional reports by Matthias Blamont in Paris; Written by Josephine Mason in London; Edited by Elaine Hardcastle and Frances Kerry