GNB Desk: The European Medicines Agency (EMA) found the vaccine was “not associated” with higher risk of clots.
But it said it would continue to study the possibility of such links.
AstraZeneca’s COVID-19 vaccine is “safe and effective” and should continue to be used, the European Medicines Agency announced today.
But EMA said it could not rule out a link with two rare blood clotting conditions seen in 25 people who were given the vaccine, and said that warnings should be added to information about the vaccine provided to doctors and patients. Nine of these people have died.
EMA’s safety committee, PRAC, concluded its preliminary review of a signal of blood clots in people vaccinated with COVID-19 Vaccine AstraZeneca at its extraordinary meeting of 18 March 2021. The Committee confirmed that:
- the benefits of the vaccine in combating the still widespread threat of COVID-19 (which itself results in clotting problems and may be fatal) continue to outweigh the risk of side effects;
- the vaccine is not associated with an increase in the overall risk of blood clots (thromboembolic events) in those who receive it;
- there is no evidence of a problem related to specific batches of the vaccine or to particular manufacturing sites;
- however, the vaccine may be associated with very rare cases of blood clots associated with thrombocytopenia, i.e. low levels of blood platelets (elements in the blood that help it to clot) with or without bleeding, including rare cases of clots in the vessels draining blood from the brain (CVST).
The EU’s Pharmacovigilance Risk Assessment Committee (PRAC) was asked to review the safety of the AstraZeneca vaccine after more than 20 European countries — including Germany, France, Italy, and Spain — halted vaccinations following reports of rare clotting disorders.
EMA executive director Emer Cooke told a press briefing that the committee found a reduced overall incidence of blood clots, compared to the general population, in almost 20 million people given the vaccine so far worldwide.
“The committee has come to a clear scientific conclusion,” she said. “This is a safe and effective vaccine.”
It is up to individual EU countries to decide whether to re-start administering the jab.
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