Europe's drug regulator, the Europe Medicines Agency (EMA), said Thursday the AstraZeneca COVID-19 vaccine is safe and effective in protecting people from the disease and its benefits outweigh its possible risks.
Speaking to a remote news conference from the agency's Amsterdam headquarters, Executive Director Emer Cooke said the review by the agency's safety committee also concluded that the vaccine is not associated with an increase in the overall risk of blood clots, also known as thromboembolic events.
Several European nations in the past week had suspended administering the AstraZeneca vaccine after reports patients who had received it had developed blood clots, that, in a few cases, led to death. The EMA review sprang from those reports.
Cooke added, however, the committee found during its investigation that a small number of rare and unusual but very serious cases of clotting disorders, which triggered a more focused review. She said it found very rare cases of unusual blood clots accompanied by low levels of blood platelets, which help blood to clot, after vaccination. The reported cases were almost all in women under 55.
Based on the evidence available, Cooke said the EMA "still cannot rule out definitively a link between these cases and the vaccine."
The EMA chief said the committee recommended raising awareness of the possible risks and ensuring they are included in the product information. She said they would also provide information to health care professionals as well as vaccinated people to help identify and mitigate any possible side effects.
Cooke repeated the EMA's overall finding, that the AstraZeneca vaccine is a safe and effective option to protect citizens against COVID-19.