The European Medicines Agency has said the Oxford-AstraZeneca jab is a “safe and effective vaccine”, the regulator’s executive director Emer Cooke said.
In a significant intervention after major EU countries halted the roll-out of the vaccine amid fears over cases of blood clotting, Cooke said the “benefits outweigh the possible risks”.
The regulator’s conclusions comes after the UK’s Medicines and Healthcare products Regulatory Agency said there was no proven link between the AstraZeneca vaccine and rare blood clotting.
Cooke told a press briefing: “The committee has come to a clear scientific conclusion.
“This is a safe and effective vaccine. Its benefits in protecting people from Covid-19, with the associated risks of death and hospitalisation, outweigh the possible risks.
“The committee also concluded that the vaccine is not associated with an increase in the overall risk of thromboembolic events, or blood clots.”
The EMA said the committee had recommended “raising awareness” of possible risks associated with the AstraZeneca vaccine and ensuring they are included in the product information.
Cooke said: “During the investigation and review, we began to see a small number of cases of rare and unusual, but very serious, clotting disorders, and this then triggered a more focused review.
“Based on the evidence available, and after days of in-depth analysis of lab results, clinical reports, autopsy reports and further information from the clinical trials, we still cannot rule out definitively a link between these cases and the vaccine.
“What the committee has therefore recommended is to raise awareness of these possible risks, making sure that they are included in the product information.
“Drawing attention to these possible rare conditions and providing information to health care professionals and vaccinated people will help to spot and mitigate any possible side effects.”