The EU’s drugs regulator said on Thursday that it had found the AstraZeneca coronavirus vaccine was “safe and effective” and was not linked to an increased risk of blood clots.
Around a dozen countries had suspended the use of the vaccine and were awaiting the outcome of an investigation by the European Medicines Agency (EMA) safety committee.
“The committee has come to a clear scientific conclusion: this is a safe and effective vaccine,” Emer Cooke, the head of the Amsterdam-based EMA, told a press conference.
“Its benefits in protecting people from Covid-19 with the associated risks of death and hospitalisation outweigh the possible risks,” she said.
“The committee also concluded that the vaccine is not associated with an increase in the overall risk of thromboembolic events or blood clots.”
Cooke added: “If it was me I would be vaccinated tomorrow.”
The EMA said however that it “could not rule out definitively” a connection to a particularly rare type of clotting disorder and would update the vaccine’s product information.
“During the investigation and review we began to see a small number of cases of rare and unusual but very serious clotting disorder and this then triggered a more focused review,” she said.
“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.”
The new warning in the vaccine information would draw attention to the “possible rare conditions” to help patients and healthcare professionals “stop and mitigate any possible side effects.”
The EMA was launching a further probe into the rare cases, she added.
