AstraZeneca COVID-19 vaccine benefits outweigh risks: EMA
Based on its preliminary investigation, the European Medicines Agency on Thursday concluded that the AstraZeneca COVID-19 vaccine is "safe and effective," while not definitely ruling out possible link to rare blood clots accompanied by low levels of blood platelets.
"Close safety monitoring of reports of blood clotting disorders will continue, and further studies are being instituted to provide more laboratory data as well as real-world evidence," the European Union regulator for medicines said in a statement.
Stressing the effectiveness of the vaccine jointly developed by British multinational pharmaceutical company AstraZeneca and Oxford University, EMA Executive Director Emer Cooke told a press conference that EMA's Pharmacovigilance Risk Assessment Committee "has come to a clear scientific conclusion: this is a safe and effective vaccine."
The AstraZeneca vaccine's benefits in protecting people from COVID-19 with the associated risks of death and hospitalization outweigh the possible risks, Cooke said, adding that "the vaccine is not associated with an increase in the overall risk of thromboembolic events or blood clots."
The EMA's green light, however, came with a proviso: "Based on the evidence available, and after days of in-depth analyses 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," Cooke said.
She said the EMA has recommended adding a warning to the vaccine's product information so that patients and health care professionals "stop and mitigate any possible side effects."
Many European countries have fully or partially suspended the use of the AstraZeneca vaccine following reports of several suspected deaths from clotting after vaccinations, which sparked concerns over the pace of the EU's vaccination drive under the pressure of current supply shortages.
"If it was me, I would be vaccinated tomorrow," Cooke said, adding that "but I would want to know if anything happened to me after vaccination what I should do about it, and that's what we're saying today."