European Regulators: Benefits of AstraZeneca COVID-19 Vaccine Outweigh Potential Risks

By Kelly Young

Edited by André Sofair, MD, MPH

The European Medicines Agency (EMA) on Thursday concluded that the benefits of the AstraZeneca COVID-19 vaccine outweigh the potential risks — "despite [a] possible link to rare blood clots with low blood platelets." Several European Union countries have temporarily suspended vaccination over thrombotic concerns.

The regulatory agency said that while the vaccine is not associated with overall risk for thromboembolic events, it could not rule out an increased risk for "very rare cases of blood clots associated with thrombocytopenia" and cerebral venous sinus thrombosis (CVST). Most cases happened in women under age 55.

Out of 20 million vaccinated people, the EMA identified seven cases of disseminated intravascular coagulation (DIC) and 18 cases of CVST. These are higher than the rates that would be expected in the general population.

The agency urges clinicians to be on the lookout for post-vaccination cases of thromboembolism, DIC, or CVST.