EU drug regulator backs AstraZeneca vaccine

Europe’s top drug agency on Tuesday said regulators remain confident in the safety of AstraZeneca’s COVID-19 vaccine after a dozen European countries suspended use of the drug over concerns about blood clots. 

Emer Cooke, executive director of the European Medicines Agency (EMA), said during a press conference the agency remains “firmly convinced” the benefits of AstraZeneca’s COVID-19 vaccine outweigh the risks of side effects. 

The agency has convened a safety committee of experts from across the European Union and beyond for an emergency meeting on Thursday to discuss and release the findings of its investigation into reports of rare but dangerous blood clots in the brain.

“At present, there is no indication that vaccination has caused these conditions,” Cooke said. “They have not come up in clinical trials and they’re not listed as known or expected side events.”

The overall number of events “seemed not to be higher” in vaccinated people than in the general population, Cooke said. 

She said that as of March 10, the EMA had received 30 reports of blood clotting events from about 5 million vaccinated people. The safety committee was also looking at “serious thromboembolic events from the U.K.,” Cooke said.

But while the events are rare, Cooke said the possibility of a link between blood clots and the vaccine is a “serious concern, and it does need serious, detailed scientific evaluation.”

Sweden and Latvia on Tuesday suspended use of the vaccine, joining a growing list of countries in recent days that have suspended use of the vaccines pending an investigation. 

AstraZeneca has pushed back against the allegations, saying the number of blood clotting events is no more than one would see in the general population. The World Health Organization has also stood by the safety of the vaccine with a similar message.

The AstraZeneca vaccine has not been authorized for use in the United States, but the government has already purchased 300 million doses. Tens of millions are currently being stored in preparation for when authorization is granted.