The Atlanta Journal-Constitution
EU agency deems Astrazeneca safe, favors clot warning
The European Union’s drug regulatory agency said Thursday the Astrazeneca vaccine doesn’t increase the overall incidence of blood clots, and the benefits of using it outweigh the possible risks, paving the way for European countries to resume dispensing the shots.
What’s happening
Several European nations, including Germany, France, Italy and Spain, had suspended their use of the vaccine during the past week following reports of clots in a few dozen of the millions of people across the continent who have gotten the shot. The question was whether the vaccine had anything to do with those clots.
What it means
Italian Premier Mario Draghi welcomed the finding by a committee of the European Medicines Agency and immediately announced Italy would resume administering Aztrazeneca’s vaccine as early as today.
Germany, France and others had said they would wait for the EMA’S determination before deciding whether to start using the vaccine again.
“The committee has come to a clear scientific conclusion,” said the head of the EMA, Emer Cooke. “This is a safe and effective vaccine.”
However, she said the agency “still cannot rule out definitively a link” between certain rare types of blood clots and the vaccine. The EMA recommended adding a description of these cases to the vaccine leaflets so health workers and patients would be aware.
Why it matters
Clots that form in the arms, legs or elsewhere can break free and travel to the heart, brain or lungs, causing strokes, heart attacks or other deadly blockages.
While many countries have continued to use the Astrazeneca vaccine, there are concerns the debate could seriously undermine confidence in the shot, which is key to efforts to immunize the world’s population, especially in poorer countries.
Astrazeneca is expected to apply in the coming weeks for U.S. authorization for its vaccine. The U.S. now relies on vaccines from Pfizer, Moderna and Johnson & Johnson.