AstraZeneca-Oxford University COVID-19 vaccine gets green light from Europe's top drug regulator
Europe's top drug regulator on Thursday said the AstraZeneca-Oxford University COVID-19 vaccine is safe, despite reports of unusual blood clots in a small number of the nearly 18 million people who have received at least one dose in Europe and the U.K.
"The committee has come to a clear scientific conclusion," said Emer Cooke, executive director of the European Medicines Agency. "This is a safe and effective vaccine."
Researchers with the EMA – the European equivalent of the U.S. Food and Drug Administration – said they can't rule out the possibility that the few dozen cases of blood clots and related disorders were triggered by the shot.
But overall, the vaccine is safe can be delivered across Europe and elsewhere, Cooke said.
More than a dozen European countries including Germany, France and Italy have paused giving the AstraZeneca-Oxford University vaccine or banned the use of particular batches, pending the EMA's review.
It's not clear whether and how quickly those countries might resume distributing the vaccine.
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The AstraZeneca-Oxford University vaccine is not available in the United States, where a large-scale trial has been completed but not yet made public. That data is expected within the next few weeks, and the company and university are then expected to ask for FDA authorization.
None of the vaccines available in the U.S. have been linked to unusual numbers of blood clots or related problems, although at least one American apparently died of a similar condition after receiving a different COVID-19 vaccine.
COVID-19 itself is known to cause blood clots and other vascular problems.
EMA scientists said Thursday that the data on the AstraZeneca-Oxford vaccine remains inconclusive, but that any clotting problems, if related to the vaccine, are so rare that they shouldn't stop people from getting it.