European agency: Vaccine is safe
AstraZeneca doses were scrutinized after reports
Europe’s top drug regulator on Thursday said that the AstraZenecaOxford 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 can be delivered, Cooke said.
More than a dozen European countries including Germany, France and Italy have paused on 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.
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. has 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.
Among any large group of people over time, some are likely to have med
ical problems. To prove an issue is related to vaccination, it has to occur in larger numbers than the general population and close in time to a shot.
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. The EMA did recommend adding a warning to the information provided to patients and healthcare providers about the possible connection between vaccination and vascular issues.
The number of blood clots seen among Europeans who received the AstraZeneca-Oxford vaccine was lower than would be expected over the same period in the general population, EMA scientists said. About 100,000 Europeans would be expected to develop clots every month, so some would be expected to occur among the 7 million Europeans who have received the vaccine.
“There is no increase in overall risk of blood clots with this vaccine,” said Sabine Straus, chair of the EMA’s Pharmacovigilance Risk Assessment Committee, which reviewed the data.