‘Safe and effective’: 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.

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.

A medical worker draws up a dose of the Oxford/AstraZeneca vaccine during the vaccination of priests in Kiev, Ukraine on March 16, 2021. (Photo: AFP via Getty Images)

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.

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The EMA did recommend adding a warning to the information provided to patients and health care 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. “These cases occur always and they also will occur in temporal relationship with the vaccination.”

By preventing infection with COVID-19, the vaccine probably reduces the number of blood clots, she said.

A patient receives a shot of the Moderna COVID-19 vaccine at a CVS Pharmacy branch in Los Angeles. (Photo: Marcio Jose Sanchez, AP Images)

The EMA also carefully examined the cases of seven people who developed tiny clots in multiple blood vessels in the first week or two after a shot, a condition called disseminating intravascular coagulation, and 18 people who developed clots in blood vessels draining blood from the brain, which is called cerebral venous sinus thrombosis, or CVST. These conditions are linked to having low levels of blood platelets, also known as thrombocytopenia.

“The evidence we have is at the moment not sufficient to conclude with certainty whether these adverse events were indeed caused by the vaccine,” Straus said.

In addition to adding the warning information, Straus said her agency would closely track any future reports of these types of problems with the AstraZeneca-Oxford vaccine or any of the other three authorized for use in Europe.

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There was no indication that these events were linked to a particular batch of the vaccine or a quality issue, she said.

Hans Kluge, the World Health Organization’s regional director for Europe, said Thursday in a news conference the benefits of the vaccine “far outweigh its risk” and the international body continued to urge countries not to stop using the vaccine. 

The pauses in vaccination across Europe came as COVID-19 infections were accelerating, prompting new lockdowns in Italy, France and Poland. Vaccination coverage in the region has lagged behind the U.S., where 75 million people have been vaccinated at least once, and Britain, where more than 27 million people have had a first dose of a COVID-19 vaccine.

AstraZeneca is based in Wilmington, Delaware. (Photo: Roland Magnusson / iStock Editorial via Getty Images)

American vaccine scientists have criticized the pause in use of the AstraZeneca-Oxford vaccine, accusing European countries of over-reacting and damaging the global vaccination effort by raising unnecessary fears.

Several vaccine experts, speaking on a Thursday call with reporters, said they agreed with the EMA’s interpretation of the data but worried that a formal warning label added to the vaccine could dampen enthusiasm for the shots at a time when the virus continues to rage out of control.

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Dr. Paul Offit, one of three members of the COVID-19 Vaccine Analysis Team on the call, said he thinks the European countries should resume using the vaccine.

“If there was just an abundance of other vaccines that that people could use in that European community, then I could understand it. But I personally think they should take it off of this hold,” said Offit, also director of the Vaccine Education Center at Children’s Hospital of Philadelphia. 

Offit said he’s concerned that the warning label could reinforce concerns some people have about vaccines, but Dr. Jesse Goodman, a professor of medicine at Georgetown University, said he thinks the transparency will promote knowledge and vigilance. 

“I think EMA’s position, which is to allow informed immunization while this continues to be investigated, is a reasonable assessment of risk and benefit based on the current situation,” Goodman said. “You have thousands of people dying every day in the European Union… . As information evolves, we’ll learn more, and I think transparency and honesty with the public is always the best approach, even though it’s often difficult to explain.”

Contact Karen Weintraub at [email protected]

Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.

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