AstraZeneca Vaccine Cleared by EU After Blood-Clot Concerns

EU authorities are hoping the EMA’s statement could put a problem-plagued vaccination campaign back on track, although it remains to be seen whether the new analysis will overcome mistrust of the AstraZeneca shot among many Europeans.

Many European countries, including Germany, France and Italy, suspended the vaccine’s use over the past week following reports that people who had received it developed rare blood clots, and some had died, further slowing Europe’s already sluggish vaccination rollout.

Those reports compounded the delays and uncertainties surrounding a drive that has left the EU far behind the U.S. and the U.K. in vaccinating its citizens.

In a sign of European leaders’ impatience, Italian Prime Minister Mario Draghi said after the EMA announcement that the country would resume giving AstraZeneca vaccinations on Friday.

The EMA’s safety committee found the vaccine to be “safe and effective in preventing Covid-19, and its benefits outweigh its risk,” said committee chair Sabine Straus. Dr. Straus said that since blood clots are associated with Covid-19, by inoculating people against the disease, the vaccine “likely reduces the risk of thrombotic incidents overall.”

Health officials have noted that blood clots are widespread for a variety of reasons. Clots have also been noted among people receiving other Covid-19 vaccines and can be caused by medications as common as birth-control pills.

Dr. Straus said the EMA identified a predominance of the blood clots found were among women, particularly younger women. She said it remained “premature to conclude” whether this is linked to greater risk among the groups or the makeup of the populations receiving the vaccine.

EMA Executive Director Emer Cooke said the experts found a limited number of blood clots that require further study and the agency “still cannot rule out definitively a link.”

The EMA as a result recommended “raising awareness” by including a warning with the vaccination and informing the public. Such a campaign could help people who receive the AstraZeneca vaccine to know what to look for after getting the shot.

Ms. Cooke on Tuesday had expressed concern that doubts being cast on it could hurt public trust in vaccines. Asked in a news conference Wednesday if she personally would get the AstraZeneca shot, she said, “If it was me, I would be vaccinated tomorrow, but I would want to know that if something happened to me,” what to do.

Ms. Cooke, noting that many EU countries had suspended use of the AstraZeneca vaccine pending the EMA’s review, said its conclusions should give them “the information they need to take an informed decision regarding the use of the AstraZeneca vaccine in their vaccination campaigns.”

So far roughly seven million people in the EU, and 11 million in the U.K., have received the vaccine, Ms. Cooke said.

Analysis of the vaccine took on extra urgency this week after the Paul Ehrlich Institute, Germany’s medicines regulator, Monday recommended suspending the vaccine’s rollout pending further investigation.

Institute President Klaus Cichutek defended the recommendation, saying his experts identified seven cases in Germany of cerebral vein thrombosis, a severe brain condition, and three of the people died. Germany’s healthcare ministry said that, based on the number of vaccinations given, it would have expected as many as 1.4 cases of cerebral vein thrombosis, and the seven cases merited a pause.

The EMA collected reports from across Europe, giving it a much larger data set to analyze.

Some EU countries, including Greece and Belgium, have continued using the vaccine, as have Australia, Canada and India.

The U.K., where AstraZeneca developed the vaccine with scientists from University of Oxford, is relying heavily on the vaccine for its relatively fast vaccination campaign. British politicians have criticized their EU counterparts for suspending the vaccine’s use against expert advice.

The AstraZeneca shot is the world’s most widely used Covid-19 vaccine.

Many medical experts in Europe and beyond criticized politicians’ decisions to halt vaccinations, saying the known risks posed by the coronavirus are greater than possible ones from AstraZeneca shots. German officials said their suspension was merited because they are urging citizens to take the vaccine, unlike other medications such as contraceptives, which are a personal choice.

European officials who paused vaccinations framed their decisions as precautionary. But based on available data and Covid-19 risks, “The cautionary approach would be to carry on vaccinating,” said Prof. David Spiegelhalter, an expert on statistics and risk at the University of Cambridge. “Casting doubt—lasting doubt—on the safety of the vaccines is not a precautionary position.”

—Jenny Strasburg and Giovanni Legorano contributed to this article.

Write to Daniel Michaels at [email protected]