EU says no need to limit COVID vaccine

Reports of blood clots have led some nations to restrict the use of AstraZeneca’s shot.

BERLIN — The head of the European Union’s drug regulator says there is “no evidence” that would support restricting the use of AstraZeneca’s COVID-19 vaccine in any population, as Germany and a handful of other European countries have done amid concerns over rare blood clots in people who received the shot.

Emer Cooke, executive director of the European Medicines Agency, said Wednesday that her Amsterdam-based agency continues to study reports of new cases as they come in and will provide a further assessment next week.

On Tuesday, an independent vaccine expert panel in Germany said AstraZeneca shots should not routinely be given to people younger than 60 because of a rise in reported cases of unusual blood clots in the days after vaccination. The German government followed the recommendation and said the vaccine would be prioritized for people 60 and older, although exceptions can be made in consultation with doctors.

On Thursday, German President Frank-Walter Steinmeier was vaccinated with the AstraZeneca shot to try to boost confidence in the vaccine. The presidential office said in a statement that Steinmeier, 65, received his first shot at a hospital in Berlin on Thursday.

“According to the current scientific knowledge, there is no evidence that would support restricting the use of this vaccine in any population,” Cooke told reporters Wednesday.

Last month, the European Medicines Agency, which authorized the AstraZeneca vaccine in January, said the vaccine’s benefits outweigh any risks. The agency issued the guidance after some European countries, including Germany and France, suspended its use over blood clot fears.

Cooke said the agency’s assessment was based on 62 cases worldwide of unusual blood clots, including 14 deaths, reported to the EMA by March 22. Those figures included a “significant” number of the cases reported in Germany but not all, she said.

German regulators said they had received 31 reports of rare blood clots in the head in recipients of the AstraZeneca vaccine and nine deaths up to March 29, roughly doubling the number that had been reported in the country by March 22.

Cooke said the EMA would include the Germany cases in its review.

Based on the numbers reported so far, there have been 4.8 cases of the blood clots per million doses of the AstraZeneca vaccine administered, she said.

For the Pfizer-BioNTech vaccine, “based on the same criteria, it was 0.2 cases per million,” Cooke added. “And for the Moderna vaccine based on the same criteria, zero cases per million. But that probably reflects that there’s a lot less use of Moderna at the moment in Europe.”

She said the EMA’s experts so far had not determined any underlying risk factors for the blood clots or established a causal relationship with the AstraZeneca vaccine.