German cities halt AstraZeneca vaccine for people under 60 due to clot worries
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BERLIN —Two of Germany’s largest cities halted Tuesday use of AstraZeneca’s coronavirus vaccine for people under 60 years old due to concerns that is causing rare but occasionally deadly blood clots.
The moves by Berlin and Munich marked the latest action by authorities across Europe and elsewhere concerned over possible blood-clot links with the vaccine by AstraZeneca, which is also seeking approval for use in the United States.
Germany’s regulator, the Paul Ehrlich Institute, said it had recorded 31 cases of cerebral venous thrombosis, a rare kind of brain clot that can result in hemorrhaging, among 2.7 million people in the country that have received the vaccine developed by the Swedish-British pharmaceutical giant AstraZeneca and the University of Oxford. A total of nine people have died.
AstraZeneca said that “patient safety remains the company’s highest priority” and that a causal relationship between the vaccine and blood clots had not been established by British and European regulators.
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“Regulatory authorities in the UK, European Union, the World Health Organization have concluded that the benefits of using our vaccine to protect people from this deadly virus significantly outweigh the risks across all adult age groups,” AstraZeneca said in its statement.
The European Union’s medical overseer, the European Medicines Agency, had deemed the vaccine “safe and effective,” but did not rule out potential rare cases of blood clots.
The EMA said that the risks outweighed the benefits, and added a blood clot warning to the product about two weeks ago. At the time, it said that 25 cases were being investigated among 20 million jabs across Europe.
Berlin health authorities cited an expected change in guidelines from German regulators. The southern city of Munich also said it would also pause using the vaccine for younger people as a precautionary measure “until the question of possible vaccination complications has been clarified.” Several smaller districts have also announced pauses.
German Chancellor Angela Merkel and Health Minister Jens Spahn were expected to give further details later Tuesday after an urgent meeting with regional leaders.
Germany had resumed vaccinations with AstraZeneca after an initial pause triggered by three initial deaths among those receiving the jab due to the clots.
But there have been growing calls from parts of the medical community to reassess. Of particular concern has been the risk for younger women, who have made up the majority of the blood-clot cases in Germany.
All but two cases were in women between ages 20 and 63, according to the country’s regulator.
[Does the AstraZenca vaccine cause rare blood clots? How scientists determine side effects.]
In an open letter to health authorities, the heads of five university hospitals in the German state of North-Rhine Westphalia, wrote that there was an “extremely unfavorable risk/benefit profile for the use of the AstraZeneca vaccine” for women ages 20 to 29 because of the unlikelihood of dying from the coronavirus, according to excerpts carried by Germany’s DPA news agency.
Regulators have said they are still investigating whether there is a link to clots. But experts in Germany and Norway who have treated patients suggest the rare type of blood clots are caused by an overactive immune response triggered by the vaccine.
Some other countries that had initially paused AstraZeneca earlier this month, had been more cautious about restarting vaccinations. France limited its use to people over 55 years old.
Norway, where regulators say four people died from blood clots among around 120,000 people who received the AstraZeneca jab, has continued its pause. Sweden has resumed AstraZeneca use for over 65s.
The vaccine is yet to be approved in the United States, where the independent medical board overseeing its trials took the unusual move last week of accusing the company of providing an “incomplete view” of its efficacy data in its U.S. trials.
Regulators in Britain, where the majority of AstraZeneca vaccines in Europe have been administered, said they had found five cases of blood clots as of March 14 but has not updated on numbers since.
“There is a time lag between reports received and publication to allows us time to fully evaluate the data before we issue any conclusions on it,” it said.
A Canadian panel of scientists on Monday recommended against the administration of the AstraZeneca vaccine in people 55 years of age and younger, citing “substantial uncertainty” over its benefits for that age group because of “rare” cases of blood clots reported in Europe.
Canada’s National Advisory Committee on immunization cast the guidance as a “precautionary measure” while Health Canada, the country’s drug regulator, investigates. It said the rate at which the clotting incidents occur is not known “with certainty.”
No such cases have been reported in Canada, which has administered roughly 300,000 jabs of the AstraZeneca vaccine.
The panel’s guidance is nonbinding, but Canadian provinces, which are responsible for the administration of vaccines, said they would follow the advice.
Luisa Beck in Berlin and Amanda Coletta in Toronto contributed to this report.
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