Mon, December 06, 2021

in-focus

Germany halts AstraZeneca vaccine for people under 60 because of clot worries


BERLIN - German Chancellor Angela Merkel on Tuesday said the country will halt the use of AstraZeneca's coronavirus vaccine for people under 60 due to concerns that is causing rare but occasionally deadly blood clots.

Merkel said the government "cannot ignore" a recommendation for such a move by the country's vaccine committee and new data about blood clots developing after being vaccinated with the vaccine developed by the Swedish-British pharmaceutical giant AstraZeneca and the University of Oxford.

Germany's medical regulator, the Paul Ehrlich Institute, said earlier that 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 who have received the vaccine in the country.

All were under age 63, and all but two were women. Nine people have died of the clots.

"We all know that vaccination is the most important tool against the coronavirus," said Merkel, but she said there were other options for younger people.

"We are not faced with the question of AstraZeneca or no vaccine," she said. "Instead we have several vaccines at our disposal."

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.

"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. Younger Germans will still be able to receive an AstraZeneca vaccine if they consult with a doctor and sign a waiver.

After an initial review this month, the European Union's medical overseer, the European Medicines Agency, had deemed the vaccine "safe and effective," but it said it is continuing to investigate a "possible link" between the vaccine and rare cases of particularly unusual blood clots.

The EMA said that the risks outweighed the benefits, and it added a blood-clot warning to the product about two weeks ago. At the time, it said 25 cases were being investigated among 20 million vaccinations across Europe.

Germany had resumed vaccinations with AstraZeneca after the recommendations, having recorded three deaths before pausing.

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.

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.

While the EMA continues its investigations, experts in Germany and Norway who have treated patients suggest that 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 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 of blood clots among about 120,000 people who received the AstraZeneca vaccine, has continued its pause. Sweden has resumed AstraZeneca use for people over 65.

The vaccine has not been 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 they have not updated numbers since.

"There is a time lag between reports received and publication to allow 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 about 300,000 doses 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.

Published : March 31, 2021

By : The Washington Post · Loveday Morris, Luisa Beck