Germany has suspended the use of the AstraZeneca coronavirus vaccine for people under the age of 60 amidst fresh concerns of unusual blood clot cases among some people receiving the vaccine, particularly women, and leading to the deaths of nine people in all. 

German Chancellor Angela Merkel and Health Minister Jens Spahn made the announcement on Tuesday after the country’s Standing Committee on Vaccination (STIKO) reviewed more data on emerging cases of rare blood clots in people immunised with the vaccine, produced by the Anglo-Swedish drug maker.

Germany’s medical regulator made the call after researchers at the federal government’s  Paul Ehrlich Institute, said they had recorded 31 cases of rare blot clot abnormalities, among the 2.7-million Germans who have thus far received the AstraZeneca vaccine. 

All cases were younger than 63, and all but two were women. The cases involved cerebral venous thrombosis (CSVT), a rare clot in blood draining from the brain, but also related to abnormally low levels of platelets, which help blood clot, and bleeding near the site of vaccination.  

“The experts of the Paul-Ehrlich-Institut now see a striking accumulation of a special form of very rare cerebral vein thrombosis (sinus vein thrombosis) in connection with a deficiency of blood platelets (thrombocytopenia) and bleeding in temporal proximity to vaccinations with the COVID-19 vaccine AstraZeneca,” said a news release of PEI, the Federal Institute for Vaccines and Biomedicines.

Several German regions — including the capital Berlin and the country’s most populous state, North Rhine-Westphalia — had already suspended use of the shots in younger people  earlier on Tuesday. 

Merkel said that the government “cannot ignore” STIKO’s  recommendation or the data about blood clots developing following shots with the vaccine.

Germany Has Other Vaccine Options For Younger People

“We all know that vaccination is the most important tool against the coronavirus,” said Merkel, adding 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.”

Spahn said the vaccine would only be administered to people aged 60 or older, unless they belong to a high-risk category for serious illness from COVID-19 and have agreed to take the vaccine despite the small risk of a serious side-effect.

“In sum it’s about weighing the risk of a side effect that is statistically small, but needs to be taken seriously, and the risk of falling ill with corona,” Spahn said during a press briefing.

He said the decision was taken “on the basis of currently available data on the occurrence of rare, but very serious thrombosis-related side-effects.” The commission said that it would issue guidelines on what to do for adults under 60 who had received a first AstraZeneca shot and were due another by the end of April.

Suspension – A Blow To Germany’s Vaccine Roll-out

The decision to suspend use of the vaccine for under-60s was “without doubt a setback” for the vaccination campaign, in which the AstraZeneca vaccine was a centrepiece, Spahn acknowledged.

It comes as Germany, along with other European countries, scrambles to ramp up its vaccine programme, which lags far behind those in Britain and the United States. By Monday, some 13.2 million people in Germany, a country of some 83 million people, had received at least one dose of one of Europe’s approved vaccines, while only 4 million had received two vaccine doses.

Germany is due to receive 15 million more AstraZeneca doses in the second quarter of 2021. Spahn said the new supply would be made available to people over 60 who might otherwise have had to wait longer, reducing their risk of falling seriously ill with COVID-19.

Germany’s U-turn On AstraZeneca

Use of the AstraZeneca vaccine was temporarily halted in Germany, as well as in several other European countries, earlier this month when concerns about occurrences of the rare blood clots first emerged. 

Then, just under two weeks ago, the European Medicines Agency said that the vaccine is safe and that its benefits outweigh the risks, and the vaccine rollout in Germany and elsewhere in Europe resumed.

Paradoxically, earlier in the vaccine rollout, Germany had refrained from administering the AstraZeneca vaccine to people 65 and over, citing insufficient evidence of its efficacy in that age group at the time. 

Other Countries Restrict Use of AstraZeneca

On March 29, Canada’s vaccination committee also recommended suspending the AstraZeneca jab for people under 55, citing reports coming out of Europe of blood clotting incidents.

France limited its use to people older than 55. Norway, where regulators say four people died of blood clots among about 120,000 people who received the AstraZeneca jab, has also suspended the vaccine. Sweden has resumed AstraZeneca use for people older than 65.

The vaccine is not yet cleared for use in the United States. An independent panel of medical experts overseeing the US trials took the unusual move last week of accusing the company of providing an “incomplete view” of efficacy data in its U.S. trials.

On Monday, Canada also recommended halting the use of the jab for people under 55 “pending further analysis”.

Researchers Find Association with Clots; AstraZeneca says Vaccine is “safe and effective”

The suspensions also come in the wake of a March 28 pre-print report from researchers in Germany, Canada and Austria, including a scientist at the Paul-Ehrlich-Institute, which linked the vaccine to the development of a blood clotting disorder.

However, some academics have said that the paper’s implication of a causal association isn’t backed up by evidence.

In a statement ahead of the announcement, AstraZeneca said tens of millions of people worldwide have received its vaccines.

The company said it would would analyse its own records to understand whether the rare blood clots reported occur more commonly “than would be expected naturally in a population of millions of people.”

Image Credits: Clemens Bilan.