AZN AstraZeneca PLC

By Bojan Pancevski 

BERLIN -- Germany's vaccine authority will recommend the government ban AstraZeneca PLC's Covid-19 vaccine for people younger than 60 following fresh blood-clotting incidents among recipients, an official at the country's disease-control agency said Tuesday -- potentially presenting the country's sputtering vaccine rollout with fresh delays.

The final decision on changing who may receive the AstraZeneca vaccine rests with the federal government, but local authorities from Berlin to Munich and individual hospitals elsewhere were already anticipating a partial ban on Tuesday by withholding the shot for younger recipients.

Like other European Union countries, Germany has struggled to ramp up vaccinations amid a shortage of doses and bureaucratic and logistical bottlenecks. Barring anyone under 60 from receiving the shot could make it hard for the government to reach its revised target of offering all residents a vaccine by the end of September.

It could also exacerbate already widespread misgivings about the vaccine. Germany originally authorized the shot only for those under 65 due to a lack of data about efficacy in older age groups before briefly banning it altogether for several days earlier in March amid concerns about rare blood clotting incidents following the injections.

Since its approval earlier this year, local authorities have reported reluctance to take the shot among those eligible for it.

The latest change in recommendation comes after authorities in Germany recorded 31 cases of rare blood clotting in the brain among the nearly 2.7 million people who had received the shot by Monday. Nine people died, and all but two of the incidents affected women aged 20 to 63, according to Germany's medicines regulator, the Paul Ehrlich Institute.

"AstraZeneca continues to analyze its database on tens of millions of records for COVID-19 Vaccine AstraZeneca to understand whether these very rare cases of blood clots associated with thrombocytopenia occur any more commonly than would be expected naturally in a population of millions of people," a spokeswoman for AstraZeneca said. "We will continue to work with German authorities to address any questions they may have."

The new recommendation by the standing vaccination committee of the Robert Koch Institute, Germany's center for disease control, will be published by the end of the week. The government has so far followed the recommendations of the committee.

The news comes as Germany is facing a sharp increase in Covid-19 infections despite imposing a succession of lockdowns since early November. Chancellor Angela Merkel called an emergency conference with the premiers of Germany's 16 states on Tuesday to discuss the pandemic response, including the future use of the AstraZeneca vaccine.

The European Union, of which Germany is a member, purchased 400 million doses from AstraZeneca and relies on the shot for about 30% of its vaccination program.

Germany briefly suspended the AstraZeneca rollout earlier this month after detecting seven cases of cerebral venous sinus thrombosis or CVST, a very rare and potentially deadly condition that causes blood clotting in the brain. France, Italy and other countries also temporarily halted the use of the shot.

Vaccination in most European countries resumed however after the European Medicines Agency, the EU drug regulator, ruled that the vaccine was safe for general use.

Now, after the number of CVST incidents exceeded three dozen, all of them people of working age, the German vaccine committee decided to recommend against its use in younger people. Officials of the German ministry of healthcare said that the expected incidence of CVST would be about one case in 1.6 million.

Some nations, such as Norway, haven't resumed use of the vaccine despite the EMA ruling and decided to wait for more research into the origin of a condition that appears to affect primarily younger women, a senior Norwegian healthcare official said.

Two medical teams in Germany and Norway separately concluded that the CVST incidents, which are often followed by a condition called thrombocytopenia, were caused by an autoimmune reaction prompted by the vaccine. The German team of Andreas Greinacher, professor of transfusion medicine at the Greifswald University Clinic, published their findings in a study that is yet to be peer-reviewed.

Prof. Greinacher's team examined nine cases from Germany and Austria, and suggested that the incidents linked to the vaccine resemble a rare disorder known as heparin-induced thrombocytopenia or HIT, which they said is easily treatable with immunoglobulin and blood-thinning medicine if identified promptly.

The AstraZeneca vaccine is "associated with development of a prothrombotic disorder that clinically resembles heparin-induced thrombocytopenia but which shows a different serological profile," their study stated.

The vaccine, the study argues, generates so-called anti-PF4/heparin antibodies, which then activate thrombocytes that cause blood clotting. The condition can be diagnosed and treated in any midsize or larger clinic, Dr. Greinacher said last week.

Ms. Merkel called this week on Germany's state governments, which have authority over most pandemic-fighting measures, to tighten restrictions on the public to curb the current surge in infections. Experts warned that the significant rise in new cases was partly due to the so-called British coronavirus variant, which is believed to be more infectious and possibly more deadly, becoming dominant in Germany.

Write to Bojan Pancevski at bojan.pancevski@wsj.com

(END) Dow Jones Newswires

March 30, 2021 12:55 ET (16:55 GMT)

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