EU Review of Astra Vaccine Risks Finds 246 U.K. Adverse Events

The European Union’s drugs regulator said a link between AstraZeneca Plc’s Covid-19 vaccine and a rare type of blood clot is possible, identifying at least 62 cases of the condition while insisting the shot’s benefits still outweigh its risks.

The comments further cloud the picture around the vaccine after Germany restricted it to older people this week amid growing concerns about side effects. That could slow Europe’s already lagging immunization program as virus cases surge anew.

The European Medicines Agency said its safety committee will probably issue an updated recommendation next week. If the panel concludes there’s a connection between the clots and Astra’s vaccine, the EMA will change its recommendations to patients and health-care officials, Executive Director Emer Cooke said.

“At the moment, at this stage of our investigations, the link is possible, and we cannot say any more than that at this point,” Cooke said in a press conference. For now, there’s no evidence to support restricting use of the vaccine in any population of people, she said.

AstraZeneca’s vaccine, developed with the University of Oxford, is under mounting scrutiny and has faced dwindling support in Europe. Still, countries are counting on the shot to help them exit the pandemic, and millions of doses have been administered across the region.

“The U.K. needs to be on high alert as it starts using the vaccine in younger people,” Sam Fazeli, an analyst with Bloomberg Intelligence, wrote in a report.

Read More: U.K. Can No Longer Ignore Safety Risk of Astra’s Covid Vaccine

Concerns surrounding the Astra shot have focused on an unusual type of blood clot known as cerebral venous sinus thrombosis. It’s associated with a low number of blood platelets and occurs most commonly in women between the ages of 30 and 45 -- a group that, in the EU, has been disproportionately vaccinated with Astra’s shot, EMA officials said.

In individuals under the age of 60, health authorities are seeing more cases of the rare clots in people who recently got the Astra vaccine than would be normally expected, said Peter Arlett, EMA’s head of pharmacovigilance and epidemiology. The agency has identified about one report per 100,000 people under the age of 60 who got the vaccine in the European economic area. It hasn’t yet been able to identify specific risk factors, however, such as age, gender or previous medical history of clotting disorders.

The figure of 62 cases of the rare clots includes all side effects reported in the EMA’s EudraVigilance system, which includes cases both in and outside Europe, the agency said. The count dates to March 22, and additional cases have occurred since then.

Looking beyond the rare clots, most of the adverse reactions reported in patients who had received Astra’s vaccine occurred in the U.K., where it has been used most and where the government has defended the homegrown shot. A March 8 review identified 246 reactions involving various types of artery blockages or blood clots in Britain, including a range of conditions. That’s out of 269 instances in a dozen countries, which included about 40 deaths, the regulator said. Just because the reactions were reported after vaccination doesn’t mean they’re linked to the vaccine.

©2021 Bloomberg L.P.

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