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 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.
Overall, most of the adverse reactions reported after patients received AstraZeneca Plc’s vaccine happened in the U.K., where the government has defended the homegrown shot. A March 8 review identified 246 such reactions 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.
The analysis of the Astra shot has focused on an unusual type of blood clots 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.
The EMA report said it “hasn’t identified any specific risk factors, such as age, gender or a previous medical history of clotting disorders,” for the cases that have occurred after vaccination.