The European Medicines Agency (EMA) has deemed AstraZeneca’s Covid-19 vaccine “safe and effective” after an extensive review of possible blood clot risks, the agency’s chief said on Thursday.
Blood clot reports from several countries prompted governments around the world to halt inoculations with the AstraZeneca jab. This slowed down already sluggish inoculation campaigns in the European Union. The EMA, which had approved the jab in January, launched a review of the risks.
“The committee has come to a clear scientific conclusion,” the agency’s chief Emer Cooke said when presenting the findings. “This is a safe and effective vaccine.
Its benefits in protecting people from Covid-19, with the associated risks of death and hospitalization, outweigh the possible risks,” Cooke said. The agency’s committee concluded that the vaccine was not associated with an increase in the overall risk of thromboembolic events or blood clots.
“When you vaccinate millions of people, it’s inveitable that rare or serious incidences or illnesses will occur in the time immediately following vaccination,” she said.
However, the agency could not definitively rule out a link between cases of rare, very serious clotting disorders and the vaccine, and said it launched additional investigations to understand the issue. The EMA therefore recommended issuing warnings by including the risks in the product information.
The World Health Organization has also recommended the continued use of the vaccine. These assessments now clear the way for countries to take up their AstraZeneca vaccine campaigns again. Before the announcement of the results, some governments indicated that they would follow the EMA’s advice.
But while AstraZeneca’s jab received backing from the EU medicines agency, the company itself remains at loggerheads with the European Commission.