EU drugs regulator: Oxford/AstraZeneca vaccine is safe

Several days after most EU countries suspended the use of Oxford/AstraZeneca’s vaccine over blood clot concerns, the bloc’s medicines regulator concluded Thursday the vaccine is safe and effective in preventing COVID-19 and its benefits far outweigh the risks — but it could not eliminate a possible link to a rare type of clot.

Emer Cooke, executive director of the European Medicines Agency, said the safety committee PRAC concluded the vaccine is “not associated with an increase in the overall risk of thromboembolic events or blood clots.”

An analysis of a small number of cases of “rare and unusual but very serious clotting disorders” concluded “we still cannot rule out definitively a link between these cases and the vaccine,” she added.

In light of this, EMA recommended raising awareness of these possible risks to make sure that they’re included in the product information. It also called for providing information to health care professionals and vaccinated people to help spot and mitigate any possible side effects.

EMA is launching additional investigations to understand more about these rare cases, Cooke added.

It comes after 20 EU countries, starting with Austria, either suspended, entirely or partially, their vaccination program with Oxford/AstraZeneca’s jab — despite statements from the drugmaker, the EMA and the U.K.’s drugs regulator that stood by the safety of the vaccine with regard to blood clots.

Austria, Estonia, Latvia, Lithuania and Luxembourg all suspended use of a specific batch of the vaccine. France, Germany, Italy, Spain, Portugal, Slovenia, Cyprus, Sweden, Norway, Denmark, Bulgaria, Iceland, Ireland, the Netherlands and Luxembourg halted the entire rollout with the jab.

It will now be down to each country to decide whether to resume vaccinating people with the jab.

Some health experts fear, however, that European capitals’ decision to ignore the EMA’s advice last week — and instead halt the Oxford/AstraZeneca program nationally — will now weaken those countries’ abilities to convince people to accept the jab again.