EU regulator backs Oxford/AstraZeneca vaccine, confirms link to ‘very rare’ blood clot

The European Medicines Agency on Wednesday backed continued use of the Oxford/AstraZeneca vaccine in all adults, in a statement confirming a “possible link” to “very rare” cases of blood clotting.

The statement following a fresh review by the regulator’s safety committee said the overall benefits of the vaccine in protecting against the coronavirus still outweigh the risks. The vaccine remains approved in the EU for anyone over the age of 18.

It’s the first time the regulator has confirmed a possible link between the Oxford/AstraZeneca vaccine and blood clotting. The EMA said that unusual blood clots with low blood platelets should now be listed as a very rare side effect.

It asked health care professionals distributing the jabs and those receiving it to “remain aware of the possibility of very rare cases of blood clots combined with low levels of blood platelets occurring within 2 weeks of vaccination.”

It said people experiencing symptoms including shortness of breast and chest pain after having the vaccine should seek urgent medical assistance.

The agency’s safety committee PRAC assessed 62 cases of cerebral venous sinus thrombosis (CVST) and 24 cases of splanchnic vein thrombosis reported across the European Economic Area and the U.K., 18 of which were fatal, according to the regulator.

Most of the reported cases have been in women under the age of 60 two weeks after being vaccinated. Regulators “have not confirmed” any risk factors. 

The announcement comes after Marco Cavaleri, the head of the EMA’s vaccine strategy, told Italian newspaper il Messaggero that it was “clear that there is a link” between the AstraZeneca vaccine and rare blood clots, but that the balance of risks and benefits still supported its use.

It is yet to be seen whether EU countries will follow the EMA’s guidance or continue to restrict the use of the vaccine as a precautionary measure. The vaccine is currently restricted to older populations in Germany, France, the Netherlands, Sweden and Finland, while Denmark has suspended its use completely.