AstraZeneca’s Covid-19 vaccine, Vaxzevria, should include a warning about the risk of blood clots as one of the jab’s very rare side effects, the EU’s drug regulator, the European Medicines Agency (EMA), has said.
The latest review by the EMA’s safety committee on the Anglo-Swedish vaccine has found that its benefits continue to outweigh the associated risks.
However, the agency said in a statement on Wednesday that both healthcare professionals and anyone receiving the vaccine should be reminded that “unusual blood clots with low blood platelets” remain a “very rare side effect.”
The EMA said most reported cases of blood clots have been in women under 60 years of age within two weeks of being vaccinated with the Oxford/AstraZeneca jab.
The regulator’s safety committee reviewed 62 cases of cerebral venous sinus thrombosis and 24 cases of splanchnic vein thrombosis in people who received the vaccine in the EU and the UK up to March 22. A total of 18 cases of blood clotting were fatal among the 25 million people to have received the vaccine across the UK and EEA (European Economic Area), the EMA said.
The regulator’s latest review comes after a number of EU states suspended their use of the vaccine last month amid reports of blood clots in a small number of people who received it.
The results of a previous EMA review, published on March 18, found that the vaccine was not associated with an increase in the overall risk of blood clots.
A number of countries subsequently resumed their rollouts, but imposed age limits on who could take the vaccine, due to the apparently younger profile of people who reported suffering blood clots after being administered the jab.
The French drug regulator has recommended it only for people aged over 55, and Germany only for those over 60. Ahead of the EMA’s news briefing on Wednesday, Estonia also announced it was suspending the jab for those under 60.
On Tuesday, Oxford University – which was involved in developing the inoculation with AstraZeneca – paused its trial of the vaccine in children while the UK regulator investigated a possible link between the jab and blood clots among some adult recipients.
The World Health Organization’s committee on vaccine safety said in a statement on Wednesday that cases of blood clots linked to AstraZeneca’s vaccine are “concerning” but “very rare” and further studies into the issue are needed.
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