AstraZeneca vaccine: Blood clots should be listed as ‘very rare’ side effect, says EU regulator

A attainable hyperlink between AstraZeneca’s COVID-19 vaccine and very rare cases of unusual blood clots has been discovered, the European Union’s drug regulator mentioned Wednesday. Nevertheless, it added the general advantages of the shot outweigh the danger of negative effects.

The European Medicines Company concluded that “uncommon blood clots with low blood platelets ought to be listed as very uncommon negative effects” of AstraZeneca’s COVID-19 vaccine, the regulator mentioned in a launch. The evaluation comes after an professional committee reviewed stories of bizarre blood clots in individuals who had obtained the vaccine.

Many of the instances occurred in ladies beneath 60, mentioned the EMA, however there’s not but sufficient proof to verify particular danger components. The regulator mentioned it is necessary for well being care professionals and vaccinated individuals to concentrate on the indicators of those uncommon blood clots, together with shortness of breath, chest ache, leg swelling and chronic stomach ache in addition to neurological signs, resembling extreme and chronic complications or blurred imaginative and prescient. 

AstraZeneca’s vaccine got here beneath scrutiny after the deaths of two vaccinated sufferers in March prompted some European international locations to pause their rollout whereas the EMA investigated. On Wednesday, EMA Govt Director Emer Cooke reiterated that the advantages of the vaccine outweigh the dangers of negative effects.

“The danger of mortality from COVID is way better than the danger of mortality from these negative effects,” mentioned Cooke during a briefing. “I believe it is necessary that we give the message that vaccines will assist us within the struggle towards COVID and we have to proceed to make use of these vaccines.”

AstraZeneca did not instantly reply to a request for remark.