EU Regulator: AstraZeneca Vaccine Effective, Blood Clots May Be A Rare Side Effect

The European Union’s drug regulator said Wednesday that the benefits of AstraZeneca’s COVID-19 vaccine outweigh its risks, but that very rare blood clotting events should be listed as a possible side effect.

The European Medicines Agency’s assessment comes after a panel of experts reviewed reports of unusual blood clots occurring in some vaccine recipients. Officials stressed that these events are very rare, and said that while they appear to be more common in women under the age of 60, there is not enough available evidence to confirm specific risk factors such as age, gender or previous medical history.

They said it is important for healthcare providers and the public to be aware of the signs and symptoms of these unusual events — which include shortness of breath, persistent abdominal pain and leg swelling — and that the vaccine’s product information will be updated to list them as a possible adverse reaction. They are still recommending its use, and emphasized the vaccine has been proven to prevent severe disease, hospitalizations and deaths.

“The risk of mortality from COVID is much greater than the risk of mortality from these side effects,” said Emer Cooke, executive director of the EMA. ” I think it’s important that we give the message that vaccines will help us in the fight against COVID and we need to continue to use these vaccines.”

Last month, reports emerged of dozens of blood clots occurring after vaccination, several of them fatal. That prompted more than a dozen countries, mostly in Europe, to temporarily suspend use of the AstraZeneca vaccine, though the EMA and World Health Organization both continued to recommend its use.

 

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