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AstraZeneca COVID-19 shot tagged with new warning in EU, highlighting rare blood clot risk


Europe’s drug regulator has been probing cases of rare blood clots in AstraZeneca COVID-19 vaccine recipients since mid-March—and now it has confirmed a possible link. The agency stressed that the benefits of the shot still outweigh the risks. Unusual blood clots with low blood platelets should be listed as a “very rare” side effect of the vaccine, the European Medicines Agency (EMA) said Wednesday. Incidents have mostly been reported within two weeks of vaccination in women below the age of 60. With cases piling up over the past month, several countries have stopped using the shot altogether. The EMA's safety arm, the Pharmacovigilance Risk Assessment Committee (PRAC), specifically noted clots in the brain, abdomen and arteries associated with thrombocytopenia, or low levels of blood platelets.

FiercePharma - April 7, 2021

View the full story here: https://www.fiercepharma.com/pharma/astrazeneca-s-covid-shot-should-list-blood-clots-as-rare-side-effect-ema-says