The European Medicines Agency’s (EMA) safety group said that capillary leak syndrome must be added as a new side effect of the AstraZeneca vaccine, known as Vaxzevria.
People who had formerly sustained the condition, where fluids leak from the smallest blood vessels producing swelling and a drop in blood pressure, should not receive the shot, the EMA added.
The regulatory first began looking into these cases in April and the reference adds to AstraZeneca’s anguishes after its vaccine was associated with very rare and potentially deadly cases of blood clotting that come with a low platelet count.
Last month, the EMA had directed against using the second AstraZeneca vaccine shot for people with that clotting condition, known as thrombosis with thrombocytopenia syndrome (TTS).
The committee studied six validated cases of capillary leak syndrome in people, mostly women, who had received Vaxzevria, including one death. Three had had a history of the condition.