EMA's PRAC issues safety warnings on COVID-19 vaccines

11 March 2022

Following the March meeting of the European Medicines Agency Pharmacovigilance Risk Assessment Committee (PRAC), safety warnings were issued on two COVID-19 vaccines, one from Johnson & Johnson’s (NYSE: JNJ) Janssen unit and the other from US mRNA specialist Moderna (Nasdaq: MRNA).

COVID-19 Vaccine Janssen: small vessel vasculitis added as a side effect

The PRAC has recommended that small vessel vasculitis with cutaneous manifestations (inflammation of blood vessels in the skin which may result in a rash, pointed or flat, red spots under the skin’s surface and bruising) should be added to the product information of COVID-19 Vaccine Janssen as a possible side effect of unknown frequency.

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