PRAC March 2022 – Update on COVID-19 vaccines and new safety information for dexmedetomidine
March 22, 2022
During its March 2022 meeting, the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency has recommended a change to the product information for the COVID-19 vaccines of Janssen and Moderna. The Committee also discussed a direct healthcare professional communication containing important safety information for dexmedetomidine.
Source: FAMHP
COVID-19 Vaccine Janssen: small vessel vasculitis added as a side effect
The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) 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.