As part of its advice on safety-related aspects, the PRAC agreed on direct healthcare professional communications (DHPCs) containing important safety information for COVID-19 Vaccine Janssen and Vaxzevria about immune thrombocytopenia (ITP) and venous thromboembolism (VTE) (Janssen) and risk of thrombocytopenia including immune thrombocytopenia (Vaxzevria).

The DHPCs for COVID-19 Vaccine Janssen and Vaxzevria will be forwarded to EMA’s human medicines committee, the CHMP.

Following the CHMP agreement, the DHPCs will be disseminated to healthcare professionals by the marketing authorisation holders, according to an agreed communication plan.