EMA Recommends Including Adverse Reaction Warning to Janssen COVID-19 Vaccine

The European Medicines Agency (EMA) announced on August 6, 2021 that its Pharmacovigilance Risk Assessment Committee (PRAC) recommended that immune thrombocytopenia be added to the list of adverse reactions for Janssen’s COVID-19 vaccine. It also recommended that thrombocytopenia be reclassified as an important identified risk in the risk management plan of the vaccine.

The recommendations came after PRAC assessed scientific literature and cases reported to the European database for suspected side effects and the Vaccine Adverse Event Reporting System in the United States, as well as other evidence.

PRAC also recommended amending product information to add dizziness and tinnitus as adverse reactions after an analysis of 1183 cases of dizziness and more than 100 cases of tinnitus. EMA stated in a press release that, “The benefit-risk balance of the vaccine remains unchanged. EMA will continue to closely monitor this issue and will communicate further when new information becomes available.”