European PRAC updated safety issues with Janssen COVID-19 Vaccine
PRAC has recommended including immune thrombocytopenia, dizziness and tinnitus as adverse reactions, and to re-classify ‘thrombocytopenia’, currently an important potential risk, as an important identified risk.
Source:
European Medicines Agency
SPS commentary:
The PRAC recommendations on dizziness and tinnitus are based on an analysis of 1,183 cases of dizziness and 114 cases of tinnitus.
The benefit-risk balance of the vaccine remains unchanged.