Janssen Vaccine Warning on Myocarditis/Pericarditis

FDA has revised the fact sheets on Janssen’s Covid-19 vaccine to include a warning about reported adverse events that suggest increased risks of myocarditis and pericarditis, particularly within the first seven days after administration. “An additional revision to the fact sheets was made to include that facial paralysis (including Bell’s Palsy) has been reported during post-authorization use,” FDA says.

Janssen’s vaccine is authorized for preventing Covid-19 caused by SARS-CoV-2 in individuals 18 years of age and older for whom other FDA-authorized or approved Covid-19 vaccines are not accessible or not clinically appropriate. It is also authorized for use in individuals 18 years of age and older who elect to receive it because they would otherwise not receive a Covid-19 vaccine. Additionally, it may be administered as a first booster dose at least two months after completion of primary vaccination with an authorized or approved Covid-19 vaccine.