The US Food and Drug Administration (FDA) has revised the Janssen COVID-19 vaccine fact sheet for providers to include a warning about increased risks of myocarditis and pericarditis following vaccination.
The revision states that the vaccine can cause thrombosis with thrombocytopenia syndrome (TTS), which may be life-threatening. “TTS may involve thrombosis at unusual locations for a thrombus (i.e., cerebral vein, visceral artery or vein, extremity artery, central artery, or vein) or in an extremity vein or pulmonary artery,” according to the fact sheet.
Among reported cases of TTS following administration of the Janssen COVID-19 vaccine, symptoms began approximately one to two weeks after vaccination.
The fact sheet for recipients and caregivers was also revised to include information about myocarditis and pericarditis following administration of the vaccine.
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. Also, the scope of authorization for a booster dose of the Janssen COVID-19 vaccine has been revised to reflect that the vaccine 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.
The FDA reissued the letter of authorization for Janssen COVID-19 vaccine to revise the scope of authorization related to the administration of a booster dose and the conditions of authorization related to the Vaccine Adverse Event Reporting System reporting requirements for vaccination providers and Janssen to include myocarditis and pericarditis.
The Janssen COVID-19 vaccine is authorized for emergency use for the prevention of 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 clinically appropriate and in individuals 18 years of age and older who elect to receive the Janssen COVID-19 vaccine because they would otherwise not receive a COVID-19 vaccine.