COMIRNATYยฎ (COVID-19 Vaccine, mRNA) suspension for injection,
for intramuscular use
Initial U.S. Approval: 2021
5.2 Myocarditis and Pericarditis
Post-marketing data demonstrate increased risks of myocarditis and pericarditis, particularly within 7 days
following the second dose. The observed risk is higher among males under 40 years of age than among females
and older males. The observed risk is highest in males 12 through 17 years of age. Although some cases
required intensive care support, available data from short-term follow-up suggest that most individuals have had
resolution of symptoms with conservative management. Information is not yet available about potential long term sequelae. The CDC has published considerations related to myocarditis and pericarditis after vaccination,
including for vaccination of individuals with a history of myocarditis or pericarditis
(https://www.cdc.gov/vaccines/covid-19/clinical-considerations/myocarditis.html).
Manufactured by
Pfizer Inc., New York, NY 10017
LAB-1448-1.3a
US Govt. License No. 2229