Initial U.S. Approval: 2021
COMIRNATY is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older.
There are no data available on the interchangeability of COMIRNATY with COVID-19 vaccines from other manufacturers to complete the vaccination series.
Postmarketing 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… Information is not yet available about potential long- term sequelae.
Participants are being monitored for unsolicited adverse events, including serious adverse events, throughout the study [from Dose 1 through 1 month (all unsolicited adverse events) or 6 months (serious adverse events) after the last vaccination].
In analyses of all unsolicited adverse events in Study 2 from Dose 1 up to the participant unblinding date… Among participants 16 through 55 years of age… unsolicited adverse events were reported by… 33.8%… in the COMIRNATY group and… 16.4%… in the placebo group.
[In] participants 56 years of age and older… unsolicited adverse events were reported by… 28.6%… in the COMIRNATY group and… 16.1%… in the placebo group.
Bell’s palsy (facial paralysis) was reported…
[A]mong participants 12 through 15 years of age… serious adverse events… were reported by… 0.9%… COMIRNATY recipients and… 0.2%… placebo recipients.
Postmarketing Experience
– myocarditis, pericarditis
– diarrhea, vomiting
– severe allergic reactions, including anaphylaxis, and other hypersensitivity reactions (e.g., rash, pruritus, urticaria, angioedema)
– pain in extremity (arm)
Available data on COMIRNATY administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy.
It is not known whether COMIRNATY is excreted in human milk. Data are not available to assess the effects of COMIRNATY on the breastfed infant or on milk production/excretion.
COMIRNATY contains 30 mcg of a nucleoside-modified messenger RNA (mRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2.
Each 0.3 mL dose… also includes the following ingredients: lipids [lipid nanoparticle / LPN*]… polyethylene glycol [PEG]… tromethamine… tromethamine hydrochloride…
COMIRNATY has not been evaluated for the potential to cause carcinogenicity, genotoxicity, or impairment of male fertility.