Comirnaty FDA Approval History
Last updated by Judith Stewart, BPharm on Sep 13, 2023.
FDA Approved: Yes (First approved August 23, 2021)
Brand name: Comirnaty
Generic name: COVID-19 Vaccine, mRNA
Dosage form: Injection
Company: Pfizer Inc.
Treatment for: Prevention of COVID-19
Comirnaty (COVID-19 Vaccine, mRNA) 2023-2024 Formula and Pfizer-BioNTech COVID-19 Vaccine 2023-2024 Formula are mRNA vaccines indicated for active immunization to prevent COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
- Comirnaty (COVID-19 Vaccine, mRNA) 2023-2024 Formula is approved for use in individuals 12 years of age and older.
- Pfizer-BioNTech COVID-19 Vaccine 2023-2024 Formula is authorized under an Emergency Use Authorization (EUA) in individuals 6 months through 11 years of age. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b) (1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.
- The COVID-19 vaccines (2023-2024 Formula) are monovalent and encode the spike protein of SARS-CoV-2 Omicron variant lineage XBB.1.5. Pre-clinical data show that the updated COVID-19 vaccine generates improved neutralizing antibody responses against multiple circulating Omicron-related sublineages including XBB.1.5, BA.2.86 (Pirola), and EG.5.1 (Eris).
- Comirnaty and Pfizer-BioNTech COVID-19 Vaccine are administered by intramuscular injection.
- Warnings and precautions associated with authorized or approved mRNA COVID19 vaccines include increased risks of myocarditis and pericarditis, particularly within the first week following vaccination. For Comirnaty, the observed risk is highest in males 12 through 17 years of age. Syncope (fainting) may also occur in association with administration of injectable vaccines, including Comirnaty and Pfizer-BioNTech COVID-19 Vaccine. Procedures should be in place to avoid injury from fainting.
- Common adverse reactions for Comirnaty:
- in individuals 12 years of age and older include pain at the injection site, fatigue, headache, chills, muscle pain, joint pain, fever, injection site swelling, and injection site redness. - Common solicited adverse reactions for Pfizer-BioNTech COVID-19 Vaccine:
- in infants 6 months through 23 months of age include injection site redness; swelling and tenderness; decreased appetite; drowsiness; fever; and irritability.
- in children 2 through 11 years of age include injection site pain; redness and swelling; chills; diarrhea; fatigue; fever; headache; new or worsened joint pain; new or worsened muscle pain; and vomiting.
Development timeline for Comirnaty
Further information
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