Spikevax (Moderna COVID-19 Vaccine) FDA Approval History
Last updated by Judith Stewart, BPharm on July 13, 2025.
FDA Approved: Yes (First approved January 31, 2022)
Brand name: Spikevax (Moderna COVID-19 Vaccine)
Generic name: COVID-19 Vaccine, mRNA
Dosage form: Injection
Company: Moderna, Inc.
Treatment for: Prevention of COVID-19
Spikevax (COVID-19 Vaccine, mRNA) and Moderna COVID-19 Vaccine are mRNA vaccines for active immunization to prevent COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
- Spikevax (COVID-19 Vaccine, mRNA) is approved for use in individuals who are:
- 65 years of age and older, or
- 6 months through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19. The Moderna COVID-19 Vaccine was previously authorized under an Emergency Use Authorization (EUA) in individuals 6 months through 11 years of age. - The 2024-2025 Formula COVID-19 vaccines have been adapted for Omicron KP.2 based on guidance from the FDA, which stated that KP.2 is the preferred strain of the JN.1 lineage for COVID-19 vaccines for use in the U.S. during the 2024-2025 fall and winter season.
- Spikevax and Moderna COVID-19 Vaccine are administered by intramuscular injection.
- Warnings and precautions associated with authorized or approved mRNA COVID19 vaccines include:
- an increased risk of myocarditis and pericarditis, particularly within the first week following vaccination.
- For Spikevax, the observed risk is highest in males 12 years through 24 years of age. - Common adverse reactions for Spikevax or Moderna COVID-19 Vaccine, Bivalent containing the same amount of mRNA as the Spikevax 2024-2025 Formula (≥10%):
- in participants 6 months through 36 months of age include irritability/crying (up to 82.8%), pain at the injection site (up to 77.2%), sleepiness (up to 52.2%), loss of appetite (up to 46.5%), fever (up to 26.8%), erythema (up to 19.2%), swelling at the injection site (up to 19.2%), and axillary (or groin) swelling/tenderness (up to 12.2%).
- in participants 37 months through 11 years of age include pain at the injection site (up to 98.4%), fatigue (up to 73.2%), headache (up to 62.2%), myalgia (up to 35.3%), chills (up to 34.6%), nausea/vomiting (up to 29.3%), axillary (or groin) swelling/tenderness (up to 27.0%), fever (up to 25.8%), erythema (up to 24.1%), swelling at the injection site (up to 22.3%), and arthralgia (up to 21.3%).
- in participants 12 years through 17 years of age include pain at the injection site (up to 90.6%), fatigue (up to 58.1%), headache (up to 56.3%), myalgia (up to 40.1%), chills (up to 30.2%), axillary swelling/tenderness (up to 27.8%), arthralgia (up to 23.9%), nausea/vomiting (up to 17.9%), and swelling at the injection site (up to 13.3%).
- in participants 18 years through 64 years of age include pain at injection site (up to 86.3%), fatigue (up to 62.0%), headache (up to 58.9%), myalgia (up to 49.6%), arthralgia (up to 41.9%), chills (up to 40.3%), axillary swelling/tenderness (up to 24.8%), and nausea/vomiting (up to 16.7%).
- in participants 65 years of age and older include pain at injection site (up to 76.3%), fatigue (up to 58.1%), myalgia (up to 47.4%), headache (up to 42.1%), arthralgia (up to 39.5%), chills (up to 18.4%), and axillary swelling/tenderness (up to 14.3%).
Development timeline for Spikevax (Moderna COVID-19 Vaccine)
Further information
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