Spikevax (Moderna COVID-19 Vaccine) FDA Approval History

Last updated by Judith Stewart, BPharm on Aug 28, 2024.

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 12 years of age and older.
• Moderna COVID-19 Vaccine is authorized under an Emergency Use Authorization (EUA) in individuals 6 months through 11 years of age. The EUA for this product is in effect for the duration of the COVID-19 EUA declaration justifying emergency use of the product, unless the declaration is terminated or the authorization is revoked sooner.
• 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 18 years through 24 years of age.
• Common adverse reactions for Spikevax:
  - in adults 65 years of age and older include pain at injection site, fatigue, myalgia, headache, arthralgia, chills, and axillary swelling/tenderness.
  - in adults 18 years through 64 years of age include pain at injection site, fatigue, headache, myalgia, arthralgia, chills, axillary swelling/tenderness, and nausea/vomiting.
  - in adolescents 12 years through 17 years of age include pain at the injection site, fatigue, headache, myalgia, chills, axillary swelling/tenderness, arthralgia, nausea/vomiting, and swelling at the injection site.
• Common solicited adverse reactions for Moderna COVID-19 Vaccine:
  - in children 37 months through 11 years of age include injection site erythema, pain and swelling; arthralgia, axillary (or groin) swelling/tenderness, chills, fatigue, fever, headache, myalgia, and nausea/vomiting.
  - in infants 6 months through 36 months of age include injection site erythema, pain and swelling; axillary (or groin) swelling/tenderness, fever, irritability/crying, loss of appetite and sleepiness.

Development timeline for Spikevax (Moderna COVID-19 Vaccine)

Further information

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