Spikevax (Moderna COVID-19 Vaccine) FDA Approval History
Last updated by Judith Stewart, BPharm on Sep 13, 2023.
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) 2023-2024 Formula and Moderna COVID-19 Vaccine 2023-2024 Formula 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) 2023-2024 Formula is approved for use in individuals 12 years of age and older.
- Moderna COVID-19 Vaccine 2023-2024 Formula 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.
- Moderna COVID-19 Vaccine (Original monovalent) and Moderna COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) are no longer authorized for use in the United States.
- The COVID-19 vaccines (2023-2024 Formula) are monovalent and encode the spike protein of SARS-CoV-2 Omicron variant lineage XBB.1.5. Clinical data have demonstrated robust immune responses across multiple circulating variants, including EG.5, FL.1.5.1, and BA.2.86.
- Spikevax and Moderna 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 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
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
