Emergency uses of the vaccine have not been approved or licensed by the FDA, but have been authorized by the FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019
(COVID-19). The Moderna
COVID-19 Vaccine is authorized in individuals
6 months of age and older as a primary series. The Moderna COVID-19 Vaccine, Bivalent is authorized as a booster dose in individuals
6 months through 5 years of age at least 2 months after the Moderna COVID-19 Vaccine primary series and is authorized in individuals 6 years of age and older at least 2 months after any authorized or approved vaccine.
The EUA for these products 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.
For more information on the EUA authorized uses of the vaccine, refer to the Fact Sheets for Healthcare Providers Administering Vaccine (Vaccine Providers) and Full Prescribing Information.
Current Clinical Trials
Here are some of the clinical trial programs that are currently investigating Moderna COVID-19 Vaccine.
Study 6: Bivalent Booster Dose
Study 6 is a Phase 2/3 open-label study to evaluate the immunogenicity, safety, and reactogenicity of Moderna COVID-19 Vaccine, Bivalent in participants 18 years of age and older.
Phase 2/3 Trial (NCT04927065)
- Study evaluation is ongoing
- View Phase 2/3 trial overview on Clinical Trials.gov
Study 1: Primary Series
Study 1 is an ongoing Phase 3 randomized, placebo-controlled, observer-blind clinical trial to evaluate the efficacy, safety, and immunogenicity of the Moderna COVID-19 Vaccine in participants 18 years of age and older in the United States.
Phase 3 Trial, Study P301 (NCT04470427)
Other Primary Series Studies
Phase 1 Trial, Study P101 (NCT04283461)
- See the preliminary report published in New England Journal of Medicine
- Follow‑up evaluation of subjects is ongoing
- View phase 1 trial overview on ClinicalTrials.gov