For certain indications, the Moderna COVID‑19 Vaccine has not been approved or licensed by the US Food and Drug Administration (FDA), but has been authorized for emergency use by the FDA, under an Emergency Use Authorization (EUA), to prevent Coronavirus Disease 2019 (COVID‑19) in individuals 18 years of age and older. There are two presentations/formulations of the Moderna COVID‑19 Vaccine authorized for use.
The EUA for the Moderna COVID‑19 Vaccine 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.
See below for Moderna COVID‑19 Vaccine authorized uses.
Current Clinical Trials
Here are some of the clinical trial programs that are currently investigating Moderna COVID-19 Vaccine.
Independent study: Second Booster Dose
This independent study is an ongoing Phase 3, non-randomized, parallel assignment, open-label study to test the effect of a 4th dose by comparing the immune response before and after the 4th dose given to 150-200 volunteers with various control groups.
Phase 3 Trial, Study 9035-21 (NCT05230953)
Study 2: Booster Dose
Study 2 is an ongoing Phase 2, randomized, observer-blind, placebo-controlled, dose-confirmation study to evaluate the safety, reactogenicity, and immunogenicity of the Moderna COVID-19 Vaccine in participants 18 years of age and older.
Phase 2 Trial, Study P201 (NCT04405076)
- Study evaluation is ongoing
- View phase 2 trial overview on ClinicalTrials.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 in ongoing
- View phase 1 trial overview on ClinicalTrials.gov