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) in either individuals 6 months of age and older or as a booster dose in individuals 18 years of age and older, as appropriate.
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.
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.
Clinical Trial Results: Pediatric
For information regarding safety, reactogenicity, and immunogenicity please see the Fact Sheets and Full EUA Prescribing Information: