The U.S. Food and Drug Administration (FDA) initially made the Spikevax (Moderna), Comirnaty (Pfizer), Novavax and Johnson & Johnson (Janssen) COVID-19 vaccines available during the current public health emergency using an Emergency Use Authorization (EUA) (https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-vaccines). The EUA is supported by a Secretary of Health and Human Services (HHS) declaration that “circumstances exist to justify the emergency use of drugs and biological products during the COVID-19 pandemic.” The FDA’s decision is based on scientific evidence showing the vaccines are effective to prevent COVID-19 and that the benefits of the products outweigh the risks.

Spikevax (Moderna) has full FDA approval for ages 18 and older, and Comirnaty (Pfizer) has received full approval for ages 12 and older.