What was the first mRNA vaccine to receive full FDA approval?

Comirnaty was the first mRNA vaccine to receive full FDA approval.

The U.S. Food and Drug Administration approved Comirnaty, made by Pfizer and BioNTech, on 23 August 2021 for preventing COVID-19 in people aged 16 and older. It had previously been available under emergency-use authorization.

Comirnaty uses messenger RNA instructions that cause cells to make a version of the SARS-CoV-2 spike protein. The immune system responds to that protein and can develop memory against the virus without receiving the whole virus.

The FDA’s full approval was distinct from an emergency authorization, which uses a different regulatory standard during a public-health emergency. Moderna’s mRNA vaccine, Spikevax, also received full FDA approval later. Vaccine formulations and authorized age groups have changed as public-health guidance evolved.