Yes, COVID-19 vaccines are FDA approved. Three vaccines currently have full FDA approval in the United States: Comirnaty (Pfizer-BioNTech), Spikevax (Moderna), and Nuvaxovid (Novavax). The approval status depends on which vaccine you’re looking at and how old the recipient is, so here’s a clear breakdown.
Which Vaccines Have Full FDA Approval
Pfizer-BioNTech’s vaccine, marketed as Comirnaty, was the first COVID-19 vaccine to receive full FDA approval on August 23, 2021, for people 16 and older. It has since been approved for ages 12 and up. Moderna’s vaccine, marketed as Spikevax, received full approval on January 31, 2022. Spikevax is approved for people 65 and older, and for those aged 6 months through 64 who have at least one underlying condition that puts them at higher risk for severe COVID-19. Novavax’s vaccine, marketed as Nuvaxovid, received full approval in 2025 for people 65 and older and those 12 through 64 with at least one high-risk condition.
The updated 2024-2025 formulas of both Comirnaty and Spikevax carry full FDA approval for individuals 12 and older. These aren’t holdovers from the original emergency period. They went through the standard approval process for the current formula.
What’s Still Under Emergency Use Authorization
For younger children, the picture is different. Kids aged 6 months through 11 years receive COVID-19 vaccines under Emergency Use Authorization (EUA), not full approval. The Pfizer-BioNTech and Moderna vaccines are both authorized for this age group under EUA. Novavax is authorized under EUA for ages 12 and older who don’t meet the criteria for the fully approved version.
EUA is not the same as being unapproved or experimental. It means the FDA determined that the vaccine’s known and potential benefits outweigh its known and potential risks, based on clinical trial data. But the evidence package is smaller than what full approval requires.
How Full Approval Differs From Emergency Authorization
The gap between EUA and full approval comes down to how much data the FDA reviews. For emergency authorization, the FDA requires phase 3 trial data with a median follow-up of at least two months after vaccination, plus a safety database of well over 3,000 vaccine recipients. Manufacturers can submit data from an interim analysis, meaning the trial doesn’t need to be finished.
Full approval (technically called a Biologics License Application) demands substantially more. It requires completed clinical trials, longer follow-up periods, more extensive safety data, and a thorough review of manufacturing processes, facility inspections, and product consistency. The FDA also expects manufacturers who receive an EUA to continue running their clinical trials and eventually pursue full licensure.
By the time the COVID-19 vaccines received full approval, hundreds of millions of doses had been administered, and the FDA had access to real-world safety data on top of the clinical trial results. The agency runs multiple surveillance systems to track vaccine safety after authorization or approval, including VAERS (a reporting system co-managed with the CDC), the Sentinel system for active surveillance, and the CDC’s v-safe monitoring program.
What About the Johnson and Johnson Vaccine
The Janssen (Johnson & Johnson) COVID-19 vaccine is no longer available in the United States. Janssen requested a voluntary withdrawal of its emergency use authorization on May 22, 2023, and the FDA formally revoked the EUA on June 1, 2023. It never received full FDA approval. If you previously received the J&J vaccine, it remains a valid part of your vaccination history, but it is not being manufactured or distributed for COVID-19 prevention in the U.S.
The Short Version
If you’re 12 or older, the current COVID-19 vaccines available to you (Comirnaty, Spikevax, and Nuvaxovid) are fully FDA approved, though some carry conditions based on age and health status. For children under 12, the vaccines are authorized under EUA. Both pathways involve FDA safety review, but full approval reflects a more extensive evidence package and a longer regulatory process.