COVID-19 Vaccine FDA Approval Status
Yes, two COVID-19 vaccines have received full FDA approval: Pfizer-BioNTech's Comirnaty and Moderna's Spikevax, both approved under Biologics License Applications (BLA) for specific age groups, while other formulations and age groups remain under Emergency Use Authorization (EUA).
Current FDA Approval Status
Fully Approved Vaccines
- Pfizer-BioNTech (Comirnaty) received full FDA approval on August 23,2021, for individuals aged ≥16 years 1, 2
- Moderna (Spikevax) received full FDA approval for the 2024-2025 formulation on August 22,2024, for persons aged ≥12 years 3
- The 2024-2025 Pfizer-BioNTech vaccine also received full FDA approval on August 22,2024, for persons aged ≥12 years 3
Emergency Use Authorization (EUA) Status
- Pfizer-BioNTech vaccine remains under EUA for children aged 6 months-11 years 3
- Moderna vaccine remains under EUA for children aged 6 months-11 years 3
- Novavax (NVX-CoV2373) operates entirely under EUA for persons aged ≥12 years 3
- Janssen (Johnson & Johnson) vaccine was authorized under EUA but is now recommended only in very limited situations due to thrombosis with thrombocytopenia syndrome risk 3
Current Vaccine Formulations (2024-2025)
- The most recent approved formulations target the Omicron KP.2 strain (Pfizer-BioNTech and Moderna) or JN.1 strain (Novavax) 3
- These updated monovalent vaccines replaced the previous bivalent formulations that targeted both ancestral and Omicron BA.4/BA.5 strains 3
Clinical Implications of Approval Status
- Full FDA approval indicates completion of comprehensive Phase 3 clinical trials with extended follow-up data demonstrating safety and efficacy 1
- EUA status for pediatric formulations reflects ongoing data collection in younger age groups while allowing access to vaccination during the public health emergency 4
- The distinction between full approval and EUA does not reflect differences in vaccine quality or manufacturing standards—both undergo rigorous FDA review 2
Important Caveats
- The specific formulation and age indication matter when determining approval status—a vaccine may be fully approved for adults but under EUA for children 3, 5
- Booster doses initially operated under EUA even when primary series had full approval, though current 2024-2025 formulations have received full approval for eligible age groups 3
- Vaccine approval status evolves as new formulations are developed to match circulating variants, requiring updated regulatory submissions 3