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Vaccine Licensure FDA
About Vaccine Licensure FDA
The FDA regulates vaccine licensure in the United States. Vaccines are licensed under Section 351 of the Public Health Service Act and regulated as biological products. The vaccine development and approval process typically takes many years and includes preclinical studies, Phase 1 safety trials, Phase 2 immunogenicity trials, and Phase 3 efficacy trials involving thousands of participants. The Vaccines and Related Biological Products Advisory Committee VRBPAC reviews data and recommends approval. After licensure, the FDA monitors safety through VAERS, the Vaccine Safety Datalink, and postmarketing studies. The Biologics License Application BLA is the formal approval document. Emergency Use Authorization EUA provides faster access during emergencies, as used for COVID vaccines. The FDA also regulates vaccine manufacturing facilities and inspects them regularly. The licensure process is designed to establish safety and efficacy before approval, with monitoring continuing afterwards.
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