U.S. FDA requirements for Human Vaccine Product Safety and Potency Testing

The Office of Vaccines Research and Review (OVRR) at the Center for Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA) regulates preventative and therapeutic vaccines for infectious disease indications for use in humans. The framework for regulation of biological products includes Statutes (e.g. The U.S. Food, Drug and Cosmetic Act and the Public Health Service Act), regulations as defined in the Code of Federal Regulations (CFR) and guidance documents. Approval of a biologics license for a product, including vaccines, is based on a demonstration of safety, purity, and potency and assurance that the facility for manufacture, processing, and packaging meets standards to ensure that product released for distribution is safe, pure and potent. The regulatory definitions of safety, purity and potency are detailed in Title 21 of the Code of Federal regulations (CFR) Part 600. All manufacturing information including tests for safety, purity, and potency for a particular product must be documented in the Biologics License Application (BLA). Potency testing may be performed on the final bulk sample or final container sample and may consist of either in vivo or in vitro tests or both. To change a potency or safety test post-licensure requires a Supplement to the License and data to support a modified or alternative test. CBER encourages the development and use of appropriate alternative methods for vaccine safety and potency testing.