Regulation and Testing of Vaccines

Abstract

Federal regulation of vaccine safety began in 1902, with the passage of the Biologics Control Act. Since the act’s introduction, several federal agencies have become involved in vaccine safety, including the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), the Department of Veterans Affairs (VA), and the Food and Drug Administration (FDA). This chapter focuses primarily on the FDA and its Center for Biologics Evaluation and Research (CBER), which is charged with ensuring the safety, purity, and effectiveness of vaccines in the United States (U.S.) (Bodie and Sekar, Congressional Research Service: Vaccine Safety in the United States: Overview and Considerations for COVID-19 Vaccines, 4, 2021.). The FDA’s primary statutory authority for regulating vaccines is derived from Section 351 of the Public Health Service Act from 1944 (PHSA) and from the Federal Food, Drug, and Cosmetic Act (FFDCA) (the next chapter will address other ways we monitor and regulate vaccine safety) (Baylor and Marshall, Regulation and Testing of Vaccines, 2013:1431, 2012.). Section 351 of the Provincial Health Services Authority (PHSA) permits the FDA to approve a Biologics License Application (BLA) if: (1) the biologic product is “safe, pure, and potent;” and (2) the facility where the product is manufactured “meets standards designed to assure that the biological product continues to be safe, pure, and potent.” (The PHSA’s definition of a “biological product” includes vaccines.) The FDA implements its statutory authority to regulate vaccines primarily via Title 21, parts 600 through 680 of the Code of Federal Regulations (CFR). And because vaccines meet the legal definition of a “drug” under the FFDCA, vaccine manufacturers must also comply with regulations for good manufacturing practices found under CFR Title 21, parts 210 and 211. Vaccine safety regulations govern areas like standards for vaccine manufacturing and clinical trial requirements.

This means that vaccines are subject to more oversight than many other kinds of drugs. First, they are subject to two sets of regulatory commands instead of just one. Second, in addition to licensing the vaccines, the manufacturing facility needs to be licensed.