Which agency approves and regulates human vaccines in the United States?

Which agency approves and regulates human vaccines in the United States?

• A. Center for Disease Control and Prevention
• B. Food and Drug Administration
• C. National Institutes of Health
• D. Environmental Protection Agency

Answer: (B)

The agency that approves and regulates human vaccines in the United States is the Food and Drug Administration. Within FDA, the Center for Biologics Evaluation and Research reviews data from preclinical studies and clinical trials to assess a vaccine’s safety, effectiveness, and manufacturing quality. If the evidence meets FDA’s standards, a license to market the vaccine is granted, and the agency continues to oversee manufacturing practices and post‑licensure safety monitoring. The CDC does not approve vaccines; it develops vaccination recommendations and schedules through its advisory committees. NIH conducts research, but does not license vaccines, and the EPA is not involved in vaccine regulation.

The agency that approves and regulates human vaccines in the United States is the Food and Drug Administration. Within FDA, the Center for Biologics Evaluation and Research reviews data from preclinical studies and clinical trials to assess a vaccine’s safety, effectiveness, and manufacturing quality. If the evidence meets FDA’s standards, a license to market the vaccine is granted, and the agency continues to oversee manufacturing practices and post‑licensure safety monitoring. The CDC does not approve vaccines; it develops vaccination recommendations and schedules through its advisory committees. NIH conducts research, but does not license vaccines, and the EPA is not involved in vaccine regulation.