Public Health On Call 1001 - Vaccines 101: How FDA Regulates Vaccines
Jan 26, 2026
Dr. Jesse Goodman, former FDA chief scientist and current Georgetown professor who studies medical product safety. He walks through how FDA reviews vaccine safety, manufacturing, and monitoring. He describes the multidisciplinary teams and vaccine ingredients. He raises concerns about leadership interference and the risks to the agency’s credibility and public trust.
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Goodman's FDA Career And Responsibilities
- Jesse Goodman described his FDA roles from senior advisor to chief scientist overseeing pandemic preparedness.
- He led the Center for Biologics and later coordinated agency scientific activities and pandemic planning.
FDA Oversees Vaccines From Lab To License
- The FDA must evaluate vaccines from early R&D through licensing to ensure safety and effectiveness.
- This multi-year review includes manufacturing, clinical trials, and post-approval oversight.
Deep, Cross-Product Expertise Drives Reviews
- FDA vaccine review draws on multidisciplinary career scientists with deep, product-spanning experience.
- Reviewers' exposure to many products helps spot issues and set high quality standards.