NEJM Interviews NEJM Interview: Peter Marks on the disruption of traditional approaches to establishing Covid-19 vaccine policy in the United States.
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Jul 16, 2025 Peter Marks, the former director of the FDA Center for Biologics Evaluation and Research, discusses the evolving role of public health agencies in vaccine policy. He highlights the shift towards an evidence-based strategy during the COVID-19 pandemic and the challenges of implementing new vaccine policies, emphasizing transparency. Marks warns of the public skepticism growing from these changes and stresses the need for clear communication to maintain vaccine confidence, particularly among vulnerable populations. His insights reveal a critical examination of modern health policymaking.
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FDA's Vaccine Role Explained
- The FDA reviews vaccine clinical trial data to ensure safety and efficacy for labeled uses.
- It finalizes the vaccine prescribing information based on this comprehensive review.
CDC's Complementary Vaccine Role
- The CDC evaluates vaccine labels in the context of broader public health data, including real-world evidence.
- Sometimes the CDC's vaccine recommendations differ from the FDA label to better address public health needs.
Controversy Over New COVID-19 Policy
- The administration's evidence-based approach to COVID-19 vaccination limits vaccine use beyond FDA's approved recommendations.
- Peter Marks sees this as an overstep of FDA's authority without transparent benefit-risk justification.