COVID-19 Vaccine Policy: a Response and Way Forward

The New England of Journal of Medicine Sounding Board article by Prasad and Makary, entitled “An Evidence-Based Approach to Covid-19 Vaccination” [1], outlines a significant shift in U.S. COVID-19 vaccine policy that continues to reverberate to today. The authors, serving as FDA Commissioner (Makary) and Director of the Center for Biologics Evaluation and Research (Prasad), advocate limiting COVID-19 vaccine access to individuals age 65 and older and those 18–64 years with high-risk conditions, citing as motivation for this policy declining public trust, low booster uptake, and the need for more robust data for broader approvals. While the idea of restoring trust and aligning policy with evidence is critical, the proposed framework raises concerns about the evidence base, consistency, lack of expert input and consensus, and implications for medical choice. This response critically evaluates their approach through four pillars: (1) the evidence base and risk-benefit considerations, (2) consistency of policy, (3) the value of content experts and consensus, and (4) preserving medical choice for those seeking immunization against COVID-19. We conclude with recommendations for a balanced path forward.