An Evidence-Based Approach to Covid-19 Vaccination

 This commentary outlines a recalibrated framework for U.S. Covid-19 vaccination policy, emphasizing the need for risk-based precision and stronger clinical trial data in healthy populations. In contrast to Europe and other high-income nations that target older or high-risk individuals, the U.S. has adopted a broad, age-inclusive approach one the authors argue lacks sufficient evidence for continued boosters in low-risk groups under age 65. FDA's updated stance supports continued vaccine approval for high-risk individuals (based on immunogenicity) while urging randomized, controlled trials for healthy adults and children, particularly for annual booster recommendations. The authors cite low booster uptake (<25% overall) and rising public vaccine skepticism, which may be harming broader immunization efforts (e.g., MMR). They stress the importance of generating robust clinical outcome data (infection, hospitalization, death), not just antibody response, especially for repeat boosters. The article also calls for nuanced risk communication, greater trial transparency, and postmarketing commitments to evidence development for younger, healthy populations.

 This commentary outlines a recalibrated framework for U.S. Covid-19 vaccination policy, emphasizing the need for risk-based precision and stronger clinical trial data in healthy populations. In contrast to Europe and other high-income nations that target older or high-risk individuals, the U.S. has adopted a broad, age-inclusive approach one the authors argue lacks sufficient evidence for continued boosters in low-risk groups under age 65. FDA's updated stance supports continued vaccine approval for high-risk individuals (based on immunogenicity) while urging randomized, controlled trials for healthy adults and children, particularly for annual booster recommendations. The authors cite low booster uptake (<25% overall) and rising public vaccine skepticism, which may be harming broader immunization efforts (e.g., MMR). They stress the importance of generating robust clinical outcome data (infection, hospitalization, death), not just antibody response, especially for repeat boosters. The article also calls for nuanced risk communication, greater trial transparency, and postmarketing commitments to evidence development for younger, healthy populations.