FDA's New Approval Plan for COVID-19 Vaccines: An Inquiry of "Benefit" Rather than the Statutory Scope of "Safety, Purity, and Potency"?

This article analyzes the FDA's proposed policy plan issued in May 2025 regarding the approval of Covid-19 boosters for different groups of persons. It offers two constructive recommendations that will help prevent constitutionality challenge on impermissible intrusion of the freedom of health. The first is to avoid using the confusing term "benefit" but instead focus on the statutory parameters of "safety, purity, and potency." The affected group can make a strong case that their free choice of vaccination should not be deprived, as long as the vaccine qualifies for the statutory thresholds of being safe, pure, and potent. They are free to choose what "benefits" them, not the FDA. Second, the FDA should also clarify for the public on the relevance (or irrelevance) of individualized factors that are currently not included in the proposed exhaustive list of risk factors, such as one's antibody level and varied exposure like workplace setting. The freedom of health guards against unconstitutional blanket policy that is deliberately indifferent to relevant individual medical circumstances.