FDA\u27s New Approval Plan for COVID-19 Vaccines: An Inquiry of Benefit Rather than the Statutory Scope of Safety, Purity, and Potency ?

Abstract

This article analyzes the FDA\u27s 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\u27s 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