1. United States
2. Mich.
3. Letter

The FDA's new requirement for placebo-controlled trials before approving updated Covid vaccines for healthy children and adults is an unnecessary barrier that will likely delay this fall's vaccine rollout. This policy ignores the proven safety and efficacy of the existing mRNA vaccines, which have already undergone rigorous clinical trials and review. Mandating additional placebo testing provides no added benefit and will hinder efforts to protect public health by limiting timely access to updated vaccine formulations. Reinstating the previous approach of using smaller immunogenicity studies is sufficient for evaluating updated compositions aimed at matching circulating variants. Demanding full placebo trials is an overreaction that prioritizes bureaucratic processes over expediting critical vaccine availability when emerging Covid strains inevitably arise. Public faith in vaccines has already been challenged by disinformation - further delaying access will only aggravate distrust and hesitancy. Maintaining straightforward pathways for modifying vaccine compositions is essential for rapidly responding to viral evolution. Current immunization gaps leave millions of Americans at risk of serious illness each year. Upholding needless regulatory hurdles jeopardizes lives and undermines efforts to control the pandemic's substantial, ongoing burden. I urge you to reconsider this new placebo trial mandate and restore streamlined procedures for updating Covid vaccines based on existing evidence and past precedent.