When HHS Secretary Robert F. Kennedy Jr. revealed a plan to require placebo testing for all new vaccine approvals, the agency added few details about the policy shift.
The announcement raised alarm bells — and questions — among experts, especially because new vaccines are already tested against placebos. So what would be considered a “new” vaccine under this policy?
HHS agencies have dropped hints as to how they could answer this question.
Just days before announcing the placebo requirement, the FDA delayed full approval for Novavax’s COVID-19 vaccine, asking the company to provide a post-market commitment for additional clinical data. FDA Commissioner Dr. Marty Makary wrote on X, “This is a new product that Novavax is trying to introduce to the market with a study of a different product from 2021. New products require…