Questionable Data Used for New Covid Vaccine Approvals - Interview with David Wiseman, PhD

Ordinarily, the Food and Drug Administration’s (FDA) approval of a drug is generally followed by the Center for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) recommending that the public take it. In the case of the latest COVID-19 vaccine, this took only one day. In a September 11 press release, FDA reported on that day’s approvals for updated mRNA vaccines. Importantly the agency used an “Accelerated Approvals Program.” More specifically the agency issued an emergency use authorization for the under 12-year-old cohort, while granting formal approvals for all else under the Accelerated Approvals Program, based on a surrogate endpoint. This means they used an exception they have to rush when there are serious unmet needs—and they don’t have to have comprehensive clinical evidence.