Two Step: FDA and CDC In Sync on New COVID-19 Vaccines—Shoddy Data Raises Questions of Objectivity

Like a two-step dance, the Food and Drug Administration&rsquo;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, the FDA reported on that day&rsquo;s approvals for updated mRNA vaccines. Importantly the agency used an &ldquo;Accelerated Approvals Program.&rdquo; 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&mdash;and they don&rsquo;t have to have comprehensive clinical evidence. Given that the variant chosen for the &ldquo;update&rdquo; (not a &ldquo;booster&rdquo;) is almost extinct, the agency&rsquo;s headline is fairly misleading: &ldquo;FDA Takes Action on Updated mRNA COVID-19 Vaccines to Better Protect Against Currently Circulating Variants.&rdquo; The release notes that the FDA has given both approval and an Emergency Use Authorization to the new Moderna and Pfizer vaccines to, &ldquo;more closely target currently circulating variants and to provide better protection against serious consequences of COVID-19, including hospitalization and death.&rdquo; &ldquo;Consistent with the totality of the evidence and input from the FDA&rsquo;s expert advisors, these vaccines have been updated to include a monovalent (single) component that corresponds to the Omicron variant XBB.1.5.&rdquo; After reviewing both the FDA and CDC data, it becomes quite apparent that they probably should not have approved the products and given the national public health emergency has come and gone, and the latest Omicron-related variants appear mild for most, one has to question why issue any EUAs at all.
However, one hero in all of this emerges. Dr. Pablo Sanchez, Professor of Pediatrics, Division of Neonatal-Perinatal Medicine, Division of Pediatric Infectious Diseases, The Ohio State University &ndash; Nationwide Children&rsquo;s Hospital, Columbus, Ohio. Every member of the CDC ACIP voted uniformly in favor of all the recommendations except for Sanchez, who was not in favor of the universal recommendation, except for older or at-risk patients.