With the upcoming November election and calls by President Trump for 1 or more vaccines for coronavirus disease 2019 (COVID-19) to be ready before the end of the year, if not by the election, many have started to wonder whether the US Food and Drug Administration (FDA) can withstand this type of political pressure. Noting the FDA’s historically robust review process and decades of experience with regulatory flexibility in multiple product areas, the answer is an unqualified vote of support for the FDA. The public should be reassured that vaccines approved by the FDA will have been subject to the same strenuous reviews that have characterized the agency’s previous reviews.
The vaccine review process follows a prescribed set of steps and is regulated by the FDA’s Center for Biologics Evaluation and Research. The 30-year-old FDA center is headed by Peter Marks, MD, PhD, a triple board-certified hematologist and oncologist, with experience in both industry and academic medicine, who has worked at the FDA for nearly a decade. The agency’s Office of Vaccines staff, including its leader Marion Gruber, PhD, who oversaw the introduction of the H1N1 vaccines in response to the 2009 influenza A (H1N1) pandemic, the development of a novel Ebola vaccine, and supported the response to Zika virus outbreaks, have deep experience.