AAMC issues statement on approval of COVID-19 vaccines

The American Association of Medical Colleges (AAMC) has issued a statement recommending that the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) evaluate any candidate vaccines prior to the FDA issuing an emergency use authorization. Please see the AAMC’s statement below, along with a statement from Jeff Balser, MD, PhD, President and Chief Executive Officer for Vanderbilt University Medical Center and Dean of the Vanderbilt University School of Medicine.

“To maintain public faith in a COVID-19 vaccine, as well as to optimally assure the safety and effectiveness of new products for widespread public distribution, the AAMC recommends that the Vaccines and Related Biological Products Advisory Committee (VRBPAC) of the Food and Drug Administration (FDA) evaluate any candidate vaccines prior to the FDA issuing an emergency use authorization. Full approval of a new vaccine or biologic requires demonstration of safety and effectiveness through a process that includes evaluation by the VRBPAC. Their recommendations are considered by FDA staff who ultimately have the authority to approve the new product. Stopping the COVID-19 pandemic demands our best science and our best approval processes. The health of our nation depends on it.”  The AAMC’s statement is available online here.

“The nation’s leading academic health centers play a vital role in providing the very latest treatments and diagnostics to the public. This statement by AAMC highlights the kind of process leading centers like VUMC have historically relied upon when making important decisions impacting patient care – the wisdom of our nation’s top scientific experts. In the case of vaccines and other biological treatments for COVID-19, the VRBPAC are independent experts appointed to make these determinations, with the necessary training and experience to make well-informed, data-driven recommendations,” said Balser.