An open letter to the US Food and Drug Administration urging politics-free review of COVID-19 vaccines and new drugs

October 29, 2020

Stephen M. Hahn, MD
Food and Drug Administration

We, the undersigned, representing the American Society for Clinical Investigation (ASCI), write to endorse and support our colleagues at the FDA in following established procedures of review for all new COVID-19 drug applications, including vaccines, as detailed in  “Emergency Use Authorization for Vaccines to Prevent COVID-19: Guidance for Industry” (FDA, October 2020, docket 2020-D-1137-0019).

Researchers across the world from diverse fields of basic and clinical science have come together in record time to make critical advances aimed at ending the COVID-19 pandemic. These advances have been facilitated by the active engagement of government funding agencies and key regulatory bodies. This work must move forward expeditiously but without cutting corners. Processes have been created and tested to ensure that scientific standards across the continuum of drug development are upheld, and these should be respected. To do otherwise would jeopardize the safety, rigor, and integrity of these studies.

The ASCI is a nonprofit organization of physician-scientist leaders founded in 1908. The Society has more than 3,200 members active in academic medical centers and industry who are committed to science and patient care. The ASCI has full confidence in the FDA’s career scientists and advisory bodies to evaluate forthcoming new drugs and vaccines with impeccable, science-based scrutiny, free of all political pressures. Such scrutiny is key to maintaining the public’s trust in the FDA to ensure that drugs and vaccines made available to our nation’s population are safe and effective.

The 2020-2021 American Society for Clinical Investigation Council:

Lorraine B. Ware, MD (President)
Vanderbilt University School of Medicine

Hossein Ardehali, MD, PhD (President-Elect)
Northwestern University Medical Center

Sohail F. Tavazoie, MD, PhD (Vice President)
Rockefeller University

Benjamin D. Humphreys, MD, PhD (Secretary-Treasurer)
Washington University School of Medicine in St. Louis

Rexford S. Ahima, MD, PhD (Editor, The Journal of Clinical Investigation)
Johns Hopkins University

Kathleen L. Collins, MD, PhD (Editor, JCI Insight)
University of Michigan

W. Kimryn Rathmell, MD, PhD (Immediate Past President)
Vanderbilt University School of Medicine

Anna Greka, MD, PhD (Councilor)
Brigham and Women’s Hospital, Harvard Medical School

Priscilla Y. Hsue, MD (Councilor)
University of California, San Francisco

Sophie Paczesny, MD, PhD (Councilor)
Medical University of South Carolina

Doris A. Stoffers, MD, PhD (Councilor)
University of Pennsylvania

Jennifer A. Wargo, MD, MMSc (Councilor)
University of Texas MD Anderson Cancer Center