September 15, 2020

Warren, Hassan, Colleagues to FDA: Maintain Public Trust in COVID-19 Vaccine Decisions by Making Reviews Transparent

"Full transparency throughout the review and authorization process is essential to countering real or perceived politicization and building public confidence in any approved vaccine."

Text of Letter

Washington, DC - United States Senators Elizabeth Warren (D-Mass.) and Maggie Hassan (D-N.H.), members of the Senate Health, Education, and Pensions (HELP) Committee, led 13 senators in sending a letter to the U.S. Food and Drug Administration (FDA) calling on the agency to commit to full transparency in the COVID-19 vaccine review process amidst mounting political pressure from the President to approve a vaccine before Election Day. The lawmakers expressed concern that the Trump Administration has overruled scientists and pressured federal agencies to approve products based on weak evidence and urged the FDA to ensure transparency in vaccine review efforts in order to maintain public trust. 

"We write to seek your commitment that the Food and Drug Administration's (FDA) review process for potential vaccinations against the coronavirus disease 2019 (COVID-19) will be fully transparent and accountable," wrote the senators. "We are encouraged by the development of a number of vaccine candidates, and we share the FDA's goal of facilitating ‘the timely development of safe and effective vaccines to prevent COVID-19.’ However, we are concerned that the accelerated timeline and intense political pressure around the vaccine development process could have the unintended consequence of undermining public confidence in the safety and quality of an eventual vaccine."

More than 100 vaccines against COVID-19 are currently in development worldwide, with 37 in human clinical trials proceeding at an unprecedented pace. To address public concerns that the rapid speed of vaccine development could compromise the integrity of the review process, the FDA issued guidelines in June 2020 to assist in the clinical development and licensure of vaccines for COVID-19. However, President Trump and his Administration have continuously applied political pressure on the agency — including promising that a vaccine will be approved by the end of 2020. The Centers for Disease Control and Prevention (CDC) also recently announced that states should be prepared to distribute a vaccine by November 1, further raising concerns that the approval process will be rushed. Such recent statements made by the Trump Administration may risk undermining public confidence in the FDA unless the agency commits to expanding transparency even further.

Recent polling shows significant public skepticism about a future vaccine, including a recent poll which found that only 49% of American adults plan to accept a coronavirus vaccine, with 20% not planning to be vaccinated and 31% unsure. The same poll found that only 25% of Black Americans and 37% of Hispanic Americans plan to be vaccinated. 

"In order to achieve broad acceptance with the public, a future vaccine for COVID-19 will need to overcome public skepticism about the speed of the process, underlying doubts about vaccine safety, long-standing mistrust of the medical system among communities of color – and the effects of the President's ongoing political interference," wrote the senators. The senators asked a series of questions, including whether meetings of the Vaccine and Related Biological Products Advisory Committee would be open to the public, if  data and design details from clinical trials will be made available to the public, and how the FDA is involving representatives of communities of color, people with disabilities, older Americans, and other groups at elevated risk from COVID-19. 

The letter was also signed by Senators Dianne Feinstein (D-Calif.), Kirsten Gillibrand (D-N.Y.), Richard Blumenthal (D-Conn.), Tina Smith (D-Minn.), Jeffrey A. Merkley (D-Ore.), Angus S. King, Jr. (I-Maine.), Jack Reed (D-R.I.), Christopher S. Murphy (D-Conn.), Mazie K. Hirono (D-Hawaii.), Tammy Baldwin (D-Wis.), Bernard Sanders (D-Vt.), Michael F. Bennet (D-Colo.), and Sherrod Brown (D-Ohio). 

The senators requested a response to their letter no later than September 28, 2020.

Throughout the COVID-19 pandemic, Senator Warren has advocated for decisions to be based on science rather than politics. During a HELP Committee hearing on Tuesday, September 8, Senator Warren questioned top U.S. health officials on the impact of President Trump's politicization of the vaccine development process, and in response to her questioning, Dr. Collins, head of the National Institutes of Health, said he hopes that Americans "choose to take the information they need from scientists and physicians, and not from politicians."