More than a dozen senators call on FDA to make COVID-19 vaccine reviews transparent

In a letter to the U.S. Food and Drug Administration (FDA) this week, 15 Democratic senators called for the agency to be fully transparent in its COVID-19 vaccine review process, over concerns President Donald Trump is pressuring it to approve a vaccine before Election Day.

Public trust must be maintained, the senators insisted, and if scientists are overruled and federal agencies pressured to accept weak evidence, that will not be the case. More than 100 potential vaccines against COVID-19 are currently in development worldwide, with 37 currently working their way through human clinical trials. Amid federal efforts like Operation Warp Speed and others, however, concerns have begun to mount that speed is being favored at the possible expense of quality and integrity.

“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,’” the senators wrote. “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.”

Addressing public concerns are, in theory, also a goal of the FDA, which released guidelines earlier this year to assist in the clinical development and licensure of COVID-19 vaccines. However, Trump recently promised that a vaccine would be approved by the end of 2020, and the Centers for Disease Control and Prevention went further, telling states to be prepared to distribute a vaccine by Nov. 1.

That tension has only been exacerbated by a spat between CDC Director Robert Redfield and Trump this week. Redfield told the Senate that most of the American public would not see a vaccine against COVID-19 until next year. Trump promptly contradicted him, saying that his CDC chief was wrong.

“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,” the senators wrote.

Signatories — all Democrats — included U.S. Sens. Dianne Feinstein (CA), Elizabeth Warren (MA), Maggie Hassan (NH), Kirsten Gillibrand (NY), Richard Blumenthal (CN), Tina Smith (MN), Jeffrey Merkley (OR), Angus King, Jr. (ME), Jack Reed (RI), Christopher Murphy (CN), Mazie Hirono (HI), Tammy Baldwin (WI), Bernard Sanders (VT), Michael Bennet (CO) and Sherrod Brown (OH).

They requested a response by Sept. 28, 2020.