CBER sets controversial date for vaccine advisory committee meeting

Aug. 28, 2020

The Center for Biologics Evaluation and Research’s (CBER) recently added a Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting to the calendar.

The committee will meet in open session to discuss, in general, the development, authorization and/or licensure of vaccines to prevent COVID-19. While the FDA stated in its announcement that "No specific application will be discussed at this meeting," this did not stop backlash and speculation surrounding the meeting.

The meeting date — Oct 22 — notably just two weeks prior to the election, immediately ignited public concern.

With phase 3, large-scale clinical trials of the leading vaccine candidates from Moderna and Pfizer already underway, scientists, public health officials and lawmakers alike have expressed concern that the Trump administration will pressure the FDA to authorize a vaccine in advance of the November presidential election, even if data from clinical trials do not support its widespread use. The concern was further strengthened by Vice President Pence's assertion during the RNC that the US will see a vaccine in 2020. 

FDA Commissioner Hahn, currently under fire for statements related to convalescent plasma, has repeatedly reaffirmed that the FDA will use science and data to make decisions on treatments and vaccines. Regarding the advisory meeting, Hahn promised on Twitter that, during the meeting, "the public will be able to see the data that we have been asked to evaluate" — but it was not immediately clear which data he was referencing. 

The meeting is public and interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. The committee may also be joined by scientific experts on the novel coronavirus.