Washington D.C. (July 13, 2020)—On Tuesday, July 14, 2020, at 10:45 a.m. (ET), Rep. Raja Krishnamoorthi, Chairman of the Subcommittee on Economic and Consumer Policy, will hold a virtual briefing entitled “Guardrails to Ensure a Safe and Effective COVID-19 Vaccine.”
The briefing will examine the processes that the Food and Drug Administration (FDA) will use to review and license or authorize any vaccine candidates for the novel coronavirus.
The Members will also examine the need for guardrails in vaccine development and review, including: (1) requiring large phase 3 clinical trials with at least 30,000 participants, and (2) requiring the use of advisory committees made up of independent scientists who make public recommendations to federal agencies.
There are more than 100 vaccine candidates in preclinical development around the world. At least seventeen vaccines have already proceeded toward clinical trials globally, including four in the United States. The US-based candidate being developed by Moderna Inc. is reportedly on track to begin large-scale efficacy trials by the end of July. “Operation Warp Speed” has a stated goal of vaccine deployment by early 2021, which would be extraordinary and unprecedented for a vaccine.
FDA typically seeks advice from the Vaccines and Related Biological Products Advisory Committee (VRBPAC), which reviews and evaluates data concerning the safety, effectiveness, and appropriate use of vaccines. While the FDA Commissioner can ultimately disregard the recommendation of VRBPAC, its findings will be public. Currently, it is optional for FDA to consult VRBPAC.
On June 18, 2020, Chairs Krishnamoorthi, Maloney and Clyburn wrote to FDA Commissioner Hahn seeking a commitment to “involving VRBPAC in the decision-making process for every vaccine candidate” in order to “significantly increase public confidence” in the FDA’s future decisions. FDA did not agree to make this commitment, and Chair Krishnamoorthi plans on introducing legislation to require it to do so.