On May 15 President Donald Trump announced Operation Warp Speed, a project which “aims to deliver 300 million doses of a safe, effective vaccine for COVID-19 by January 2021.”
However, there’s growing concern that COVID-19 vaccine trials sponsored by OWS lack expert input from the U.S. Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee according to a report from MedPage Today. The committee reviews and evaluates data related to the safety and effectiveness of vaccines and related products before a vaccine is licensed and recommended to the public.
The VRBPAC has not been involved in OWS as it is currently optional for the FDA to consult the committee. While the FDA Commissioner can disregard a VRBPAC recommendation, all findings are made public.
Seeking to “significantly increase public confidence” in vaccine-related decisions, three U.S. House leaders wrote to FDA Commissioner Dr. Stephen Hahn asking the agency to involve “VRBPAC in the decision-making process for every vaccine candidate,” according to a press release.
The FDA did not agree to the request, which was made on June 18 by U.S. Reps. Carolyn Maloney (D-NY), chair of the House Committee on Oversight and Reform, Raja Krishnamoorthi (D-IL), chair of the Subcommittee on Economic and Consumer Policy, and James Clyburn (D-SC), chair of the House Select Subcommittee on the Coronavirus Crisis.
Subsequently on Aug. 6, Krishnamoorthi introduced the “EVALUATE Act” (Expeditious Vaccine Advice with Legitimate, Unbiased, Apolitical, and Technical Expertise) which would require the FDA to ask and take into account recommendations from the VRBPAC before licensing or authorizing of any COVID-19 vaccine.
FDA Leaders, However, Say VRBPAC Will Review All COVID-19 Vaccines
While the FDA declined House leaders’ request to “commit” to VRBPAC involvement for every COVID-19 vaccine candidate, FDA leaders have nonetheless expressed their strong support for exactly that in written opinions.
“Given the widespread potential use of a COVID-19 vaccine, transparent discussion at FDA’s Vaccines and Related Biological Products Advisory Committee will be needed prior to vaccine authorization or licensure to ensure clear public understanding of the evidence supporting vaccine safety and efficacy,” FDA Commissioner Dr. Stephen Hahn, Deputy Commissioner for Medical and Scientific Affairs Dr. Anand Shah, and Director of the Center for Biologics Evaluation and Research Dr. Peter Marks wrote in “Unwavering Regulatory Safeguards for COVID-19 Vaccines,” a “Viewpoint” published Aug. 7 in the Journal of the American Medical Association.
And in an Aug. 18 Health Affairs blog, the three FDA leaders went further, expressing their intention to convene the VRBPAC to review every COVID-19 vaccine candidate.
“To this end, the agency intends to convene its Vaccines and Related Biological Products Advisory Committee (VRBPAC) when data from trials becomes available. VRBPAC is one of the many advisory committees at FDA, and is composed of independent experts in the fields of vaccine safety and infectious disease. By convening VRBPAC, FDA will ensure public transparency around discussions of vaccine safety and effectiveness to provide a window into its decision-making process and help address potential concerns from vaccine-hesitant populations,” Hahn, Shah and Marks wrote.