Experts Tell Oversight Subcommittee that Transparency, Independent Scientific Review are Crucial to Safe, Effective Coronavirus Vaccine
Washington, DC — On Tuesday, the House Committee on Oversight and Reform’s Subcommittee on Economic and Consumer Policy held a virtual briefing entitled “Guardrails to Ensure a Safe and Effective COVID-19 Vaccine” to examine the process used by the Food and Drug Administration (FDA) to review and license or authorize any vaccine candidates for the novel coronavirus.
At the hearing, Oversight Committee Chairwoman Carolyn B. Maloney (D-NY) said, “Operation Warp Speed has promised that a safe and effective coronavirus vaccine will be approved and that 300 million doses will be available by January 2021. While we are all eager for a vaccine to be developed and deployed, I am troubled by reports that the President is pressuring FDA to cut corners.”
The briefers shared the following with the Subcommittee:
We Must Not Cut Corners. There was bipartisan agreement that in developing a COVID-19 vaccine, even at record speed, we must not cut any corners. Transparency and rigorous scientific review are essential to building strong public trust, which we will need to widely deploy a vaccine and finally end this pandemic.
FDA Should Consult with the Vaccines and Related Biological Products Advisory Committee (VRBPAC). Dr. Bruce Gellin, former Director of the National Vaccine Program, stated that he strongly recommends that “any vaccine” that is being considered for licensure or use under an Emergency Use Authorization be “reviewed in an open public meeting” of VRBPAC. When asked about VRBPAC by Chairman Raja Krishnamoorthi, Drs. Ruth Karron and Jason Schwartz agreed that VRBPAC should be engaged in reviewing a COVID-19 vaccine for safety and efficacy, to add a strong dose of public deliberation to the process.
Any Phase 3 Trials Must have 30,000 Participants to Show Safety and Efficacy for All. When asked about the requirement of 30,000 participants in phase 3 trials endorsed by the National Institutes of Health, Dr. Gellin explained that having 30,000 participants will help ensure that we have the data we need to know that a vaccine is safe and effective for everyone.
We Need Diverse Trial Populations and a Promise of Access. It’s important to recruit and engage a diverse population in large-scale efficacy and safety trials, especially for at-risk populations like the elderly and Black and Latino communities as well as pregnant women and those with comorbidities. Dr. Karron, Director of Johns Hopkins’ Center for Immunization Research, stated that promising fair and easy access of an eventual vaccine will help recruit a sufficiently diverse trial group.
FDA Has High Standards for Safety and Efficacy. The panelists all agreed that the Food and Drug Administration has high standards for reviewing vaccines for safety and efficacy, and that if FDA scientists are allowed to do their job free from political influence they will carefully assess all of the data to arrive at a sound scientific judgment.