Experts Tell Subcommittee that Transparency, Independent Scientific Review are Crucial to Safe, Effective Coronavirus Vaccine
Washington, D.C. (July 15, 2020)—The 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.
Rep. Raja Krishnamoorthi, the Chairman of the Subcommittee on Economic and Consumer Policy, issued the following statement:
“This briefing demonstrated that there is a bipartisan desire to have a safe and effective vaccine approved as quickly as possible. To instill public confidence in an eventual vaccine, our expert panelists testified to the importance of a clear and transparent FDA review process, starting with large 30,000 person clinical trials and involving FDA’s consultation with an advisory committee made up of independent experts.”
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.