In a bid to build public confidence and demonstrate its transparency in determinations about potential COVID-19 vaccines, the FDA will convene its Vaccine Advisory Committee for a virtual meeting Oct. 22 to discuss the general development of the vaccines for the U.S. market.
It could be the first of several invitations for the committee to weigh in on SARS-CoV-2 vaccines over the next several months. The FDA is “prepared to rapidly schedule additional meetings of this committee upon submission of any applications as appropriate,” FDA Commissioner Stephen Hahn said, as he reiterated his promise that “the process and review for vaccine development will be as open and transparent as possible.”
While no vaccine may be ready for full approval or licensure until next year, Hahn has indicated that, if the evidence and circumstances support it, an emergency use authorization (EUA) could be granted before phase III trials are completed. Similar remarks from President Donald Trump have been used to suggest the FDA might authorize a vaccine for political expediency rather than the science.
Not so, Hahn has said repeatedly. “I want to assure the American people that the process and review for vaccine development will be as open and transparent as possible,” he said in announcing the October meeting.
“A discussion with this committee, made up of outside scientific and public health experts from around the country, will help ensure clear public understanding regarding clinical development of these vaccines indicated to prevent COVID-19 and the data needed to facilitate their authorization or licensure,” he added. “It is critical for people to see FDA’s expectations for data to support safety and effectiveness.”
Future adcoms ahead of a vaccine EUA or approval would help provide the transparency needed to counter accusations of politics at play and encourage people to get the vaccine.
Chaired by Hana El Sahly, an associate professor in Baylor College of Medicine’s Department of Molecular Virology and Microbiology, the 16-member vaccine committee consists mostly of experts in infectious diseases, with some of those also recognized for their expertise in pediatrics or vaccines.
The members of the standing committee include a biostatistician from the Fred Hutchinson Cancer Research Center’s Division of Vaccines and Infectious Diseases and the medical director on infection prevention at the Seattle Cancer Care Alliance, as well as professors from Stanford University Medical Center, the University of South Dakota, Tufts Medical Center, the University of Maryland School of Medicine, the Children’s Hospital of Philadelphia, Emory University School of Medicine, University of Cincinnati School of Medicine and Duke University.
A few Health and Human Services (HHS) agencies also are represented on the committee – the Office of the Assistant Secretary of Health, the CDC and NIH’s National Center for Advancing Translation Sciences. Then there are the consumer representative, in this case an attorney, and a nonvoting industry representative.
As is its practice, the FDA will screen the regular members for conflicts of interest and add temporary members as needed as substitutes or to provide a relevant area of expertise.