VaccinesFDA Head: Outside Pressures Won't Rush COVID Vaccine
The decision to authorize and approve a COVID-19 vaccine will be based on data and science—not politics, Stephen Hahn, MD, commissioner of the US Food and Drug Administration (FDA), said. “Science will guide our decision, and I will not, and the FDA will not, allow pressure from anybody to change that. We plan to fight for science, we will fight for the integrity of the agency, we will always put the interest of the American people ahead of anything, and that includes personal considerations,” Hahn said.
The decision to authorize and approve a COVID-19 vaccine will be based on data and science—not politics, Stephen Hahn, MD, commissioner of the US Food and Drug Administration (FDA), said yesterday in a Center for Infectious Disease Research and Policy (CIDRAP) webinar.
“We will use science and data to drive those decisions, we will be transparent about those decisions, and we will do everything in our power to prevent anything other than science and data from being involved in those decisions,” Hahn said. “That is the promise that we as the FDA, that I as the commissioner of food and drugs, make to the American people.”
The webinar, “The Review Process for Vaccines to Prevent COVID-19: A Discussion,” also included former FDA Commissioner Margaret Hamburg, MD, and moderator Michael Osterholm, PhD, MPH, director of the University of Minnesota’s CIDRAP, publisher of CIDRAP News.
The FDA has been clear about its criteria for vaccine authorization and approval and has created an open, public vaccine advisory committee to foster trust in its vaccine approval process, Hahn said. “None of us, including most importantly our career scientists, would want a vaccine approved or authorized that we wouldn’t give to ourselves or our families,” he said.
Hamburg said that transparency and rigor are critical for public acceptance and uptake of the vaccine. “We appreciate the urgency to get vitally needed products out there, and a vaccine in particular can really make a difference, but we also recognize that even if it is demonstrated to be safe and effective, if the public doesn’t have trust and confidence in the vaccine and won’t use it, it won’t achieve our public health goals,” she said.
Clear Standards, Criteria
Development of a COVID-19 vaccine has sped along much faster than the usual 10- to 15-year timeline, something that Hahn said was made possible by advances in molecular biology. “These allowed developers, manufacturers to understand the genetic sequence of the coronavirus and use it either with established platforms or newer technology to produce the vaccine candidates,” he said.
The rapid development has been spurred by Operation Warp Speed, a partnership of the FDA, the US Centers for Disease Control and Prevention, the National Institutes of Health, the Biomedical Advanced Research and Development Authority, and the Department of Defense, in conjunction with private firms and other federal agencies, to accelerate development of a safe and effective COVID-19 vaccine.
