He said the center — which, in addition to overseeing vaccines, regulates biologics, stem cells and gene therapies — is “thoughtfully reprioritizing” its work to focus on the vaccine as much as possible. Pfizer received emergency authorization for its two-shot vaccine in December and applied to the FDA for full approval May 7.
Moderna, whose vaccine also is being administered under emergency authorization, filed for full FDA approval June 1. Typically, it takes the agency at least several months to grant a full approval for a vaccine.
Marks would not speculate on when the FDA might grant full approval, but some agency officials have suggested it could be a matter of weeks, not months.
The move comes as the agency faces mounting pressure from lawmakers and some public health experts to fully approve a vaccine that has already been administered to millions of people in the United States, and more worldwide, without major problems.
Those pushing for quick approval say it could encourage vaccinations among people who have qualms about receiving what is still officially an experimental vaccine. They say it also could make governments, employers and other institutions more comfortable in mandating vaccinations.
“This will remove one more layer for the vaccine-hesitant,” Marks said. “If all this does is get five to 10 million more people vaccinations down south, that will save lives.”
The Kaiser Family Foundation, which is tracking sentiment toward the shots, reported in June that among unvaccinated adults who are aware that the vaccines are available under emergency use authorization, 32 percent said they would be more likely to get vaccinated if one of the vaccines were granted full approval by the FDA.
Stat, a news site that covers health and medical news, first reported the FDA’s reprioritization.
The need for a fully approved product is becoming more urgent as the start of the academic year approaches. Some governments and universities are interested in requiring vaccinations but are holding off until the FDA grants full approval to the vaccine.
The stepped-up effort is “essentially a sprint” using a team that focuses on one task at a time, rather than on multiple tasks, as FDA staff typically do, Marks said, adding that the agency would stick to its high standards for safety and efficacy.
Marks said the center would try to minimize delays that might affect other biologic products, because of missed meetings or slower action on applications — but couldn’t guarantee it.
“We are risk managers, and this is a matter of maximizing the potential benefit of getting the vaccine out,” he said.