The FDA could take multiple approaches to OK'ing the boosters, former agency officials say. It could first grant a full approval to Pfizer or Moderna for two doses and then issue an emergency use authorization for a booster dose, for instance. Or it could delay granting full approval and ultimately grant it later for two doses and a booster.
Either way, if the FDA follows its usual protocol, the agency would first convene a meeting of its outside advisory committee, as it did when it originally granted emergency use authorization for each COVID-19 vaccine.
"We know in sort of the heat of the moment, and when we're all dealing with a real public health emergency, it becomes almost doubly important that we continually reassess and have the normal processes in place," saysDr. Jesse Goodman, a professor at Georgetown University's School of Medicine who used to be the chief scientist at FDA.
Goodman says he worries that setting a start date for a booster program before the relevant data can be evaluated through the normal federal processes may put "the cart before the horse."
The committee of outside experts typically hears presentations from the government, the product manufacturer and the public. Then, it often votes on whether the FDA should give a given product the green light. The agency doesn't have to follow the committee's advice, but it usually does.
Norman Baylor, a former director of the Food and Drug Administration's Office of Vaccines Research and Review, says putting those committee meetings together in a month as the administration's Sept. 20 booster start date would imply is "pushing it."
The agency's interim commissioner, Janet Woodcock, tweeted about the agency's booster plans, Aug. 18, though she didn't commit to convening the FDA's Vaccines and Related Biological Products Advisory Committee.
"FDA supports the administration's work to plan for the deployment of additional vaccine doses, or boosters, this fall," she wrote. "FDA will undertake an independent scientific evaluation of the safety and efficacy of boosters for each vaccine."
After an FDA authorization, the CDC's independent vaccine advisory committee would also weigh the evidence and make a recommendation.
Note - As the situation surrounding COVID-19 continues to evolve, it's possible that some data have changed since publication. While we are trying to keep our articles as up-to-date as possible, we also encourage readers to stay informed on news and recommendations for their own communities by using the CDC, WHO, and their local public health department as resources.
