Scott Gottlieb, the former commissioner of the Food and Drug Administration (FDA), said the Pfizer-BioNTech vaccine could be approved for children by early winter.
Gottlieb, who is on Pfizer’s board of directors, said the company “could be in a position” to file an application as early as October, setting up an early winter approval.
“This fall, Pfizer is going to be in a position — the company I’m on the board of, as you mentioned — be in a position to file data with the FDA at some point in September and then file the application potentially as early as October, so that’ll put us on a time frame where the vaccine could be available at some point late fall, more likely early winter, depending on how long FDA takes to review the application,” Gottlieb told guest host Ed O’Keefe on CBS’s “Face the Nation.”
He said the agency has “historically” taken four to six weeks to review authorizations.
He did, however, caution that the process could take longer if the FDA requests additional information.
“It could take longer to get to an authorization, but the agency will be in a position to make an authorization, I believe, at some point late fall, probably early winter, and probably they’re going to base their decision on what the circumstances around the country, what the urgency is, to get to a vaccine for kids,” he said.
Currently, the Pfizer vaccine is the only shot authorized for kids ages 12 to 17. The Moderna and Johnson & Johnson vaccines are authorized only for individuals 18 years and older.
Schools are already grappling with the effects of COVID-19 in the early days of the academic year, with tens of thousands of students forced to stay home to quarantine or isolate because of the virus.
The former FDA commissioner also gave his recommendations for how to mitigate the spread of COVID-19 in schools.
He said the “two best things” schools can do to curb the spread is testing twice a week and keeping students in “geographic pods” and “social pods” so they do not “intermingle with the entire student body” but instead stick with the people in their classrooms.
“Those two elements alone, according to the literature, are probably the two most effective steps schools can be taking,” Gottlieb said.
He also touted the importance of wearing masks and getting eligible children vaccinated.
“And then using masks and improving ventilation is also going to be very important and finally getting kids vaccinated. About 50 percent of kids who are eligible to be vaccinated have been vaccinated, so there’s still a lot of work we can do there, getting parents more information, trying to encourage parents to vaccinate their children,” Gottlieb said.
— Face The Nation (@FaceTheNation) August 29, 2021
Gottlieb’s comments come as the U.S. is seeing a surge in COVID-19 cases driven largely by the highly infectious delta variant, which has taken hold as the dominant strain in the U.S.