• Pfizer could file an application for emergency use approval of its two-dose vaccine on younger children as early as October
  • Gottlieb predicted that the FDA could grant the approval by late fall or early winter
  • COVID-19 cases involving children have increased amid the return of in-person classes

The U.S. Food and Drug Administration may approve Pfizer/BioNTech's two-dose COVID-19 vaccine for children younger than 12 by early winter, a board member predicted. 

Former FDA commissioner Dr. Scott Gottlieb, on Sunday, predicted that the drug agency could authorize Pfizer's COVID-19 vaccine for children ages 5 to 11 as early as October should the drug maker file data with the agency next month. As of Sunday, the FDA has only given emergency use authorization of the two-dose vaccine for children ages 12 to 17 and full approval for use in people ages 16 and older.

“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 said on CBS' “Face the Nation.”

“It could take longer to get an authorization, but the agency will be in a position to make an authorization, I believe, at some point late fall, probably early winter,” he added.

The number of COVID-19 cases in children is increasing as more kids return to in-person classes amid the spread of the Delta variant. 

"What we're seeing in the South is very concerning," Gottlieb said. "An epidemic that coursed its way through the adult population is now coursing its way through children, particularly as they reenter school."

His statement comes after a dozen children at an elementary school in Marin County, California, tested positive for COVID-19. Officials linked the outbreak to one teacher who, on May 19, removed her mask during storytime so she could read to the class. 

The teacher, who was unvaccinated against the virus, had been diagnosed with COVID-19 two days later. At least half of the 24 children in her class, as well as their families and children from other classes, had also been infected with the coronavirus.

“The mask was off only momentarily, not an entire day or hours. We want to make the point that this is not the teacher’s fault — everyone lets their guard down — but the thing is delta takes advantage of slippage from any kind of protective measures,” Tracy Lam-Hine, an epidemiologist for Marin County, told The Washington Post.  

Other COVID-19 vaccines, such as those produced by Moderna and Johnson & Johnson, are only authorized for use in people ages 18 and older. 

The FDA's decision to fully approve Pfizer-BioNTech's Covid drug has lifted hopes for a further boost to US vaccination efforts The FDA's decision to fully approve Pfizer-BioNTech's Covid drug has lifted hopes for a further boost to US vaccination efforts Photo: AFP / Robyn Beck