Washington — Dr. Scott Gottlieb, former head of the Food and Drug Administration and a member of Pfizer's board of directors, predicted Sunday that the drug company's COVID-19 vaccine could be available to children younger than 12 by early winter, a crucial development in the nation's vaccination efforts as kids return to the classrooms.
In an interview with "Face the Nation," Gottlieb said Pfizer will be in a position to file data with the FDA at some point next month, and then submit its application to expand its emergency use authorization for its vaccine in children 5 years and older as early as October.
"The agency will be in a position to make an authorization, I believe, at some point, late fall, probably early winter," Gottlieb told "Face the Nation. "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."
The FDA in Mayfor emergency use for children ages 12 to 15, and the company has been of its COVID-19 shot in children ages 2 and older.
Gottlieb said the data on children 2 to 5 years old will be available in November. If the FDA authorizes Pfizer's vaccine in kids between the ages of 5 and 11 in November or early December, "that, again, puts you on a timeframe that you could start rolling out these vaccinations before the end of the year."
Allowing younger children to get vaccinated against COVID-19 would be crucial in the nation's efforts to combat the highly contagious Delta variant. Kids in the South have already returned to in-person school, and the Northeast will open its classrooms next month.
Gottlieb said there are roughly 300 kids being hospitalized each day with COVID-19, and infection rates among children have spiked with schools reopening.
"What we're seeing in the South is very concerning," he said. "An epidemic that coursed its way through the adult population is now coursing its way through children, particularly as they reenter school."
Gottlieb said schools that are preparing to welcome students back to the classroom should look at what's occurred in the South and take "adequate precautions."
"I don't think that we should be going into the school year lifting the mitigation that may have worked and probably did work last year to control outbreaks in the school setting until we have firm evidence on what works and what doesn't," he said. "I think we have to throw everything we can at this challenge of trying to keep the infection from becoming epidemic in the school setting as we head back to school here in the Northeast."
The two "best things" schools can do, he said, is testing students twice a week and keeping them in geographic or social pods to cut down on intermingling among the full student body.
"Those two elements alone, according to the literature, are probably the two most effective steps schools can be taking," he said.
Gottlieb also advocated for students to wear face masks and schools to improve ventilation, as well as getting children who are eligible vaccinated.
"About 50% of kids who are eligible to be vaccinated have been vaccinated," he said. "So, there's still a lot of work we can do there, getting parents more information, trying to encourage parents to vaccinate their children."