Washington – The former commissioner of the Food and Drug Administration (FDA), Dr. Scott Gottlieb, predicted Sunday that the agency he ran will authorize Pfizer coronavirus vaccine for emergency use in children ages 5 to 11 in late October.
In an interview with Face the Nation, Gottlieb, who serves on Pfizer’s board of directors, said the pharmaceutical company expects to have data on its vaccines in young children before the end of September, which will then be presented to the FDA “very quickly.” The agency then said it would take weeks, rather than months, before determining whether to authorize the vaccine for children ages 5 to 11.
“At best, given the timeline they just defined, you may have a vaccine available for kids ages 5 to 11 for Halloween,” Gottlieb said. “If all goes well, the Pfizer data package is in order and ultimately the FDA makes a positive determination, I have confidence in Pfizer in terms of the data they have collected. But that really depends on the Food and Drug Administration make an objective determination “.
Pfizer has conducted clinical trials of its two-dose vaccine in children 2 years of age and older and its approval could be crucial in helping to combat the spread of the highly contagious Delta variant in schools. Children account for 25% of new COVID-19 infections.
The shot has already been authorized for children from 12 to 15 years, and Gottlieb said he believes COVID vaccines will eventually be some of the ones needed for public school children.
“I think you’ll see more local school districts and governors make those recommendations,” he said. “Finally, ACIP will make a recommendation on whether this should be included in the childhood vaccination program. I guess they expect to have all vaccines fully licensed to make that kind of recommendation. But I would hope that eventually, as part of the childhood vaccination program “.
For parents who may be suspicious that their children are receiving a vaccine that is being used urgently, rather than having been approved by the FDA for children, Gottlieb encouraged them to consult with their pediatricians, but stressed that they do not face a “binary decision” to get their children vaccinated against COVID-19 or not.
“There are different ways to approach vaccination. You can go with a dose for now. You could expect the lowest dose vaccine to be available and some pediatricians can make that judgment. If your child already had COVID, a dose may be enough You can space the doses more, ”he said. “So there’s a lot of discretion that pediatricians can exercise, making judgments largely off-label, but exercising discretion in the context of what an individual child’s needs are, their risk, and what the parents’ concerns. “
While the FDA is expected to make a decision on whether to authorize the COVID vaccine in children in the coming weeks, federal health agencies are also weighing up whether booster vaccines should be approved for children. vaccinated Americans.
The Biden administration initially announced in August that it did ready to start bidding promoters the week of Sept. 20, and Americans should receive their additional vaccines eight months after receiving their second dose of vaccine. But Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told “Face Nation” last week that only the Pfizer booster can receive federal approval before Sept. 20.
The FDA advisory committee is scheduled to meet Friday to discuss reinforcement features, and Gottlieb said the agency is in a position to act “very quickly” based on the outcome of the meeting. If the promoters are approved, he said an advisory committee from the Centers for Disease Control and Prevention would recommend which populations would get them first, probably those most at risk for serious illness or death from COVID-19, such as elderly Americans living in lactation. homes.
Pfizer has already filed its application with the FDA for approval of its reinforcement, and Gottlieb predicted that Johnson & Johnson will likely be the next to do so.
“They have very good data on the drivers as well. They’ve shown a good response,” he said of Johnson & Johnson. “And I think the vaccine could also be in a position to be authorized by the FDA in the short term.”