8:52 AM PDT, September 13, 2021
The Food and Drug Administration (FDA) could soon approve Pfizer’s COVID-19 vaccinations for children ages 5-11, according to Dr. Scott Gottlieb former commissioner of the FDA.
In an interview with “Face the Nation,” Gottlieb said the authorization for emergency use could come by the end of October as the drug company could have the data they’ve been collecting on young children by the end of December. Gottlieb, who serves on Pfizer’s board of directors, also said Pfizer’s request for authorization with the FDA could come “very quickly.”
“In a best-case scenario, given that timeline they’ve just laid out, you could potentially have a vaccine available to children aged 5 to 11 by Halloween,” Gottlieb said. “If everything goes well, the Pfizer data package is in order, and the FDA ultimately makes a positive determination, I have confidence in Pfizer in terms of the data that they’ve collected. But this is really up to the Food and Drug Administration to make an objective determination.”
Pfizer has been holding clinical trials for the vaccine with children two years and older. Their vaccine shot is already approved for children 12-15, but with children making up 25% of new COVID-19 infections, the approval could make a big difference in slowing the spread of the virus.
Pfizer has been conducting clinical trials of its two-dose vaccine in children 2 years and older, and its approval could be crucial to helping combat the spread of the highly contagious Delta variant in schools. Children represent 25% of new COVID-19 infections.
Gottlieb said he also thinks schools will recommend that children be vaccinated.
“I think you’re going to see more local school districts and governors make those recommendations,” he said. “Eventually ACIP is going to make a recommendation about whether this should be included in the childhood immunization schedule. My guess is they’re waiting for more of the vaccines to be fully licensed to make that kind of a recommendation. But I would expect this eventually to be required as part of the childhood immunization schedule.”
Gottlieb also said there may be options for parents who are wary about letting their child get the vaccine without full FDA approval.
“There’s different ways to approach vaccination. You could go with one dose for now. You could potentially wait for the lower dose vaccine to be available, and some pediatricians may make that judgment. If your child’s already had COVID, one dose may be sufficient. You could space the doses out more,” he said.
“So, there’s a lot of discretion that pediatricians can exercise, making largely off-label judgments, but exercising discretion within the context of what an individual child’s needs are, their risk is, and what the parents‘ concerns are.”