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09/16/2021

Pfizer will seek FDA emergency use for its COVID-19 vaccine in younger children

Former FDA commissioner and Pfizer board member Scott Gottlieb said that Pfizer's COVID-19 vaccine could be available to children aged 5 to 11 years old by Halloween.
Sandra Levy
Senior Editor
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Former Food and Drug Administration Commissioner Dr. Scott Gottlieb predicted Sunday that the agency will authorize Pfizer's coronavirus vaccine for emergency use in children ages 5 to 11 years old by the end of October, according to a CBS report.

In an interview with "Face the Nation," Gottlieb, who serves on Pfizer's board of directors, said Prizer is expecting to have data on its vaccines in young children before the end of September, which will then be filed with the FDA "very quickly." The agency then has said it will be weeks, rather than months, before determining whether it will authorize the vaccine for kids ages 5 to 11.

"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 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."

[Read more: Retail, supplier orgs call for clarity on Biden's vaccination requirement

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.

The shot has already been authorized for children ages 12 to 15 years old, and Gottlieb said he believes COVID vaccines will eventually be among those required for children in public schools, the report said.

"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."

For parents who may be wary of their children receiving a vaccine that is under emergency use, rather than fully approved by the FDA for children, Gottlieb encouraged them to consult with their pediatricians, but stressed they are not facing a "binary decision" of getting their children vaccinated against COVID-19 or not, according to the report.

[Read more: Pfizer/BioNTech, Moderna booster shot to be available in September]

"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."

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