Pfizer director and former FDA chief Dr Scott Gottlieb said that he expects US drug regulators to clear the Pfizer-BioNTech Covid-19 vaccine for emergency use in children ages 5 to 11 by late fall or early winter this year.
Gottlieb, who resigned as FDA commissioner in 2019, to join the Pfizer board of directors, told CNBC that the spread of the delta variant could see pressure placed on regulators to act more quickly.
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“If we continue to see these accelerating rates of infections in kids, particularly as the delta variant moves to the Northeast, I think there could be more pressure to try and make an earlier authorization for a vaccine”he said.
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CNBC reports: The former FDA chief Pfizer board member said data from the company’s vaccine trials for kids in that age group “should be available in September,” and then submitted to the Food and Drug Administration that month.
“The application probably isn’t going to be submitted until some point in October,” said Gottlieb, who led the FDA from 2017 to 2019 during the Trump administration.
“If the FDA sticks to its normal timeline, in terms of how it reviews these applications, you would expect that review to be a four-to-six week review for a potentially emergency use authorization, so that puts you on a timeline where you’re late fall, early winter,” Gottlieb added in a “Squawk Box” interview.
Gottlieb’s expectations are in line with recent remarks from White House chief medical advisor Dr. Anthony Fauci on NBC’s “Today” show.
The Pfizer-BioNTech two-shot Covid vaccine is currently the only one to receive full FDA approval, which happened Aug. 23. However, that designation is only for people ages 16 and up. Kids ages 12 to 15 are still able to get Pfizer but on an emergency use basis.
The single Johnson & Johnson shot and the two-dose Moderna vaccine, both under emergency use in the U.S., are cleared for those 18 and up. Moderna has applied for full FDA approval for that age range. J&J has not sought any type of full approval yet. Back in June, Moderna applied to expand its emergency use authorization to cover kids ages 12 to 17.
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