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The FDA could authorize Pfizer's COVID-19 vaccine for children under age 5 in the next month, Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, said Wednesday.
"My hope is that it's going to be within the next month or so and not much later than that, but I can't guarantee that because I can't out-guess the FDA," he said during an interview with Blue Star Families, a nonprofit group that supports military families.
The younger age group will likely need three vaccine doses, he said, since two shots didn't provide enough of an immune response during Pfizer's clinical trials for kids ages 2-4.
Pfizer announced in mid-December that it planned to submit data to the FDA during the first half of 2022 if the three-dose study was successful. At that time, Pfizer said it didn't identify any safety concerns with the 3-microgram dose for children ages 6 months to 4 years, which is much lower than the 30-microgram dose given to adults.
Pfizer also plans to evaluate third vaccine doses for ages 5-12 and 12-17.
Children under age 5 are particularly vulnerable to COVID-19 infection right now because they are the only age group not eligible for vaccination, CNBC reported. Hospitalizations among young kids rose as the Omicron variant spread across the U.S. during the past month.
About 8 out of every 100,000 children under age 5 were hospitalized with COVID-19 in early January, according to CDC data from 14 states. That was more than double the rate in early December.
During Wednesday's interview, Fauci also talked to military and veteran communities about the Omicron variant. He predicted that the U.S. will pass the peak of cases by mid-February.
"It is very likely that most of the states in the country will have turned around with their peak and have started to come down," he said.
Blue Star Families: "COVID-19 in 2022: What Military & Veteran Communities Need to Know about the Omicron Variant."
Pfizer: "Pfizer and BioNTech Provide Update on Ongoing Studies of COVID-19 Vaccine," Dec. 17, 2021.
CNBC: "Fauci says FDA could authorize Pfizer's Covid vaccine for kids under 5 in the next month."
CDC: "COVID-NET Laboratory-confirmed COVID-19 hospitalizations."
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Cite this: FDA Could Authorize Pfizer Vaccine for Kids Under 5 in Next Month, Fauci Says - Medscape - Jan 20, 2022.