Pfizer Seeks Approval for Vaccine for Kids Under 5

Regulator urged company to apply earlier than planned
By Newser Editors and Wire Services
Posted Feb 1, 2022 5:16 PM CST
Pfizer Asks FDA to Allow Vaccine for Kids Under 5
A nurse in Romania displays a vial of the Pfizer-BioNTech COVID-19 vaccine for children 5 to 11 year.   (AP Photo/Andreea Alexandru)

(Newser) – Pfizer on Tuesday asked the US to authorize extra-low doses of its COVID-19 vaccine for children under 5, potentially opening the way for the very youngest Americans to start receiving shots as early as March. In an extraordinary move, the Food and Drug Administration had urged Pfizer and its partner BioNTech to apply earlier than the companies had planned, the AP reports. The nation's 19 million children under 5 are the only group not yet eligible for vaccination against the coronavirus. Many parents have been pushing for an expansion of shots to toddlers and preschoolers, especially as the omicron wave sent record numbers of youngsters to the hospital.

"I would say the parents in my office are desperate" to get their youngest kids vaccinated, says Dr. Dyan Hes, who runs a pediatrics practice in New York City where vaccination rates are high. For many, "that’s the first thing they ask when they walk through the door: 'When do you think the shot is going to come out?'" If the FDA agrees, Pfizer shots containing one-tenth of the dose given to adults could be dispensed to children as young as 6 months. Pfizer said Tuesday it had started submitting its data to the FDA and expects to complete the process in a few days. An open question is how many shots those youngsters will need. Two of the extra-low doses given three weeks apart turned out to be strong enough for babies but not for preschoolers in early testing.

Pfizer is testing three shots, and the final data is expected in late March. That means the FDA may consider whether to authorize two shots for now, with potentially a third shot being cleared later if the study supports it. The FDA asked Pfizer to begin submitting its application now due to omicron's "greater toll on children," an agency spokeswoman said, citing record cases among children under 5. "What we’re seeing right now is still a lot of hospitalizations and unfortunately some deaths in this age group," says Dr. Sean O’Leary of the University of Colorado, who is on the American Academy of Pediatrics infectious disease committee. (Read more coronavirus vaccine stories.)

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