Pfizer on Tuesday asked the U.S. 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 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.
If the FDA agrees, Pfizer shots containing just 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. Pfizer is testing three shots after two of the extra-low doses turned out to be strong enough for babies but not for preschoolers, and the final data from the study isn't expected until 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 said Tuesday it will convene a panel of independent researchers and physicians in mid-February to help review the Pfizer data. The agency isn't required to follow the panelists' advice but their input is a key step in publicly vetting vaccine safety and effectiveness.