Pfizer, BioNTech seek FDA’s approval for Covid-19 vaccine for kids under 5

Pfizer on Wednesday 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 (FDA) 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 a 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 one-tenth of the dose given to adults could be dispensed to children as young as 6 months. Pfizer said Wednesday it had started submitting its data to the FDA and expects to complete the process in a few days.

The FDA said Wednesday 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 their advice, but their input is a key step in publicly vetting vaccine safety and effectiveness.

The Biden administration has been trying to speed the authorization of Covid-19 shots for children, contending vaccinations are critical for opening schools and daycare centers and keeping them open, and for freeing up parents from child care duties so they can go back to work.