Pfizer Prepares To Ask FDA To OK Covid-19 Vaccine For Kids Under 5

by Lauren Levy

Depending on how soon Pfizer submits the official request, young kids could be eligible this month

For so many parents of young children, the news they’ve been waiting for is nearly here: Pfizer-BioNTech is expected to ask the FDA to authorize emergency use of their COVID vaccine for kids ages 5 and under as early as today. If this emergency authorization is granted, it will make children ages 6 months to 5 years old eligible to receive two doses of the vaccine — as early as the end of February.

This age group, which is the only one still not authorized for a COVID vaccine, could be eligible by the end of this month or early March, according to sources familiar with the plan and first reported by The Washington Post. This comes as a relief to countless parents who have been navigating trying to keep their young kids safe without a vaccine’s protection as omicron cases surge and older siblings as well as adults have resumed some normalcy after having access to vaccines and boosters.

Although the FDA is expected to eventually sign off on three doses for kids under 5, more research is still needed and may not be ready until March, according to CNN. This follows the disappointing clinical trial results from last year that found a low dose of the vaccine failed to create a significant immune response in children between the ages of 2 and 5.

In the meantime, approval of a two-dose regimen is the first huge step in shielding little ones as research on a potential third shot continues. This comes as pediatric COVID cases are still surging, with omicron behind the alarming spike. According to the American Academy of Pediatrics, over 808,000 additional child COVID cases were reported during the week ending Jan. 27, bringing the total of new cases in kids to 3.5 million just in the month of January. The AAP also noted that pediatric cases remain “extremely high” at triple the peak level of the Delta surge in 2021.

Before parents start fully rejoicing, it’s important to note that Pfizer hasn’t officially filed for this latest FDA authorization yet, according to a statement to NBC News on Monday. “We’re continuing to collect and analyze data from both two and three doses in our younger age cohort,” the company said.

It’s been a difficult time for parents with babies and toddlers but hopefully this gives them a glimmer of hope that vaccine approval for entire families is almost here.