Pfizer could submit for EUA for two-dose Covid-19 vaccine for children younger than 5 as soon as today

The company will seek emergency use authorization for a two-dose regimen
Originally Published: 01 FEB 22 07:00 ET

(CNN) — Pfizer is expected to seek authorization from the US Food and Drug Administration as soon as today for its Covid-19 vaccine for children age 6 months up to 5 years, a person familiar with the plan says.

The company will ask the agency to grant emergency use authorization for a two-dose regimen of its product while continuing to test three doses in this younger age group, the person said.

Pfizer was encouraged to seek authorization for the two doses by federal regulators, who hope it can be granted by late February. Waiting on data for three doses could extend the wait until March.

The Pfizer/BioNTech vaccine is already authorized for use in people as young as 5, and if authorized, this shot would be the first Covid-19 vaccine available for the youngest children.

The timeline development was first reported by the Washington Post

In December, Pfizer extended its vaccine in trial in younger children after two child-sized doses of the vaccine did not produce the expected immunity in the 2- to 5-year-olds, although it did so for the babies up to age 2. The company said it would “amend” the trial to add a third 3-microgram dose at least two months after the second.

A Pfizer spokesperson told CNN on Monday the company has not yet submitted a request to the FDA and said the company is “continuing to collect and analyze data from both two and three doses in our younger age cohort.” The US Food and Drug Administration has not responded to CNN’s request for comment.

Dr. Scott Gottlieb, a former commissioner of the US Food and Drug Administration and current Pfizer board member, said Sunday that that if the vaccine was two doses instead of three, it could receive emergency use authorization by early March.

“I’m hopeful that you could see some movement on trying to entertain that application earlier,” Gottlieb said on CBS’ “Face the Nation.” “Ultimately the decision resides with the FDA, but there is some indication that there may be an earlier action on that application.

“If the goal of the vaccine is to get baseline immunity in the kids — to prevent really bad outcomes and you’re really not using the vaccine as a tool to prevent infection in the first place — two doses could do that,” Gottlieb said. “I think that may be why federal health officials are rethinking this. If in fact, they decide to authorize this on the basis of two doses, it could be out much sooner, perhaps as early as early March.”

The-CNN-Wire
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