Pfizer expected to seek EUA for its Covid-19 vaccine for children younger than 5 as soon as today

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. 

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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.

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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.

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Pfizer set to request emergency approval of COVID-19 vaccine for children younger than 5

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