Children Under 5 May Be Eligible for COVID Vaccine This Month with Pfizer Set to Ask for FDA Approval

The company will reportedly apply for emergency use authorization of its two-dose regimen while continuing studies on three doses of the COVID vaccine

A child getting a COVID-19 vaccine dose. Photo: Getty

Pfizer and BioNTech are expected to submit data to the Food and Drug Administration for emergency use authorization of the COVID-19 vaccine for children 6 months to 5 years old, according to The New York Times and The Washington Post.

The companies will reportedly submit an application on Tuesday for emergency use of its two-dose regimen while continuing studies on the impacts of three doses for the age group.

Federal regulators hope the COVID vaccine could be authorized for young children as early as the end of February, per the Times.

"We know that two doses isn't enough, and we get that,"sources told the Post. "The idea is, let's go ahead and start the review of two doses. If the data holds up in the submission, you could start kids on their primary baseline months earlier than if you don't do anything until the third-dose data comes in."

In December, Pfizer and BioNTech announced that they would study the impacts of a third COVID-19 vaccine dose in children under 5 after determining a two-dose regimen did not elicit enough of an immune response in some children.

At the time, the companies claimed that the two-dose vaccine was effective in children under age 2, similar to those in the 16-24 age bracket. However, children ages 2 through 5 generally did not have the same response. The delay came just as the United States saw an increase in hospitalizations among children due to COVID as the highly contagious omicron variant continues to spread.

The Centers for Disease Control and Prevention first approved the Pfizer-BioNTech vaccine for emergency use in children ages 12 to 15 back in May. The vaccine received the same approval for children ages 5 to 11 six months later in November.

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