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Pfizer has asked the Food and Drug Administration to approve its three-dose Covid-19 vaccine for children under 5 years old, a move that could extend protection against the coronaviruses to the U.S.'s 18 million young children.

Influenza Vaccine

A child is getting a vaccine.

BSIP/UIG Via Getty Images

The request came just days after Pfizer and BioNTech published clinical trial results indicating three low-dose shots of their coronaviruses vaccine produces a strong immune response among children under 5.

ABC News reported that the FDA could not give a time frame for when it would review the application.

Moderna asked the FDA to grant emergency authorization for its own coronaviruses vaccine for children ages 6 months to 5 years.

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Pfizer-BioNTech's vaccine may be extended to children ages 6 months to 4 years at the FDA's June 14-15 meeting. The committee's recommendations aren't binding, but the FDA's approval decisions often align with the panel.

Key Background

After months of delays, Pfizer and BioNTech applied for emergency use authorization. Pfizer was asked by the FDA to submit data on the first two doses of its three-dose course for infants and young children, in a move that could allow parents to begin vaccinations for their children while the third dose is pending. The FDA evaluation of Pfizer's first two doses was delayed in order to give the company and regulators more time to gather and review data. The U.S. has enough vaccine for all 18 million children under the age of 5, according to the American Hospital Association.

There was 80.3%. According to research by Pfizer, the vaccine is effective in preventing Covid-19 in children ages 6 months to 4 years.


Pfizer and BioNTech plan to submit data for their vaccine to the European Medicines Agency and other international regulators.

The Pfizer says three shots of low-Dose vaccine generate strong immune response in kids under 5 years old.

Live updates on the coronaviruses.