The Wall Street Journal

Pfizer asks FDA to authorize its 3-dose COVID vaccine for children under 5

Published: June 1, 2022 at 6:34 p.m. ET

By

Jared S. Hopkins

A vial of Pfizer-BioNTech COVID-19 vaccine is seen at a pop-up vaccine clinic in Los Angeles in 2021.
AFP/Getty Images

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Pfizer?Inc. and partner?BioNTech SE?asked U.S. health regulators to authorize three doses of their?vaccine for children?under 5 years.

The request Wednesday to the Food and Drug Administration comes after the companies?said last month?that three doses of the shot were 80% effective at preventing symptomatic COVID-19 and generated a robust immune response in children ages 6 months to 5 years old.

The Pfizer PFE, -0.57% -BioNTech BNTX, -0.49% vaccine was also found to be safe and well-tolerated among the children in studies, according to the companies.

FDA clearance could come before the end of the month. If the Centers for Disease Control and Prevention signs off, the last remaining group of people in the U.S. — roughly 19 million young children — would get access to shots at doctors’ offices, pharmacies and other locations

The FDA is also?weighing a request?from?Moderna?Inc. MRNA, -0.96% to authorize two doses of its vaccine for children under 6 years.

The agency has scheduled meetings of outside medical advisers on June 14-15 to discuss data and review the applications from Pfizer-BioNTech’s and Moderna’s vaccine trials in young children.

An expanded version of this report appears on WSJ.com.

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