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,
-1.26%
-BioNTech
BNTX,
-1.14%
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,
-1.33%
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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