Pfizer, BioNTech Ask FDA to Approve Booster for Children
By Dean Seal
Pfizer Inc. and partner BioNTech SE have asked the U.S. Food and
Drug Administration to approve the use of its Omicron-specific
Covid-19 vaccine booster shot for children.
The regulator granted this version of the vaccine an Emergency
Use Authorization for use in people 12 or older on Aug. 31.
The companies said Monday that they have submitted an
application for emergency use authorization of the 10-ug booster
dose for children ages five to 11.
An application to approve the booster for children in Europe
would be submitted to the European Medicines Agency in the next few
days, the companies said.
Pfizer and BioNTech have launched a Phase 1/2/3 study to
evaluate the safety of the shot for children as young as 6 months
old, following the same regulatory guidance as trials of their
original Covid-19 vaccine.
Write to Dean Seal at email@example.com
(END) Dow Jones Newswires
September 26, 2022 07:42 ET (11:42 GMT)
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