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 dean.seal@wsj.com

 

(END) Dow Jones Newswires

September 26, 2022 07:42 ET (11:42 GMT)

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