US FDA sets January target to decide on approval of Pfizer's COVID-19 shot

FDA says it will review Pfizer and German partner BioNTech SE's application for full approval of their COVID-19 vaccine in people 16 years and older by January, the companies said on Friday.

FDA says it will review Pfizer and German partner BioNTech SE's application for full approval of their COVID-19 vaccine in people 16 years and older by January, the companies said on Friday. (Dado Ruvic, Illustration, Reuters)


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WASHINGTON — The Federal Drug Administration will review Pfizer and German partner BioNTech SE's application for full approval of their COVID-19 vaccine in people 16 years and older by January, the companies said on Friday.

The vaccine is among the three being used in the United States under the FDA's emergency use authorization alongside shots from Johnson & Johnson and Moderna Inc.

Pfizer/BioNTech finished submitting their application for a full U.S. approval in May and the agency will review the data under its "priority review" pathway.

The FDA in May expanded the emergency use of the two-shot vaccine to children 12 through 15 years of age.

The companies said on Friday they intend to submit an application to support approval of the vaccine in this age group once the required data six months after the second vaccine dose is available.

Moderna also filed for full U.S. approval of its COVID-19 vaccine for adults early in June.

(Reporting by Manojna Maddipatla in Bengaluru; Editing by Sriraj Kalluvila)

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