U.S. FDA sets January target to decide on approval of Pfizer’s Covid-19 shot
U.S. FDA sets January target to decide on approval of Pfizer’s COVID-19 shot
July 16, 2021; 11:44 AM EDT
(Reuters) – The U.S. health regulator will review Pfizer (PFE.N) and German partner BioNTech SE’s (22UAy.DE) 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 Food and Drug Administration’s emergency use authorization alongside shots from Johnson & Johnson (JNJ.N) and Moderna Inc (MRNA.O).
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.
Syringe and vial are seen in front of displayed new Pfizer logo in this illustration taken, June 24, 2021. REUTERS/Dado Ruvic/Illustration
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. read more
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