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US FDA accepts Pfizer’s application for vaccine use in people aged 16 and above

Vaccine vial. Stock photo: By Ali Raza/Pixabay

Washington, July 17 (MNN) The US Food and Drug Administration (FDA) has formally accepted Pfizer’s Biologics License Application (BLA) to request approval of Pfizer-BioNTech COVID-19 vaccine for use on individuals aged 16 and older and granted the application priority review.

Currently, the vaccine is authorised for emergency use in individuals ages 12 and older.

“The Prescription Drug User Fee (PDUFA) Goal Date of January 2022 reflects the PDUFA deadline for Priority Review and does not mean approval will not happen before that time. Quite to the contrary, the review of this BLA has been ongoing, is among the highest priorities of the agency, and the agency intends to complete the review far in advance of the PDUFA Goal Date,” the FDA said on Saturday.

The FDA has created new product codes for certain medical devices authorised for emergency use under Emergency Use Authorisations (EUAs).

An applicable product code has been assigned to each authorised device category. The product codes are listed in the tables for each category of devices that have EUAs. The categories of devices are available on the Coronavirus Disease 2019 (COVID-19) Emergency Use Authorisations for Medical Devices page.

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