07.19.21

FDA Sets January Deadline to Decide on Full Approval of Pfizer, BioNTech Vaccine

Source: FirstWord
Pfizer and BioNTech said that the FDA has granted a priority review for an application seeking full approval of their vaccine BNT162b2 to prevent COVID-19 in people 16 years and older, according to a FirstWord report. According to the companies, the FDA has set a goal date for a decision in January 2022, although an agency official suggested one is likely to come within two months.

The mRNA-based vaccine first received an emergency-use authorization last December for people 16 and up, with the EUA expanded more recently to include preventing COVID-19 in adolescents 12 through 15 years of age.

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