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Pfizer/BioNTech Near Full Approval for Vaccine

The two companies began their application for full approval of their two-dose Covid-19 vaccine in May.

According to a recent CNN Health article, Pfizer and BioNTech have received priority review designation from the FDA for their two-dose Covid-19 vaccine. The vaccine received emergency use authorization for adults in December 2020 and adolescents in May 2021. Now the companies are seeking full approval for people ages 16 and older, and will apply for approval for people ages 12 to 15 when data becomes available. The FDA is required to make its decision by January, but it will likely come sooner as the agency considers approval a priority.