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.

The other vaccine makers aren’t far behind; Moderna has already begun submitting data for approval, and Johnson & Johnson is expected to seek approval soon as well. Full approval has certain implications on vaccine mandates that emergency use authorization doesn’t. For instance, many schools and businesses have said they’d consider mandating Covid-19 vaccines once approved, and could help sway folks who are on the fence. Some feel approval can’t come quick enough with Delta variant on the rise.

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