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First US COVID-19 Vaccine Approval

The US Food and Drug Administration has approved the SARS-CoV-2 vaccine from Pfizer and BioNTech for people 16 years old and older, CNN reports, noting that the vaccine will be marketed as Comirnaty.

The mRNA-based vaccine was previously available under an emergency use authorization. Pfizer and BioNTech announced in May that they were seeking full approval for their vaccine, and calls for approval sounded to help increase vaccination rates as the Delta variant has swept across the US.

"While this and other vaccines have met the FDA's rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product," Janet Woodcock, the acting FDA commissioner, says in a statement.

This full approval is expected to tip off additional vaccine requirements at universities, businesses, and local governments, Bloomberg says, and CNN notes it may sway some hesitant individuals to get vaccinated. The New York Times adds United Airlines, the state of Oregon, and the Pentagon have policies in place to mandate vaccinations following regulatory approval.

Moderna has also applied for full approval of its SARS-CoV-2 vaccine, which is currently available under an EUA.