F.D.A. Approves Pfizer-BioNTech Covid-19 Vaccine

U.S. VIRGIN ISLANDS — The Food and Drug Administration announced Monday that it has fully approved the Pfizer-BioNTech coronavirus vaccine for people 16 and up. Now that the vaccine is approved, businesses, schools and other organizations can implement vaccine requirements for their employees, students, and members.

The Pfizer-BioNTech vaccine, along with other COVID-19 vaccines, was previously approved for emergency use. It is the first vaccine to be granted full approval. Although the full approval specified use in people age 16 and older, the vaccine will continue to be available under emergency use authorization for people 12 through 15 years of age.

Pfizer presented the F.D.A. with data from 44,000 clinical trial participants in United States, the European Union, Turkey, South Africa and South America, as reported by the New York Times. According to the pharmaceutical company, the trial results showed the vaccine was 91 percent effective in preventing infection.

Officials hope that more people will be willing to get the vaccine now that it is officially approved. “While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.,” said Acting FDA Commissioner Janet Woodcock, M.D.

The vaccine will now be marketed as Comirnaty.

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