The US Food and Drug Administration (FDA) granted full approval on Monday (Aug. 23) to Pfizer BioNTech’s coronavirus vaccine.
The vaccine – first receive a green light for use beyond emergency use status — is approved for use in people ages 16 and older.
The approval comes just as the highly contagious Delta variant of the coronavirus is bearing down on the United States, and the approximately 85 million unvaccinated Americans at risk — slightly less than half of the total US population.
The approval came after a review of nearly three months that followed submission of an application submitted to the FDA by Pfizer and its German partner BioNTech.
Data from 44,000 clinical trial participants in the US, European Union, Turkey, South America and South Africa were presented to the FDA, showing the Pfizer BioNTech coronavirus vaccine was 91 percent effective in preventing infection with the coronavirus.
“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,” Dr. Janet Woodcock, the acting FDA commissioner, said in a statement. “Today’s milestone puts us one step closer to altering the course of this pandemic in the US”
New York City Mayor Bill de Blasio announced Monday there will be a new vaccine mandate for school staff, without the option of testing instead.
All staff must provide proof of having received at least one dose of COVID-19 vaccine by September 27.