The U.S. Food and Drug Administration on Monday granted full approval to the Pfizer-BioNTech coronavirus vaccine for people who are 16 years of age or older, a long-awaited step that came as Covid-19 cases and hospitalizations are rising sharply across the country—particularly in undervaccinated regions.
Some public health experts have argued that the FDA’s decision to issue a final seal of approval for the Pfizer vaccine—which until Monday had been administered under emergency authorization—could be helpful in easing hesitancy among those who have yet to get vaccinated against the coronavirus, which has killed more than 628,000 people in the U.S.
“It takes away from a certain number of people the argument that it’s not approved,” Dr. O’dell Owerns, a longtime public health leader in Cincinnati, told a local news outlet on Monday. “That’s been their argument of not getting it. Now we’ve eliminated that. I’m not sure what type of dent we’re going to make, but it takes away that argument.”
Acting FDA Commissioner Janet Woodcock echoed that sentiment, arguing in a statement Monday that “for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated.”
“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,” said Woodcock. “Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”
This is fantastic and clearly warranted
— Ashish K. Jha, MD, MPH (@ashishkjha) August 23, 2021
We have SO much data on the safety and effectiveness of these remarkable vaccines
Approval will boost confidence for companies, schools, and others who want to create a safe space by requiring vaccinations
I am thrilled
Great work FDA! https://t.co/qawcsqELPQ
The Washington Post noted Monday that the FDA’s move could “spark a wave of vaccine mandates” by employers and universities as they attempt to combat the highly transmissible Delta variant, which now accounts for the majority of new cases in the U.S.
Just minutes after news of the FDA’s decision broke, local officials announced that the New York City public school system—which is the largest in the U.S.—will begin requiring teachers and all other staff to get vaccinated against Covid-19.
“The city previously said teachers, like other city employees, would have to get the shots or get tested weekly for the virus,” the Associated Press reported. “The new policy marks the first flat-out vaccination mandate for city workers in the nation’s most populous city.”
In an appearance on CNN‘s “State of the Nation” on Sunday, U.S. Surgeon General Vivek Murthy argued that it is “very reasonable” for business and schools to implement their own coronavirus vaccine mandates.
Murthy said that requiring “employees in the school, including teachers and other staff,” to get vaccinated would help “create a safer environment for our kids,” many of whom are not yet eligible for the coronavirus vaccine.
With kids’ “health and wellbeing on the line,” Murthy said, “we’ve got to take every step we can.”
The Republican governors of several states have recently signed bills and executive orders aimed at barring public institutions from instituting vaccine mandates. However, in Texas and Ohio, the anti-mandate measures specifically barred government entities from requiring employees to receive “emergency-use” vaccines, meaning the FDA’s move on Monday renders the bans obsolete.
“There’s a bunch of Republicans—[Texas Gov.] Greg Abbott and [Sen.] Ted Cruz included—who hid behind emergency-use authorization for their little game of banning vaccine mandates,” noted Sawyer Hackett, executive director of People First Action. “What will they do now that Pfizer is fully approved?”
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