PHOENIX - On Aug. 23, the U.S. Food and Drug Administration granted full approval to the COVID-19 vaccine made by Pfizer and BioNTech. The two-dose vaccine, which will now be marketed as Comirnaty, now carries the strongest endorsement from the FDA, which has never before had so much evidence to judge a shot’s safety.
Vaccine administered under emergency use authorization
More than 200 million Pfizer doses already have been administered in the U.S. — and hundreds of millions more worldwide — since emergency use began in December 2020.
A decision had been expected by early 2022 after U.S. regulators agreed to a "priority review" of Pfizer’s application in July, though many were expecting the decision to come much sooner given how closely the agency has been monitoring the vaccine’s widespread use.
Pfizer’s application for full approval included the latest data from a large study that tracked participants 16 years of age and older, for six months after their second dose.
The FDA called the vaccine’s approval a "key achievement for public health."
"The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic," said acting FDA Commissioner Janet Woodcock in a statement. "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."
The vaccine is still administered to those 12 to 15 under an emergency use authorization.
Doctors preparing to vaccinate more people against COVID-19
Health experts hope FDA's full approval of the Pfizer/BioNTech vaccine will give anyone on the fence confidence to get the shot.
Doctors at Noah Palomino Health Center in Phoenix say they have been busy administering vaccines since the rise of the delta variant, and they are now expecting more people to show an interest.
"I do expect now with the FDA stamp of approval we will find more people coming out for the vaccine," said Jennifer Vanyo-Movak.
Officials with the Arizona Department of Health Services used FDA's announcement as a way to persuade anyone hesitant to get the shot, adding that 86% of COVID-19 cases in the state between July and the first half of August occurred among those who were not fully vaccinated.
FDA approval could push companies to implement vaccine mandates
Some say with the FDA's announcement, they could see more pushes for vaccine mandates.
Meanwhile, FDA's announcement could spur vaccine mandates from private companies. On Aug. 20, Arizona Attorney General Mark Brnovich announced, via a legal opinion, that businesses within Arizona can require their employees to get vaccinated against COVID-19.
Schools, public universities, community colleges, state government entities, and local government entities are banned by state law from requiring their employees to get vaccinated against COVID-19. Some of the laws, however, will take effect on Sept. 29.
Attorneys, however, say accommodations must be made.
"They can make accommodations. If this is a religious or medical accommodation, they need to do so," said Heather Macre, an attorney at Fennemore Craig. "What they could do is have that person work from home, or have that person work different hours where they wouldn’t be interacting with coworkers."
The Associated Press (AP) contributed to this report.
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CDC Website for COVID-19
https://espanol.cdc.gov/coronavirus/2019-ncov/index.html (In Spanish/En Español)
AZDHS Website for COVID-19
https://www.azdhs.gov/covid19/es/index.php (In Spanish/En Español)
AZDHS Website for COVID-19 Vaccination
https://www.azdhs.gov/covid19/es/vaccines/index.php (In Spanish/En Español)
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