"The public can be confident that this vaccine meets the FDA's gold standards for safety, effectiveness, and manufacturing quality," Acting FDA Commissioner Dr. Janet Woodcock said.
It's a move the medical community hopes will convince more Americans to roll up their sleeves and more workplaces to require it.
Keck Hospital of USC didn't wait for FDA approval for their employees. It issued a vaccine mandate Aug. 9 that will be enforced starting Monday. Felipe Osorno, executive administrator of continuum of care operations at Keck Medicine of USC, said the vaccination rate there is 86%.
Federal officials report 82 million Americans who are eligible to get a shot remain unvaccinated.
"We're hopeful that those people who might have been on the fence about getting the vaccine will now see it's been fully approved by the FDA," said Dr. John Rodarte with Descanso Pediatrics.
In Los Angeles County, less than half of 12- to 15-year-olds are fully vaccinated. Although this group remains under the emergency authorization category, pediatricians hope Pfizer's approval convinces more parents to get their adolescents vaccinated.
"As we see with kids getting back to school, there are small outbreaks that are occurring. And sometimes if you're unvaccinated, that means you have to go back to learning remote," Rodarte said.
But news of the approval also prompted a warning from the nation's leading pediatric group.
"While this means it is legally permissible for physicians to administer the vaccine off-label for children aged 11 and younger, who currently have no available vaccine, the American Academy of Pediatrics strongly discourages this practice," the organization said in a statement.
"There are still ongoing tests for children under 12 for the vaccination. And they're also looking into what the actual dosage might be, the dosage or schedule," Rodarte said.
So when will a pediatric COVID-19 vaccine be available? Pfizer's CEO Albert Bourla says the company plans to complete their studies on children ages 5 to 11 by the end of September.
"School season is coming and that could become quite a big issue with the kids being unprotected. So we do everything we can to accelerate this timeline," Bourla said.
After Pfizer's data is submitted to the FDA, it will be reviewed for emergency use authorization.