FDA Grants Pfizer COVID Vaccine Full Approval, Moderna Could Follow

The Food and Drug Administration (FDA) granted full approval to the Pfizer-BioNTech COVID-19 vaccine on Monday, the agency said in a press release.

The vaccine becomes the first COVID-19 vaccine to be fully approved by health authorities in the United States.

The FDA had recently set an unofficial deadline for granting full approval to the Pfizer-BioNTech shot by Labor Day on September 6, amid a surge in infections across the United States fueled by the more transmissible Delta variant.

Like the other two COVID-19 vaccines currently available in the United States—manufactured by Johnson & Johnson and Moderna respectively—the Pfizer-BioNTech shot had only been authorized for use under what's known as an EUA.

An EUA, or emergency use authorization, is a temporary mechanism that the FDA can use to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies, such as the current COVID-19 pandemic.

Under an EUA, the FDA can allow the use of an unapproved medical product, or unapproved uses of approved medical products, in an emergency situation if certain criteria are met.

"The FDA's approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. 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," acting FDA Commissioner Janet Woodcock said in a statement.

"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."

The Pfizer-BioNTech was the first COVID-19 vaccine in the U.S. to be granted authorization under an EUA on December 11, 2020. The shot continues to be available under emergency use authorization for individuals 12 through 15 years of age and for the administration of a third booster dose in immunocompromised people.

So far, more than 203 million doses of the vaccine have been administered in the United States. According to the Centers for Disease Control and Prevention, 170 million people have been fully vaccinated with one of the three authorized COVID-19 shots in the United States, which is equivalent to around 60 percent of the total population aged over 18.

Moderna has also submitted an application to the FDA seeking full approval of its COVID-19 vaccine, which the agency is still reviewing, with any decision expected several weeks after the Pfizer-BioNTech one at the least, the Times reported.

Full approval for the Pfizer-BioNTech vaccine will likely open the door for a host of public and private organizations to introduce vaccine requirements. Health officials are also hoping that full approval could help convince some vaccine hesitant individuals to receive the shot.

"This may tip them over toward getting vaccinated," Vivek Murthy, the surgeon general, told CNN on Sunday.

Newsweek has contacted the FDA for comment.

A dose of the Pfizer COVID-19 vaccine
A syringe is filled with a first dose of the Pfizer COVID-19 vaccine at a mobile vaccination clinic in Los Angeles, California on August 7, 2021. The FDA could grant full approval to the Pfizer vaccine this week, according to reports. PATRICK T. FALLON/AFP via Getty Images