FDA Grants Full Approval to Pfizer COVID-19 Vaccine

The Food and Drug Administration (FDA) on Monday granted full approval to Pfizer’s COVID-19 vaccine. The shot will be marketed under the new name Comirnaty.

The approval is currently designated for people age 16 and older. It allows for Pfizer to communicate with advertisers and healthcare providers directly.

Health officials hope the decision will increase people’s confidence in the Pfizer vaccine and encourage more companies to issue vaccine mandates for employees.

"If you're one of the millions of Americans who said that they will not get the shot until it has the full and final approval of the FDA, it has now happened," President Joe Biden said at a press conference. "The moment you've been waiting for is here."

FDA Approval May Combat Vaccine Hesitancy

Leana Wen, MD, MSc, an emergency physician and a public health professor at George Washington University, says the decision marks a turning point in the country’s vaccination rollout and in combating vaccine hesitancy.

“There is a pervasive narrative—that is untrue—about how this is somehow an experimental vaccine,” Wen tells Verywell. “Once there’s full approval, you've taken away that particular argument.”

The Pfizer vaccine has been authorized for emergency use since December 2020. FDA’s new full approval means that the agency officially deems the vaccine safe and effective, having reviewed data from places like clinical trials, testing results, the manufacturing processes, and inspections of the manufacturing site.

A recent Kaiser Family Foundation poll found that three in 10 unvaccinated adults said they would be more likely to get vaccinated if one of the COVID-19 vaccines received full approval.

Jonathan Baktari, MD, CEO of both e7Health and US Drug Test Centers, says the FDA approval of the Pfizer vaccine is unique because of how widely it has been administered. Normally, the FDA would not have as much real-world data aside from those submitted by the pharmaceutical companies. 

“It should significantly prove how legitimate this is, because where else in the history of drug approval have you had, essentially, another clinical trial of 92 million people being presented data to the FDA before they actually had to pull the trigger?” Baktari says.

Pfizer’s clinical trials consisted of about 20,000 vaccine recipients and 20,000 placebo recipients 16 and older. Based on the results, the vaccine was found to be 91% effective at preventing COVID-19.

How Will the Approval Affect Vaccine Mandates?

The FDA approval could lead to an uptick in vaccine mandates, which have already been happening at state and federal employment levels.

Just after the approval, New Jersey Governor Phil Murphy announced a vaccine mandate for all school and state employees, with an option to undergo frequent testing instead, WHYY reported.  New York City Mayor Bill de Blasio also announced a vaccine mandate for the city's public school teachers and employees today.

When looking at private corporate mandates, Baktari sees the FDA approval as providing a legal  protection from employee backlash.

“The tone and tenor of corporate America is the mandate,” Baktari says. “This will give their legal departments the cover they need to go ahead with a mandate.”

What About People Under the Age of 16?

The vaccine remains authorized for emergency use for children aged 12 to 16. It is not yet authorized for children younger than 12.

There is not yet enough data on efficacy, dosage, and safety on how the vaccine is used in younger children, Janet Woodcock, MD, the FDA’s acting commissioner, told reporters at a briefing on Monday.

Baktari says he suspects some backlash from critics who think the vaccine should be studied for longer periods of time, but adds that side effects or complications from any vaccine typically show up relatively early after vaccination. With this in mind, Pfizer has been studied for a good length of time, he says.

“Mandating FDA approved vaccines has been a time honored tradition in the United States for many, many decades,” Baktari adds. “While this appears like a watershed moment, in the vaccine world, this is pretty standard fare.”

The information in this article is current as of the date listed, which means newer information may be available when you read this. For the most recent updates on COVID-19, visit our coronavirus news page.