Pfizer’s COVID-19 vaccine received full FDA approval. Here’s what that means.

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More than eight months after authorizing Pfizer’s COVID-19 vaccine for emergency use, the U.S. Food and Drug Administration has now fully approved the vaccine for people 16 and older.

What does that mean?

It depends on your perspective.

For those who’ve already received the Pfizer vaccine, the Aug. 23, 2021, announcement doesn’t really change anything. “It basically confirms what we already knew — that those who were vaccinated did the right thing,” said Ashley Lipps, MD, an infectious diseases physician and assistant professor at The Ohio State University Wexner Medical Center.  

For those who’ve been hesitant to get vaccinated, the full approval should help put those fears to rest. In December 2020, the FDA authorized the emergency use of COVID-19 vaccines using a process it deploys in situations when there are no adequate, approved and available alternatives.

The emergency use authorization, or EUA, was based on safety data gathered over two months from participants who were vaccinated in clinical trials, Lipps said. The full approval takes into account more than six months of participant monitoring. It also comes after more than 170 million people nationally have been vaccinated, 92 million of whom received the Pfizer vaccine.

“The FDA announcement of full approval for the Pfizer COVID-19 vaccine is a momentous development in our fight against vaccine hesitancy and vaccine refusal, which are prolonging the pandemic,” said Iahn Gonsenhauser, MD, chief quality and patient safety officer at the Ohio State Wexner Medical Center. “Millions of Americans have voiced safety concerns and the lack of full FDA approval as a reason for waiting to be vaccinated. The additional safety monitoring required to designate a fully approved vaccine is now complete, and the FDA observed all protocols without any shortcuts. We are eager to see this group of cautious but responsible citizens pursue their own immunization and move us one step closer to ending the pandemic.”

In a June 2021 poll, the Kaiser Family Foundation found that three in 10 unvaccinated adults said they’d be more likely to receive a COVID-19 vaccine if one were to receive full FDA approval. 

For companies and organizations looking to mandate COVID-19 vaccines, the FDA approval could be game changing. The Pentagon announced it would be moving forward with plans to require active-duty troops to be vaccinated, and more businesses, schools and local governments are expected to follow suit with mandates. “Not that they couldn’t have done this under the EUA,” Lipps said, “but it’s easier and more compelling based on the full approval.”

For those who received the Moderna COVID-19 vaccine, a full FDA approval is likely forthcoming, Lipps said. Pfizer was the first to apply for FDA approval, a month ahead of Moderna. Johnson & Johnson has yet to submit its application for full approval of its one-dose shot.

For Pfizer, FDA approval means the company can now advertise its vaccine. It will be marketed as Comirnaty (koe-mir’-na-tee), a name you’ll likely be hearing on TV in the weeks and months to come.