Pfizer's COVID-19 Vaccine Gets Full Approval From the FDA

The approval may spur vaccine mandates and convince some holdouts that it's time to get vaccinated

A syringe is filled with a dose of the Pfizer COVID-19 vaccine at a mobile vaccination clinic at the Weingart East Los Angeles YMCA in Los Angeles, California on August 7, 2021.
A syringe is filled with a dose of the Pfizer COVID-19 vaccine on Aug. 7, 2021, at a mobile vaccination clinic in Los Angeles.
Photo: Patrick T. Fallon/Getty Images

The Pfizer-BioNTech vaccine was approved by the Food and Drug Administration on Monday, becoming the first COVID-19 vaccine to gain full approval. The shot had previously been administered under an emergency use authorization (EUA), which restricted its use to specific circumstances as part of a public health emergency.

“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,” Janet Woodcock, MD, acting commissioner of the FDA, said in a statement. A June poll from the Kaiser Family Foundation found that 3 in 10 unvaccinated adults said they would be more likely to get vaccinated if one of the available vaccines received full FDA approval.

“The approval provides additional reassurance that the vaccine is safe and effective,” says Robert Atmar, MD, professor of medicine and infectious diseases at the Baylor College of Medicine in Houston and a member of the Baylor Vaccine Research Center. “I marvel that we have been able to reach this point so expeditiously since the disease was first recognized.”

What Full Approval Means

Though the vaccines had already undergone rigorous clinical trials before emergency authorization, the bar for full approval—also called licensure—is higher.

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For example, before issuing the emergency authorization, the FDA reviewed data that followed trial participants for a median of two months after vaccination. Before giving the vaccine full approval, the agency reviewed data that followed participants for a minimum of six months, says Atmar, a former member of the Advisory Committee on Immunization Practices (ACIP). Approximately 12,000 participants were followed for at least six months after their Pfizer shots.

The agency also conducted further evaluation of the risk of myocarditis (heart inflammation) after vaccination. It determined that there is an increased risk of myocarditis within seven days after the second dose. Though millions of doses have been administered, cases of myocarditis remain rare, according to the Centers for Disease Control and Prevention.

The risk of myocarditis is most pronounced in boys ages 12 to 17, though it is also elevated in men younger than 40, compared with women and older men. In most people who experienced such symptoms, they resolved, according to the FDA, though longer-term follow-up is still needed. For now, the prescribing information for the Pfizer vaccine will include a warning about these risks.

The Pfizer vaccine is approved only for those 16 and older. Under the EUA, it will continue to be available to kids between 12 and 15, and third shots will continue to be available to people who are immunocompromised.

The FDA will need to go through a separate process to fully approve the vaccine for 12- to 15-year-olds and each younger age group after that, according to Gregory Poland, MD, director of the Vaccine Research Group at the Mayo Clinic in Rochester, Minn. (Poland has consulted with Pfizer, Moderna, and Johnson & Johnson on the development of their vaccines.)

Clinicians have more leeway in how they can use a fully approved, licensed vaccine. For example, it may lead to more off-label uses, such as in younger age groups or as a booster shot, Atmar says. There are “potential safety concerns in using the vaccine in such ways,” he says, because studies on the safety and efficacy of those uses are still pending review by the FDA and ACIP.

On Monday, the American Academy of Pediatrics released a statement that strongly discouraged the use of the Pfizer vaccine in younger children, even though the group acknowledged that it would be "legally permissible."

"The clinical trials for the COVID-19 vaccine in children ages 11 years old and younger are underway, and we need to see the data from those studies before we give this vaccine to younger children,” AAP President Lee Savio Beers, MD, said in the statement. “The dose may be different for younger ages. The AAP recommends against giving the vaccine to children under 12 until authorized by the FDA.”

Full approval of the Moderna vaccine, which is based on similar technology, will probably be coming soon, and approval of the Johnson & Johnson vaccine is likely coming eventually as well, according to Poland.

More Mandates May Be on the Way

“Full FDA approval strengthens the case for vaccination requirements as an important strategy to curb infection and prevent hospitalizations and deaths due to COVID-19,” Barbara D. Alexander, MD, president of the Infectious Diseases Society of America, said in a statement.

Though some employers, universities, and other institutions are already requiring COVID-19 vaccination, that trend may accelerate now that there is a vaccine that has been fully approved.

“Mandatory vaccination was always an option,” says Diane M. Juffras, professor of public law and government at the University of North Carolina Chapel Hill School of Government. “But many employers and universities were sensitive to the fears of employees and students and opted to encourage vaccination while waiting for full approval.”

Full approval may also make institutions that implement vaccine mandates less likely to face lawsuits. “The main argument in lawsuits challenging university and employer mandates was the legal argument that you cannot mandate a vaccine under an EUA. It is one of the few open questions on this, since university mandates and employer mandates have a long history,” says Dorit Reiss, a professor of law at UC Hastings College of the Law in San Francisco. “Licensure removes that argument, and would make challenging mandates much harder.”

Some states currently bar vaccine mandates, but in Texas, for example, the text of the executive order currently in place only prohibits public entities from requiring “any COVID-19 vaccine administered under an emergency use authorization.”

“This [approval] is really important,” says Poland, of the Mayo Clinic. “In the face of this highly contagious Delta variant . . . we either allow the virus to run rampant at the cost of tens of thousands to hundreds of thousands of deaths, millions of infections, and an unacceptable amount of illness, or we get to the point where we mandate vaccines and masks.”

Additional reporting by Catherine Roberts.

Editor’s Note: This story was updated to include a statement from the AAP.


LAUREN FRIEDMAN

Lauren F. Friedman

I'm a science journalist and storyteller, always regarding fads with skepticism and analyzing studies with care. Decisions about our health are some of the most difficult and critical we all make, so I favor evidence over anecdote and aim to find clarity amidst the confusion. When I'm not reading, writing, and editing, I enjoy hiking, bike touring, and trying new foods in Queens, where I live. Follow me on Twitter (@fedira).