FDA grants Pfizer’s COVID-19 vaccine full approval

The Food and Drug Administration announced Monday that it has granted full approval to Pfizer and BioNTech for their COVID-19 vaccine to be given to Americans as young as 16, clearing the way for a wave of moves that health officials say could reverse a nationwide slowdown in the pace of first doses. 

The approval caps a months-long “sprint” by the FDA to clear the shot’s final remaining regulatory hurdles in record time, scrutinizing reams of the company’s latest safety data and conducting inspections at Pfizer’s vaccine factories around the world.

“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.,” said the FDA’s Acting Commissioner Janet Woodcock said in a statement.

Pfizer completed its submission of a “biologics license application” for the shot in May, providing the extensive documentation required for full approval, and has told investors it plans to seek full approval for younger age groups and a booster shot.

Moderna said it plans to finish its application this month. Johnson & Johnson, which is currently gathering data from trials of two-dose regimens, also plans to file for full approval this year.

Pfizer’s vaccine has been available since December under an Emergency Use Authorization, which was expanded in May to include children ages 12 and up.

But the FDA had also faced growing pressure to speed the review as cases surged among mostly unvaccinated Americans from the fast-spreading Delta variant of the virus. Though already allowed under federal law, full approval could open the door for more places that have waited to require the shots. 

On “CBS This Morning” Monday, Dr. Ashish Jha, dean of the Brown University School of Public Health, said such a decision would be “very good news.”

“I actually think it’s going to end up making a pretty big difference,” Jha said. “For some people, the emergency use has been a barrier to getting vaccinated, and a lot of companies and businesses and schools, they have been waiting for full approval before mandating vaccines.”

Full approval for Pfizer’s vaccine was inevitable, federal health officials had predicted. More than 92 million Americans have already been fully vaccinated with Pfizer doses, according to the Centers for Disease Control and Prevention, and real-world evidence gathered by the company, health agencies, and academics have all found the shots to be safe and highly effective at preventing severe COVID-19 cases, hospitalization, and death for most people.

Changes to expect with full approval

The FDA had faced growing pressure to speed the review as cases surged among mostly unvaccinated Americans from the fast-spreading Delta variant of the virus. Though already allowed under federal law, full approval could open the door for more places that have waited to require the shots.

New York City announced Monday that teachers and staff at the nation’s largest school district will be required to get their first dose by September 27.  Some of the nation’s largest companies and organizations have announced plans for vaccination requirements tied to the full approval of a vaccine, from United Airlines to the University of Minnesota. The FDA’s approval will also speed up the military’s vaccine requirement, which the Pentagon had planned to begin by mid-September.

A number of labor unions had opposed employers requiring shots without full FDA approval.. Last month, Ohio’s governor signed into law a measure blocking the state’s schools from requiring vaccines that had yet to clear the FDA’s final review.

It’s also possible that the licensing of the vaccine will convince more people to take it. Thirty-one percent of unvaccinated adults said they would be more likely to get the shot if the FDA granted full approval, according to a June survey by the Kaiser Family Foundation. Three percent said they would get the shot “only if required,” in a July poll from the group.

The approval comes as the average pace of new vaccinations has dropped for more than a week in the CDC’s latest tally. Most states are currently averaging a pace of new vaccinations slower than a week prior. 

Only around half of Americans are fully vaccinated.

Off-label use

Full approval ends many of the limits around Pfizer marketing the shots in the U.S.  It also lifts the FDA’s restrictions barring unapproved or “off-label” use, such as doctors offering shots to younger age groups or giving additional doses. 

Pediatricians could face demands from parents to prescribe “off-label” use of the shots for younger children, as schools reopen and the pace of new hospital admissions among Americans under 18 has spiked past last winter’s record highs. Emergency use authorization for Pfizer’s vaccine in children younger than 12 is not expected until the late fall or early winter.

“We do not have data on the proper dose, nor do we have data — full data — on safety in children younger than what is in the EUA, and so that would be a great concern,” Woodcock said at an FDA briefing on Monday.

“We need to get the information and data on uses in younger children. They are not just small adults. And we’ve learned that time and time again,” Woodcock added later.

The CDC’s agreement with vaccination providers still requires that the shots only be given following recommendations adopted from the agency’s panel of vaccine advisers. And federal health authorities have urged Americans to wait for both the FDA and CDC’s formal determinations of safety and efficacy. But the CDC recently disclosed that more than a million Americans have already received an additional shot ahead of the formal authorization of a booster shot. 

In San Francisco, where local health officials decided to allow recipients of Johnson & Johnson’s vaccine to get a “supplemental dose” of Pfizer or Moderna, a spokesperson for the region’s health department says fewer than 2,000 people have so far gotten the extra shot.

Residents are required to attest to having “discussed the risks and benefits with their healthcare provider,” the San Francisco Department of Health told CBS News.

“To our knowledge, there have not been any reports of adverse events or other safety issues. We continue to monitor for adverse events,” they said.