Pfizer asks FDA to amend booster authorization to include all adults

Pfizer boosters for a subset of Americans were authorized six weeks ago.

November 9, 2021, 6:38 PM

Pfizer on Tuesday requested the Food and Drug Administration allow all Americans over 18 to be eligible for booster shots, submitting data from a 10,000-person trial that found its third shots to be safe and effective for adults of all ages.

The request from Pfizer comes six weeks after independent panels of experts at the FDA and Centers for Disease Control and Prevention reviewed the company’s initial request for booster shots and ultimately determined that only Americans over 65 years old or who are frequently exposed to the virus should get a third dose.

That decision, in part, was because experts at the FDA and CDC said they wanted more data on how the third shot might affect young people, and whether they even needed one given the enduring protection from the vaccine against hospitalization and death among that group.

Pfizer’s submission on Tuesday brings more data to the table. A source familiar with the discussions said that because the FDA has a clear sense on where the advisors stand, it's not likely that its committee of experts will be asked to meet again and discuss the new data.

The CDC's advisory panel could still be a part of the process, but that would come after the FDA amends the emergency use authorization to include everyone 18 and up for boosters, if they do.

PHOTO: Safeway pharmacist Ashley McGee fills a syringe with the Pfizer COVID-19 booster vaccination at a vaccination booster shot clinic on Oct. 1, 2021, in San Rafael, Calif.
Safeway pharmacist Ashley McGee fills a syringe with the Pfizer COVID-19 booster vaccination at a vaccination booster shot clinic on Oct. 1, 2021, in San Rafael, Calif.
Justin Sullivan/Getty Images

People who received a third dose of Pfizer had 95% efficacy against the virus compared to people who received two shots, Pfizer said in a press release on Tuesday. Compared to unvaccinated people, Pfizer projected that efficacy was 98%.

The FDA and CDC have both left the door open to widening booster recommendations out to everyone as more data comes out, and as immunity wanes.

And last week, chief medical advisor to the White House Dr. Anthony Fauci told reporters that he thought boosters for all adults were imminent.

"It will be very likely that everyone will be able to get a booster within a reasonable amount of time," Fauci said at the White House COVID briefing.

"People who have a primary vaccination are still really quite protected against severe disease and hospitalization,” he said, but said he supported boosters as a way to “stay ahead of the virus.”

Still, there will be a debate among experts over whether boosters are needed for all, which largely centers on whether the U.S. should be boosting to prevent breakthrough infections.

Dr. Paul Offit, an FDA advisory panel member and director of the Vaccine Education Center at Children's Hospital of Philadelphia, doesn’t think there’s a strong need for boosters as long as the initial two shots protect against hospitalizations and death, which they still do for most young people.

"I think those who benefit the most from a third dose are those who are over 65 years of age. I think those who are over 50, who have a high risk medical condition, will likely benefit from a third dose. And for all others, I think you should consider yourself fully vaccinated with two doses,” Offit told ABC News in an interview on Tuesday.

"But the advantage of a third dose is that you're less likely to have an asymptotic or mildly symptomatic infection. Where you could still, for example, be contagious," Offit said.

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