Pfizer Asks US Regulators to Authorize COVID-19 Vaccine Boosters for All Adults

A vial of the Pfizer-BioNTech COVID-19 vaccine is seen in a file photograph. Justin Sullivan/Getty Images

Pfizer wants clearance for booster shots of its COVID-19 vaccine for all American adults, the company announced Tuesday.

Rebuffed in September by experts on a Food and Drug Administration (FDA) vaccine advisory panel, the company is trying again, pointing to data from a recent trial examining the safety and efficacy of boosters in a more than 10,000 people 16 or older.

The trial showed that a third dose of Pfizer’s jab boosted efficacy to 95.6 percent, Pfizer and its partner BioNTech said, much higher than the effectiveness seen recently in real-world settings.

They also said the trial revealed no safety concerns.

“These important data add to the body of evidence suggesting that a booster dose of our vaccine can help protect a broad population of people from this virus and its variants,” Dr. Ugur Sahin, CEO and co-founder of BioNTech, said in a statement last month.

The companies pushed earlier this year for authorization for boosters for any adult 16 or older but the FDA’s Vaccines and Related Biological Products Advisory Committee rejected that request, instead advising the agency to clear the boosters for everybody 65 and older and select groups of those between 18 and 64. The FDA took up the advice and later authorized boosters for the Moderna and Johnson & Johnson vaccines.

Over 25 million people have received a booster dose as of Nov. 9, according to federal data.

It’s not clear if an advisory panel meeting will be held to consider Pfizer’s renewed request.

Members were asked by the FDA on Oct. 14 to consider whether updated information would support boosters for the general population. A number expressed concern about widening the booster recommendations, pointing to how the vaccines, though waning sharply against infection, have been holding up nearly as well as time goes on against severe disease and hospitalization.

“I’m uncomfortable with how we sort of tripped down the line here regarding the thought of universal booster dosing, which I just think is wrong,” said Dr. Paul Offit, professor of pediatrics in the Division of Infectious Diseases at Children’s Hospital of Philadelphia.

Dr. Eric Rubin, another panel member, said that there wasn’t enough data showing how boosters would benefit younger, healthy people, “and there’s a good reason to think that there isn’t much benefit.”

Dr. Amanda Cohn, a Centers for Disease Control and Prevention scientist who sits on the panel, later said she wanted to consider at least moving the age for which anybody could get a booster to 50.

“Sixty-five is really a construct for being older or not. And given the incredible impact that COVID has had on many older communities of color, it’s even especially important that we protect older persons of color who may not actually meet that 65 age cutoff,” she added.