Pfizer asks for FDA authorization for booster for everyone 18 and up

Pfizer-BioNTech asked the Food and Drug Administration on Tuesday for emergency use authorization for its Covid-19 booster shot for everyone ages 18 and up, a ruling the company has been angling for for several months. 

Pfizer’s request will be considered by the FDA, which will make a final decision in the coming weeks. It’s unclear whether the agency will ask its independent advisory group, called the Vaccines and Related Biological Products Advisory Committee, to offer guidance.

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Pfizer’s booster shot is authorized for certain subsets of adults in the U.S.: people ages 65 and up, people living in long-term care facilities and people ages 18 to 64 at high risk of Covid because of underlying medical conditions or their jobs. It is given six months after completion of the initial two-dose vaccination series.

But those complicated criteria are not what the company initially intended. 

In its first push for a booster, Pfizer asked the FDA to authorize the additional shots for everyone ages 16 and up. The FDA advisory panel, however, rejected the request, limiting the shots to certain groups, in part because of safety concerns in younger people.

Pfizer’s latest request says results from a Phase 3 clinical trial with more than 10,000 participants found that the third dose was safe and effective.

If the FDA authorizes the booster shot for the younger age group, the Centers for Disease Control and Prevention must officially recommend it before it can be administered. 

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The question of when to lower age requirements for boosters came up in a meeting of the FDA advisory committee last month; no votes were taken on the subject. At the time, some committee members signaled openness to revisiting it.

“This is a complex topic,” a committee member, Dr. Ofer Levy, the director of the Precision Vaccines Program at Boston Children’s Hospital, said at the time. “And I think we need to follow the data and keep an open mind, and I’m generally supportive of coming down in age on the boosters, and I look forward to those conversations.”

Dr. Peter Chin-Hong, an infectious disease doctor at the University of California, San Francisco, said his thinking on boosters has changed in recent months. 

“I think a lot of people are actually changing their minds a little bit from the initial thought of ‘no boosters are needed,’” Chin-Hong said. The shift came, he said, from personal experience seeing patients with breakthrough cases of Covid and from better data showing the waning effectiveness of the vaccinations over time.

That the initial vaccinations still hold up against hospitalization and death for younger age groups is reassuring, but protection against infection is important, too, Chin-Hong said.

“It is a drag to even get an infection right now, meaning you have to tell everybody you are in contact with, you stay home from work and school,” he said.

Since Pfizer’s booster was first authorized in late September, more than 14 million people have rolled up their sleeves for the shot in the U.S., according to the CDC.

Booster shots of the Moderna and Johnson & Johnson vaccines were authorized in October. Anyone over 18 who was initially vaccinated with the Johnson & Johnson vaccine is eligible for a booster. Eligibility rules for a booster after having been vaccinated with the Moderna vaccine mirror the Pfizer criteria.

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Akshay Syal, MD contributed.