Pfizer-BioNTech asked the Food and Drug Administration on Tuesday for emergency use authorization for its Covid-19 booster shot for all adults ages 18 and up, a move the company has been angling for over the past several months.
Pfizer’s request will now 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 on authorizing the booster.
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Pfizer’s booster shot is currently authorized for certain subsets of adults in the United States: 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 either underlying medical conditions or their jobs. It’s 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 that request, limiting the shots to certain groups, in part due to safety concerns in younger people.
In Pfizer’s latest request, the company says that 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 for the younger age group, the Centers for Disease Control and Prevention must officially recommend the shot before it can be administered.
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The question of when to lower age requirements for boosters came up during an FDA advisory committee meeting last month, though no votes were taken on the subject. At the time, some committee members signaled openness to revisiting it.
“This is a complex topic,” committee member Dr. Ofer Levy, 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. That shift came, he said, from both personal experience seeing patients with breakthrough cases of Covid as well as better data showing waning effectiveness 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 Americans have rolled up their sleeves for the shot, 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 Johnson & Johnson is eligible for a booster. The eligibility for a booster after initially being vaccinated with Moderna mirrors the Pfizer criteria.
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Akshay Syal, MD contributed.
Source: | This article originally belongs to Nbcnews.com
