FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Tuesday voted 17-0 to recommend the Pfizer-BioNTech Covid-19 vaccine for children ages five to 11, marking a major step toward making children eligible to receive Covid-19 vaccines.
Details on the meeting
During the meeting, Pfizer presented data showing its vaccine had a 90.7% efficacy rate in preventing symptomatic Covid-19 in its clinical trial of about 4,500 children ages five to 11.
Fiona Havers, a viral disease specialist at CDC, noted during the meeting that hospitalization rates among five- to 11-year-olds were highest during the delta-driven surge in September. "There's clearly a lot of susceptible children still out there that are vulnerable to severe disease," she said.
Amanda Cohn, a top vaccine official at CDC, said at the meeting that Covid-19 is "the eighth-highest killer of kids in this age group over the past year. Use of this vaccine will prevent deaths, will prevent ICU admissions, and will prevent significant long-term adverse outcomes in children."
Some panel members expressed dissatisfaction at having to make a binary "yes or no" vote on the recommendation, rather than issuing a recommendation with more nuance.
James Hildreth, president and CEO of Meharry Medical College, argued that not every child may need a vaccine, especially those who previously had Covid-19.
"It just seems to me that in some ways we're vaccinating children to protect the adults, and it should be the other way around," he said. "I do believe that children at highest risk do need to be vaccinated. But vaccinating all of the children to achieve that just seems a bit much for me."
Similarly, Michael Kurilla, an official at NIH who abstained from the panel's vote, said the federal government was using a "one-size-fits-all" approach.
"I think for many children who have experienced Covid already, they're probably more than adequately protected. One dose may be sufficient," he said. "I think for the high-risk children, it's very different."
However, Peter Marks, director of FDA's Center for Biologics Evaluation and Research, noted that approving the vaccine "for some subset of the group … could potentially lead to a situation where this becomes a vaccine that gets used more" by those of higher socioeconomic status.
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Ultimately the panel voted 17-0 with one abstention to recommend the vaccine for five- to 11-year-olds. The recommended dose would be one-third of the strength given to those ages 12 and older, and the two shots would be given three weeks apart.
The panel's recommendations are not binding on FDA, but the agency usually follows its advice. In the coming days, FDA will consider the recommendation and could choose to extend the emergency use authorization for Pfizer and BioNTech's vaccine to include children ages five to 11.
A separate CDC advisory panel will meet next week to discuss whether to recommend the vaccine to children ages five to 11. CDC Director Rochelle Walensky would then issue a final recommendation on who should receive the vaccine.
According to Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, it's possible children ages five to 11 will be eligible for Covid-19 vaccines in early November.
"If all goes well, and we get the regulatory approval and the recommendation from the CDC, it's entirely possible, if not very likely, that vaccines will be available for children from five to 11 within the first week or two of November," Fauci said.
In separate study, Moderna's vaccine shown to be effective in children
In related news, the Covid-19 vaccine developed by Moderna was found to produce a strong antibody response in children ages six to 11, the company announced Monday.
In a clinical trial undertaken in collaboration with NIH, 4,753 children ages six to 11 were given a 50-microgram dose of Moderna's vaccine—half the dose given to adults. According to Moderna, by one month after being fully vaccinated, the children had produced a robust antibody response that was 1.5 times stronger than the response seen in young adults.
The most commonly reported side effects were headache, fatigue, fever, and injection site pain. Ultimately the vaccine showed a "favorable safety profile," Moderna said. The company added that it will submit its data to federal regulators. (LaFraniere/Weiland, New York Times, 10/26; Walker, MedPage Today, 10/26; Fox, CNN, 10/26; Hensley, "Shots," NPR, 10/25; Rabin, New York Times, 10/264; Ferek, Wall Street Journal, 10/24; Mandavilli, New York Times, 10/25)