FDA panel recommends Pfizer's COVID-19 vaccine for kids, setting it up for approval

An FDA authorization of the Pfizer-BioNTech COVID-19 vaccine for children ages 5 to 11 would make it the first shot to cover that age group. (Fierce Pharma)

The Pfizer-BioNTech mRNA COVID-19 vaccine is one step closer to winning FDA approval for use in children. But a rousing debate as to whether inoculating kids would reduce transmission of the virus, coupled with some hesitancy from parents, is raising questions about how the approval will impact demand for the shot.

A positive recommendation from the FDA’s Vaccines and Related Biological Products Advisory Committee on Tuesday set the vaccine up for a green light in the coming days. The panel voted 17-0, with one abstention, to extend the vaccine to kids between the ages of 5 and 11. It would become the first to be approved in the United States for this age group, which includes 28 million kids.

The Pfizer dosage for children is one-third the size of that for those age 12 and older. The second of the two-shot series can be administered three weeks after the first. 

The committee’s recommendation was based on data showing efficacy of 90.7% and a strong safety profile in a trial of 2,268 kids in the age group. Additionally, the shot “effectively neutralized the delta variant,” William Gruber, M.D., Pfizer’s VP of vaccine clinical research and development, told the panel.

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An approval could offer relief to some parents who have been hesitant to send their children to school this fall. Kids ages 5-11 have accounted for 9% of cases reported in the U.S. and the current rate is “near the highest” of any age group, Doran Fink, M.D., told the committee on Tuesday.

But Pfizer's ability to capitalize on a green light for its COVID vaccine in kids could be hampered by resistance among many parents. Only 34% of parents in the U.S. said they would vaccinate their children “right away,” according to a poll conducted last month by the Kaiser Family Foundation. The survey was done after Pfizer released data showing the shot was safe and effective in kids ages 5 to 11. In the same poll, 24% of parents said they definitely would not vaccinate their children while 32% would “wait and see” how the vaccine is working.  

A risk of side effects may be contributing to vaccine hesitancy among parents. Myocarditis, an inflammation of the heart, has been seen in adolescents and young adults, mostly male, after a second dose of the vaccine. But the risk appears to be low, the FDA advisory committee concluded. Matthew Oster, M.D., a pediatric cardiologist at Children’s Healthcare of Atlanta, told the committee that myocarditis is much more common in males aged 16 to 29 and children, and adolescents who do get it are likely to recover.

RELATED: Pfizer plans to seek FDA nod for COVID-19 shot in kids 5 to 11 after positive data 

The Pfizer COVID vaccine is fully authorized for people 16 and older. Those between the ages of 12 and 15 can use it on an emergency basis.

Moderna's rival mRNA vaccine is awaiting an FDA nod for use of its shot by those aged 12 to 17. A decision was due earlier this month but was delayed after four Nordic countries suspended use of the Moderna shot in those under age 30 because of myocarditis concerns. In the company's study of 3,700 children between the ages of 12 and 17, there were no reports of myocarditis. The company followed with its request for authorization in this age group in June.

On Monday, Moderna announced positive data from a trial testing the shot in kids between the ages of 6 and 11. The company added that it will submit the data to regulators soon.