A key Food and Drug Administration (FDA) expert advisory panel on Tuesday recommended the agency authorize Pfizer's COVID-19 vaccine for use in children between the ages of 5 and 11, bringing those children one step closer to getting a shot.
The Vaccines and Related Biological Products Advisory Committee (VRBPAC) found that the benefits of the vaccine outweighed its risks and voted nearly unanimously 17-0, with one abstention, to recommend the agency authorize the shot.
FDA is not bound to follow the panel's recommendation, though it often does.
Extending vaccine eligibility to children younger than 12 has been a major goal of public health officials and eagerly awaited by many pediatricians and families. The FDA has been under pressure for months to move quickly to authorize vaccines for younger children, one of the final barriers to overcome in the country's historic vaccination campaign.
Pfizer submitted data to the FDA in late September, and formally asked for emergency use authorization earlier this month. An agency review of the data published late Friday found that the benefits of the vaccine "clearly outweigh the risks," indicating that FDA scientists have a favorable view of the evidence.
Some members of the panel said they felt the recommendation was too broad. Not all children will need the vaccine, they argued, or some may only need a single dose because they've been previously infected with COVID-19.
There were also concerns about monitoring the safety profile of the vaccine, because of the potential for extremely rare but serious condition called myocarditis, or heart inflammation.
Cases of myocarditis are generally more common in teenagers between the ages of 16 and 19. It's less common in adolescents, and even more rare in young children. The problem did not turn up in the Pfizer-BioNTech pediatric clinical trial, though experts said it was too small to detect such a rare complication.
Patrick Moore, a professor at the University of Pittsburgh Cancer Institute, said the potential risks of myocarditis are important, but theoretical. The risks of COVID-19 to children are much more real, he said.
Moore noted that 94 children in the 5-11 year old age group have died of COVID. "All of them had names. All of them had mothers," he said. "It's very hard for me to believe the risk for a severe outcome is going to come close to the risk, known risk, that we've seen for this virus in this age group."
A decision by agency regulators is expected in the coming days, and a Centers for Disease Control and Prevention (CDC) panel is scheduled to meet Nov. 2 and 3 to recommend how the vaccines should be used.
If the panel gives favorable recommendations and CDC Director Rochelle Walensky accepts them, the vaccination campaign would begin.
A study from Pfizer released as part of its panel briefing document last week showed that smaller doses of its COVID-19 vaccine for children ages 5 to 11 appear safe, and are nearly 91 percent effective at preventing symptomatic disease.
Pfizer said vaccinating children in that age group "could prevent harms" including interruption of education, hospitalization, severe illness, long-term consequences, and death.
The Biden administration last week said it's purchased enough vaccine to inoculate all 28 million 5- to 11-year-olds in the U.S., and will distribute it through a network that will rely on more than 25,000 pediatrician's offices, as well as community health centers, schools and pharmacies.
Children ages 5 to 11 account for about 9 percent of all reported COVID cases in the U.S., according to FDA data presented to the panel on Tuesday. While it has been declining in recent week, the number of new COVID-19 cases in kids remains exceptionally high. This past week almost 118,000 child COVID cases were added, with more than one million over the past six weeks, according to the American Academy of Pediatrics.
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