The Food and Drug Administration’s committee of independent vaccine experts on Tuesday is debating the merits of Moderna’s coronavirus vaccine for children ages 6 to 17. Thus far, Moderna’s shots have been authorized only for adults.
Committee members will vote on whether to recommend the company’s two-dose vaccine for 6- to 11-year-olds at half the strength of the adult version and for 12- to 17-year-olds at the same strength as adults.
The FDA will then decide whether to authorize the children’s doses for emergency use – following what has been a considerable wait. Moderna asked federal regulators to clear its vaccine for adolescents and older teens last June, a month after Pfizer won emergency authorization for its coronavirus vaccine to be used in 12- to 15-year-olds.
Tuesday’s meeting focused first on the pediatric impact of COVID-19. Dr. Katherine E. Fleming-Dutra, a medical officer at the Centers for Disease Control and Prevention, ran through a slew of data that she said showed that children and adolescents face significant risks of severe illness, even though the risks for adults are higher.
According to CDC data as of June 7, there have been more than 10 million cases among children ages 5 to 17, out of roughly 50 million children in the age group. That infection rate is likely a significant undercount because many cases go unreported.
As of last month, 189 children ages 5 to 11 and 443 adolescents and teens had died of COVID over the course of the pandemic, CDC data shows. The surge from the omicron variant over the winter led to the highest numbers of pediatric COVID cases, emergency department visits and hospitalization rates. Roughly two-thirds of children ages 6 to 17 who were hospitalized with COVID-19 had underlying conditions.
Fleming-Dutra also displayed charts showing the social impact of the virus. She said it had caused thousands of school disruptions each week during the omicron wave, worsening education gaps. Many parents, especially those with lower incomes, left jobs or changed work schedules to look after children, she said. The pandemic has also led to mental health problems, less physical activity and fewer routine immunizations among children, she said.
Moderna first applied to cover 12- through 17-year-olds a year ago. But federal health officials, concerned about possible links between the Moderna vaccine and a rare heart condition, myocarditis, chose to delay a decision. Moderna then held off on an application to cover 6- to 11-year-olds.
The company says concerns about myocarditis have now subsided after further research and real-world evidence. Federal health officials spent much of the morning presenting data to the advisory committee on the risks of that side effect.
Dr. Tom Shimabukuro, a vaccine safety official at the CDC, told the committee that some data on people ages 18 to 39 had suggested a higher risk of myocarditis among Moderna recipients compared to those who received the Pfizer-BioNTech vaccine. Moderna’s dosage is substantially higher than Pfizer’s.
But he cautioned that the evidence was not consistent across U.S. monitoring systems. And he stressed that myocarditis, which can also be caused by the virus itself, was a rare side effect.
Shimabukuro said the CDC had confirmed 635 cases of myocarditis in children ages 5 to 17, out of almost 55 million doses of the Pfizer-BioNTech vaccine administered. The condition was concentrated in adolescent boys after receiving the second dose.
Based on health provider assessments, around 80% of those diagnosed appeared to have fully recovered, he said. Another 18% had improved but not fully recovered.
To evaluate how the vaccine works, Moderna studied immune responses generated in children ages 6 to 17 and compared them to the level of neutralizing antibodies in people ages 18 to 25 after vaccination. The FDA found that the vaccine met the criteria for success but cautioned that a third dose would likely be necessary for children and teens, just as it has been for adults, to counter waning of the vaccine’s potency against infection over time.
The FDA’s assessment, combined with its conclusion that side effects in the age group are minimal, suggests that the advisory panel may recommend it and federal regulators may authorize it.
A separate committee that advises the CDC is expected to take up the matter this weekend, after which Dr. Rochelle Walensky, the agency’s director, will issue her own recommendation. Children could begin receiving the shots soon after Walensky’s approval.
In a second all-day meeting Wednesday, the FDA panel will consider Moderna’s vaccine for children younger than 6 and Pfizer-BioNTech’s vaccine for children younger than 5. About 18 million children age 4 and younger are the only Americans not yet cleared for coronavirus shots.
Whether there will be any real demand for Moderna’s vaccine among teens and older children, given that the Pfizer-BioNTech vaccine has already been available to them for months, is a question likely to surface at Tuesday’s meeting. Uptake of the Pfizer vaccine, which uses the same technology, has been halting among 5- to 11-year-olds. Just over one-third of the 28 million children in the age group have received at least one dose, compared to nearly 70% of those ages 12 to 17.
Jason L. Schwartz, a vaccine policy expert at the Yale School of Public Health, said the authorization of Moderna’s vaccine for children ages 6 to 17 would be useful even if relatively few of them get it.
The Moderna option, he said, would be like an “insurance policy” in case manufacturing problems or new safety concerns arise with Pfizer’s vaccine. Pediatricians and primary care physicians, he said, may choose to stock their offices with both products.
Schwartz said the Moderna authorization could also prove to be valuable in the long term.
“We’re still learning how these vaccines perform, both about levels and duration of protection,” he said. “We may learn over time that one vaccine is better.”
This article originally appeared in The New York Times.
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