FDA committee recommends COVID-19 vaccines for youngest children
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An FDA advisory committee on Wednesday unanimously recommended that Moderna and Pfizer-BioNTech’s COVID-19 vaccines be authorized for children as young as 6 months old.
Members of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) recommended that Moderna’s emergency use authorization (EUA) be amended to make the company’s vaccine available for children aged 6 months through 5 years in a two-dose series, at 25 μg per dose.
The committee also recommended the FDA amend Pfizer-BioNTech’s EUA to allow infants and children aged 6 months through 4 years to receive a three-dose series, at 3 μg per dose.
In both cases, the committee voted 21-0 that the benefits of the vaccines outweighed the risks.
The FDA will now consider the VRBPAC’s recommendations while determining whether to amend the EUAs, which it is widely expected to do. The CDC’s Advisory Committee on Immunization Practices is already scheduled to vote on clinical recommendations for the vaccines on Saturday, the second day of a 2-day meeting on pediatric COVID-19 vaccines.
Moderna asked the FDA to authorize its vaccine for younger children in April, citing data from the phase 2/3 KidCOVE study, in which young children in two age groups — 6 months to less than 2 years and 2 years to less than 6 years — received the vaccine and had an immune response against the virus that was consistent with those seen in older children and adults.
According to the FDA’s briefing documents for Wednesday’s meeting, the vaccine’s efficacy among kids aged 2 to 5 years was 36.8% based on a CDC definition and 46.4% based on a Moderna study’s definition.
Other briefing documents compiled by the FDA reported that the efficacy of Pfizer-BioNTech’s three-dose series — calculated during the omicron wave — was 80.4% (95% CI, 14.1%-96.7%), based on three cases of COVD-19 that occurred in the study’s vaccine group and seven in its placebo arm. According to the documents, efficacy was far lower (28.3%) when calculated in between dose two and three.
This last point was noted Wednesday by some members of the committee, including Healio Pediatrics Editorial Board Member Paul A. Offit, MD, director of the Vaccine Education Center at The Children’s Hospital of Philadelphia.
“It does worry me that there was no protection in dose two. That was surprising — and I think that was surprising for the company, and I fear that they may have underdosed,” Offit said during the meeting.
“With Moderna, you have low levels of protective efficacy after dose two, but you can assume that is predictive of better protection against serious disease. I’m not so sure you can predict that with Pfizer’s vaccine,” Offit said. “Now with the third dose, you get the kind of immune-bridging data that is reassuring, but that’s dose three.”
Offit said he supports the vaccine, “but I do worry that parents aren’t necessarily going to know that after two doses they won’t be protective at all and might engage in activity that could put their child at risk.”
Pfizer and BioNTech announced last December that they were evaluating the addition of a third 3 μg dose — one-tenth the size of an adult dose — after a two-dose series failed to produce the expected level of protection in children aged 2 to 4 years.
The VRBPAC also voted unanimously on Tuesday to back Moderna’s two-dose series for adolescents aged 12 through 17 years at 100 μg per dose, and a two-dose series at 50 μg per dose for children aged 6 through 11 years of age. Moderna and Pfizer’s vaccines are already approved for adults.
Committee member Jeannette Y. Lee, PhD, of the University of Arkansas for Medical Sciences, acknowledged that the pandemic and the search for worthy vaccines is not complete.
“I think it’s clear the story isn’t over,” Lee said. “The pandemic has taken some twists and turns, and when there may be more options for protecting children in the future, we will look at those as well.”
According to the AAP, more than 87,644 new pediatric COVID-19 cases were reported in the U.S. during the week ending June 9, representing 635,980 of the weekly reported cases.
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VRBPAC Meeting, June 15, 2022.
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