Advisers on the Centers for Disease Control and Prevention voted unanimously to recommend Moderna’s coronavirus vaccine for children and adolescents aged 6 to 17 years.
Their endorsement was neither a surprise, nor urgently anticipated. The Food and Drug Administration authorized the Moderna vaccine for that age group late last week, and decisions made by the two agencies have rarely been on odds.
The recommendation was one of the last hurdles before the second vaccine option becomes available to a larger swath than those younger than 18. The vaccine was produced by Pfizer and BioNTech has been available to children from 5 to 15 since last year and to Americans 16 and older. late 2020.
Moderna’s vaccine was authorized for adults in December 2020. Last June, the company applied its vaccine in adolescents aged 12 to 17 years, which would receive 100 micrograms, the same dose as adults. But while the FDA took roughly a month to sign off on Pfizer’s application for older children, it stalled Moderna’s application.
In an announcement in October, Moderna said the FDA was reviewing reports that suggested its vaccine could cause heart problems in adolescent boys. The company also said it would hold off on applying for authorization for children from 6 to 11 until the FDA had made a decision for the older children.
In May, Moderna submitted its application to the FDA for children 6 through 11, who would receive 50 micrograms, or half the adult dose.
In a closely watched two-day meeting last week, advisers to the FDA first endorsed the Moderna vaccine for children 6 to 17 years, and then used both the Moderna and Pfizer vaccines for children as young as 6 months.
At their meeting on Thursday, committee members presented with data indicating that the Moderna vaccine has an efficacy against symptomatic infection in children of about 80 percent to 6 years and about 90 percent in adolescents 12 to 17 years. But that data were all collected before the arrival of the Omicron variant, which has shown some ability to dodge immunity.
“We know that Covid can cause severe illness and death among children and adolescents, including those without underlying medical conditions,” said Dr. Sara Oliver, a CDC scientist who presented some of the data.
“The benefits outweigh the risks for mRNA Covid-19 vaccines in all ages,” Dr. Oliver said.
CDC researchers say the Moderna vaccine is safe overall. It carries a very small risk of transient heart problems in adolescent boys aged 12 to 17, but a similar risk has been observed with the Pfizer vaccine, according to Dr. Tom Shimabukuro, a CDC scientist who presented the data.
Several studies have shown that Covid itself carries a much higher risk of heart problems than either vaccine.
Still, to minimize the risk of heart problems, the CDC now recommends that boys and men age between 12 and 39 years space their doses apart by eight weeks.
Much of the discussion on Thursday was focused on the potential confusion for providers administering different vaccines, at different doses, for several different age groups.
There is no data on the usefulness of a booster shot of the Moderna vaccine for children and adolescents, and the FDA authorized the vaccine for primary doses only. But those data are likely to be available by the time these children become eligible for a Moderna booster shot, CDC scientists said.