Advisors to the Centers for Disease Control and Prevention voted unanimously on Thursday to recommend Moderna’s coronavirus vaccine for children and adolescents ages 6 to 17.
Their approval was neither a surprise nor urgently anticipated. The Food and Drug Administration approved the Moderna vaccine for that age group late last week, and the two agencies’ decisions have rarely been at odds.
The recommendation was one of the last hurdles before a second vaccine option became available to a large proportion of individuals under the age of 18. The vaccine, produced by Pfizer and BioNTech, has been available to children ages 5 to 15 since last year and to Americans ages 16 and older as of late 2020.
Moderna’s vaccine was approved for adults in December 2020. Last June, the company submitted an application to use the vaccine in adolescents aged 12 to 17 years, who would receive 100 micrograms, the same dose as adults. But while the FDA took about a month to sign Pfizer’s application for older children, it blocked Moderna’s application.
In an October announcement, Moderna said the FDA was reviewing reports that suggested the vaccine could cause heart problems in adolescent boys. The company also said it would wait to apply for authorization for children ages 6 to 11 until the FDA made a decision for the older children.
In May, Moderna filed its filing with the FDA for children ages 6 through 11, who would receive 50 micrograms, or half the adult dose.
At a closely followed two-day meeting last week, FDA advisors approved first the Moderna vaccine for children ages 6 to 17, then the use of both the Moderna and Pfizer vaccines for children as young as 6 months.
In their meeting on Thursday, committee members were presented with data indicating that the Moderna vaccine has an efficacy against symptomatic infection of about 80 percent in children ages 6 to 11 and about 90 percent in adolescents ages 12 to 17. But that data was all collected before the advent of the Omicron variant, which has shown some ability to evade immunity.
“We know that Covid can cause serious illness and death in children and adolescents, including children 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 across all ages,” said Dr. Oliver.
CDC researchers said the Moderna vaccine is generally safe. It carries a very small risk of transient heart problems in adolescent boys ages 12 to 17, but a similar risk has been seen 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.
But to minimize the risk of heart problems, the CDC now recommends that boys and men ages 12 to 39 keep their doses eight weeks apart.
Much of Thursday’s discussion focused on the potential confusion for providers administering different vaccines, at different doses, for different age groups.
There is no data on the benefit of a booster injection of Moderna vaccine for children and adolescents, and the FDA has only approved the vaccine for primary doses. But that data will likely be available by the time these kids qualify for a Moderna booster shot, CDC scientists said.
