Health · June 24, 2022

CDC advisers recommend Moderna’s vaccine for children and adolescents ages 6 to 17.

Advisors to the Centers for Disease Control and Prevention voted unanimously Thursday to recommend Moderna’s coronavirus vaccine for children and adolescents ages 6 to 17.

Her endorsement was neither a surprise nor much anticipated. The Food and Drug Administration approved the Moderna vaccine for this age group late last week, and the two agencies’ decisions have rarely been at odds.

The recommendation was one of the final hurdles before a second vaccine option becomes available to a large proportion of under-18s. The vaccine, made by Pfizer and BioNTech, has been available for children ages 5 to 15 since last year and for Americans ages 16 and older since late 2020.

Moderna’s vaccine was approved for adults in December 2020. Last June, the company applied for its vaccine to be used in adolescents aged 12 to 17, who would receive 100 micrograms, the same dose as adults. But while the FDA took about a month to approve Pfizer’s application for older children, it delayed Moderna’s application.

In an October announcement, Moderna said the FDA is reviewing reports suggesting its vaccine could cause heart problems in adolescent boys. The company also said it would wait until the FDA makes a decision on the older children before filing for approval in children ages 6 to 11.

In May, Moderna submitted its application to the FDA for children ages 6 to 11 who would receive 50 micrograms, or half the adult dose.

In a closely watched two-day meeting last week, FDA advisers first endorsed the Moderna vaccine for children ages 6 to 17, and then endorsed the use of both Moderna and Pfizer vaccines for children 6 months and older.

At their Thursday meeting, committee members were presented with data suggesting that the Moderna vaccine has an efficacy against symptomatic infections of about 80 percent in children ages 6 to 11 and about 90 percent in adolescents ages 12 to 17. But this data was all collected prior to the arrival 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, even those without pre-existing conditions,” said Dr. Sara Oliver, a CDC scientist, who presented some of the data.

“The benefits outweigh the risks of mRNA Covid-19 vaccines across all age groups,” said Dr. Olivier.

CDC researchers said the Moderna vaccine is overall safe. It carries a very low risk of transient heart problems in adolescent boys aged 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 any vaccine.

However, to minimize the risk of heart problems, the CDC now recommends that boys and men between the ages of 12 and 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 several different age groups.

There is no data on the benefit of a booster dose of the Moderna vaccine in children and adolescents, and the FDA has approved the vaccine for primary doses only. But that data will likely be available by the time these children are eligible for a Moderna booster shot, CDC scientists said.