FDA Panel Supports Authorizing Moderna Vaccine for Children 6 to 17

Older children and teenagers may soon have two COVID-19 vaccine options. On Tuesday, a Food and Drug Administration (FDA) advisory panel voted unanimously to extend emergency use authorization for Moderna's two-dose series to people under the age of 18.

Currently, only Pfizer's COVID-19 is authorized for use in minors.

At the panel meeting, which was open to the public, Moderna officials presented data on the safety and efficacy of a two-dose series of its COVID-19 vaccine for 12- to 17-year-olds as well as for 6- to 11-year-olds. The dosage for the older group is the same as that given to adults (100 micrograms), while the younger adolescents received a dose half that strength (50 micrograms).

For children 12 to 17 years, the vaccine was about 93% efficacious at protecting against infection when the original COVID-19 strain and the first variant, Alpha, were circulating. The vaccine efficacy was 76.8% among children 6 to 11 years old who were vaccinated during the Delta wave.

While these groups have had access to the Pfizer vaccine for months, some FDA panelists emphasized the importance of having more than one option.

"I'd like to give parents as many choices as possible, and let them make the decisions about this for their children," said Arthur Reingold, MD, division head and professor of epidemiology at University of California, Berkeley, during the panel.

Why Is Authorization Taking So Long?

Moderna originally asked regulators to greenlight its vaccine for adolescents last June, a month after Pfizer’s vaccine was granted emergency use authorization for those aged 12 to 15 years old. But that decision meeting was delayed due to concerns about associations between Moderna’s vaccine and cases of myocarditis, a rare heart condition.

After Moderna collected more clinical and real-world data, the FDA said the risk of that side effect is not significantly greater for youth who receive this vaccine, compared to Pfizer’s.

In Moderna’s clinical trials, there were no deaths among either the younger or older group of children and adolescents, nor were there any cases of myocarditis.

While weighing the merits of the vaccine, several FDA panelists commented on the health and social consequences of COVID-19 for teenagers. There have been more than 10 million COVID-19 cases among 5- to 17-year-olds, though that may be an undercount. Evan Anderson, MD, associate professor of pediatrics and medicine at Emory University, said 365 adolescents died of COVID-19 in 2021—more than the number of adolescents who died during the first year of the H1N1 outbreak in 2009.

Boosters Not Yet Authorized

Paul Offit, MD, an FDA panelist and director of the Vaccine Education Center at Children's Hospital of Philadelphia, said he had voted to recommend the vaccine with the assumption that the FDA would eventually authorize a third dose of the vaccine for this age group to protect against Omicron and its subvariants.

But given how challenging it has been to keep up with the quickly-evolving COVID-19 virus, scientists have to offer the best protection they can with the data they have, said Eric Rubin, MD, PhD, a panelist and adjunct professor of immunology and infectious diseases at the Harvard T.H. Chan School of Public Health.

“You’re always going to be behind the eight ball,” Rubin said. “I don’t think we want to pass up the opportunity to offer something to these kids.”

Moderna officials said they plan to submit data on booster doses for this age group soon. They will also continue to evaluate safety and efficacy data.

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