FDA committee clears the way for authorization of Moderna vaccine for kids 6-17

A committee of advisers at the Food and Drug Administration voted unanimously Tuesday in favor of authorizing the Moderna vaccine for kids ages 6 through 17, paving the way to add one more vaccine to the options available for this age group.

Currently, only Pfizer's vaccine is available for kids over 5 years old. Moderna's vaccine, which was stalled in the regulatory process for months, would give parents another option.

The process to get Moderna's vaccine out to pharmacies and clinics now moves to FDA leadership, which must decide whether to issue an official emergency use authorization of the vaccine.

After that, the Centers for Disease Control and Prevention's team of advisers will review Moderna's data, and finally, CDC Director Rochelle Walensky will issue her recommendation.

It's not clear whether adding Moderna as another option in the vaccine arsenal will move the needle for uptake in the kids and adolescent age group.

More than 25.4 million eligible kids between the ages of 5 and 17 are still unvaccinated, and only about 44% have been fully vaccinated.

At the meeting before FDA's advisory committee on Tuesday, though, Moderna representatives argued there was a significant need for a second vaccine because of the continued threat of COVID-19 among kids.

"Recent data have shown that approximately 25% or one in every four children and adolescents hospitalized due to COVID-19 require ICU intervention," said Carla Vinals, Moderna's vice president of regulatory affairs strategy for infectious diseases.

Emory associate professor Dr. Evan Anderson, who works with Moderna, presented an analysis showing that COVID-19 is worse than the flu -- killing more children ages 5 to 17 than any other vaccine-preventable disease.

Moderna scientists said their vaccine would prevent pediatric hospitalizations if authorized. They estimate the two-dose Moderna vaccine would prevent 95 hospitalizations per 1 million kids ages 5 to 11 and 200 hospitalizations per 1 million kids ages 12 to 17.

The FDA also cleared the air on the issue that delayed Moderna's authorization for this age group -- the potential for the rare incidence of heart inflammation called myocarditis.

Data for international surveillance had suggested a higher risk for myocarditis following vaccination with Moderna compared to the Pfizer-BioNTech vaccine. But after looking into it, those concerns subsided.

The FDA did not find a "statistically significant" difference in risk when comparing the two vaccines, officials said Tuesday.

The risk of myocarditis is also primarily seen among males 18 to 25. Moderna's vaccine is only for kids and adolescents ages 6 to 17.

If authorized, Moderna's vaccine dosing would be 100 micrograms for 12- to 17-year-olds, or the same as the adult dose, and 50 micrograms for 6- to 11-year-olds, which is half the adult dose.