A Food and Drug Administration (FDA) advisory panel on Tuesday recommended the agency expand the authorization of Moderna’s COVID-19 vaccine to children and teenagers ages 6 to 17.
The vaccine is currently approved for adults only.
The panel voted 22-0 to recommend authorizing Moderna’s two-dose vaccine for adolescents and teenagers ages 12 to 17. The panel similarly voted 22-0 to recommend authorizing the shot for 6-year-olds to 11-year-olds.
Children ages 6 to 11 would receive a smaller 50 microgram shot, while teens ages 12 to 17 would receive the same dose as adults at 100 micrograms.
The FDA is likely to follow the panel’s advice in the coming days, but there ultimately won’t likely be much of an impact on vaccination rates, since children and teenagers have had access to Pfizer-BioNTech”s vaccine since last year.
After the FDA, the Centers for Disease Control and Prevention will consider the matter as early as Friday.
Moderna initially asked the FDA to clear its vaccine for adolescents ages 12 to 17 last June, but concerns over a rare heart condition led officials to delay authorization.
On Tuesday, health officials said the risks for myocarditis and pericarditis may be higher in male adolescents, but the overall incidence is relatively rare and not statistically significant enough to draw definitive conclusions. In addition, the vast majority who suffer the side effect fully recover.
Several panel members expressed concern that the emergency authorization would only be for a two-dose primary series, even though there’s evidence that a third dose will be needed.
Moderna’s clinical trials were conducted before the omicron variant became dominant throughout the country. The data was based on variants that are no longer a threat.
The FDA’s Doran Fink said Moderna will present data on a third dose soon.
“I think the benefits clearly outweigh the risks, but I say that with the comfort being provided that there will be a third dose,” said panel member Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia. “If that was not true, I wouldn’t feel the same way. We’re not in the same part of this pandemic anymore. It’s a different time.”
Updated at 4:53 p.m.
