After an all-day meeting, an FDA advisory committee unanimously voted to recommend Moderna’s two-dose COVID-19 vaccine for kids ages 6 to 17. This means an FDA authorization is likely coming for the age group, opening Moderna’s program to a wider group of people in the U.S.
At the meeting of the Vaccines and Related Biological Products Advisory Committee, Moderna had an answer to those concerned about the necessity of the shot for kids. In a presentation, Moderna said that for every 1 million doses of vaccines distributed in the country, 95 hospitalizations and 24 intensive care unit stays would be avoided for those aged 6 through 11 years old. The number goes up to 200 hospitalizations and 52 ICU stays avoided in the 12 through 17 years old group.
The Centers for Disease Control and Prevention (CDC) data show that there have been more than 10 million confirmed cases of COVID-19 among the age group, and the real number is likely higher due to unreported cases. In all, 443 adolescents and 189 children aged 5 to 11 have died of COVID-19, according to CDC data.
While Pfizer’s rival vaccine won FDA nods for kids and teens last year, only about 60% of the 12 to 17 age range are fully vaccinated, Fox Business reports. A third of kids 5 to 11 years old are fully vaccinated.
Considering those numbers, members of the committee were eager to give families more options.
“I’d like to give parents as many choices as possible, and let them make the decisions about this for their children,” said Dr. Arthur Reingold, a member of the advisory committee and head of epidemiology at the University of California, Berkeley, as quoted by Fox Business.
Previously, the FDA delayed its authorization for the Moderna vaccine to review the risk of heart inflammation. At the meeting, CDC expert Tom Shimabukuro said “some evidence suggests that myocarditis and pericarditis risk may be higher after Moderna than after Pfizer-BioNTech,” but that the “findings are not consistent in all U.S. monitoring systems.”
The Moderna shots for kids 6 to 17 are half the doses of adult vaccines. A third dose of the Moderna shot will likely be necessary to combat waning protection, but so far, the series is set at two shots.
The company told the committee that it plans to submit clinical trial data on booster shots for children soon and will examine real-world evidence pending authorization.
“I don’t think we want to pass up the opportunity to offer something,” as the virus evolves, said Dr. Eric Rubin, another panel member, as quoted by The New York Times.
A separate committee that advises the CDC is expected to discuss the vaccines in the age group next week. On Wednesday, the FDA panel will consider Moderna’s vaccine for under 6-year-olds, and Pfizer/BioNTech’s for under 5-year-olds. The agency has already published findings concluding that the shots are generally safe and effective.