Moderna's two-dose COVID vaccine for children between the ages of 6- and 17-year-old received unanimous approval from the U.S. Food and Drug Administration's (FDA) independent panel of experts earlier this week, bringing the vaccine a step closer to being authorized for use in the United States.
The committee reached its decision at the conclusion of an all-day meeting discussing the vaccine's safety profile and efficacy for younger children and adolescents. Authorizing Moderna's shot for this age group would bring its eligibility in-line with the vaccine developed by Pfizer
The vaccine had a similar safety profile in the 6- to 17-years-old age group as it does with adults, with the most common side effects being the standard pain at injection site, fatigue, headache, chills, nausea, and muscle pain.
Moreover, no cases of heart inflammation, known as myocarditis, were documented in the company's clinical trials for this age group. Moderna had previously asked the FDA to authorize its vaccine for adolescents ages 12 to 17, but the shot's eligibility was put on hold after international data indicated that the vaccine carried a higher risk of myocarditis than Pfizer's shot.
FDA official Hui-Lee Wong, however, said during a presentation to the panel on Tuesday that U.s. vaccine surveillance did not find a significantly higher risk of heart inflammation between Moderna's vaccine compared to Pfizer's in men ages 18 to 25, CNBC reports.
The U.S. Centers for Disease Control and Prevention (CDC) has identified over 600 cases of myocarditis in children and teens ages 5 through 17 out of the more than 54 million Pfizer doses administered. The CDC said the highest risk is among boys ages 12 to 17 after their second dose, while children ages 5 to 11 do not appear to be at higher risk.
As for efficiency, like Pfizer's vaccine, Moderna's clinical trials took place before the Omicron variant became the dominant global strain. That means the shots--which are currently formulated to target the original SARS-CoV-2 strain--may not offer strong protection against infection without a booster shot.
Dr. Paul Offit, a committee member and pediatrician and infectious disease expert at Children's Hospital of Philadelphia, said the two dose vaccine is still likely to protect against severe illness from Omicron with a third dose.
"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 Offit, quoted by CNBC. "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."
Under the expanded emergency use authorization, children ages 6 to 11 would receive a course of two 50 microgram shots, while adolescents ages 12 to 17 would receive the same dosage as adults at 100 micrograms.
