Moderna Inc.’s COVID-19 vaccine is effective in children and adolescents, with mostly mild to moderate side effects, the U.S. Food and Drug Administration staff said.
“Available data support the effectiveness of the Moderna Covid-19 vaccine in preventing symptomatic Covid-19 in pediatric age groups from 6 months through 17 years of age,” the FDA staff said Friday in the report posted to the agency’s website. Side effects were “mostly mild to moderate in severity, generally of short duration.”
The release of the report precedes a two-day meeting starting on June 14 where experts will weigh recommending clearance of the vaccine for use in those age groups.
A vaccine from Pfizer Inc. and partner BioNTech SE has been cleared for children 5 through 17 and is the only one available for that group. While Moderna’s shot for adolescents has been rolled out in Europe, Japan and Canada, its application for U.S. authorization has faced setbacks in the U.S. over concern about heart complications.
Called myocarditis, the problem been seen in a relatively small number of mostly young men. Regulators asked for more time to examine the post-vaccination risks of the condition, which affects the wall of the heart.
Whether Moderna’s shot will make a significant change in the number of children getting their shots remains to be seen. Many parents have been slow to get shots for their kids since the vaccine was recommended late last year. Just 28% of children ages 5 to 11 are fully vaccinated, according to data presented by the Centers for Disease Control and Prevention last month.
The first day of the two-day meeting will focus on Moderna’s shot in school-age kids. On the second day, the FDA panel will examine Moderna’s application for clearance for the youngest kids, as well as Pfizer and BioNTech’s application for their COVID-19 shot in children under age 5.
