Moderna’s COVID-19 vaccine is safe and efficacious for children ages 6 to 11 years old who recieve two half doses, the company said today. That’s based on the results of its KidCOVE study, which involved more than 4,700 kids in that age group.
The children participating in Moderna’s trial were randomly assigned to receive two half doses of the vaccine or two shots of a placebo. Those who got the vaccine generated adequate virus-fighting antibodies that met the U.S. Food and Drug Administration’s (FDA) requirements for efficacy, and the vaccine produced an immune response in nearly all the children. Most of the side effects after vaccination were mild to moderate, including fatigue, fever, headache and pain at the injection site.
Meanwhile, an independent FDA panel will review data on the Pfizer-BioNTech vaccine in children ages 5 to 11 on Oct. 26. The age range in KidCOVE varies slightly, given that Pfizer-BioNTech included children as young as 5. Moderna is continuing to study younger children and will report results on kids ages 2 to 5 and 6 months to under 2 years in the coming months.
The FDA and Centers for Disease Control and Prevention recently authorized a half dose of Moderna’s vaccine as a booster for certain adults over 18 years old.