Moderna Completes EUA Submission for Use of COVID-19 Vaccine in Children

Moderna has completed its submission to the FDA for Emergency Use Authorization (EUA) of its primary series COVID-19 vaccine Spikevax for children and adolescents between the ages of six months and 17 years.

For dosing purposes, the EUA would separate the pediatric population into three distinct age groups: from six months to six years, from six years to 11 years, and from 12 to 17 years.

Moderna’s COVID-19 vaccine received its first EUA from the agency in December 2020 for adults 18 years and older and gained FDA’s full approval as a primary series in January 2022. Spikevax is not currently authorized or approved for children under 18.