Moderna starts COVID-19 vaccine trial in young children

After an initial stumble, the coronavirus disease 2019 (COVID-19) vaccine rollout has rapidly expanded throughout the United States with more and more states opening the vaccine rollout to all approved ages. It’s expected that data from Moderna’s trial in children aged 12 to 17 years will expand vaccine access to more of the pediatric population in the next few months. Moderna has also just announced that they have begun a Phase 2/3 study of their mRNA COVID-19 vaccine to children aged 6 months to >12 years.¹

The study will include roughly 6750 participants from the United States and Canada and will be a two-part, open label, dose-escalation, with age de-escalation in Part 1 and a randomized, observer-blind, placebo-controlled expansion study in Part 2. In part one, each participant aged 2 years to > 12 years, will be given a dose of either 50 μg or 100 μg. Children aged 6 months to >2 years in the study will be given a dose of 25 μg, 50 μg, or 100 μg. An analysis will determine the dose that will be used in the second part of the study. Following the second vaccination dose, participants will be followed for 12 months.

The trial is being conducted in collaboration with National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health and the Biomedical Advanced Research and Development Authority, part of the Office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services.

Reference

1. Moderna. Moderna announces first participants dosed in phase 2/3 study of covid-19 vaccine candidate in pediatric population. Published March 16, 2021. Accessed March 17, 2021. https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-first-participants-dosed-phase-23-study-0