Plain Language Summary of a Clinical Trial Evaluating mRNA-1273, Moderna's mRNA-Based COVID-19 Vaccine, in Children 6 Through 11 Years of Age

Abstract

The PLSP summarizes results from the phase 2/3 KidCOVE trial examining mRNA-1273 (Moderna's COVID-19 vaccine) in children 6 through 11 years of age. This study reviewed results from two parts of the KidCOVE clinical trial: Part 1 of the study was performed to select a dose of mRNA-1273 (50 μg or 100 μg) in children. A 50-μg dose was selected for further evaluation based on minimally unwanted side effects and sufficient antibodies (immune responses) against SARS-CoV-2. Part 2 of the study further evaluated the 50-μg dose of mRNA-1273 and compared it with placebo in children. Two 50-μg doses of mRNA-1273 were well tolerated with no new safety concerns. Two 50-μg doses also produced antibodies (immune responses) similar to those in young adults who received mRNA-1273 (100 μg) in a separate phase 3 study (the COVE trial). Study findings suggest that two 50-μg doses of mRNA-1273 were well-tolerated, and can prevent COVID-19 in children 6 through 11 years of age. Clinical Trial Registration: NCT04796896 ( ClinicalTrials.gov )