Two doses of Moderna’s COVID-19 vaccine “were found to be safe and effective in inducing immune responses and preventing COVID-19,” according to an analysis of the results of Moderna’s vaccine trial in children ages 6 to 11.
However, a closer look at the analysis, published May 11 in the New England Journal of Medicine (NEJM), finds the trial results showed the vaccine provided meager benefit when compared to risk, and the study was too small to assess serious and known adverse events such as myocarditis and pericarditis in children of this age.
The NEJM paper presented findings from both Phase 1 (complete) and Phase 2 and 3 (ongoing) trials of Moderna’s mRNA-1273 vaccine. Phase 1 results were used to determine an appropriate dose for the Phase 2 and 3 trials.
The authors of the analysis concluded:
“Two 50-μg doses of the mRNA-1273 vaccine were found to be safe and effective in inducing immune responses and preventing Covid-19 in children 6 to 11 years of age; these responses were non-inferior to those in young adults.”
The scope of my analysis below is limited to the Phase 2 and 3 portions of the trial where 4,016 children were randomly assigned to receive two injections of mRNA-1273 (50 μg each) or a placebo.
