11 May Moderna’s COVID vaccine holds up for kids 6-11 years
Interim results get peer-reviewed journal treatment ahead of potential emergency use authorization (EUA).
By Molly Walker, MedPage Today
Moderna’s COVID vaccine (Spikevax) was safe, effective, and produced an immune response in children ages 6-11, an interim analysis of a phase II/III trial found.
Two 50 μg doses of vaccine — half the dose of Moderna’s primary series for adults — administered 28 days apart produced a non-inferior immune response in children ages 6-11 as in adults ages 18-25, reported Sabine Schnyder Ghamloush, MD, of Moderna in Cambridge, Massachusetts, and colleagues.
In a modified intention-to-treat population, estimated vaccine efficacy (VE) was 88.0% (95% CI 70.0-95.8) against symptomatic COVID (primarily the Delta variant) at 14 days or more following the first injection, the authors wrote in the New England Journal of Medicine.
The manufacturer first shared top-line data from this trial in October 2021, although no efficacy results were reported at that time. More recently, Moderna announced it would be filing for emergency use authorization (EUA) for this vaccine and its vaccine for children 6 months to 5 years of age (two 25 μg doses). Read more …