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The company has publicized data from the TeenCOVE study of the vaccine along with plans to seek authorization in the coming weeks.
Moderna announced that the Phase 2/3 study of the company’s COVID-19 vaccine has reached its endpoint.1 No cases of COVID-19 were seen in in participants who had both doses. The data will be submitted to regulators in the next few weeks.
The trial included 3732 participants aged 12 to <18 years who were randomized 2:1 to either receive a placebo or 2 100 µg doses of the Moderna vaccine. Following 2 doses, no cases were found in the vaccine group versus 4 cases in the placebo group. Due to the lower incidence rate of COVID-19, the investigators also used the secondary Centers for Disease Control and Prevention (CDC) case definition, which needs just 1 COVID-19 symptom and a nasopharyngeal swab or a saliva sample that was positive for COVID-19. AN efficacy of 93% was seen after 14 days following the first dose when using the secondary CDC case definition.
The vaccine safety profile was similar to what was seen with adults. No major safety concerns have been identified so far. Most adverse events have been mild or moderate in severity and the most common local adverse event was pain at the injection site. Following the second dose, the most common systemic adverse events were fatigue, chills, myalgia, and headache.
1. Moderna Inc. Moderna announces TeenCOVE study of its COVID-19 vaccine in adolescents meets primary endpoint and plans to submit data to regulators in early June. Published May 25, 2021. Accessed May 25, 2021. https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-teencove-study-its-covid-19-vaccine