Moderna Shares TeenCOVE study Results: Initial Data Reveals mRNA-based Vaccine Safe & Effective for Adolescents 12 yrs. & Up

Moderna Shares TeenCOVE study Results: Initial Data Reveals mRNA-based Vaccine Safe & Effective for Adolescents 12 yrs. & Up

Moderna recently issued a press release to investors reporting that the TeenCOVE study met its primary immunogenicity endpoint, that is the results indicate that the vaccine successfully bridges immune response to the adult vaccination for adolescents. Involving 3,700 participants ages 12 to less than 18 years old, the company reports that no cases of COVID-19 (prime definition) were observed in participants who had received two doses of the mRNA-1273 product currently under U.S. Food and Drug Administration (FDA) emergency use authorization (EUA). The industry vaccine sponsor reports a vaccine efficacy of 93% in seronegative participants, observed at 14 days post the first dose using secondary CDC case definition of COVID-19, which tested for the milder disease. The company reports it will submit this latest data from TeenCOVE to regulators worldwide by early June. TrialSite shares some of the findings, notes that part of the funding for the study originates from Department of Defense contracts via the U.S. Biomedical Advanced Research and Development Authority (BARDA), and introduces some of the challenges with pediatric-based studies. A rapidly growing trial site organizat...

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