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Moderna files to expand the conditional marketing authorization for its COVID-19 vaccine.

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Published:11th Nov 2021
Moderna Inc.announced that it has submitted for a variation to the conditional marketing authorization (CMA) with the European Medicines Agency (EMA) for the evaluation of a 50 µg two-dose series of mRNA-12731 in children ages 6-11 years.

The Phase II “KidCOVE” study of mRNA-1273 in pediatric population ages 6 months to under 12 years is ongoing. Moderna recently shared new data from the KidCOVE study of mRNA-1273 in children ages 6 years to under 12 years. Vaccine efficacy of 100% using the P301 primary case definition for COVID-19 was observed two weeks after the first dose of mRNA-1273 at the 50 µg dose level. Additionally, for asymptomatic infection two weeks after the first dose, vaccine efficacy was 65% (95% CI: .16, .85). For SARS-CoV-2 infection regardless of symptoms, vaccine efficacy was 80% (95% CI: .62, .90) two weeks after the first dose. On October 24, the Company announced positive top line top line data from the Phase II/III study of mRNA-1273 in children 6 to under 12 years of age. Geometric mean ratio (GMR) comparing the response in children to the response in young adults from the Phase III COVE study was 1.5 (95% CI: 1.3, 1.8), with a seroresponse rate of 99.3%. Two 50 ug doses of mRNA-1273 were generally well tolerated..

Condition: Coronavirus/COVID-19 Infection
Type: drug

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