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Moderna Files to Expand the Conditional Marketing Authorization for its COVID-19 Vaccine in the European Union to Include Children Ages 6-11 Years

Published: 2021-11-09 13:32:00 ET

Submission based on Phase 2/3 study of mRNA-1273 in children ages 6 to 11

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Moderna Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today 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.

“We are pleased to announce the submission of this variation to the EMA for use of our COVID-19 vaccine in children ages 6-11 in the European Union. This marks our first submission for the use of our vaccine in this age group,” said Stéphane Bancel, Chief Executive Officer of Moderna. “We are encouraged that the Moderna COVID-19 vaccine at the 50 µg dose level helped prevent SARS-CoV-2 infection in children. We plan to submit these data to other regulatory agencies around the world to protect this important younger age population with our COVID-19 vaccine.”

The Phase 2 “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 2/3 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 3 COVE study was 1.5 (95% CI: 1.3, 1.8), with a seroresponse rate of 99.3%. Two 50 μg doses of mRNA-1273 were generally well tolerated2.

The KidCOVE study is a randomized, observer-blind, placebo-controlled expansion study to evaluate the safety, tolerability, reactogenicity and effectiveness of two 50 µg doses of mRNA-1273 given to healthy children 28 days apart. The study population is divided into 3 age groups (6 to

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All statements made via social media sites sponsored or maintained by Enhanced Investments and its affiliates are for informational purposes only and do not constitute a comprehensive description of Enhanced Investments' investment advisory services.
Certain investments are not suitable for all investors. Before investing, consider your investment objectives and applicable fees. The rate of return on investments can vary widely over time, especially for long term investments. Investment losses are possible, including the potential loss of all amounts invested. Information provided by Enhanced Investments is for informational and general educational purposes only and is not investment or financial advice.