Moderna Files for Authorization of its COVID-19 Vaccine with Health Canada to Include Children Ages 6-11 Years
Submission based on Phase 2/3 study of SPIKEVAX in children ages 6 to 11
Excerpt from the Press Release:
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 authorization with Health Canada for the evaluation of a 50 µg two-dose series of SPIKEVAX™ (elasomeran mRNA vaccine)1 in children ages 6 to 11 years.
“We are pleased to announce that we have submitted for authorization of a 50 µg two-dose series of our COVID-19 vaccine for use in children 6 to 11 years old with Health Canada,” 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 2/3 “KidCOVE” study of SPIKEVAX in pediatric population ages 6 months to under 12 years is ongoing. Moderna recently shared new data from the KidCOVE study in children ages 6 years to 11 years. Vaccine efficacy of 100% using the Phase 3 COVE study primary case definition for COVID-19 was observed two weeks after the first dose of SPIKEVAX 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 data in children 6 to 11 years of age. The 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 SPIKEVAX were generally well tolerated2.
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