Press release
Health Canada Authorizes Moderna's Omicron-Targeting Bivalent COVID-19 Vaccine in Children & Adolescents (6-17 Years)
The recommendation is based on clinical data for Moderna's bivalent Omicron-targeting COVID-19 vaccine, mRNA.1273.214Moderna's bivalent Omicron-targeting
About this update from Moderna, Inc.
[{"type":"text","content":"The recommendation is based on clinical data for Moderna's bivalent Omicron-targeting COVID-19 vaccine, mRNA.1273.214Moderna's bivalent Omicron-targeting COVID-19 vaccines (mRNA.1273.214 (BA.1) & mRNA.1273.222 (BA.4/5)) are currently authorized for use in individuals 18 years of age and older in CanadaBoth bivalents have been shown to trigger a superior antibody response compared to a booster dose of mRNA-1273, the Company's prototype vaccine, against Omicron (BA.4/5) in Phase 2/3 clinical trialsCAMBRIDGE, MA / ACCESSWIRE / February 17, 2023 / Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that Health Canada has authorized the use of its Omicron-targeting bivalent COVID-19 booster vaccine, mRNA-1273.214 (Spikevax Bivalent Original/Omicron) in children and adolescents 6 to 17 years of age. The authorizations are based on a 25 μg booster dose for children ages 6 to 11 years old and a 50 μg booster dose for adolescents 12 to 17 years old, each following a completed primary series of any of the authorized COVID-19 vaccines or a previous booster.\"The authorization of a booster dose of mRNA-1273.214 in children and adolescents is a critical step to broaden protection against the Omicron family of variants, and the emergence of new variants of concern in Canada,\" said Stéphane Bancel, Chief Executive Officer of Moderna. \"This decision highlights the effectiveness and safety of our vaccine in this important age group.\"The pediatric and adolescent authorization is based on clinical trial booster data for Moderna's original vaccine, Spikevax, which was administered to over a thousand participants in each cohort. The application described data from a 25 μg booster dose administered to children ages 6 to 11 years old and a 50 μg booster dose for adolescents 12 to 17 years old, following a completed primary series of the Moderna COVID-19 vaccine. In addition, the application included clinical trial data from a Phase 2/3 studying mRNA-1273.214.\"We are pleased with Health Canada's authorization of our bivalent booster for children and adolescents and our continued collaboration to provide boosters to help protect all Canadians from current and future COVID-19 variants of concern, especially as this virus continues to circulate across the country and around th...