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Moderna Files For Authorization Of COVID-19 Vaccine In Canada To Include Children Ages 6-11 Yrs

Moderna Inc. (MRNA) said Wednesday that it has submitted for authorization with Health Canada for the evaluation of a 50 µg two-dose series of SPIKEVAX (elasomeran mRNA vaccine) in children ages 6 to 11 years.

The company noted that 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.

In September 16, 2021, Health Canada approved the New Drug Submission (NDS-CV) for SPIKEVAX for active immunization to prevent COVID-19 in individuals 12 years of age and older.

On November 12, 2021 Health Canada authorized the use of a 50 µg booster dose for individuals aged 18 and older administered at least six months after completion of the primary series.

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