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Health Canada approves Spikevax in COVID-19 for children age 6-11.- Moderna

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Published:19th Mar 2022

Moderna announced that Health Canada has approved the use of Moderna's mRNA COVID-19 vaccine, Spikevax, in a two-dose series of 50 microgram per dose for active immunization to prevent COVID-19 caused by SARS-CoV-2 in children aged 6 to 11 years.

 

Moderna's vaccine was investigated in the ongoing Phase II/III "KidCOVE" study, a randomized, observer-blind, placebo-controlled expansion study to evaluate the safety, tolerability, reactogenicity, and effectiveness of Spikevax (mRNA 1273) given to healthy children 28 days apart. Data submitted to Health Canada from over 4,000 children demonstrated that vaccination of children aged 6 to11 years with a 50 ug mRNA 1273 primary series is associated with non-inferior anti-SARS-CoV-2 neutralizing antibody responses when compared to that in individuals 18 to 25 years old from the Phase 3 COVE study. Positive direct efficacy of two 50 ?g doses of mRNA 1273 was also demonstrated, and vaccination was generally well tolerated.

Condition: Coronavirus/COVID-19 Infection
Type: drug

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