Health Canada authorizes SPIKEVAX COVID-19 Vaccine in Children (6-11 Years).-Moderna Inc.
Moderna, Inc. has announced that Health Canada has approved the use of Moderna's mRNA COVID-19 vaccine, SPIKEVAX, in a two-dose series of 50 µg per dose for active immunization to prevent COVID-19 caused by SARS-CoV-2 in children aged 6 to 11 years.
The announcement follows the recent authorization of the Company's COVID-19 vaccine in the same age group in both Australia and the European Union.
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 to 11 years with a 50 ?g 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 III COVE study. Positive direct efficacy of two 50 ug doses of mRNA-1273 was also demonstrated, and vaccination was generally well tolerated..
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