Moderna: Canadian health authority approves Spikevax

(CercleFinance.com) - Moderna today announced Health Canada has approved the New Drug Submission (NDS-CV) for SPIKEVAX (elasomeran mRNA vaccine), which has been known as COVID-19 Vaccine Moderna, for active immunisation to prevent COVID-19 in individuals 12 years of age and older.


“Health Canada's approval of our COVID-19 vaccine is an important milestone as it is our first full approval for Spikevax.” said Stéphane Bancel, Chief Executive Officer of Moderna.

Health Canada approved the New Drug Submission for SPIKEVAX based on clinical data from the Phase 3 COVE study of the Moderna COVID-19 vaccine, which enrolled more than 30,000 participants in the U.S.

In final analysis of Phase 3 COVE study data, SPIKEVAX showed 93% efficacy, with the efficacy remaining durable through six months after administration of the second dose.

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