Health Canada approves Moderna's COVID-19 vaccine

Health Canada has approved the New Drug Submission (NDS-CV) for Moderna’s (Nasdaq: MRNA) Spikevax (elasomeran mRNA vaccine), which has been known as COVID-19 Vaccine Moderna, for active immunization to prevent COVID-19 in individuals 12 years of age and older, with the news sending the US biotech’s shares up as much as 4% to $446.66 on Thursday.

“Health Canada’s approval of our COVID-19 vaccine is an important milestone as it is our first full approval for Spikevax. I would like to thank Health Canada for their hard work throughout the process,” said Stéphane Bancel, chief executive of Modern, adding: “I would also like to thank the Government of Canada for the partnership they have built with us and for their confidence in our mRNA platform in addressing the COVID-19 pandemic.”

Health Canada approved the New Drug Submission for Spikevax based on clinical data from the Phase III COVE study of the Moderna COVID-19 vaccine, which enrolled more than 30,000 participants in the USA. In final analysis of Phase III COVE study data, Spikevax showed 93% efficacy, with the efficacy remaining durable through six months after administration of the second dose. The safety profile based on extended safety follow-up was consistent with the Phase III COVE study primary results.