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Health Canada approved the new drug submission for Spikevax—more commonly known as the Moderna COVID-19 vaccine—for active immunization to prevent COVID-19 in individuals 12 years of age and older.
Health Canada approved the new drug submission (NDS-CV) for Spikevax (elasomeran mRNA vaccine)—more commonly known as the Moderna COVID-19 vaccine—for active immunization to prevent COVID-19 in individuals 12 years of age and older, according to Moderna’s Sept. 16, 2021, press release.
The NDS-CV for Spikevax was approved 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 United States. The final analysis of Spikevax showed 93% efficacy , with the efficacy remaining durable through six months after administration of the second dose. In addition, the safety profile was consistent with the Phase III COVE study primary results.
Spikevax was originally authorized in Canada under an interim order for individuals 18 years of age and older, which was granted by Health Canada on Dec. 23, 2020. On Aug. 27, 2021, the interim order authorization for the Moderna COVID-19 vaccine was expanded to include adolescents 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, CEO of Moderna, in the company press release. “I would like to thank Health Canada for their hard work throughout the process. 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.”