Health Canada has approved Moderna’s New Drug Submission (NDS-CV) for Spikevax (elasomeran mRNA vaccine), it has granted full approval (Notice of Compliance or NOC) for Pfizer’s Comirnaty, and it has approved the AstraZeneca vaccine, which will be named Vaxzevria.
“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 Officer of Moderna. “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.”
“Based on the longer-term follow-up data that we submitted, today’s decision by Health Canada affirms the efficacy and safety profile of our vaccine at a time when it is urgently needed,” said Fabien Paquette, Vaccines Lead, Pfizer Canada. “While a significant number of eligible Canadians are fully vaccinated, there is still much work to be done as infection and hospitalization rates continue to rise across the country, primarily among unvaccinated populations.”
Although Pfizer’s vaccine’s brand name will be Comirnaty following this approval, Canada will continue to receive vials of the vaccine labeled as Pfizer-BioNTech Covid-19 Vaccine. Given the current ongoing pandemic, a gradual transition to new labeling with the Comirnaty brand name will occur at a later date.
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 US. 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.