Cambridge: Moderna recently announced that Health Canada has accepted the New Drug Submission (NDS-CV) for SPIKEVAX (elasomeran mRNA vaccine), formerly known as COVID-19 Vaccine Moderna, for active vaccination to prevent COVID-19 in people aged 12 and up.
“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.
SPIKEVAX’s New Drug Submission was authorised by Health Canada based on clinical results from the Phase 3 COVE trial of the Moderna COVID-19 vaccine, which included over 30,000 individuals in the United States. SPIKEVAX demonstrated 93 percent effectiveness in the final analysis of Phase 3 COVE trial data, with efficacy lasting six months following administration of the second dosage. The safety profile based on prolonged safety follow-up was consistent with the principal outcomes of the Phase 3 COVE trial.
The Moderna COVID-19 vaccine was originally authorized in Canada under an Interim Order for individuals 18 years of age and older granted by Health Canada on December 23, 2020. On August 27, 2021, Health Canada expanded the Interim Order authorization for the Moderna COVID-19 vaccine to include adolescents 12 years of age and older.
The Moderna COVID-19 vaccine, brand name SPIKEVAX, is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein.On December 18, 2020, the US FDA authorized the emergency use of the Moderna COVID-19 Vaccine in individuals 18 years of age or older.Moderna has received emergency (or other conditional, interim or provisional) authorization for use of its COVID-19 vaccine in adults from health agencies in more than 50 countries and an Emergency Use Listing (EUL) from the World Health Organization (WHO).