Health Canada approved the Moderna’s NDS-CV based on clinical data from the Phase 3 COVE study in more than 30,000 participants
Health Canada has approved Moderna’s New Drug Submission (NDS-CV) for its mRNA-based Covid-19 vaccine, dubbed Spikevax (elasomeran).
The regulatory approval allows for immunisation of Spikevax, previously called Moderna Covid-19 vaccine to prevent Covid-19 in people aged 12 years and above.
Spikevax was initially authorised in Canada for use in people aged 18 years and above, under an interim order granted by Health Canada in December 2020.
In August this year, the interim order authorisation of the vaccine has been expanded to include children aged 12 years and above.
Moderna chief executive officer Stéphane Bancel said: “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. 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 Moderna’s (NDS-CV) based on clinical data from the Phase 3 COVE study, which enrolled more than 30,000 participants in the US.
In the final analysis of Phase 3 COVE study data, Spikevax demonstrated 93% efficacy, which remained durable through six months after the administration of the second dose.
The safety profile of Moderna’s Covid-19 vaccine, based on extended safety follow-up, was consistent with the Phase 3 COVE study primary results.
In December last year, the US FDA granted the emergency use authorisation for Moderna Covid-19 Vaccine to immunise people aged 18 years and above.
The vaccine has been authorised by health agencies in more than 50 countries and an Emergency Use Listing (EUL) from the World Health Organization (WHO).
Last month, Moderna has unveiled new study data that confirmed the effectiveness of its Covid-19 vaccine against SARS-CoV-2 variants of concern.