Moderna has received authorisation for its Covid-19 vaccine from Health Canada for the immunisation of individuals aged 18 years and above.
Co-developed by Moderna and NIAID Vaccine Research Center investigators, the mRNA-1273 SARS-CoV-2 vaccine encodes for a prefusion stabilised form of the Spike (S) protein.
The approval comes under Health Canada’s Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to Covid-19.
It is based on a rolling review of data, including that from the Phase III COVE study on 30,000 subjects.
Moderna CEO Stéphane Bancel said: “I want to thank Health Canada and the Canadian government for this authorisation, which is a significant moment in our company’s history.
“Health Canada provided a comprehensive, thorough review and provided us with ongoing guidance as we worked together to achieve this authorisation.”
Earlier, the Canadian Government increased its confirmed order commitment of the Moderna vaccine by 20 million doses, taking it to a total of 40 million doses.
The latest development is based on the totality of scientific evidence submitted by the company to Health Canada, including a data analysis from the pivotal Phase III clinical study.
Data from the primary efficacy analysis of this study conducted on 196 cases showed that the vaccine was 100% efficient against severe Covid-19.
Last month, Moderna sought emergency use authorisation from the US Food and Drug Administration (FDA) and a conditional marketing authorisation (CMA) from the European Medicines Agency for the vaccine.
Earlier this week, the FDA authorised the emergency use of the company’s vaccine in people aged 18 years and above.
The US Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted to recommend the use of Moderna’s Covid-19 vaccine in adults under the EUA issued by the FDA.