Health Canada has granted full approval to Moderna’s Spikevax and Pfizer-BioNTech’s Comirnaty Covid-19 vaccines for use in individuals aged 12 years and above.
The regulator originally authorised Moderna’s Covid-19 vaccine under an interim order for use in individuals aged 18 years and above last year and also expanded the authorisation to include adolescents aged 12 years and above.
Pfizer-BioNTech’s vaccine also secured initial authorisation under an interim order based on the preclinical and clinical data.
This enabled the essential rollout of vaccine doses across the country to help provide protection during the Covid-19 pandemic.
BioNTech CEO and co-founder Ugur Sahin said: “Today’s full approval is a testament to the vaccine’s efficacy and safety profile. Our companies have shipped more than 1.4 billion doses worldwide, and we will continue to work tirelessly to broaden the access to our vaccine and to be prepared for potential emerging escape variants.”
Health Canada approved the New Drug Submission (NDS) for Moderna’s vaccine based on the data obtained from Phase III COVE clinical study conducted on more than 30,000 subjects in the US.
According to the data, the vaccine showed 93% efficacy that remained durable through six months after the second dose.
Spikevax is an mRNA vaccine against Covid-19 encoding for a prefusion stabilised form of the Spike (S) protein.
The full approval for Pfizer-BioNTech’s Covid-19 vaccine is based on a comprehensive data package that includes data from the Phase III trial, which evaluated the efficacy and safety of the vaccine observed up to six months after the second dose.
Developed by both BioNTech and Pfizer, Comirnaty is based on the former’s proprietary mRNA technology.