Health Canada announced Wednesday that it has authorised Pfizer and BioNTech's mRNA-based coronavirus vaccine BNT162b2 (tozinameran) under an interim order for emergency use, becoming the third country to do so after the UK and Bahrain. The initial indication of the vaccine in Canada is for use in people 16 years of age or older, while media reports say the country is on schedule to begin inoculations next week.
Health Canada's decision is based on late-stage trial data that was filed through a rolling submission regulatory pathway. The vaccine demonstrated efficacy of 95% at the final analysis in subjects without prior evidence of SARS-CoV-2 infection seven days after the second dose of the vaccine.
The Canadian regulator indicated recently that it could approve one or more COVID-19 vaccines early in the first quarter of 2021, under a new accelerated process akin to the FDA's emergency-use authorisation. Meanwhile, Health Canada said that Pfizer and BioNTech must continue to supply the agency with information on the "safety, efficacy and quality of the vaccine to ensure the benefits…continue to be demonstrated through market use." It also noted that the drugmakers are running further clinical trials on children of all age groups, and the vaccine's label "could be revised in the future to include children if the data from these studies support it."
Pfizer and BioNTech said they will supply the Canadian government with a minimum of 20 million doses, and up to 76 million doses, through 2021. Financial details of a supply agreement reached between the parties in August were not disclosed.
Meanwhile, an FDA advisory panel meeting is scheduled to meet on December 10 to discuss a potential emergency-use authorisation of BNT162b2 in the US, while the European Medicines Agency is also evaluating the vaccine, having started a rolling review in early October.
For additional analysis, see ViewPoints: No surprises for BNT162b2 in AdCom documents is good and bad.
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