Pfizer Canada and BioNTech initiate rolling submission to Health Canada for vaccine candidate
Pfizer Canada and BioNTech will continue regular and open dialogue with Health Canada providing results from their ongoing Phase 3 study
KIRKLAND, Que. and MAINZ, Germany — Pfizer Canada and BioNTech SE announced the initiation of a rolling submission to Health Canada for BNT162b2, a lead candidate from the companies’ vaccine development program against COVID-19.
The rolling submission has been accepted under the Minister of Health’s Interim Order allowing companies to submit safety and efficacy data and information as they become available. Often referred to as a rolling review, this allows Health Canada to start its review right away, as information continues to come in, to accelerate the overall review process.
Health Canada will not make a decision on whether to authorize any vaccine being considered under rolling review until it has received the necessary evidence to support its safety, efficacy and quality.
The BNT162b2 vaccine candidate is based on BioNTech’s mRNA technology and supported by Pfizer’s vaccine development and manufacturing capabilities. It encodes an optimized SARS-CoV-2 full-length spike glycoprotein (S), which is a target of virus neutralizing antibodies. The vaccine candidate is currently being evaluated in a global Phase 3 study ongoing at more than 120 clinical sites worldwide. To date, the trial has enrolled approximately 37,000 participants with more than 28,000 having received their second vaccination.