Posted by Michael Wonder on 10 Oct 2020
Pfizer Canada and BioNTech initiate rolling submission to Health Canada for SARS-CoV-2 vaccine candidate BNT162b2
9 October 2020 - Pfizer Canada and BioNTech will continue regular and open dialogue with Health Canada providing results from their on-going Phase 3 trial.
Pfizer Canada and BioNTech today announced the initiation of a rolling submission to Health Canada for BNT162b2, the 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.
