BRIEF—Health Canada joins EMA in rolling review of BNT162b2

The Canadian subsidiary Pfizer and Germany BioNTech have announced the initiation of a rolling submission to Health Canada for BNT162b2, their lead candidate from the companies' vaccine development program against COVID-19.

The move comes just a week after similar action with the European Medicines Agency, which has also started a rolling review of AstraZeneca’s novel coronavirus vaccine.

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.

Following the authorization of any vaccine submission, Health Canada will publish the evidence it reviewed in making its decision for transparency purposes.