By Chris Wack

 

Pfizer Canada and BioNTech SE said Wednesday they signed an agreement with the government of Canada to supply their BNT162 mRNA-based vaccine candidate against SARS-CoV-2, subject to clinical success and Health Canada approval.

Financial details of the agreement weren't disclosed, but the terms were based on the timing of delivery and the volume of doses. As requested by the government of Canada, deliveries of the vaccine candidate are planned for over the course of 2021.

Pfizer and BioNTech are continuing to scale up manufacturing capacities to be able to produce up to 100 million doses in 2020 and more than one billion doses in 2021.

The BNT162 program is based on BioNTech's proprietary mRNA technology and supported by Pfizer's global vaccine development and manufacturing capabilities. The vaccine development program is evaluating at least four experimental vaccine candidates, each of which represents a unique combination of messenger RNA format and target antigen. The BNT162 vaccine candidates are undergoing clinical studies and aren't currently approved for distribution anywhere in the world.

Recently, two of the companies' four investigational vaccine candidates -- BNT162b1 and BNT162b2 -- received Fast Track designation from the U.S. Food and Drug Administration. This designation was granted based on preliminary data from Phase 1/2 studies that are currently ongoing in the United States and Germany as well as animal immunogenicity studies.

Assuming clinical success, Pfizer and BioNTech are on track to seek regulatory review for BNT162b2 as early as October and, if regulatory authorization or approval is obtained, plan to supply up to 100 million doses worldwide by the end of 2020 and 1.3 billion doses by the end of 2021.

 

Write to Chris Wack at chris.wack@wsj.com

 

(END) Dow Jones Newswires

August 05, 2020 08:40 ET (12:40 GMT)

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