Canada made the timely move to strike a deal with the Project Lightspeed sponsors Pfizer and BioNTech SE to diversity that North American country’s COVID-19 vaccine options. Canada had entered into a strategic alliance with China-based CanSino Biologics but in an embarrassing fiasco, the experimental vaccine has been delayed at Chinese customs, possibly due to political tensions. The Canadian government entered into an agreement led by Pfizer (Canada) and Germany’s BioNTech to supply the promising BNT162 mRNA-based vaccine candidate against SARS-COV-2. Of course, any final acceptance is based on clinical success and approval by Health Canada.
The Deal & Diversification
Although terms weren’t disclosed, they are based on the timing of delivery and dose volume. The delivery of the product is scheduled for 2021. As TrialSite has tracked and shared, Canada put a lot of faith in the CanSino Biologics partnership. However, by July 17, TrialSite suggested Prime Minister Trudeau was on to a “Plan B,” in a bid to diversity its COVID-19 vaccine options.
Operation Warp Speed Less Canada goes to Lightspeed
Canada is traditionally one of America’s closest allies. From economics and military cooperation, to pure proximity; both with close cultural ties—Anglo (language, common law system, shared colonial past) heritage and allies in nearly ever military endeavor in the modern era.
Contemplating this long standing, enduring closeness—between the United States and Canada—the TrialSite has been surprised by the lack of Canada’s participation in Operation Warp Speed and for that matter the NIH-led ACTIV group. Canada, rich in natural resources and various industry sector sophistication, not to mention an educated workforce, its economy ranks 10th in the world. This number impresses when considering the population of Canada, 37.6 million, leaves it 39th in global ranking.
Why did Canada have to venture to China and attempt to do business with what is essentially a start up called CanSino Biologics? There are certainly ties as the founders of CanSino Biologics actually conceived of the idea for the company while residing in Canada. This observation is not meant to disparage CanSino Biologics, which appears to have accomplished a lot, but more broadly to raise the question as to why two traditionally close nations couldn’t’ collaborate more during the pandemic.
The whole affair perplexes, given that Canada was already experiencing political tensions with China over the detention and arrest of Meng Wanzhou, an executive (and the founder’s daughter) with Huawei, China’s largest private held company.
Now Canada has signed up with “Team Lightspeed” formally known as “Project Lightspeed”, that is the Pfizer and BioNTech COVID-19 vaccine development alliance.
The Investigational Vaccine Product
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 (mRNA) format and target antigen. The BNT162 vaccine candidates are undergoing clinical studies and are not currently approved for distribution anywhere in the world. Both collaborators are committed to developing these novel vaccines with pre-clinical and clinical data at the forefront of all their decision-making.
Recently, two of the companies’ four investigational vaccine candidates – BNT162b1 and BNT162b2 – received Fast Track designation from the U.S. Food and Drug Administration (FDA). 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.
BNT162b2 on to Phase 2/3
On July 27, Pfizer and BioNTech announced that following extensive review of preclinical and clinical data from Phase 1/2 clinical trials, and in consultation with the U.S. FDA’s Center for Biologics Evaluation and Research (CBER) and other global regulators, the companies selected the BNT162b2 vaccine candidate to move forward into a Phase 2/3 study. BNT162b2 encodes an optimized SARS-CoV-2 full length spike glycoprotein (S), which is the target of virus neutralizing antibodies. In the late-stage trial, the companies will study a 30 µg dose level in a 2-dose-regimen among up to 30,000 participants aged 18 to 85 years. It is expected to include approximately 120 sites globally including in regions with significant expected SARS-CoV-2 transmission. BNT162b2 has received Fast Track designation from the U.S. FDA.
Ready to Produce 100m Doses by end of 2020
Assuming clinical success, Pfizer and BioNTech are on track to seek regulatory review for BNT162b2 as early as October 2020 and, if regulatory authorization or approval is obtained, plan to supply up to 100 million doses worldwide by the end of 2020 and approximately 1.3 billion doses by the end of 2021.
In addition to engagements with governments, Pfizer and BioNTech have provided an expression of interest for possible supply to the COVAX Facility, a mechanism established by Gavi, the Vaccine Alliance, the Coalition for Epidemic Preparedness Innovations (CEPI) and World Health Organization (WHO) that aims to provide governments, including those in the emerging markets, with early access to a large portfolio of COVID-19 candidate vaccines using a range of technology platforms, produced by multiple manufacturers across the world.
Pfizer Canada ULC is the Canadian operation of Pfizer Inc., one of the world’s leading biopharmaceutical companies. Our diversified health care portfolio includes some of the world’s best known and most prescribed medicines and vaccines. We apply science and our global resources to improve the health and well-being of Canadians at every stage of life. Our commitment is reflected in everything we do, from our disease awareness initiatives to our community partnerships.
Biopharmaceutical New Technologies, founded in Germany, is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab, Sanofi, Bayer Animal Health, Genentech, a member of the Roche Group, Genevant, Fosun Pharma, and Pfizer.