Novavax, Inc., a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced a memorandum of understanding with the Canadian government to produce NVX-CoV2373, the Company’s protein-based vaccine candidate against COVID-19 in Canada.
Novavax plans to produce its COVID-19 vaccine at the National Research Council’s Biologics Manufacturing Centre in Montréal once both the vaccine candidate and the facility receive Health Canada approvals. The memorandum of understanding also includes a broader intention for the Government of Canada and Novavax to work together to increase the company’s Canadian presence. They will explore a range of partnership opportunities for Novavax to expand vaccine production in Canada, including partnerships with Canadian contract manufacturers.
The Government of Canada has previously signed an agreement with Novavax to provide up to 76 million doses of Novavax’ COVID-19 vaccine candidate. Novavax recently initiated the rolling submission process for regulatory approval to Health Canada.
Prime Minister Justin Trudeau also announced additional investments to support vaccine, therapeutic, and biomanufacturing projects in Canada. These include:
- Up to $25.1 million to Precision NanoSystems Incorporated (PNI), a Vancouver-based biotechnology company, to expand our ability to produce ribonucleic acid vaccines and future genetic medicines in Canada. PNI will build a $50.2 million biomanufacturing centre to produce vaccines and therapeutics for the prevention and treatment of diseases such as infectious diseases, rare diseases, cancer and other areas of unmet need.
- Up to $14 million to Edesa Biotech Inc. (Edesa), a biopharmaceutical company based in Markham, Ontario, to advance work on a monoclonal antibody therapy for acute respiratory distress syndrome, which is the leading cause of COVID-19 deaths. Edesa’s $18.7 million project has received Health Canada approval to conduct its phase 2 clinical trials, and has begun administering its treatment to clinical trial participants in Canada.
- Canada has already approved vaccines to prevent COVID-19, which are being distributed across the country. The Pfizer-BioNTech COVID-19 vaccine was approved by Health Canada on December 9, 2020, and the Moderna COVID-19 vaccine was approved on December 23, 2020.
- The memorandum of understanding with Novavax enables the government to pursue options to produce the Novavax COVID-19 vaccine at the National Research Council’s Biologics Manufacturing Centre in Montréal, once both the vaccine candidate and the facility receive Health Canada approvals. Novavax recently initiated the rolling submission process for regulatory approval to Health Canada.
- The Government of Canada currently has an agreement with Novavax to purchase up to 76 million doses of the Novavax COVID-19 vaccine candidate.
- Precision NanoSystems Incorporated is a global leader in innovative solutions for the discovery, development, and manufacturing of nanomedicines to treat infectious diseases and cancer. Its project proposal was reviewed by the COVID-19 Joint Biomanufacturing Subcommittee.
- Once the biomanufacturing centre is completed, targeted for March 2023, PNI will have the capacity to produce up to 240 million doses of its self-amplifying ribonucleic acid (RNA) COVID‑19 vaccine every year.
- PNI will create and maintain up to 125 highly-skilled jobs and invest $120 million on research and development in Canada, thanks in part to today’s investment by the Government of Canada.
- On October 23, 2020, the government invested $18.2 million in PNI to support the development of its promising COVID-19 self-amplifying RNA vaccine candidate through clinical trials.
- Edesa Biotech Inc. is a biopharmaceutical company founded by experts in the fields of inflammation and infectious diseases. It has a strong record in biologics, and has demonstrated success in its ongoing clinical development programs. Its project proposal was reviewed by the COVID-19 Therapeutics Task Force.
- Today’s investment will help Edesa advance its monoclonal antibody therapy (EB05). In addition to its potential to treat acute respiratory distress syndrome and mitigate inflammation complications in COVID-19, Edesa’s therapy has the potential to also treat other pathogens known to cause pandemics, such as influenza.
- There is also progress on the biomanufacturing facilities under construction in Quebec and Saskatchewan.
- The University of Saskatchewan’s Vaccine and Infectious Disease Organization received federal contributions of $46 million in 2020 to help strengthen its COVID-19 research and vaccine development as well as complete the construction of its pilot scale manufacturing facility to good manufacturing practice (GMP) standards. The construction of the GMP facility is on track to be completed by the end of 2021. This facility will be able to produce up to 40 million doses annually depending on the production efficiency of specific vaccines.
- The National Research Council’s new Biologics Manufacturing Centre at its Royalmount site in Montréal received a $126 million investment in August 2020. Once built, the new centre will be capable of large-quantity, end-to-end production of vaccines – approximately 24 million made-in-Canada doses per year – depending on the vaccine candidate. Construction remains on schedule and is anticipated to be completed in July 2021. The ultimate timeline for production at the facility depends on reaching a full production agreement with an approved vaccine producer and Health Canada approval of the manufacturing process for the specific product.