Question Period Note: MOU WITH NOVAVAX, & VACCINE PRODUCTION at NRC’s BIOLOGICS MANUFACTURING CENTRE

What is the status of the partnership with Novavax to have domestically-produced vaccines from the National Research Council (NRC) Royalmount facility?

• The Government of Canada’s number one priority is protecting the health and safety of Canadians.

• The construction and interior fit-up of the National Research Council’s new Biologics Manufacturing Centre in Montreal was completed on budget and ahead of schedule.

• The facility can accommodate the production of two different vaccine products. One line is earmarked to produce the COVID-19 vaccine being developed by Novavax, once it is approved for use in Canada.

• Currently, the NRC is working with Novavax to share the company’s antigen production technology.

• The government is open to partnering with other companies to maximize use of the facility.

• For a vaccine to be produced in Canada, Health Canada approvals are required for: 1) the vaccine; 2) the production facility; and 3) the specific vaccine to be produced in the specific facility.

• The NRC is focused on completing the commissioning, Good Manufacturing Practices (GMP) qualification and validation processes, and all related documentation. Subsequently, the NRC will seek a drug establishment licence from Health Canada for the facility.

• The timing for the release and distribution of the vaccine is dependent on the successful completion of the technology transfer, the quality assurance processes that ensure vaccines produced in Canada are consistently safe and effective for human use, and Novavax receiving regulatory approval of its vaccine candidate.

• Once GMP-certified, the Biologics Manufacturing Centre will have a production capacity of approximately 4,000 litres per month. Based on 500 doses/L, this would translate into approximately two million doses of a vaccine per month. The number of doses will vary widely depending on the type of vaccine, and its manufacturing yield.

If pressed on concerns about Novavax’s manufacturing processes:

• In clinical trials to date, the Novavax COVID-19 vaccine has proven highly effective.

• In all cases, including with respect to Novavax, Health Canada undertakes a thorough, independent review of vaccines to ensure that they are effective and safe for use in Canada.

• The Government continues to monitor information and developments with respect to the Novavax vaccine, as it does with all vaccines of interest in this pandemic.

• On February 2, 2021, Prime Minister Justin Trudeau announced that the Government of Canada signed a memorandum of understanding with Novavax to pursue options to produce its COVID-19 vaccine at the Biologics Manufacturing Centre (BMC) once both the vaccine candidate and the facility receive the required Health Canada approvals.

• In March 2021, the NRC and Novavax signed a collaboration agreement to enable the technology transfer of the Novavax COVID-19 vaccine to begin. This technology transfer has been under way since May.

• Novavax is a good fit for the BMC because its vaccine candidate is compatible with the facility, it is in the right stage of development and Novavax has a need to manufacture their vaccine in Canada.

• The commissioning, qualification and validation (CQV) of the BMC as a brand new facility with more than 250 pieces of critical equipment is a very complex, time consuming and rigorous process. The results of the CQV, along with the development of all the quality management and quality control documentation, are critical for the GMP certification and granting of the drug establishment licence by Health Canada.

• In addition, processes customized for specific vaccine production include:
o Technology transfer – to establish the process of making the specific vaccine in the facility
o Process qualification – to ensure the process will produce the specific vaccine with precisely the same quality in every dose
o Health Canada approval – regulatory checks to ensure the specific vaccine, produced with the specific process, in the specific facility will result in precisely the same quality in every dose

• Production of Novavax’s COVID-19 initial quality and stability batches can begin once the tech-transfer is completed, the drug establishment licence for the facility is granted and Novavax has received vaccine regulatory approval from Health Canada.

• On October 19, 2021, Politico released an article claiming that Novavax’ methods to test the purity of the vaccine have fallen short of regulators’ standards and that the company has not been able to prove that it can produce a vaccine of sufficient quality. On October 20, 2021, Minister Champagne conveyed to the Toronto Star that Canada is following production problem concerns, but that the technology and science of the vaccine is solid, and that Health Canada will conduct a thorough review through the regulatory process and certification of the BMC.

• The BMC will be capable of large-quantity, end-to-end manufacturing (production, purification, fill and finish and secondary packaging) of biopharmaceuticals (including vaccines) from cell based biologics production (i.e., viral vector, protein subunit, virus-like particle base).

• Along with the collaboration with Novavax for production of their vaccine candidate at the BMC, the NRC continues to explore options with potential collaborators for technology transfer of vaccines that can be manufactured at the facility. All production will be subject to the technology transfer process described above. Consistent with standard policy, agreements will be announced once they are finalized.