Due to lengthy delays in the shipment of the vaccine doses to Canada, and the fact that CanSino's candidate had already entered advanced testing in other countries, the opportunity to conduct clinical trials in Canada had passed and the government focused on more promising candidates.
The work with CanSino in no way slowed down the Canadian effort to secure vaccines. At the time the agreement with the company fell through, the Government of Canada was working with other companies in Canada, none of which were ready yet to be in clinical trials. CanSino was only one of multiple avenues pursued to secure vaccines for Canadians, including through the funding of domestic organizations to pursue their own vaccine candidates - such as VIDO-Intervac and Medicago, announced just a few days after the WHO declared a pandemic in March 2020. In total, the Government of Canada had funded numerous Canadian companies pursuing vaccine candidates, which are at various stages of clinical trials.
The Government of Canada also later entered into advanced purchase agreements (APAs) for seven leading vaccines, including Pfizer, Moderna, AstraZeneca, Johnson & Johnson, Novavax, Sanofi, and Medicago. Canada was among the first countries in the world to secure APAs with these firms (for example, Canada was first in the world to secure a deal with Moderna). Canada's procurement strategy was informed by the advice of scientific experts and resulted in a diverse and extensive vaccine portfolio. CanSino was not a part of this procurement process or the subject of negotiations for an advanced purchase agreement with Canada.
The collaboration involved the transfer of CanSino's vaccine candidate to Canada so that a Canadian institution could conduct a clinical trial. CanSino was transferring its IP to Canada - not the other way around. No Canadian IP was to be provided to CanSino as part of the agreement to develop its COVID-19 vaccine. Nevertheless, as part of the NRC's due diligence for this collaboration, we engaged the Government of Canada's lead security agencies before proceeding.
The NRC had previously collaborated with CanSino in the development of a vaccine against tuberculosis, which made use of our proprietary cell line, meaning the NRC was familiar with CanSino's general production process. The NRC's proprietary cell line was licensed to CanSino in 2014 and CanSino used this cell line to produce this vaccine; this same cell line is used by other companies on a similar commercial basis.
In spring 2020, the NRC began work on a temporary clinical trial manufacturing facility within our existing Royalmount building to produce vaccine candidates for Canadian clinical trials. The initial candidate was identified as the CanSino vaccine, but the facility upgrades were also intended to accommodate other COVID-related clinical trials as needed on an emergency basis.
Based on feedback provided by Health Canada later that fall, and in the absence of a product being immediately transferred, the NRC decided to build out a permanent Good Manufacturing Practices-compliant (GMP) clinical trial material facility. This permanent facility will ensure Canadians have access to a publicly owned, dedicated manufacturing facility for clinical trial materials to better prepare Canada in responding to future health emergencies. This new facility will be an essential part of Canada's biomanufacturing capacity, enabling the NRC to support three distinct, but complementary stages of biomanufacturing in Canada: vaccine research and development in the existing research labs, GMP-compliant production of clinical trial material at the new clinical trial material facility, and GMP-compliant vaccine production at the Biologics Manufacturing Centre (BMC).
On August 31, 2020, the Prime Minister announced a new BMC would be constructed at our Royalmount site. The construction of this BMC was completed this past June - which was 10 months after this announcement.
The work with Novavax is proceeding as planned, to prepare for the production of the Novavax vaccine candidate at the BMC. This includes working on the technology transfer to establish the step-by-step process of producing the Novavax vaccine at the facility. Vaccine production is a complex process, which is highly regulated, including rigorous testing and oversight to ensure the product is safe for human use.
