The University of Saskatchewan’s Vaccine and Infectious Disease Organization (VIDO) has developed a COVID-19 vaccine headed to human clinical trials as Health Canada just gave the greenlight last week. The Canadian Centre for Vaccinology (CCfV), based in Halifax, will lead the charge, recruiting participants for this important Phase 1 Canadian trial commencing in January, 2021. Made from a proven technology with a good safety record, the Saskatchewan candidate is a subunit-based vaccine—the same approach used to develop other well-known vaccines targeting diphtheria and hepatitis. This is the first of two COVID-19 vaccine candidates out of VIDO. Positive trials at CCfV could portend commercial licensing opportunities for pharma.
What are Subunit-based Vaccines
According to the University of Saskatchewan’s recent press release, Subunit-based vaccines are a proven technology that has been used in many commercially available vaccines—including for hepatitis, diphtheria, and whooping cough—with an excellent safety profile. These well-established vaccines are relatively stable and have not required ultra cold storage temperatures.
The R&D Effort: Externalized Collaboration Key
VIDO’s vaccine development leveraged the expertise of several international and national partners. The adjuvant (Sepivac SWE™) was developed by Seppic in collaboration with the Vaccine Formulation Institute (VFI) and is based on technology recognized for its efficacy and safety in influenza vaccines. The vaccine antigen developed by VIDO was produced under good manufacturing practices (GMP) at Biodextris using a cell line from the National Research Council of Canada.
This COVID-19 vaccine candidate was made possible by funds channeled into the University of Saskatchewan’s VIDO for this purpose. Money flowed from the Government of Canada via Western Economic Diversification as well as the Government of Saskatchewan via Innovation Saskatchewan.
The authorization from Health Canada enables the Canadian Center for Vaccinology (CCfV) in Halifax to begin recruiting volunteers for the first Phase 1 clinical trial. CCfV anticipates that the volunteers will be vaccinated in January.
Big Milestone State’s VIDO Director
In the university’s recent press release Dr. Volker Gerdts, Director and CEO of VIDO, reports, “The approval to initiate a human clinical trial is a milestone for VIDO.” He continued, “This is the first of our two COVID-19 subunit vaccines in development and demonstrates the quality of our research, development and partnerships.”
A Second Candidate in the Pipeline
The clinical trial application for the second vaccine candidate, which uses an adjuvant developed by VIDO and collaborators, will be submitted when GMP manufacturing of the adjuvant is completed by Dalton Pharma Services.
The Trial Site
The clinical trial site is a prominent place for vaccine research in Canada. Led by Dr. Scott Halperin, the Canadian Centre for Vaccinology (CCfV) is located in the KWK Health Centre in Halifax, representing a collaboration of Dalhousie University, the IWK Health Centre and Nova Scotia Health Authority. This innovation center was established in 2007 with financial assistance from the Canada Foundation for Innovation, the Nova Scotia Research and Innovation Trust, and the Government of Nova Scotia’s Department of Economic Development, as well as others, to develop, implement and evaluate vaccine technologies and vaccines for infectious diseases that could have a significant impact on Canadian and global health. The CCfV was also established to train experts in these critical and evolving fields. The CCfV’s Clinical Research/Vaccine Challenge Unit opened up in 2009, made possible by funding from France’s Sanofi Pasteur.
Dr. Scott Halperin was quoted recently on the breakthrough, “This is the first university-based COVID-19 vaccine to begin Phase 1 testing at CCfV. The purpose of this trial is to demonstrate the safety of the vaccine in humans.”
Canada learned the hard way about the perils of vaccine nationalism during the CanSino Biologics debacle. TrialSite was one of the few media platforms to cover this unacceptable situation on a regular basis: where the Chinese government ultimately blocked a shipment of investigational vaccine products to Canada to be tested at CCfV.
The tensions more than likely were triggered in association with the arrest of Huawei executive Meng Wanzhou; Ms. Wanzhou happened to be the founder’s daughter and at the end of 2018 was detained by the Royal Canadian Mounted Police at the request of the USA but this cannot be verified for the cause of why Chinese customs wouldn’t let the shipment of Ad5-nCoV through.
Regardless, possibly due to tensions between Canada’s Prime Minister and POTUS (existing), Canada didn’t participate in Operation Warp Speed, which surprised TrialSite given the close relationship between the two North American countries.
Hence now Canada set out to develop its own vaccine candidates as well as procure leading investigational products. According to Dr. Gerdts, this important product could be ready by late 2021 if all goes smoothly. Gerdts noted, “To have sustainable long-term vaccine access, I think it’s important for Canada to continue on with its own vaccines.” He emphasized, “COVID-19 is not going to go away.”
The University of Saskatchewan’s Vaccine and Infectious Disease Organization (VIDO) is internationally recognized for its role in vaccine development and is one of Canada’s national science facilities. VIDO has a 45-year history of vaccine development and commercialization—eight of its vaccines have been sold commercially, and six have been described as world-firsts. The ~150-member organization operates using an ISO:9001 certified management system in state-of-the-art containment level 2 and 3 facilities. VIDO receives operating support from the Canada Foundation for Innovation Major Science Initiatives program and the Government of Saskatchewan through Innovation Saskatchewan and the Ministry of Agriculture.
Volker Gerdts, DVM, PhD, Director and CEO of VIDO
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