Health Canada authorized the first COVID-19 vaccine-focused clinical trial with Dalhousie University in Nova Scotia. Now that nation’s National Research Council of Canada has entered the scene in discussion with manufacturers should the trials go well: with an eye toward production and distribution throughout the country. TrialSite News reported that Canada was considering a deal with CanSino Biologics—which is now verified. The research and development effort is led by Dr. Scott Halperin, director of the Canadian Center for Vaccinology at Dalhousie University. All that is needed now is ethics board approval, which they hope to receive within weeks. Canadians have taken a different approach to SARS-CoV-2 vaccine development than their large neighbors to the south.
On Saturday, Prime Minister Justin Trudeau declared that the University of Dalhousie Canadian Center for Vaccinology along with the IWK Health Centre and Nova Scotia Health Authority would spearhead the first clinical trials upon Health Canada approval. The Canadians have opted to include a leading vaccine prospect via CanSino Biologics, which according to the World Health Organization (WHO) is in a leading position of all of the prospective COVID-19 vaccine competitors.
Upon ethics committee approval of the study, likely within a couple weeks, the study will involve 100 healthy volunteers between the ages of 18 and 55 and China’s CanSino Biologics vaccine already in Phase II in China. Dr. Halperin reports that they will first undertake a Phase I/II study in a quest to assess the safety and tolerability of the investigational vaccine originating from CanSino Biologics.
The initial vaccine study in Canada will be conducted at the Halifax Lab. Dr. Halperin reports that the study team will follow the study volunteers over a six-month period to ensure there is a safe immune response to the vaccine; but also to ensure they are ready to rapidly shift to Phase II of the study prior to the completion of Phase I. Of course, given the severity of the situation, the goal of expediting the stud is of paramount interest.
As TrialSite News has reported, CanSino Biologics’ nonreplicating viral vector-based vaccine recently advanced to Phase II in China making the vaccine candidate the lead contender in the global race for an approved vaccine product. CanSino Biologics works in conjunction with the State-backed Academy of Military Medical Sciences Institute of Biotechnology to develop the adenovirus type-5 vector-based recombinant SARS-CoV-2 vaccine (Ad5-nCoV). This public-private partnership can be thought of as competitive to the recently announced American initiative called “Operation Warp Speed” that TrialSite News declared could truly lead to notable results given its focus of mobilizing, directing and orchestrating U.S. federal drug development powers.
CanSino Biologics (CanSinoBio) was established in Tianjin, China in 2009. Currently at 450 employees, they have succeeded in producing one approved vaccine for Ebola virus disease (Ad5-EBOV) and 16 vaccine candidates in the pipeline. Listed on the Hong Kong Exchange and Clearing Limited (HKEx) since March 2019, they focus primarily on the R&D of new vaccine development. The company’s senior team has considerable and deep Western “Big Pharma” pedigree, including from the likes of AstraZeneca, Wyeth (Pfizer) and CNBG (China). CanSino Biologics focuses on four key platform technologies while the company continues to develop its adenovirus-based viral vector vaccine as well as conjugation, protein structure design and recombination and vaccine formulation technologies.
The Competitive Race
The U.S. has turned up the R&D intensity level with Operation Warp Speed where Trumpian-energy potentially turbo-charges an already dynamic, diversified and directed drug development enterprise in America; this is, of course, on top of the already furious pace of R&D activity occurring in the United States represented, among other things, by historically unprecedented study start up times.
The lead vaccine candidate, mRNA-1273 from Moderna, will likely move to Phase II clinical trials in the Summer, its mRNA platform offering potential advantages in the race. In the meantime, Pfizer inked a deal with Germany-based BioNTech (backed by billionaire Thomas Struengmann) while Germany-based CureVac developed a powerful mRNA-based candidate; they were even invited for the White House to “make a deal,” which the Germans declined. Oxford’s ChAdOx1 is considered a top contender—so much so that AstraZeneca inked a global production and distribution deal with the prestigious British academic medical center. Recently, the NIH and Oxford’s Jenner Institute announced via NIAID’s Rocky Mountain Laboratories situated in beautiful Hamilton, Montana that the Oxford vaccine worked in monkeys. A couple of prominent ventures in China are in hot pursuit of the vaccine as well, including Sinovac Biotech and the Wuhan Institute of Biological Products (operating under State-owned “SinoPharm”). Of course, there are many other vaccine candidates but these are the top contenders.
Lead Research/Investigator for Canadian Vaccine Pursuit
Dr. Scott Halperin, director of the Canadian Center for Vaccinology at Dalhousie University