Canada continues to execute on an intense COVID-19 vaccine diversification strategy, led by Prime Minister Justin Trudeau, as just weeks ago the entire nation was left with no vaccine access after China’s CanSino Biologics wasn’t able to deliver the agreed upon investigational vaccine product (Ad5-nCoV) due to growing political tensions. Canada’s leadership probably has recognized the challenges in the previous strategy and now is entering into multiple deals with either American or European firms. Most recently, the government inked deals with two more American developers, including Novavax and Johnson & Johnson. These arrangements include a reservation of millions of doses of these investigational products for Canadians. The government there has already secured vaccine access from Cambridge, MA-based Moderna (mRNA-1273) and Pfizer/BioNTech (BNT162). They are in the final negotiation stages with AstraZeneca (AZD1222)—the “Oxford” vaccine rumored to be top of mind of President Trump’s administration for an emergency use authorization by the fall.
The Government of Canada negotiated a deal securing up to 76 million doses of the investigational product known as NVX-CoV2373. President and CEO Stanley C. Erck announced, “We are pleased to work with the Canadian government on supply of our COVID-19 vaccine, an essential step to ensure broad access of our vaccine candidate.” Anita Anand, Minister of Public Services and Procurement, Government of Canada, emphasized the importance of access to promising vaccine candidates in the effort “to keep Canadians safe and healthy, as the global pandemic evolves.”
Still yet to finalize the advance purchase agreement, Novavax would supply doses of NVX-COv2373 to Canada starting as early as Q2 2021 and of course is contingent on Novavax licensing conditions.
Currently, this vaccine candidate is under investigation in multiple Phase 2 clinical trials. The Phase 2 portion of the Phase 1/2 clinical trial to evaluate the safety and immunogenicity of NVX-CoV2373 beginning in August in the United States and Australia, and expands on the age range of the Phase 1 portion by including older adults 60-84 years of age as approximately 50 percent of the trial population.
Secondary objectives include preliminary evaluation of efficacy. In addition, a Phase 2b clinical trial to assess efficacy began in South Africa in August. This Phase 2 clinical trial will involve up to 2,904 participants and runs through till November, 2021.
Novavax has secured $2 billion in funding for its global coronavirus vaccine program, including up to $388 million in funding from the Coalition for Epidemic Preparedness Innovations (CEPI).
What is NVX-CoV2373
NVX-CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus behind COVID-19. The investigational product was created using Novavax’ recombinant nanoparticle technology to produce antigen derived from the coronavirus spike (S) protein and contains the company’s patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.
Johnson & Johnson
Johnson & Johnson agreed to supply up to 38 million doses of their vaccine candidate known as Ad26CoVS1 is based on Janssen (subsidiary) recombinant adenovirus technology, AdVac, a technology used to develop and manufacture Janssen’s Ebola vaccine. J&J has agreed to deliver 100 million doses of Ad26CoVS1 to the U.S. government as part of a package worth over $1 billion. The deal includes an option for the U.S. government to order 200 million additional doses.
The pharmaceutical sponsor is preparing to launch a massive Phase 3 clinical trial involving up to 60,000 participants. According to U.S. government disclosures, the study estimated start date is September 5, 2020 and will run for a few years.
The vaccine candidate is the result of a $1 billion-plus deal put together via the coming together of the company and the U.S. Government (BARDA).