J&J, Novavax in Agreements with Canada To Supply COVID-19 VaccinesBy
The government of Canada has reached agreements with Johnson & Johnson’s Janssen and Novavax, a Gaithersburg, Maryland-based clinical-stage vaccine company, to supply their respective vaccines against SARS-CoV-2, the virus that causes COVID-19.
In the first deal, Janssen has agreed in principle to supply the government of Canada with doses of its vaccine candidate, Ad26.COV2.S. The parties will negotiate a final advance purchase agreement under which the Canadian government would purchase up to 38 million doses of Ad26.COV2.S on a not-for-profit basis for emergency pandemic use. The availability of the vaccine is subject to successful development and Health Canada regulatory approval.
Ad26.COV2.S is currently in Phase I/IIa clinical trials in healthy volunteers in the US and Belgium. Planning is underway for the Phase III program, subject to interim data of the Phase I/IIa trials and approval of regulators.
In a separate deal, Novavax has reached an agreement in principle with the government of Canada to supply up to 76 million doses of NVX-CoV2373, its COVID-19 vaccine candidate. The parties are expected to finalize an advance purchase agreement under which Novavax will supply doses of NVX-CoV2373 to Canada beginning as early as the second quarter of 2021. This purchase arrangement will be subject to licensure of the vaccine by Health Canada.
NVX-CoV2373 is currently in multiple Phase II clinical trials. The Phase II portion of the Phase I/II clinical trial to evaluate the safety and immunogenicity of NVX-CoV2373 began in August (August 2020) in the US and Australia. This trial expands on the age range of the Phase I portion by including older adults 60-84 years of age to make that age group approximately 50% of the trial population. In addition, a Phase IIb clinical trial to assess efficacy began in South Africa in August (August 2020).
Earlier this week (September 2, 2020), Novavax announced the publication in The New England Journal of Medicine of Phase I data from its Phase I/II clinical trial of NVX‑CoV2373.