Potential COVID-19 vaccine still not in Canada, three months after approval for trials – National
The Ad5-nCoV potential vaccine is being produced at CanSino Biologics in Tianjin, China, and uses cell lines developed at the National Research Council of Canada (NRC).
Researchers at Dalhousie University’s Canadian Center for Vaccinology were set to test the CanSino product in Phase 1 trials in Halifax as early as late May.
A Chinese patent was granted for Ad5-nCoV this month, and Phase 3, large-scale trials — which include people who have been exposed to COVID-19 — are set to begin soon in Russia, Saudi Arabia, Brazil and Mexico.
Yet Canada — the home of the cells used to develop the candidate vaccine — is still waiting to even see the product.
In an email to Global News, the NRC said the “vaccine candidate for Phase 1 clinical trials has not yet been approved by Chinese customs for shipment to Canada. Once the Canadian Center for Vaccinology receives the vaccine candidate it will start the clinical trial for CanSino, under the regulatory supervision of Health Canada.”
When asked specifically how much the Government of Canada has invested specifically in the CanSino Ad5-nCoV vaccine project, including the planned clinical trials in our country, the communications advisor for the NRC cited confidentiality reasons for not revealing details. “For reasons of commercial confidentiality the terms of the agreement between the NRC and CanSino cannot be shared. The overall aim of the NRC’s collaboration with CanSino is to enable production of the candidate vaccine in Montreal, for the purposes of later stage clinical trials, as well as for emergency pandemic use should the vaccine be approved by Health Canada,” said Nic Defalco via email.
CanSino did not respond to a Global News request for information about the delay.
The NRC and CanSino previously teamed-up to develop a successful Ebola vaccine approved for use in 2017.
The ongoing delay comes at a time of high diplomatic tension between Ottawa and Beijing: over the detention of Canadians Michael Kovrig and Michael Spavor in China, and the U.S. extradition hearing of Huawei executive Meng Wanzhou in Canada.
“Of all the vaccine candidates that are out there … which one did Canada choose to partner with? One that is owned by a company closely allied to China’s military, at a moment when Canada’s relationship with China is the worst it’s ever been,” said Amir Attaran, professor of law and medicine at the University of Ottawa.
“And as a result, the Chinese are blocking us receiving vaccines, to do clinical trials in this country. It’s farcical.”
Attaran says Canada should have looked to its allies when making vaccine deals, and not just for political reasons.
“It’s certainly not the best vaccine of its kind in development,” said Attaran.
“It shares technological features of the vaccine that is being developed at Oxford University and manufactured by AstraZeneca. And that one, the latter one, is clearly superior in its Phase 2 outcomes to the CanSino version.”
Phase 2 trial results in July showed the Oxford-AstraZeneca vaccine to be safe — with only minor side effects — and it appeared to produce both types of immune responses, as hoped for by researchers.
AstraZeneca has inked deals with the U.K., the U.S., Australia, Europe’s Inclusive Vaccines Alliance, the Coalition for Epidemic Preparedness Innovations and Gavi the Vaccine Alliance for more than one billion doses.
The CanSino Phase 2 trial showed similar results, but with more adverse side-effects when the vaccine was delivered at the levels required to induce an immune response, and it showed a reduced immune response for older people.
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Earlier this month, the Canadian government signed new deals with pharmaceutical firms Pfizer and Moderna to secure millions of doses in 2021 of the coronavirus vaccine candidates each company is currently developing.
Pfizer is currently working on four experimental coronavirus vaccines and Moderna is also working on what’s been described as among the leading candidates for a vaccine.
Procurement Minister Anita Anand did not specify how many doses have been secured as part of the deals, only that it would be “millions of doses.”
The federal government has invested $600 million to support COVID-19–related vaccine and therapy clinical trials, but for reasons of “commercial confidentiality,” it will not reveal the terms of the CanSino deal.
However, we do know more about the two other vaccine projects involving the NRC.
One is a $56 million investment to support VBI Vaccines, a company based in Massachusetts, with operations in Ottawa.
The other is $23 million of funding for The University of Saskatchewan’s Vaccine and Infectious Disease Organization-International Vaccine Centre.
When asked by Global News if the Canadian government is in negotiations with AstraZeneca, Anand said “given the steep global competition, and in order to protect Canada’s negotiating position, it would be imprudent to provide details regarding specific suppliers with whom we are currently negotiating … We owe it to Canadians to explore every option for vaccines, and that is exactly what we will continue to do.”
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Professor Matthew Herder, Director of the Health Law Institute at Dalhousie University said the Canadian government should be more open about the deals it is making.
“I think one of the things the government should be doing is making public the deals that they’re entering into. So we can have that hard conversation about whether our interests and the interests of other populations are potentially going to benefit from these vaccines,” said Herder.
“We really don’t know how good of a deal it is; the terms of the deal between Canada and CanSino, the terms of the newer deals between the federal government and Moderna, as well as Pfizer for their vaccines. We don’t know the terms of those deals either.”
In response to questions raised by Conservative MP Scott Reid, parliamentary documents signed by Innovation, Science and Industry Minister Navdeep Bains, say “The NRC retains the intellectual property related to the cell line, while CanSino, in turn, owns all intellectual property rights for the vaccines it develops.”
It also says the agreements between the NRC and CanSino “permit the NRC to manufacture a set limit of the vaccine for emergency pandemic use in Canada for ten years. The agreements do not address large-scale manufacturing of the vaccine in Canada or distribution to other countries — these will be the subject of a subsequent agreement with the Government of Canada as required.”
Temporary patent amendment
The issuing of a Chinese patent for the CanSino vaccine candidate this month will not affect how it can be used in Canada.
The Canadian Intellectual Property Office patent database does not currently show whether CanSino has a patent pending in Canada for Ad5-nCoV, as patent applications are generally only made public 18 months after an application. It would be standard practice for CanSino to have applied in Canada and elsewhere already.
Even if a patent were granted already, the Canadian government would currently be able to bypass it, because of an amendment to the Patent Act under Bill-13 measures, passed in March, in response to COVID-19.
It allows the government “to make, construct, use and sell a patented invention to the extent necessary to respond to the public health emergency.”
Herder thinks that could be a small factor in why the candidate vaccines have been prevented from getting to Canada.
However, the legal amendment is time-limited, preventing the Patent Commissioner from making any such authorization after Sept. 30, 2020.
“I cannot understand why that deadline was added to this measure,” said Herder.
“Forecasts at the time this legislation was passed would have put the vaccine being ready in early 2021, I think, at the earliest, and so that deadline needs to be changed. And I think that’s one of the concrete steps the federal government can and should take to extend it into the foreseeable future.”
This week, the World Health Organization (WHO) called for international cooperation when it comes to developing and distributing vaccines.
“Nationalism exacerbated the pandemic and contributed to the total failure of the global supply chain. For a period of time, some countries were without key supplies, such as key items for health workers who were dealing with surging cases of COVID-19,” said WHO chief Tedros Adhanom Ghebreyesus, insisting that if the virus isn’t eliminated everywhere, it will inevitably come back.
“It’s critical that countries don’t repeat the same mistakes. We need to prevent vaccine nationalism.”
Even Pope Francis asked for richer nations to think of others when racing to procure vaccines.
“It would be sad if the rich are given priority for the COVID-19 vaccine. It would be sad if this vaccine became the property of this or that nation, if it is not universal and for everyone,” said the pontiff.
As of August 2020, 39 countries form part of a Solidarity Call to Action on COVID-19, an initiative of the WHO and Costa Rica, to pool global resources.
Canada is not a member, and neither is China.
Most of the members are poorer developing countries. Only six are also part of the Organisation for Economic Co-operation and Development (OECD), i.e. fully-developed countries, but none would be regarded as world powers.
“In the absence of that kind of commitment to collaborate and share, what we’re seeing is exactly what you’d expect. It’s a bit of ‘every nation first and for itself first’,” said Herder.
“The richer nations are, of course, better positioned to take care of people within their borders.”
So even if Canada is falling behind in the vaccine race, it’s still far ahead of most nations.