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A logo of China's vaccine specialist CanSino Biologics Inc is pictured on the company's headquarters in Tianjin, following an outbreak of the coronavirus disease (COVID-19), China August 17, 2020.

THOMAS PETER/Reuters

One of China’s leading vaccine developers is blaming domestic bureaucratic indecision for the delays in shipping supplies to Canada for a joint testing program that has now been abandoned.

Some divisions of the Chinese government were not clear on whether the vaccine should “go to global trials or how to handle it,” said Dr. Xuefeng Yu, the chairman and CEO of CanSino Biologics, which in May agreed to bring its Ad5-nCoV vaccine candidate to Canada for testing through a partnership with the National Research Council (NRC).

The agreement stood as a rare sign of co-operation between Ottawa and Beijing in the midst of the legal and diplomatic frictions that have soured relations between the two countries.

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But the deal has instead created further problems, after Chinese officials refused to ship the vaccine to Canada. They have allowed other Chinese vaccine candidates to be shipped to other countries for wide-scale testing.

In contrast, the shipment of Ad5-nCoV to Canada was so badly delayed that the planned testing will not proceed, Dr. Yu told The Globe and Mail in an interview Tuesday. Decisions in China on whether to send it to Canada were “caught in the bureaucracy,” he said. Now the time to do those trials has “already passed,” with the company reporting results of its second-phase trials in July.

The Ad5-nCoV trials were expected to be completed by the Canadian Center for Vaccinology at Dalhousie University. That centre “was ready to start clinical trials as early as June, after Health Canada’s review and approval of the CanSino clinical trial proposal,” the NRC said in a statement. It said the Chinese government changed the process for shipping vaccines out of the country subsequent to the signing of the NRC’s agreement with CanSino.

“Due to the delay in the shipment of the vaccine doses to Canada, the NRC has since moved on to focus our team and facilities on other partners and COVID-19 priorities,” the statement said.

The failure of the vaccine partnership with CanSino comes in the midst of continued tensions between Canada and China, following the arrest of Huawei executive Meng Wanzhou at the Vancouver airport, and the subsequent arrests of Canadians Michael Kovrig and Michael Spavor in China.

It’s not clear what effect, if any, that broader dispute had on CanSino’s agreement with Canada. Dr. Yu said he “cannot comment too much about politics.” In July, the office of Innovation, Science and Industry Minister Navdeep Bains cited delays at China Customs. Dr. Yu said he did not know where the problem arose, except that government decision-making around vaccine research in China is “too complicated.”

The development underscores the risk that Canada faces when working with international partners at a time when virtually every country is looking to secure a COVID-19 vaccine for its population.

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Worldwide, nearly 50 vaccines aimed at COVID-19 are now being tested in humans, though only a handful of those have progressed to large-scale trials. Earlier this month, Ottawa announced deals with two of the international front-runners, Moderna and Pfizer Inc, to secure millions of doses of their vaccines for use in Canada next year.

Ad5-nCoV is being jointly developed with the Chinese military but relies on a piece of Canadian technology, a cell line modified by the NRC. The NRC provided that cell line to CanSino in 2014, which the company then used to develop a vaccine for Ebola before pivoting to COVID-19 earlier this year. The licence to use the cell line is non-exclusive use, meaning Canada has no claim to revenue from the coronavirus vaccine if it proves successful.

As part of the agreement to stage the trial in Canada, the NRC would have been allowed to produce the vaccine domestically at a facility in Montreal for testing and emergency use.

The collapse of the trial eliminates that possibility, and Canadian officials said they are now focusing on working with other partners including VBI Vaccines, a Massachusetts-based company with research operations in Ottawa, and Saskatoon’s infectious disease laboratory VIDO-Intervac.

“It’s evident that the opportunity [with CanSino] is over,” said NRC president Iain Stewart.

CanSino completed its first and second-phase trials in China. Its second-phase results showed antibodies for the novel coronavirus in 85 per cent of participants, but also found adverse reactions in nearly three-quarters of those in the study group.

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CanSino is now planning for international third-phase tests, which typically involve thousands or tens of thousands of participants. The company has announced partnerships for such testing in Russia and Saudi Arabia, and is also looking to South America and East Africa – all places with what Dr. Yu described as a “high disease burden.” Third-phase tests compare large numbers of people injected with a vaccine candidate to people injected with a placebo. None of the proposed countries, however, boasts a pharmaceutical-testing process as rigorous or transparent as that in Canada.

And Canada is “not an ideal place to run phase three,” Dr. Yu said, citing the comparatively small number of COVID-19 cases in Canada.

He expressed confidence that “our vaccine should work, and it’s just a matter of time – how quickly we can evaluate in the large-scale phase-three clinical trial.”

In the global race to develop a pharmaceutical defence against COVID-19, Russia claimed the first success, approving a vaccine that has yet to complete full testing.

China, too, has moved quickly to assert itself as a leader. Chinese authorities issued a patent for the CanSino virus earlier this month. In June, the company also revealed that China’s Central Military Commission has granted the vaccine a one-year approval for military use.

Sinopharm, another Chinese state-owned firm, has given wide distribution to its own vaccine candidate, using phase-three trials to provide shots to a wide selection of elites. That includes upper management at state-owned enterprises, as well as large numbers of people at some government ministries, some of whom are using the option to volunteer in hopes of securing early immunity. Sinopharm is also testing the vaccine in Argentina, the United Arab Emirates, Peru, Morocco and Bahrain. The company has said it expects its vaccine, which consists of inactivated coronavirus, to be commercially available before the end of the year.

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The Ad5-nCoV vaccine candidate uses another type of virus known as an adenovirus to deliver genetic instructions for making those proteins directly inside human cells, rather than inducing an immune response by injecting an individual with coronavirus proteins. At least two other front-runner COVID-19 vaccines – one developed by Oxford University and another by the pharmaceutical company Johnson & Johnson – are using the same strategy.

The Canadian trial, based in Halifax, was to have been a combination phase-one and phase-two trial involving up to 696 participants. Researchers organizing the trial had hoped to recruit participants up to 85 years in age in order to better assess the safety and efficacy of the vaccine in the oldest members of the Canadian population – the group that is most vulnerable to COVID-19.

With CanSino now off the table, the only COVID-19 vaccine trial currently underway in Canada is one led by Quebec-based Medicago. IMV Ltd., a Nova Scotia-based biotech company, and VIDO-Intervac both have plans to launch early phase trials of their COVID-19 vaccine candidates in Canada later this year.

In a separate development, DIOSynVax, a company led by Cambridge University immunologist Jonathan Heeney, who is Canadian, announced on Tuesday that it has funding to run a phase-one clinical trial of its vaccine in Britain later this year. The company is also in discussion with collaborators at McMaster University in Hamilton, who have expertise in setting up larger-scale international vaccine trials.

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