Clinical trials in Canada of an early Chinese front runner in the race for a coronavirus vaccine are in limbo, with Chinese customs authorities holding up shipment of the injections for weeks.
Health Canada gave approval for clinical trials for Ad5-nCoV, a potential vaccine developed jointly by Tianjin-based CanSino Biologics and Chinese military scientists, on May 16.
The scientist in charge of the trials, Dalhousie University professor Scott Halperin, said in mid-May that he expected the first of the three phases of trials to start later that month. But Halperin said three weeks ago that he had yet to receive the vaccines for the trials.
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Health Canada said the vaccines were held up by China’s General Administration of Customs.
On Thursday, the National Research Council of Canada (NRC) confirmed to the South China Morning Post that the customs administration had still not allowed the shipment to proceed.
“The vaccine candidate for phase 1 clinical trials has not yet been approved by Chinese customs for shipment to Canada,” the council said.
The cause and extent of the delay are not clear.
When the agreement for the clinical trials was struck in May, many analysts were surprised given the strains between the two countries over the arrest of Huawei Technologies executive Meng Wanzhou, the arrest of two Canadians on espionage charges in China and Beijing’s blocks on imports of Canadian canola and meat.
But CanSino has extensive ties with Canada. Co-founder Yu Xuefeng, worked in Canada from 1996 to 2009, mainly at drug maker Sanofi, and CanSino worked with Canadian authorities to develop an Ebola vaccine about six years ago.
The Chinese customs administration did not respond to requests for comment.
CanSino declined to comment on Thursday but on July 11, co-founder Qiu Dongxu told a seminar in the eastern Chinese city of Suzhou that the company was in talks with Russia, Brazil, Chile and Saudi Arabia for phase III trials, with plans to recruit 40,000 volunteers.
The vaccine has been through two phases of clinical trials in China and approved for military use in the country. But it must complete all three phases in Canada.
The NRC said it was still working with CanSino.
“The National Research Council of Canada continues to work collaboratively with its federal partners and CanSino Biologics Inc. to advance bioprocessing and clinical development of the Ad5-nCoV Covid-19 vaccine candidate,” it said.
“Once the Canadian Centre for Vaccinology receives the vaccine candidate it will start the clinical trial for CanSino, under the regulatory supervision of Health Canada.”
In March, Ad5-nCoV was the first Chinese vaccine candidate to start human trials in China and the first Chinese vaccine to be approved by another country for overseas tests.
The Chinese vaccine developers need to conduct the last stage of trials overseas because transmission of the coronavirus in China is too low to test the efficacy of the injections.
CanSino published the findings of its phase II trials on July 20, but so far there has been no announcement about the third and final phase.
Other Chinese pharmaceutical companies are already in the final phase, with Sinopharm testing its candidate in Saudi Arabia and Sinovac carrying out its trials in Brazil.
CanSino is listed in Hong Kong and its secondary listing in Shanghai is under way.
Tao Lina, a Chinese vaccine specialist who is not involved in the CanSino research, said he did not know the reason for the hold-up, but he was pessimistic about the prospects for the trials because of the strained relations between Canada and China.
Tao said it would be reasonable for CanSino to consider carrying out the trials in another country.
“Relations with a country are very important for international collaboration such as clinical trials,” he said.
Countries that worked with China on clinical trials were likely to be given priority access to the vaccine and might also be given permission to manufacture the injections, he said.
In Canada, Senator Doug Black said the delays in the CanSino trials underlined the need for the government to support local vaccine research.
“These delays underline the need for Canada to aggressively pursue a maple leaf Covid solution. We need to take as many ‘shots on goal’ as possible to secure a vaccine for Canadians – including funding the research of Canadian companies like Providence Therapeutics,” Black said.
“The stakes are too high for Canada to risk being at the back of the line.”
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This article Coronavirus: Chinese customs stalls vaccine shipment for trials in Canada first appeared on South China Morning Post