Canada, China team up for vaccine candidate

The National Research Council of Canada is collaborating with China's CanSino Biologics Inc to advance the bioprocessing and clinical development in Canada of a vaccine candidate against the novel coronavirus.

The collaboration on the vaccine candidate, Ad5-nCoV, was announced Tuesday. Ad5-nCoV received Chinese regulatory approval earlier this year, allowing CanSinoBIO to move ahead with human clinical trials in China.

It is one of only a handful of COVID-19 vaccine candidates in the world approved for initial safety testing in humans, and was the first to begin conducting phase-two human clinical trials, according to a statement released by the NRC.

"This vaccine candidate holds great promise. Until such time as there is an effective vaccine for COVID-19, the virus will continue to disrupt all aspects of our society and economy," said Iain Stewart, president of the NRC.

The relationship between the NRC and CanSinoBIO was established in 2013. The NRC's HEK293 cell line was later licensed to CanSinoBIO and used in the development of an approved vaccine against the Ebola virus.

Yu Xuefeng, CEO of CanSinoBIO, said it was "perfect timing" to leverage cutting-edge technology and resources from both sides that are critical to the development of Ad5-nCoV.

"We are in this global public health emergency together, and a collaborative engagement could be the shortcut to help win this race against the novel coronavirus," said Yu.

The statement said that the new COVID-19 vaccine is also produced using HEK293 cell lines that were designed and developed at the NRC.

By bringing their technologies and expertise together to fight COVID-19, CanSinoBIO and the NRC are aiming to "pave the way" for future clinical trials in Canada, in collaboration with the Canadian Immunization Research Network at the Canadian Center for Vaccinology.

The vaccine is subject to approval by Health Canada, for which CanSinoBIO is in the process of filing a clinical trial application.

The first- and second-phase human trials have already started in China. Chinese Science and Technology Daily said that the first-phase studies for Ad5-nCoV began in March, with 108 people taking three different doses.

In an unusual step, CanSinoBIO began second-phase testing in early April with 500 people, even though the first phase will not be completed until December. A third phase could involve a far larger number of people, perhaps as many as 10,000.

Lakshmi Krishnan, director general of the NRC's Human Health Therapeutics Research Centre, said the trials in Canada will complement and expand on what's been done in China.

"We're bringing back home a Canadian technology, and we're able to have the most advanced vaccine candidate in the world potentially available for Canadians in short order," Krishnan told CBC News.

She said a phase-one trial for the Ebola vaccine took place at the Canadian Centre for Vaccinology in Halifax. The first coronavirus vaccine also will be tested on healthy human volunteers there.

If successful, the phase-two trials could start in the fall, with a vaccine available for noncommercial use for front-line workers and those at risk in late 2020 or early 2021.

The collaboration announced Tuesday will allow the NRC to advance a scaled-up production process for the vaccine candidate, using its proprietary HEK293 cell line.

As a preparatory step, the Canadian government has already announced $44 million in funding to support upgrades to the NRC's facilities in Montreal to enable compliance with good manufacturing practice standards, to ensure readiness for Canadian bioprocessing of potential vaccine candidates as they become available.