Thank you very much for the invitation to speak to the committee.
In addition to those descriptions of what I do, I am the nominated principal or co-principal investigator for two national networks relevant to vaccine research. The first is IMPACT, which is the Immunization Monitoring Program, Active. It is a Public Health Agency of Canada funded surveillance network administered at 12 of the country's pediatric tertiary care hospitals, and undertakes surveillance for selected vaccine preventable, or soon to be vaccine preventable, infectious diseases and adverse events following immunization severe enough to require hospitalization.
The second network is the Canadian Immunization Research Network, CIRN. CIRN organizes a network of networks that comprises eight subnetworks and does a broad range of vaccine-related surveillance and research. One of these subnetworks is the Clinical Trials Network, which has been involved in clinical trials related to candidate COVID-19 vaccines.
My experience related to this committee's mandate on Canadian and Chinese relations is restricted to a collaboration with a single Chinese manufacturer of a candidate COVID-19 vaccine. This is what I will describe, since I imagine that's the reason I was asked to present to the committee.
In mid-March 2020, exactly one year ago this week, I was asked to join a meeting with the National Research Council and CanSino Biologics about my centre, the Canadian Center for Vaccinology, or CCFV, and our network, CIRN, partnering with NRC and CanSino to undertake a phase one clinical trial in Canada for their adenovirus vectored COVID-19 vaccine candidate.
This vaccine had just finished enrolment of a phase one study in China, and preliminary safety information was soon going to be available. There was a plan to undertake a second follow-on phase one study in Canada to expand information generated from the first phase one trial, and to continue with the development of the vaccine in Canada following a meeting scheduled with Health Canada regulatory authorities.
The plan was, if the vaccine was demonstrated to be safe and effective by Canadian regulatory authorities, it would be manufactured in the NRC's facility in sufficient quantities to contribute to Canada's vaccine needs. A meeting with Health Canada regulators, NRC, CanSino and CCFV took place at the end of March and guidance around the design of that phase one study was received. A protocol for the phase one study was developed and, several weeks later in a follow-up meeting with Health Canada, further guidance was obtained. Based on that meeting, further modifications to the protocol were undertaken and the protocol was approved on May 15.
Arrangements were then made for the vaccine to be shipped from China to Halifax, where CCFV is located, on May 19. The vaccine moved from the company in China to the airport to be stored in a secure, temperature-controlled facility awaiting clearance for one of the flights that took place several times a week, at that time, from China to Toronto.
Over the next several weeks we were told which flights it would be on and then told the vaccine had not made it onto the flights because of lacking customs clearance. During this period, CanSino executives met with various Chinese government officials to determine what the problem was and what had to be done to get the approvals needed for exporting the vaccine from China. They were told various things and about various forms they were supposed to complete. They continued to complete whatever paperwork they were asked to provide.
Weeks later, in June, they were told that the Chinese government was setting up a new committee to review and approve any vaccines shipped out of the country, and that CanSino's approvals would be part of this new process that was going to be used for all vaccines from any company in China.
They continued to meet with government officials, but were not able to find out what the delay was. We were assured by the company that the delay was not political in nature, but rather was bureaucratic. Because of these delays, the phase one trial that we had been planning was becoming increasingly irrelevant as by this time, later in June and July, phase two trial data became available from studies that were being done in China.
While we were continuing to work on getting vaccines shipped to Canada, we assisted in the design of their phase three clinical trial, which would evaluate the efficacy of the vaccine. This phase three trial was planned for multiple countries around the world in which the rates of COVID-19 disease were high. These sites—