Question Period Note: VACCINE RESEARCH AND TIMELINES

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• The Government of Canada is committed to securing promising COVID-19 vaccines for Canada.

• The Government of Canada has entered into seven agreements with AstraZeneca, Sanofi/GlaxoSmithKline, Johnson & Johnson, Novavax, Moderna, Medicago, and Pfizer to secure millions of doses of the leading COVID-19 vaccines.

• Three of the companies with which Canada has signed agreements - Pfizer, Moderna, and AstraZeneca - have put out press releases indicating positive results and have also submitted their application to Health Canada for regulatory review.

• To complement these agreements, the Government of Canada has signed an optional purchase agreement with Gavi, committing approximately $220 million to procure roughly 15 million vaccine doses for Canadians from the COVAX Facility’s diverse portfolio of candidates.

• An additional $220 million will be channeled through the COVAX Advance Market Commitment to purchase doses for low- and middle-income countries.

• The Government of Canada has also invested more than $1 billion in support of a national medical research strategy to fight COVID-19 that includes vaccine development, production of treatments, and tracking of the virus.

• A Vaccine Task Force has been convened to provide advice to the Government of Canada on how best to support domestic vaccine research and help ensure Canadian leadership in vaccine development, related bio-manufacturing and international partnerships.

Vaccine development is a highly complex and long process that typically takes over 10 years due to the extensive research required to ensure a safe and effective product for human use. Global efforts are underway to develop a COVID-19 vaccine and work is progressing at an unprecedented pace. As of November 23, 2020, there are over 140 COVID-19 candidate vaccines in different stages of development by academia and industry globally, with 54 vaccines in clinical trials (54 vaccines in Phase 1 and/or 2, 13 vaccines in Phase 3, and 6 vaccines approved for early or limited use). Phase 3 clinical trials, which are designed to measure how well a vaccine will prevent COVID-19, have been registered in the UK, the US, Brazil, South Africa, Pakistan, Russia and the UAE. China and Russia have provided early approvals for vaccines without waiting for the results of Phase 3 trials, which has prompted expert concern about serious risks worldwide.

Government of Canada investments
On March 11, 2020, the Government of Canada announced a $1 billion package to help Canadians cope with the COVID-19 outbreak, which included $275 million for coronavirus research and medical countermeasures. Major investments to date include supporting vaccine development efforts by Quebec-based Medicago and Saskatchewan-based VIDO-Intervac.

Through the first round of its COVID-19 Rapid Research Funding Opportunities, Canadian Institutes of Health Research (CIHR) invested over $16 million in14 vaccine-related projects, including ones focused on identifying candidate vaccines through different animal models, which could be suitable for future clinical trials in humans. These projects targeted a range of vaccine strategies and, in some cases, involved industry partnerships (e.g., Medicago; Inovio) or were supported by the Public Health Agency of Canada (PHAC). Research included, for example, a focus on vertical transmission (mother to child), immune enhancement, and nanoparticle-based vaccine. One such example of a research project is from Dr. Denis Leclerc and his team from Université Laval who were awarded $717,645 in February 2020, through CIHR’s first Rapid Response competition to develop the most robust vaccine that will prevent COVID-19. The team has already developed a nanoparticle that has the potential to bond with the virus and trigger a general immune response that aims to motivate the immune system to attack the virus before it can infect cells. Another prominent example of a project is the one by a renowned expert in the field, Dr. Ève Dubé of Université Laval, who received a $499,089 grant to research online discourses related to COVID-19 in Canada (tweets and comments on news media reports) and to describe individual and community understanding of disease, priorities, fears, etc., including public health messaging that may impact the acceptance of measures to limit the spread of COVID-19. Her research will also identify interventions that will help build public trust in authorities responsible for disease transmission tracking and management, while dispelling unfounded rumours and xenophobic discourse.

CIHR also funds the Canadian Immunization Research Network (CIRN), a national network that undertakes coordinated, collaborative, and multi-disciplinary vaccine and immunization-related research. This includes examining various biomedical research questions and aspects of the vaccine life cycle including safety, short- and long-term effectiveness and protection, as well as social issues like hesitancy and uptake. CIRN has established capacity for timely evaluation of vaccines for a variety of infectious diseases, seeks to continue to improve immunization programs and coverage nationwide, and has built strong links between the research community and key decision makers. On April 7, CIHR and PHAC provided $1 million to CIRN’s Serious Outcomes Surveillance Network to gather data related to COVID-19 symptoms, as well as possible treatments and risk factors, to inform Canada’s public health response to COVID-19.
On April 23, 2020, the Prime Minister announced more than $1 billion in support of a national medical research strategy to fight COVID-19 that includes vaccine development, the production of treatments, and tracking of the virus.

Investments were announced for the National Research Council of Canada to enhance its bio-manufacturing capacity to prepare for production of a COVID-19 vaccine, while investments through the Strategic Innovation Fund continue to support COVID-19 vaccine and therapy research and development led by the private sector.

Funding will also support academia and research networks to conduct vaccine-related research and clinical trials, and to enhance Canada’s capacity to monitor vaccine safety and effectiveness.

These investments contribute to Canada’s commitment to the Coronavirus Global Response, a global pledging initiative that raised more than $17.9 billion (USD) to accelerate the development of and equitable access to new diagnostic capabilities, therapeutics, and vaccines, including through support to the World Health Organization’s Access to COVID-19 Tools Accelerator (ACT-A).

Within ACT-A, Gavi, the Vaccine Alliance, has teamed up with the Coalition for Epidemic Preparedness Innovations (CEPI) and the World Health Organization, to create a pooled procurement mechanism for the purchase of COVID-19 vaccines called the COVAX Facility. This will pool the resources of economies to make advanced purchase agreements for a number of promising vaccine candidates. The Facility will include both low- and lower-middle income countries, whose purchases will be financed by official development assistance through the COVAX Advanced Market Commitment (AMC), and upper-middle and high-income countries who will self-finance their own purchase of vaccine doses for domestic use through the Facility. The Facility is a strong multilateral mechanism that will support timely access to vaccines for all participating economies.

On September 18, Canada signed a binding commitment with the Gavi Alliance to participate in the Facility through an optional purchase agreement that could see Canada acquire vaccine doses through the Facility for upwards of 20% of the Canadian population. An additional $220 million will be channeled through the COVAX Advance Market Commitment to purchase doses for low- and middle-income countries. By joining, Canada is contributing to collective efforts towards a safe, effective, and affordable COVID-19 vaccine, in line with the Prime Minister’s commitment to help ensure that once a vaccine is developed, it will be produced at a scale and cost accessible to all countries. As of November 19, 95 high-income economies have formally joined the Facility along with 92 lower-income countries that are expected to participate in the Advance Market Commitment.

As of October 25, 2020, the Government of Canada has secured access to seven leading vaccine candidates for Canadians through agreements with Pfizer/BioNTech, Moderna, Janssen/Johnson & Johnson, Novavax, Sanofi/GlaxoSmithKline, Medicago, and AstraZeneca. Pfizer/BioNTech will supply a minimum of 20 million doses of its BNT162 mRNA-based vaccine candidate, while Moderna will provide up to 56 million doses of its mRNA-1273 vaccine candidate. Sanofi/GlaxoSmithKline will supply up to 72 million of doses of their protein subunit vaccine candidate. Agreements in principle have been struck with Janssen/Johnson & Johnson to supply up to 38 million doses of its Ad26.COV2.S vaccine candidate; Novavax to supply up to 76 million doses of its NVX-CoV2373 vaccine; Medicago up to 76 million doses of its recombinant plant-derived COVID-19 vaccine; and, AstraZeneca to supply up to 20 million doses of its viral vector vaccine candidate.

The development of a diverse portfolio of promising candidate technologies, informed by expert advice, will mitigate the risk of vaccines failing to reach market. Of the seven vaccine candidates with whom Canada has established agreements, five of these developers are in phase 3, one is in phase 2/3 and one is in stage 1/2. Should Canada find itself in the enviable position of procuring more vaccine than needed for the Canadian population, the government could stockpile excess supply for future use and/or explore other opportunities.

Vaccine research and development in Canada
At least 30 organizations in Canada are developing vaccines (some are developing multiple vaccine strategies) using 7 novel and existing vaccine platforms.

Medicago is the only vaccine developer that is actively conducting vaccine clinical trials in Canada. On July 14, 2020, Medicago launched its COVID-19 vaccine candidate’s Phase 1 clinical trial in healthy adults. Following promising phase 1 results, on November 12, the company announced their plans to start of Phase 2/3 clinical trials, to be conducted in Canada and, pending approval of the Food and Drug Administration, in the United States. Their candidate, a virus-like-particle produced in plants, is to be tested in combination with a proprietary adjuvant developed by GSK.

On May 15, 2020, Health Canada authorized CanSino Biologics Inc. (CanSinoBio) vaccine candidate for a Phase 1/2 clinical trial in healthy adults in Canada. However, this research initiative has since been cancelled, as CanSino could not secure Chinese government approval to ship the vaccine clinical trial lots to Canada.

To facilitate impactful clinical trial research in Canada, government and experts are convening a series of COVID-19 Vaccine Clinical Trials Discussion Forums. Further, a COVID-19 Vaccine Task Force provides advice to the Government of Canada on investments in vaccine development and bio-manufacturing for COVID-19. Task force members include vaccine experts, as well as industry leaders with proven ability in developing and commercializing vaccines. The co-Chairs of the task force are Joanne Langley, Head of Infectious Diseases at the IWK Health Centre in Halifax and Professor in the Department of Community Health and Epidemiology at Dalhousie University, and J. Mark Lievonen, former President of Sanofi Pasteur Limited.

The Government of Canada has already announced $44 million in funding to support upgrades to the NRC’s facilities in Montreal to enable compliance with Good Manufacturing Practice (GMP) standards, to ensure readiness for Canadian bioprocessing of potential vaccine candidates as they become available.

While every effort in Canada is being made to expedite vaccine development - safety, efficacy and quality must not be compromised. However, the Government of Canada is reviewing its regulatory pathways to help expedite access to safe and effective vaccine for Canadians.

We are also working with international regulators and partners to help fast-track clinical trials and applications for vaccines, treatments and diagnostic tests and share information on any signals of global supply disruptions. For example, the Government of Canada is monitoring international regulators’ reviews of safety signals detected during trials of the AstraZeneca vaccine candidate.

As of November 23, 2020, Health Canada has received three submission for authorization for a COVID-19 vaccine from AstraZeneca, Moderna and Pfizer. All three manufacturers are seeking authorization under Health Canada’s Interim Order on drugs and vaccines, which allows companies to submit data on the vaccine as it becomes available. This will allow the Health Canada to start its review right away, while information continues to come in, so that the Health Canada can speed up the review process.

Preparing provinces and territories for COVID-19 vaccine deployment
Provincial and territorial governments deliver vaccination programs and determine public health requirements in their jurisdictions, while considering national vaccine expert advice. Planning is underway and will take into account guidance from Canada’s National Advisory Committee on Immunization (NACI), to prepare for vaccine availability and administration through public immunization programs.

On November 3, NACI released its preliminary guidance on key populations for early COVID-19 vaccination, outlining a recommended targeted vaccination program. NACI’s preliminary guidance outlines a targeted vaccination program that achieves public health goals as efficiently, effectively and equitably as possible when vaccine supply is limited. Their recommendations are a starting point that will help inform government decision-making around rolling-out vaccine programs once Canada has access to safe and effect COVID-19 vaccines.

In addition, we are working with provinces and territories to ensure that the health care system is prepared to roll out a national vaccination program when a COVID-19 vaccine becomes available, including ensuring that we have sufficient supplies such as needles and syringes, for vaccination clinics.

SYNOPSIS
The Government of Canada is committed to supporting the timely development of a COVID-19 vaccine and securing sufficient supply for Canadians.
IF PRESSED…

• Through our $1 billion investment in COVID-19 vaccine and therapies R&D, the Government of Canada is supporting multiple organizations who are working at unprecedented speed to develop candidate vaccines and treatments.

• On November 12, Medicago, headquartered in Quebec City, announced their plans to start Phase 2/3 clinical trials of their COVID vaccine to be conducted in Canada.

• We are working closely with academia and the private sector to advance research and development of candidate vaccines by partnering on pre-clinical research, bio-manufacturing requirements to support large-scale production, enhancing capacity and access for clinical trials, and seeking solutions for domestic capacity.

• Advance purchase agreements with suppliers are an investment in the promise of vaccines.

• Novel vaccines often fail during development, which is why Canada has purchased more supply than is needed for the entire population.

• A diverse portfolio of vaccine candidates will give Canada the greatest chance of earliest access to safe and effective vaccines.

• No one wants to see vaccine doses go unused. Canada will work closely with international partners, including Gavi, the COVAX Facility, and vaccine manufacturers, to ensure that all possible options are explored in developing mechanisms to ensure doses get to people around the world who need them.