Legal & Regulatory > Canada > Canada’s COVID-19 Vaccination Strategy

Fasken Canada’s Dara Jospe and Denis Douville examine Canada’s COVID-19 vaccine strategy, from the steps the country has taken to expedite the approval process to its funding of R&D projects and the preparations needed for ensuring the necessary supply and distribution infrastructure is in place.

Vaccination is a historically successful strategy to prevent the spread of infectious diseases. The immunization of a large enough proportion of a population will reduce the percentage of vulnerable hosts to a level below an infectious disease’s transmission threshold, thus preventing its spread.[1] That is why vaccination is considered “one of the most promising counter-pandemic measures to COVID-19” and “essential in the future for reducing morbidity and mortality.”[2]

In this context, the Government of Canada is expediting regulatory approvals, funding research and development, and preparing for the supply and distribution of an eventual vaccine against COVID-19.

Canada’s efforts are part of a broader international and worldwide effort to develop a vaccine to immunize against and prevent the spread of COVID-19.[3] The scope and speed of these global efforts have progressed at what has been called “an unprecedented pace.”[4]

Details about the Government of Canada’s efforts follow.

1. Expediting Regulatory Approvals

The Canadian government has implemented temporary measures that are meant to accelerate the regulatory pathways for clinical trials and eventual approval, of a COVID-19 vaccine.

Generally speaking, Health Canada’s regulatory process requires manufacturers to put their vaccines through pre-clinical and clinical trials.[5] Following a successful clinical trial, Health Canada will review the safety and efficacy data to provide a product market authorization.[6]

In response to the COVID-19 pandemic, Health Canada intends to review COVID-19 vaccines as quickly as possible.[7] Health Canada introduced new regulatory measures to expedite the regulatory review of COVID-19 health products such as vaccines.

In particular, on May 23, 2020, the Minister of Health signed an interim order for clinical trials for medical devices and drugs related to COVID-19.[8] The order targets pharmaceutical and biologic drugs, which includes vaccinations. A stated objective of this order is to facilitate and make efficient clinical trials in Canada intended to address COVID-19.[9] In this regard, the interim order:

• provides a new path to obtain Health Canada authorization, which could otherwise not be provided under the general Food and Drugs Act and its corresponding Food and Drug Regulations;
• expands the definition of qualified clinical trial investigators to include, for example, pharmacists, rather than only physicians;
• permits clinical trials to be partially suspended or revoked, meaning that other non-suspended or revoked treatment groups can continue the trial in question; and,
• allows for relaxed consent requirements. For example, written consent can be provided from a distance, and non-written consent can be provided in certain circumstances..[10]

Additionally, on September 16, 2020, the Minister of Health signed the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19.[11] This interim order facilitates expedited authorizations for the importation, sale and advertising of drugs used in relation to COVID-19, including vaccines. To that end, the interim order provides the Minister of Health with new tools to:

• authorize drugs that are not yet licensed in Canada or elsewhere, by using a modified set of requirements;
• authorize drugs based on certain elements being approved by trusted foreign regulatory authorities; and,
• expand the use of currently authorized drugs to include a COVID-19 indication based on known evidence with, or without an application from the market authorization holder.[12]

The overall objective of the interim orders is to make the approval, sale, and importation of COVID-19 related drugs simpler and more expeditious, including for an eventual COVID-19 vaccine. The list of authorized clinical trials for COVID-19 vaccines, among other drugs, is listed on the Health Canada website.[13]

As of December 1, 2020, no vaccine to prevent COVID-19 has received Government of Canada approval.

2. Funding Research and Development

The Government of Canada has invested in scientific and medical research to accelerate the research and development of a COVID-19 vaccine.

Specifically, the Government of Canada has undertaken a “Plan to Mobilize Science to fight COVID-19,” which includes funding for the development of potential vaccines.[14] The plan includes funding to the:

• COVID-19 Response Fund, used to used to advance projects that are already underway by university researchers and others to respond to COVID-19, and intended to ensure a domestic supply of potential vaccines;[15]
• Strategic Innovation Fund, which assists companies and other private sector entities for large-scale projects, meant to assist with the development of a vaccine;[16]
• National Research Council of Canada to upgrade its Human Health Therapeutics facility in Montréal with the objective to develop, test and scale-up promising vaccine candidates to be ready for industrial production;[17] and,
• National Research Council of Canada for its Industrial Research Assistance program, which provides advisory services and research and development funding to Canadian companies that are developing COVID-19 vaccines.[18]

Overall, the funding is intended to assist companies in advancing research, progress vaccine candidacy in different stages of clinical trials, and generally assist the Canadian industry in the development of a COVID-19 vaccine.

Canada’s approach compares to other countries who have made similar investments to “fast-track” research and development of a vaccine.[19]

3. Preparing for Supply and Distribution

Currently, Canada has little to no capacity for mass production of a COVID-19 vaccine.[20]

However, the Canadian government has negotiated and signed agreements with pharmaceutical companies to provide for the supply and distribution of a potential vaccine in Canada, once it is approved.[21] Through these agreements, Canada has, as of December 1, 2020, reserved the equivalent of approximately 414 million doses of vaccines in development from several pharmaceutical companies.[22]

The federal government is also participating in and has committed approximately $220 million to the COVID-19 Vaccine Global Access Facility. This facility is an international procurement mechanism to deliver access to COVID-19 vaccines by investing in vaccine production capacity across multiple vaccine candidates. It is managed in partnership with the World Health Organization, among other organizations and partners.[23]

For distribution, the federal government is coordinating its various departments to purchase and distribute COVID-19 treatments and related supplies domestically, notably Public Services and Procurement Canada, the Public Health Agency of Canada, Health Canada, and Innovation, Science and Economic Development Canada.[24] The Canadian Armed Forces will also assist and intend to play an active role in the distribution of COVID-19 vaccines.[25] In particular, the military has committed teams to work with the Public Health Agency of Canada in order to plan for a vaccine’s eventual distribution.[26]

The intent of Canada’s supply and distribution efforts is to increase availability of a COVID-19 vaccine for Canadians once it is developed. These efforts appear to be in line with the notion that a vaccine’s effectiveness depends on its availability to a sufficient number of people representing a large enough fraction of the population.[27]

Towards Canadian Vaccination

The Canadian government’s efforts towards expedited regulatory approvals, funding for research and development, and supply and distribution are each designed to bring Canada closer to vaccination against COVID-19. The Government of Canada has stated that its objective is to offer vaccination for free and to all willing Canadians.[28] The exact date of vaccination will depend in part on these efforts. Based on current trends, Canada is predicted to approve its first vaccination by the end of 2020,[29] and begin vaccination in 2021.[30]

References

[1] Lea Skak Filtenborg Frederiksen et al., “The Long Road Toward COVID-19 Herd Immunity: Vaccine Platform Technologies and Mass Immunization Strategies,” Front Immunol. 2020; 11: 1817, online: <https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7385234/>.

[2] Frederiksen et al., supra note 1.

[3] World Health Organization, “172 countries and multiple candidate vaccines engaged in COVID-19 vaccine Global Access Facility,” August 24, 2020, online: <https://www.who.int/news/item/24-08-2020-172-countries-and-multiple-candidate-vaccines-engaged-in-covid-19-vaccine-global-access-facility>.

[4] Health Canada, “Preliminary guidance on key populations for early COVID-19 immunization,” November 3, 2020, online: <https://www.canada.ca/en/public-health/services/immunization/national-advisory-committee-on-immunization-naci/guidance-key-populations-early-covid-19-immunization.html>; World Health Organization, “Draft landscape of COVID-19 candidate vaccines,” November 12, 2020, online: <https://www.who.int/publications/m/item/draft-landscape-of-covid-19-candidate-vaccines>.

[5] Prime Minister’s Office, “Prime Minister announces funding to advance the development of Canadian COVID‑19 vaccine technologies,” October 23, 2020, online: <https://pm.gc.ca/en/news/news-releases/2020/10/23/prime-minister-announces-funding-advance-development-canadian-covid>.

[6] Public Services and Procurement Canada, “Government of Canada signs new agreements to secure additional vaccine candidate and treatment for COVID-19,” September 22, 2020, online: <https://www.canada.ca/en/public-services-procurement/news/2020/09/government-of-canada-signs-new-agreements-to-secure-additional-vaccine-candidate-and-treatment-for-covid-19.html>; Health Canada, “Drugs and vaccines for COVID-19,” November 26, 2020, online: <https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/drugs-vaccines-treatments/about.html>.

[7] Government of Canada, “What you need to know about the COVID-19 vaccine for Canada,” November 25, 2020, online: <https://www.canada.ca/en/public-health/services/diseases/2019-novel-coronavirus-infection/awareness-resources/know-vaccine.html>.

[8] Government of Canada, “Interim Order respecting clinical trials for medical devices and drugs relating to COVID-19,” May 23, 2020, online: <https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/interim-order-respecting-clinical-trials-medical-devices-drugs.html>.

[9] Government of Canada, “Drugs and vaccines for COVID-19,” supra note 6.

[10] More information on the interim order can be found in Health Canada’s guidance documents: “Applications for COVID-19 drug and medical device clinical trials under the Interim Order: Notice release of guidance documents,” May 27, 2020, online: <https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/interim-order-respecting-clinical-trials-medical-devices-drugs/notice-guidance.html>; Health Canada, “Applications for drug clinical trials under the Interim Order: Guidance document,” May 27, 2020, online: <https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/interim-order-respecting-clinical-trials-medical-devices-drugs/drug-guidance.html>.

[11] Health Canada, “Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19,” September 16, 2020, online: <https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/drugs-vaccines-treatments/interim-order-import-sale-advertising-drugs.html>.

[12] For more information see: Health Canada, “Information and application requirements for drugs authorized under the Interim Order: Guidance document,” October 16, 2020, online: <https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/drugs-vaccines-treatments/interim-order-import-sale-advertising-drugs/guidance.html>.

[13] Health Canada, “Drugs and vaccines for COVID-19: List of authorized clinical trials,” November 18, 2020, online: <https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/drugs-vaccines-treatments/list-authorized-trials.html>.

[14] Prime Minister’s Office, “Canada’s plan to mobilize science to fight COVID-19,” March 23, 2020, online: <https://pm.gc.ca/en/news/news-releases/2020/03/23/canadas-plan-mobilize-science-fight-covid-19>.

[15] Ibid.

[16] Ibid.; Prime Minister’s Office, “Prime Minister announces funding to advance the development of Canadian COVID‑19 vaccine technologies,” supra note 5.

[17] Prime Minister’s Office, “Canada’s plan to mobilize science to fight COVID-19,” supra note 14.

[18] National Research Council Canada, “Funding domestic vaccine candidates as part of the Government of Canada’s COVID‑19 response,” October 23, 2020, online: <https://nrc.canada.ca/en/stories/funding-domestic-vaccine-candidates-part-government-canadas-covid-19-response>.

[19] Frederiksen et al., supra note 1.

[20] Henri Ouellette-Vézina and Mélanie Marquis, La Presse, “Comment la distribution du vaccin au Canada se fera-t-elle?,” November 25, 2020, online: <https://www.lapresse.ca/covid-19/2020-11-25/comment-la-distribution-du-vaccin-au-canada-se-fera-t-elle.php>.

[21]Public Services and Procurement Canada, “Government of Canada signs new agreements to secure additional vaccine candidate and treatment for COVID-19,” supra note 6; Prime Minister’s Office, “Prime Minister announces funding to advance the development of Canadian COVID‑19 vaccine technologies,” supra note 5.

[22] Henri Ouellette-Vézina and Mélanie Marquis, La Presse, “Comment la distribution du vaccin au Canada se fera-t-elle?,” November 25, 2020, online: <https://www.lapresse.ca/covid-19/2020-11-25/comment-la-distribution-du-vaccin-au-canada-se-fera-t-elle.php>.

[23] Prime Minister’s Office, “New agreements to secure additional vaccine candidates for COVID-19,” September 25, 2020, online: <https://pm.gc.ca/en/news/news-releases/2020/09/25/new-agreements-secure-additional-vaccine-candidates-covid-19>.

[24] Public Services and Procurement Canada, “Government of Canada signs new agreement for a COVID-19 antibody therapy,” November 24, 2020, online: <https://www.canada.ca/en/public-services-procurement/news/2020/11/government-of-canada-signs-new-agreement-for-a-covid-19-antibody-therapy0.html>.

[25] Rachel Aiello, CTV News, “Canadian military prepares to help with COVID-19 vaccine distribution,” November 16, 2020, online: <https://www.ctvnews.ca/health/coronavirus/canadian-military-prepares-to-help-with-covid-19-vaccine-distribution-1.5191182>.

[26] Rachel Aiello, CTV News, November 27, 2020, “Top general to lead vaccine rollout, aims to immunize majority by September: PM,” online: <https://www.ctvnews.ca/health/coronavirus/former-nato-commander-to-lead-canada-s-vaccine-distribution-rollout-1.5207122>.

[27] Frederiksen et al., supra note 1.

[28] Government of Canada, “What you need to know about the COVID-19 vaccine for Canada,” supra note 7.

[29] Amanda Connolly, Global News, November 26, 2020, “Canada could approve 1st coronavirus vaccine by end of 2020,” online: <https://globalnews.ca/news/7485916/coronavirus-vaccine-rollout-canada-priority-groups/>.

[30] Lina Dib, La Presse Canadienne, November 29, 220, “COVID-19: les Canadiens seront vaccinés, mais pas les premiers, prévient Trudeau,” online: <https://www.ledroit.com/actualites/covid-19/covid-19-les-canadiens-seront-vaccines-mais-pas-les-premiers-previent-trudeau-video-44c2dec15a28c3f793ebcaf6ac0bdf5c>.