Question Period Note: ACCESS TO VACCINES FOR COVID-19

• What is Health Canada doing to help Canadians get access to vaccines for COVID-19?

• Since the start of the pandemic, Health Canada has worked closely with other departments and the Vaccine Task Force to develop and implement Canada's vaccine strategy.

• In September, I issued an Interim Order to expedite the review of drugs and vaccines by allowing companies to submit safety and efficacy data as soon as it becomes available.

• Health Canada only authorizes a vaccine if it is supported by very robust scientific data and evidence showing that the benefits of the vaccine clearly outweigh any potential risks.

• On December 9, Health Canada authorized Canada’s first COVID-19 vaccine: Pfizer-BioNTech.

• Once this vaccine is in use in Canada, it will be closely monitored through Canada’s vaccine safety monitoring system that involves healthcare professionals, vaccine manufacturers, the provinces and territories, the Public Health Agency of Canada, and Health Canada.

• If any new safety issues are identified, Health Canada will take appropriate action.

• Health Canada continues to review three other COVID-19 vaccines for authorization: AstraZeneca, Moderna, and Janssen.

Advance Purchase Agreements

• The Government has announced agreements to secure millions of doses of seven leading vaccine candidates, including those being developed by AstraZeneca, Sanofi/GlaxoSmithKline, Johnson & Johnson, Novavax, Moderna, Pfizer, and Medicago.
• The supply of any of these vaccines is dependent on it successfully completing clinical trials and authorization by Health Canada.

Stakeholder Engagement

Information about health products for COVID-19 has been consolidated into a new website for the health product industry, so they know how to apply for regulatory approval and who to contact for questions. Information relevant to health professionals and Canadians is provided on the COVID-19 website.

Health Canada is actively working with the manufacturers of the vaccine candidates recommended by the Vaccines Task Force. While regulatory approvals are separate from the procurement process, Health Canada is prepared to receive and expedite vaccine drug submissions.

Clinical Trials

Health Canada is facilitating clinical trials related to COVID-19 in Canada. Clinical trials are conducted to determine whether new vaccine are both safe and effective in human beings. Clinical trial applications will be reviewed and approved by Health Canada in under 15 days.

Vaccine Injury Support Program (VISP)

Vaccination is a shared responsibility among the federal, provincial and territorial governments. The federal government regulates vaccines for use in Canada, and the provinces and territories are responsible for the delivery of vaccination programs.

PHAC recently received approval to establish a Vaccine Injury Support Program (VISP). The VISP would cover all vaccines administered in Canadian territory, including COVID-19 vaccines, as of December 8, 2020. Officials have been working on program design and implementation, and in early December 2020, the Public Health Agency of Canada began consulting with provinces and territories.

SYNOPSIS

• The COVID-19 pandemic has created unprecedented challenges to Canada’s medical system, and there is a need for vaccines to support the response.
IF PRESSED ON ALLERGIC REACTIONS TO PFIZER VACCINE

• Health Canada is aware of reports of serious allergic reactions associated with the Pfizer BioNTech COVID-19 vaccine in the United Kingdom. We understand that the two people who experienced these events had a history of allergies and that both have recovered.

• Health Canada has reached out to the Medicines and Healthcare Products Regulatory Agency to learn more about these events and the risk management measures in the United Kingdom. We are also gathering information from the manufacturer.

• If any new safety issues are identified, Health Canada will take appropriate action, which could include communicating the new risk to Canadians and healthcare providers or changing the recommended use of the product, before vaccination starts in Canada.
IF PRESSED ON VACCINE INJURY COMPENSATION

• While serious adverse reactions to authorized vaccines are rare, they can occur.

• Several countries have vaccine injury compensation programs that compensate people who suffer a serious vaccine injury.

• In Canada, Quebec is the only jurisdiction that has this type of program.

• The federal government is consulting with provinces and territories on the creation of a pan-Canadian vaccine injury compensation program as vaccination is an area of shared jurisdiction.
IF PRESSED ON THE TIMING OF APPROVAL
• The vaccines are being reviewed as rolling submissions under the Interim Order signed in September, meaning that the evidence required to support their potential approval will be provided to Health Canada as it becomes available.

• Each manufacturer is filing a detailed plan that lays out the timing and content of the subsequent data and information submissions to Health Canada to support the rolling reviews.

• Timing for the completion of the rolling submission will depend on the outcomes of the companies’ ongoing clinical trials.
IF PRESSED ON PRE-POSITIONING
• The Interim Order allows for pre-positioning of unapproved therapies (drugs and vaccines) for COVID-19.
• Health Canada can consider allowing pre-positioning of these unapproved therapies when there has been a filing in Canada or in another trusted regulator, and where requested by the Chief Public Health Officer so that the product can be positioned within Canada and can be readily deployed upon a market approval.
Decisions on pre-positioning will be made on a case by case basis in order to meet public health needs.
IF PRESSED ON THE RECENT PAUSES TO VACCINE CLINICAL TRIALS IN THE U.S.

• Temporary pauses to clinical trials can be expected, and show that the safety monitoring system is functioning effectively. Any safety issues are being carefully assessed by regulators and independent safety monitoring boards, before decisions are made about trials resuming.

• All available safety data will be assessed by Health Canada as part of the vaccine submission review.
IF PRESSED ON VACCINE AVAILABILITY

• Health Canada is closely monitoring global vaccine and treatment development and is in active discussions with several vaccine manufacturers and researchers to provide regulatory and scientific advice for vaccine clinical trials that may launch in Canada.
• While recognizing the urgent need for vaccines, all products will undergo a rigorous scientific review to ensure they meet standards for safety, efficacy and quality before being authorized.
IF PRESSED ON INTERIM ORDER

• The Interim Order will allow Health Canada to expedite the review and authorization of drugs and vaccines for Canadians in four ways:
• authorizing a brand new drug based on available evidence with more agile administrative and application requirements;
• authorizing a new drug based on certain elements being approved by a trusted foreign regulatory authority;
• allowing expanded use of an already-approved drug to include COVID-19-related indications that were not in the original authorization; and
• permitting the Public Health Agency of Canada (PHAC) to arrange for the importation of promising COVID-19 drugs for placement (pre-positioning) in Canadian facilities prior to their authorization in Canada if the Government of Canada has entered into a contract for its procurement.
• Health Canada will ensure that these drugs are supported by sufficient evidence of safety, efficacy and quality.
• In addition, under the Interim Order, Health Canada can impose
• terms and conditions on the authorization, such as risk mitigation measures and periodic assessments of safety information.
• Health Canada will monitor the safety and effectiveness of these drugs and will take immediate action, including the suspension or cancellation of authorizations or establishment licenses, if required, to protect the health and safety of Canadians.
IF PRESSED ON CLINICAL TRIALS

• All vaccines must first be tested in clinical trials to assess their safety and efficacy. Clinical trials ensure the quality of the study, protection of the patient, and the proper collection and retention of outcomes. It is the best mechanism to provide trial volunteers access to new drugs before they are approved.

• The Department is working hard to facilitate and expedite as many clinical trials for COVID-19 in Canada as possible, without compromising their quality. To this end, in May I approved an Interim Order that supports clinical trials. Among its benefits, the Interim Order reduces the administrative burden for sponsors without compromising the safety of participants, and makes it easier to set up trials across Canada to facilitate access. As of November 18, 2020, Health Canada has authorized 14 clinical trials submitted under the Interim Order.
IF PRESSED ON UNAPPROVED PRODUCTS

• Results from large, well-designed clinical trials are needed to make any conclusions on the safety and efficacy of any or vaccines.

• Health Canada is expediting the review of clinical trials so that products can be studied and made available to Canadians as quickly as possible.
IF PRESSED ON INTERNATIONAL COLLABORATION

• Health Canada is leveraging its strong international partnerships with the US Food and Drug Administration, the European Medicines Agency, and the World Health Organization, amongst others, to share information and to raise our collective level of awareness of evidence-based approaches for vaccines and treatments. The objective is to work towards alignment on regulatory requirements and to stay informed of any potential treatments.
IF PRESSED ON STAKEHOLDER ENGAGEMENT

• Health Canada is actively engaging with stakeholders in the health product industry to proactively identify, track and provide support to sponsors of clinical trials for vaccines for COVID-19.

• Health Canada recognizes that many stakeholders, health professionals and Canadians are looking for the latest information about health products for COVID-19. The department has created a new website for the health product industry, so they know how to apply for regulatory approval and who to contact for questions. We are also making sure information relevant to health professionals and Canadians is up-to-date on our website.