Guidance for market authorization requirements for COVID-19 vaccines: Review process, communications and transparency

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Review process

Decisions made about COVID-19 vaccines will follow processes established for reviews under the modified requirements for COVID-19 drugs. Health Canada will start rolling reviews to build towards a complete dossier for each vaccine. The dossier will include data to support the safety, efficacy and quality of the proposed vaccine.

In accordance with section 21.1 (3) of the Food and Drugs Act, we will share information on the safety and efficacy of a vaccine with the Public Health Agency of Canada and the National Advisory Committee on Immunization (NACI). This collaboration will begin as early as possible to assist public health recommendations, as described in NACI's published guidance.

With the sponsor's agreement, we may also collaborate with international regulatory partners to share analyses and perspectives and supplement the Health Canada review process.

Teams of medical and scientific experts at Health Canada will carry out the vaccine reviews. These people have experience in reviewing complex data and study results on the safety, efficacy and quality of a variety of vaccines. Review activities include developing strategies for the continued accumulation of data on vaccine quality, safety and effectiveness following authorization through terms and conditions and/or pharmacovigilance activities, including post-market studies.

Collaborative review with international regulatory partners may be possible in cases where manufacturers file a rolling submission simultaneously with Health Canada and another jurisdiction with which there is a mutual collaborative agreement. While recommendations may be informed by discussions between regulatory partners during a collaborative review, authorization decisions will be based on a thorough assessment of the evidence by Health Canada. These decisions are independent of those made by international partners.

Authorization decisions will be based on the overall benefits and risks. We will also consider all of the data available, including the results that have been provided in the rolling submission and the current knowledge about the virus and disease, which will need to be continually monitored following authorization. Sources of knowledge include the scientific literature, public health and surveillance data, and collaborations with our international regulatory partners.

Vaccines are given to healthy individuals, so the tolerance for risk is much lower than that of other health products. The bar for safety is understandably higher.

Communications and transparency

Information about vaccines under review and those that are authorized is posted on our website or provided upon request.

Our lists for drug and health product submissions under review include COVID-19 vaccines under review. Once authorized, COVID-19 vaccines will be included on our list of authorized drugs and vaccines for COVID-19. We will publish a regulatory decision summary at the time of authorization. A summary basis of decision follows, giving health care system partners and the public access to data and information supporting the authorization. We will include information on drug inspection outcomes and measures in the drug and health product inspections database. Detailed clinical data will be published under the Public Release of Clinical Information initiative, in accordance with Health Canada's guidance on the public release of clinical information. We publish reported side effects following COVID-19 vaccination in Canada on a weekly basis. We provide the most up-to-date approved Canadian-specific Addendum RMPs for COVID-19 vaccines in their entirety, in conjunction with the core RMPs, to external stakeholders upon request.

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