VACCINE SAFETY

Vaccine Safety in Canada

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Vaccines are one of the safest and most effective ways to protect individuals and communities from serious infectious diseases. In Canada, vaccines undergo rigorous testing and continuous monitoring to ensure their safety and effectiveness. This page outlines how vaccines are developed and approved, who they are recommended for, and how their safety is monitored.

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Vaccine Development and Approval in Canada

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Before a vaccine is made available to the public, it must go through a strict regulatory process to ensure its safety, quality, and effectiveness. The steps include:

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1. Preclinical Research – Vaccines are first tested in laboratories and on animals to assess their potential effectiveness and safety.

2. Clinical Trials – Vaccines undergo three phases of human trials:

   • Phase 1: Small groups of healthy volunteers receive the vaccine to evaluate its safety and determine appropriate dosages.

   • Phase 2: A larger group of people receive the vaccine to assess its immune response and side effects.

   • Phase 3: Thousands of participants are involved to confirm effectiveness and monitor rare side effects.

3. Health Canada Review and Approval – Health Canada thoroughly evaluates all clinical trial data before approving a vaccine for use. Only vaccines that meet strict safety and efficacy standards receive authorization.

4. Ongoing Quality Control – Even after approval, each batch of vaccines is tested to ensure continued safety and effectiveness before distribution.​

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Recommendations for Use

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The National Advisory Committee on Immunization (NACI) provides expert guidance on vaccine use in Canada. These recommendations are based on scientific evidence and include:

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• Which vaccines should be administered and at what ages.

• Special recommendations for high-risk groups, such as older adults, pregnant individuals, and those with chronic health conditions.

• Guidelines for booster doses and seasonal vaccines, like the annual flu shot.

• Recommendations for travel vaccines and those needed in outbreak situations.

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Each province and territory follows NACI’s guidance while tailoring immunization programs to meet local public health needs.

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Vaccine Safety Monitoring in Canada

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Vaccine safety does not stop after approval. Canada has a comprehensive monitoring system to track and assess vaccine safety in real-time. Key elements include:

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• Post-Market Surveillance – Health Canada and the Public Health Agency of Canada (PHAC) continuously monitor vaccine safety through reports from healthcare providers and the public.

• The Canadian Adverse Events Following Immunization Surveillance System (CAEFISS) – This national system collects and analyzes reports of possible side effects from vaccines.

• Vaccine Safety Datalink Canada (VSDC) – A network of researchers and public health experts who study vaccine safety trends.

• Global Collaboration – Canada works with international health organizations, such as the World Health Organization (WHO), to share data and enhance vaccine safety measures worldwide.

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Most vaccine side effects are mild and temporary, such as a sore arm or mild fever. Serious reactions are extremely rare, and Canada’s monitoring systems ensure rapid investigation and response when needed.

 

Protecting Public Health

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Vaccines save lives by preventing serious diseases and reducing the burden on the healthcare system. By following Canada’s evidence-based vaccine recommendations, you can help protect yourself, your family, and your community.

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For more information on vaccines and immunization schedules, visit Canada.ca/vaccines.