Vaccine development and approval in Canada

Vaccine development

Exploratory

Scientists develop a new vaccine.

Preclinical

Scientists conduct lab and animal studies before testing on humans.

Clinical Trials

Clinical trials

Phase I: 10s of volunteers

• Is the vaccine safe?
• What is a safe dose?
• Are there any side effects?

Phase II: 100s of volunteers

• How well does the vaccine work?
• Is it safe on a larger number of people?
• Safest and most effective dose?

Phase III: 1000s of volunteers

• Does the vaccine prevent disease?
• What are the side effects?

Application

Manufacturer submits application to Health Canada for review.

Review and approval of vaccines

Scientific Review

Teams of Health Canada experts conduct a thorough and independent review of all vaccine data.

For COVID-19 vaccines, Health Canada is using a fast-tracked process that allows manufacturers to submit data as it becomes available, and for Health Canada experts to start the review process right away. Vaccines will only be authorized once we have all necessary evidence.

Approval

Health Canada approves a vaccine if it is safe, it works, it meets manufacturing standards, and the benefits outweigh the risks.

Distribution

Governments coordinate the purchase, logistics and distribution of vaccines across Canada.

Vaccination

All Canadians have access to the vaccine.

Ongoing Monitoring and Review

Continuous monitoring and review to confirm the safety of the vaccine, and that benefits outweigh risks.