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Vaccine Approvals & Development

Canada has one of the most thorough systems to approve new vaccines for use in people.

Last updated: August 27, 2021


Vaccine approval process and clinical trials

During vaccine development, vaccines are first tested in animals before being studied in humans. Testing in humans is done over three phases of clinical trials. These trials provide crucial information on vaccine safety as well as effectiveness.

Phase 1 

  • Usually involves up to 100 healthy adults 
  • Assesses whether there are any initial safety concerns 
  • Assesses whether the vaccine creates the right immune response

Phase 2 

  • Usually involves up to 500 participants 
  • Assesses safety concerns 
  • Determines the amount of vaccine that creates the right immune response. 

Phase 3 

  • Usually involves anywhere from thousands to tens of thousands of people 
  • Assesses the safety of the vaccine 
  • Assesses the ability of the vaccine to prevent the disease
Once vaccine manufacturers have successfully completed all three phases, they must submit the data to Health Canada. They have a regulatory authority responsible for approving vaccines for human use. 

The regulatory authority ensures that the laboratory and clinical studies:
  • provide evidence of product safety 
  • that the manufacturing process meets a high standard
  • that the product meets the highest standards of quality.

Results from COVID-19 vaccine trials

The COVID-19 vaccines completing Phase 3 clinical trials have been tested in a range of people. This includes: 
  • adults from a range of ages including older adults, 
  • those with stable underlying chronic diseases, and 
  • a range of ethnicities. 
Vaccines are tested in adults before being tested in children. Clinical trials of the Pfizer-BioNTech and Moderna COVID-19 vaccines in young people age 12 and older showed the vaccines were highly effective in this age group.

Learn more about COVID-19 vaccine development and clinical trials from Health Canada.

Canadian vaccine supply

Canada is recognized around the world for its high standards for drug and vaccine review, approvals and monitoring systems; these will not be compromised. 

The Government of Canada has gained real-time access to manufacturer clinical trial data for the most promising vaccine candidates and is working with the global regulatory community to ensure COVID-19 vaccines are safe and effective before regular approval is granted.

Because of unprecedented global funding and collaboration, more than 150 vaccine candidates are being researched around the world at this time.

The Government of Canada is investing in made-in-Canada research

It also has advanced purchase agreements for many hundreds of millions of doses of the most promising vaccine candidates from around the world. This will give Canadians access to safe and effective vaccines as soon as they are ready.

Health Canada is focusing on reviewing and approving COVID-19 vaccines as quickly as possible while ensuring that they are well-studied and safe.


SOURCE: Vaccine Approvals & Development ( )
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