Vaccines and treatments for COVID-19: Safety after authorization

On this page

• Safety after authorization (pharmacovigilance)
• Monitoring COVID-19 variants
• Reporting safety concerns for vaccines
• Treatment safety and reporting safety concerns for drugs
• Videos, posters and infographics to share

Vaccine safety after authorization (pharmacovigilance)

Once a vaccine has been authorized for use in Canada, we then monitor its safety and effectiveness (how well it works) in people. This monitoring system is called post-market surveillance.

During the COVID-19 pandemic, we're increasing:

• our monitoring and assessment activities of emerging safety issues
• collaboration and information-sharing with our partners here in Canada and around the world, such as the World Health Organization

Companies are also required to continuously monitor the use of their health products and report any side effects to Health Canada. This includes notifying us of potential safety concerns that weren't observed during clinical trials. A company may also be:

• asked to perform other risk monitoring activities or post-market studies (beyond existing routine collection and assessment requirements)
• encouraged to fast-track reporting of possible side effects associated with COVID-19 vaccines

Health Canada also monitors other sources of information, including actions taken for safety reasons by international regulatory agencies. Our goal is to quickly:

• respond to new information
• communicate risks to health care professionals and the public

Learn more about vaccine safety, concerns and possible side effects.

Monitoring COVID-19 variants

Genetic variations of viruses such as the one that causes COVID-19 are common. The federal government is closely monitoring the genetic variants of the virus that causes COVID-19. This includes those identified in the U.K. and South Africa as well as any potential future variants.

Health Canada is monitoring the emerging variants closely. We are working with manufacturers and international regulators to assess the impact of the new variants on the effectiveness of approved vaccines and treatments. If an issue is identified, we will work quickly with the manufacturers and public health laboratories to mitigate those risks and inform Canadians.

Reporting safety concerns for vaccines

Anyone who witnesses or experiences a possible reaction to a vaccine is encouraged to report it to their health care provider.

Health care providers are required to report possible reactions following vaccination to their local public health authority. The public health authority then reports them to the Public Health Agency of Canada.

COVID-19 vaccine safety: Weekly report on possible reactions following vaccination

Treatment safety and reporting safety concerns for drugs

Health Canada also has a strong monitoring system for drug safety.

Anyone who witnesses or experiences a side effect to a drug is strongly encouraged to report it. You can also work with your health care provider to submit a report. They may offer additional information that could be useful for our assessment.

Videos, posters and infographics to share

• COVID-19: How vaccines are developed (video)
• Vaccine development and approval in Canada (infographic)
• What you need to know about the COVID-19 vaccine for Canada (poster)

Related links

• Vaccine safety, concerns and possible side effects
• Drugs and vaccines for COVID-19

For health care professionals

• Contact information for adverse events following immunization
• Canadian Adverse Events Following Immunization Surveillance System
• MedEffect Canada: Post market surveillance for drugs and health products