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Background
Canada’s independent drug authorization process is known around the world for its high standards and rigorous review process. Decisions are based on scientific and medical evidence. Vaccines authorized for use in Canada are safe, effective and of high quality.
The work to make sure a vaccine is safe starts before the regulatory process even begins. Exploratory, preclinical studies, and clinical trials are designed to assess the vaccine’s safety. Evidence from these activities is submitted to Health Canada for regulatory review. Health Canada’s scientific and medical reviewers then conduct a thorough and independent review of all vaccine data. Only then is a vaccine authorized for use in Canada. Learn more about how vaccines are approved in Canada.
Some people have reported adverse events (side effects) after being immunized with a COVID-19 vaccine in Canada. These adverse events aren’t necessarily related to the vaccine. For example, they may be:
- anxiety about immunization
- an allergic reaction to another substance
- related to a pre-existing condition
- coincidental
Summary of this week’s report updated April 16, 2021
- A total of 7,569,321 vaccine doses have been administered in Canada as of April 9, 2021. Adverse events (side effects) have been reported by 3,444 people. That’s about 5 people out of every 10,000 people vaccinated who have reported one or more adverse events.
- Of the 3,444 individual reports, 2,980 were considered non-serious (0.039% of all doses administered) and 464 were considered serious (0.006% of all doses administered).
- Most adverse events are mild and include soreness at the site of injection or a slight fever.
- Serious adverse events are rare, but do occur. They include anaphylaxis (a severe allergic reaction), which has been reported 60 times for all COVID-19 vaccines across Canada. That’s why you need to wait for a period of time after you receive a vaccination so that you can receive treatment in case of an allergic reaction.
- All serious events undergo medical review to see if there are any safety issues needing further action. These processes include meeting regularly to review the data with provincial and territorial partners, the regulator, research networks and medical advisors to ensure there are no safety issues that require action. Any unexpected safety concerns are detected quickly and acted upon immediately. At this time, there are no such safety issues identified in Canada.
- Following rare European reports of blood clots associated with low levels of blood platelets (thrombocytopenia), the National Advisory Committee on Immunization and the Chief Medical Officers of Health recently recommended that AstraZeneca COVID-19 vaccines should not be used in adults under age 55. This recommendation was made pending the outcome of the ongoing assessment by Health Canada. There has been one report of an individual with Thrombosis with Thrombocytopenia Syndrome following vaccination with COVISHIELD in Canada. Health Canada updated the product information and issued a public advisory on April 14, 2021. Health Canada will continue to monitor information from the manufacturers and international regulators about this safety issue.
- The benefits of vaccines authorized in Canada continue to outweigh the risks.
Article From: Government of Canada Website
