Public Health Ontario releases Annual Report on Vaccine Safety in Ontario
Results show vaccines to be safe with few cases of adverse reaction
Toronto, February 24, 2014—Vaccines are safe and have a low risk of adverse reactions, according to the Annual Report on Vaccine Safety in Ontario, 2012, released today. An adverse reaction, or event, is an unwanted or unexpected health effect that happens after someone is vaccinated. It may or may not be caused by the vaccine. Of the 7.8 million doses of vaccine distributed in Ontario in 2012, only 631 adverse reactions were reported.
“Vaccines are safe and protect individuals from dangerous diseases,” said Dr. Shelley Deeks, medical director, Immunization and Vaccine-Preventable Diseases, Public Health Ontario. “It's important for Ontarians to know that the risk of serious reactions from vaccines is very small compared to the risks from the diseases they prevent. Most people who receive vaccines have little to no side effects, and serious reactions are very rare.”
The majority of the 631 adverse reactions noted in the report were mild, such as pain, redness, or swelling around the injection site, as well as fever and skin rashes. Only 56 cases of serious reactions were reported after 7.8 million vaccines were distributed in Ontario in 2012. The most frequently reported serious reactions were anaphylaxis and febrile seizures, both of which are known to occur rarely following immunization and can be safely managed without any long-term health effects.
The 2012 report is the first comprehensive annual assessment of vaccine safety in Ontario. In Canada, vaccines are highly regulated by Health Canada and monitored by governments and manufacturers to ensure they are as safe as possible. Part of that monitoring occurs when adverse reactions are reported by Ontario health professionals, patients, or their parents to public health units, who in turn report this information to Public Health Ontario. This data is used to monitor the incidence of adverse reactions and continuously evaluate and improve vaccine safety.
“Vaccines are amongst the safest of medical interventions,” said Dr. Ian Gemmill, medical officer of health, Kingston, Frontenac and Lennox and Addington Public Health, and chair, Provincial Infectious Diseases Advisory Committee—Immunization. “They are studied in depth before they are licensed and go through one of the most rigorous licensing processes by Health Canada. After they are released, monitoring continues to ensure that no new problems are identified. This study demonstrates that there is careful oversight of vaccines used in programs in Ontario, and that the safety record is extremely good.”
“Recent Ontario outbreaks of pertussis and an increase in measles cases highlight the need to continue vaccinating Ontarians,” said Deeks. “We have effective vaccines for these and many other infectious diseases, yet there continue to be outbreaks among unvaccinated Ontarians. We need to reinforce and promote the benefits of vaccination, to protect people’s health, and to let them know that risks of adverse reactions are low. This is especially important for vulnerable people who may not be able to receive vaccines themselves. They rely on others to be vaccinated.”
- This report is the first comprehensive annual assessment of vaccine safety in Ontario.
- Vaccines are highly regulated by Health Canada and are continually monitored to ensure they are as safe as possible.
- Adverse reactions are reported by Ontario health professionals, patients, or their parents to public health units, who in turn report this information to Public Health Ontario.
- Approximately 7.8 million doses of vaccine were given to Ontarians in 2012.
- Of that number, 631 adverse events following immunization (AEFI) were reported.
- The distribution of AEFI reports by age was weighted toward younger ages with over half of all reports for individuals 18 years of age and under.
- 67.4% of the AEFI reports were among females, although sex distribution varied with age.
- The majority of the 631 AEFI reports in 2012 were associated with receipt of one vaccine (84.0%); 10.1% of reports were associated with two vaccines; and 5.9% were associated with three or more vaccines given together.
- Most reported events were mild including: sore arm (40%), rash (22%), and fever (7.4%).
- Serious events after vaccines were very rare: there were 56 cases of serious events reported in Ontario in 2012—approximately seven in every one million doses distributed—and no deaths were reported.
- Reported events were consistent with the safety profile of many vaccines.
Public Health Ontario is a Crown corporation dedicated to protecting and promoting the health of all Ontarians and reducing inequities in health. Public Health Ontario links public health practitioners, front-line health workers and researchers to the best scientific intelligence and knowledge from around the world. For more information, visit www.publichealthontario.ca
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