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Information Update - Gardasil vaccine safety studies show no new risks

Starting date:
December 9, 2015
Posting date:
December 9, 2015
Type of communication:
Information Update
Source of recall:
Health Canada
New safety information
General Public
Identification number:

December 9, 2015
For immediate release

OTTAWA – After reviewing Canadian and international information regarding the safety of the HPV vaccine Gardasil, Health Canada is informing Canadians that the benefits of using this vaccine continue to outweigh the risks. The overall evidence continues to demonstrate that this vaccine can be safely used and that there are no new safety risks associated with its use.

Gardasil is authorized in 133 countries around the world and is used to protect against four types of Human Papilloma Virus (HPV types 6, 11, 16, and 18), which cause 70% of cervical cancers, 90% of genital warts, and 80-90% of anal cancers.

Vaccines are authorized for sale by Health Canada only after undergoing rigorous reviews to ensure their safety, efficacy and quality. Once on the Canadian market, Health Canada and the Public Health Agency of Canada continue to monitor the safety of all vaccines.

A review of the safety of Gardasil by Health Canada was triggered by media reports of autoimmune and cardiovascular diseases. The safety review by Health Canada concluded that there is no evidence of an increased risk of autoimmune or cardiovascular diseases. Recent international reports are in line with Health Canada’s findings.

Since its authorization in 2006, nearly 2 million Canadians, and more than 63 million people worldwide, have been vaccinated with Gardasil. Approximately 1800 people in Canada, which represents approximately 1 out of 1,000 Canadians, reported side effects following vaccination with Gardasil. These include light-headedness, dizziness, nausea, headache, fever, and pain, swelling or redness at the injection site. The side effects are known and described in the Canadian labelling information. The benefits of using the vaccine outweigh the risks and potential side effects.

Health Canada and the Public Health Agency of Canada monitor adverse effects for all vaccines on the Canadian market to find and study potential harms, and will continue to do so with Gardasil. Health Canada will take appropriate and timely action and inform Canadians if any new health risks are identified.

People including caregivers should contact their healthcare provider if they have questions about the use of Gardasil.

Report health or safety concerns

How to report side effects to health products to Health Canada:

  • Call toll-free at 1-866-234-2345
  • Visit MedEffect Canada's web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

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