Summary Safety Review - GARDASIL (Quadrivalent Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine) - Assessing General Safety with a Focus on Autoimmune and Cardiovascular Diseases

December 9, 2015

Product

Gardasil (Quadrivalent Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine)

Potential Safety Issue

Autoimmune and cardiovascular diseases

Key Messages

  • Gardasil is a vaccine 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.
  • The safety of all vaccines, including Gardasil, is under continuous monitoring by Health Canada and the Public Health Agency of Canada. The safety of Gardasil was reassessed as part of this monitoring and when cases of side effects after vaccination with Gardasil were reported in early 2015. The side effects included diseases where the body's own defence system attacks itself (autoimmune diseases), such as rheumatoid arthritis and multiple sclerosis, and diseases affecting the heart and blood vessels (cardiovascular diseases), such as low blood pressure and blood clots.
  • After reviewing all available information on its safety, Health Canada did not find any new safety issues for Gardasil. The benefits of Gardasil continue to be greater than the risks and existing prescribing information was considered appropriate. Health Canada will continue to monitor the safety of Gardasil.

Overview

The safety of all vaccines, including Gardasil, is under continuous monitoring by Health Canada and the Public Health Agency of Canada. The safety of Gardasil was reassessed as part of this monitoring and when cases of side effects after vaccination with Gardasil were reported in early 2015. These side effects included diseases where the body's own defence system attacks itself (autoimmune diseases), such as rheumatoid arthritis and multiple sclerosis, and diseases affecting the heart and blood vessels (cardiovascular diseases), such as low blood pressure and blood clots. Sources of information for this safety review included data from studies conducted before Gardasil came on the market, and side effects reported both to the Canada Vigilance program of Health Canada and the Canadian Adverse Event Following Immunization Surveillance System of the Public Health Agency of Canada by the provinces and territories. Also included was the most recent safety report received from the manufacturer, in addition to published studies on the safety of Gardasil after it was used in many countries.

Use in Canada

  • Gardasil is a vaccine 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.
  • Gardasil is recommended for girls and women 9 to 45 years of age and in boys and men 9 to 26 years of age.
  • Gardasil will not protect against diseases caused by other types of HPV or viruses, and works best when given before there has been any contact with the types of HPV included in the vaccine.
  • Gardasil was authorized in Canada on July 10, 2006, and is approved in 133 countries around the world.
  • Since 2006, more than 55 million patients have been vaccinated with Gardasil worldwide, and over 1 million in Canada.

Safety Review Findings

  • In studies received from the manufacturer before Gardasil was authorized for sale on the Canadian market, over 15,500 participants received Gardasil and over 13,500 participants received injections that did not contain Gardasil (placebo). Participants receiving Gardasil had more pain, swelling, and redness at the injection site and more mild fevers than those who did not receive Gardasil. The percentage of participants who developed autoimmune or cardiovascular diseases was similar in the two groups.
  • Since its approval, more than 183,000 side effects following vaccination with Gardasil have been reported internationally, including over 4,000 in Canada. No new safety concerns were identified in the review of reports of side effects from Canada and in the most recent safety report from the manufacturer. The most commonly reported side effects were light-headedness, dizziness, nausea, headache, or fever, as well as pain, swelling or redness at the injection site. There were very few reports of autoimmune or cardiovascular diseases.
  • Studies published in the scientific and medical literature on the safety of Gardasil after being used in the general population were conducted in the United States and several countries in Europe. More than a million girls and women received Gardasil in these studies. The studies compared the number of cases of autoimmune diseases, cardiovascular diseases, and diseases related to the brain or nervous system (neurologic) in those that received Gardasil with those that did not. No safety concerns consistently linked to Gardasil were found in these studies.

Conclusions and Actions

  • Health Canada's review of the safety of Gardasil did not find any new safety issues after reviewing all available safety information. There were very few side effect reports of autoimmune or cardiovascular diseases, and in large safety studies, the frequency of autoimmune and cardiovascular diseases was not different between those who were vaccinated with Gardasil and those who were not.
  • The most commonly reported side effects following vaccination with Gardasil are light-headedness, dizziness, nausea, headache, or fever; as well as pain, swelling or redness at the injection site. These side effects are already included in the Canadian prescribing information for Gardasil. The benefits of Gardasil continue to be greater than the risks and existing prescribing information was considered appropriate.a
  • An Information Update has been issued to inform Canadians about these findings.
  • Health Canada will continue to monitor side effect information involving Gardasil, as it does for all health products on the Canadian market, to find and study potential harms. Health Canada will take appropriate and timely action if and when any new health risks are identified.

Additional Information

The analysis that was carried out for this safety review took into consideration information from scientific and medical literature, Canadian and international adverse reaction reports as well as what is known about the use of this drug in Canada and internationally.

For additional information, contact the Marketed Health Products Directorate.

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