Summary Safety Review - Cervarix (HPV vaccine Types 16 and 18 [Recombinant, AS04 adjuvanted]) - Assessing the Potential Risk of a Condition in which the body's defense system damages nerves (Guillain-Barré Syndrome)

October 27, 2016

Product

Cervarix (Human Papillomavirus vaccine Types 16 and 18 [Recombinant, AS04 adjuvanted])

Potential Safety Issue

A condition in which the body's defense system (immune system) damages nerves (Guillain-Barré Syndrome)

Key Messages

  • Cervarix is a vaccine used to protect against infection by the human papillomavirus (HPV) types 16 and 18 that cause cervical and anal cancer.
  • Health Canada reviewed the risk of a rare disorder in which the body's own defense system (immune system) damages nerves, causing muscle weakness, and sometimes paralysis (Guillain-Barré Syndrome). This review was started after a study by France's "Agence nationale de sécurité du médicament et des produits de santé (ANSM)" reported a slight increased risk of Guillain-Barré Syndrome (GBS)Footnote a after vaccination with Cervarix.
  • Health Canada's review of all of the available information did not find an increased risk of GBS following vaccination with Cervarix. Health Canada will continue to monitor the safety of Cervarix.

Overview

Health Canada and the Public Health Agency of Canada continuously monitor the safety of all vaccines, including Cervarix. Health Canada reviewed the potential link between Cervarix and a rare disorder in which the body's own defense system (immune system) damages nerves, causing muscle weakness, and sometimes paralysis (Guillain-Barré Syndrome). This review was started after a study by France's "Agence nationale de sécurité du médicament et des produits de santé (ANSM)" reported a slight increased risk of Guillain-Barré Syndrome (GBS)Footnote a after vaccination with Cervarix. Health Canada assessed the risk of GBS with Cervarix using information provided by the manufacturer, cases of GBS reported to the Canada Vigilance ProgramFootnote and to Canadian Adverse Events Following Immunization Surveillance System (CAEFISS), as well as studies published in the literature.

Use in Canada

  • Cervarix is a vaccine used to protect against infection by the human papillomavirus (HPV) types 16 and 18 that cause cervical and anal cancer.
  • Cervarix has been sold in Canada since February 2010.
  • Approximately 30,000 people in Canada were vaccinated with Cervarix between May 2007 and November 2015.

Safety Review Findings

  • At the time of the review, there were no Canadian cases of GBS reported following vaccination with Cervarix.
  • No cases of GBS were reported in clinical trials before the marketing of Cervarix. After marketing, the manufacturer received 45 reports worldwide of GBS from May 2007 until November 2015. Only 10 of these reports had the signs and symptoms of GBS. However, it was not possible to determine if there was a link between Cervarix and GBS in these cases because not enough information was available for assessment, or there were other possible causes of GBS.
  • The review did find that the number of cases of GBS reported following vaccination with Cervarix is much lower than the number expected in the general population.
  • In the French study,Footnote a there were only 2 cases of GBS reported following vaccination with Cervarix. There was not enough clinical information to confirm that the cases were GBS.
  • There was no evidence of an increased risk of GBS with Cervarix reported in other studies.

Conclusions and Actions

  • Health Canada's review of all of the available information did not find an increased risk of GBS following vaccination with Cervarix.
  • Health Canada will continue to monitor the side effect information involving Cervarix, as it does for all health products on the Canadian market, to identify and assess potential harms. Health Canada will take appropriate and timely action if and when any new health risks are identified.

Additional Information

The analysis that contributed to this safety review included scientific and medical literature, Canadian and international adverse reaction reports and what is known about the use of this drug both in Canada and internationally.

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