Summary Safety Review - Cervarix (Human Papillomavirus 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)
Review decision
A Summary Safety Review complements other safety related information to help Canadians make informed decisions about their use of health products. Each summary outlines what was assessed in Health Canada’s review, what was found and what action was taken by Health Canada, if any.
Issued: 2016-10-27
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)
Overview
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,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.
For additional information, contact the Marketed Health Products Directorate.
Footnotes
- Agence nationale de sécurité du médicament et des produits de santé (ANSM). Vaccins anti-HPV et risque de maladies auto-immunes : étude pharmaco-épidémiologique. Rapport final. Septembre 2015.
- Canadian reports can be accessed through the Canada Vigilance Online Database.