Safety of the human papillomavirus (HPV) vaccine

The human papillomavirus (HPV) vaccines provide the best protection against HPV infections and their complications. Like all vaccines offered in Québec, the HPV vaccines are manufactured according to very strict safety standards.

According to statistics compiled, fewer than 1 in 1,000 people develop severe symptoms after being vaccinated against HPV infections.

Many scientific articles published around the world also confirm the safety of the HPV vaccine.

As a precaution, no studies have been conducted on the side effects of the HPV vaccines in pregnant women and their unborn babies. Therefore, HPV vaccination is not recommended during pregnancy.

However, an analysis was carried out on data for 2,802 women from the United States, Canada and France. These women had been given a HPV vaccine during pregnancy when they did not know they were pregnant. The analysis did not show any link between HPV vaccination and complications during pregnancy or birth defects. A World Health Organization (WHO) analysis of data for 92,000 pregnancies conducted in June 2017 confirms that there is no link.

Multiple sclerosis

In a Danish study, no association was found between the vaccine and multiple sclerosis or several other diseases of the nervous system. The study was conducted on 4 million girls and women aged 10 to 44 years from 2006 to 2013. Of these, 800,000 had been given the HPV vaccine.

Circulatory disorders

The HPV vaccine does not increase the risk of circulatory disorders, such as venous thromboembolism, in girls and women aged 9 to 26 years. This conclusion comes from a study conducted in the United States and is supported by the report published by WHO in June 2017.

Complex regional pain syndrome and postural orthostatic tachycardia syndrome

Complex regional pain syndrome is a chronic pain condition affecting the limbs.

Postural orthostatic tachycardia syndrome is a condition where the heart rate increases abnormally after changing position. When a person with this syndrome sits down or stands up, they may experience symptoms such as:

• dizziness;
• loss of consciousness;
• headaches;
• chest pain;
• weakness.

A data review carried out in Europe concluded that there was no link between the HPV vaccine and these 2 rare syndromes. WHO also confirmed that there was no link.

Guillain-Barré syndrome (GBS)

Guillain-Barré syndrome (GBS) is an extremely rare reaction that can occur after an infection or after vaccination. It causes progressive paralysis that eventually disappears, but can sometimes have permanent effects.

Since the HPV Immunization Program was launched, around 32,000 young girls receive the vaccine every year in Québec. A study conducted in Canada in 2016 did not find any evidence of an increased risk for GBS in vaccination target groups.

Numerous studies and the report published by WHO in June 2017 did not show any link between HPV vaccination and GBS or any other immune system disorder. The WHO report also confirmed that the risk of GBS does not increase following HPV vaccination.

Security

• MOREIRA, Edson, et autres. Safety Profile of the 9-Valent HPV Vaccine: A Combined Analysis of 7 Phase III Clinical Trials, [En ligne], 2016. Pediatrics. [https://www.ncbi.nlm.nih.gov/pubmed/27422279 ] (Consulté le 26 septembre 2017).

• ORGANISATION MONDIALE DE LA SANTÉ. Relevé épidémiologique hebdomadaire, Vaccin contre les papillomavirus humain : note de synthèse de l’OMS, mai 2017, [En ligne], Mai 2017. World Health Organization. [http://apps.who.int/iris/bitstream/10665/255353/1/WER9219.pdf ] (Consulté le 26 septembre 2017).

• ORGANISATION MONDIALE DE LA SANTÉ. Relevé épidémiologique hebdomadaire, Réunion du comité consultatif mondial pour la sécurité des vaccins, 7 et 8 juin 2017, [En ligne], Juin 2017. World Health Organization. [http://apps.who.int/iris/bitstream/10665/255870/1/WER9228.pdf?ua=1 ] (Consulté le 26 septembre 2017).
  Cette référence a aussi été utilisée pour les sections Grossesse, Trouble de la circulation sanguine, Syndrome de douleur régionale complexe et syndrome de la tachycardie posturale orthostatique et Syndrome de Guillain-Barré (SGB).

• R. DE VINCENZO, Rosa, et autres. Long-term efficacy and safety of human papillomavirus vaccination, [En ligne], 2014. International Journal of Women’s Health. [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4262378/ ] (Consulté le 26 septembre 2017).

• VICHNIN, Michelle, et autres. An Overview of Quadrivalent Human Papillomavirus Vaccine Safety: 2006 to 2015, [En ligne], 2015. The Pediatric Infectious Disease Journal. [http://journals.lww.com/pidj/Citation/2015/09000/An_Overview_of_Quadrivalent_Human_Papillomavirus.17.aspx ] (Consulté le 26 septembre 2017).

Pregnancy

• SCHELLER, Nikolai, et autres, Quadrivalent HPV Vaccination and the Risk of Adverse Pregnancy Outcomes, [En ligne], 2017. The New England Journal of Medicine. [https://www.ncbi.nlm.nih.gov/pubmed/28355499 ] (Consulté le 26 septembre 2017).

Multiple sclerosis

• SCHELLER, Nikolai, et autres, Quadrivalent HPV Vaccination and Risk of Multiple Sclerosis and Other Demyelinating Diseases of the Central Nervous System, [En ligne], 2015. The Journal of the American Medical Association (JAMA). [http://jamanetwork.com/journals/jama/fullarticle/2088853 ] (Consulté le 26 septembre 2017).

Circulatory disorders

• YIH, W. Katherine, et autres, Evaluation of the risk of venous thromboembolism after quadrivalent human papillomavirus vaccination among US females, [En ligne], 2016. Vaccine. [https://www.ncbi.nlm.nih.gov/pubmed/26549364 ] (Consulté le 26 septembre 2017).

Complex regional pain syndrome and postural orthostatic tachycardia syndrome

• EUROPEAN MEDICINES AGENCY. EMA to further clarify safety profile of human papillomavirus (HPV) vaccines, [En ligne], 2015. [http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2015/07/news_detail_002365.jsp&mid=WC0b01ac058004d5c1 ] (Consulté le 26 septembre 2017).

• EUROPEAN MEDICINES AGENCY. Review concludes evidence does not support that HPV vaccines cause CRPS or POTS, [En ligne], 2015. [http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2015/11/news_detail_002429.jsp&mid=WC0b01ac058004d5c1 ] (Consulté le 26 septembre 2017).

Guillain-Barré syndrome (GBS)

• ANDREWS, Nick, Julia STOWE et Elizabeth MILLER. No increased risk of Guillain-Barré syndrome after human papilloma virus vaccine: A self-controlled case-series study in England, [En ligne], 2017. Vaccine. [https://www.ncbi.nlm.nih.gov/pubmed/28245941 ] (Consulté le 26 septembre 2017).

• ANGELO, Maria-Genalin, et autres. Post-licensure safety surveillance for human papillomavirus-16/18-AS04-adjuvanted vaccine: more than 4 years of experience, [En ligne], 2014. Pharmacoepidemiology and drug safety. [https://onlinelibrary.wiley.com/doi/full/10.1002/pds.3593 ] (Consulté le 26 septembre 2017).

• ARNHEIM-DAHLSTRÖM, Lisen, et autres. Autoimmune, neurological, and venous thromboembolic adverse events after immunization of adolescent girls with quadrivalent human papillomavirus vaccine in Denmark and Sweden: cohort study, [En ligne], 2013. BMJ. [http://www.bmj.com/content/347/bmj.f5906 ] (Consulté le 26 septembre 2017).

• CHAO, Chun, et autres. Surveillance of autoimmune conditions following routine use of quadrivalent human papillomavirus vaccine, [En ligne], 2012.Journal of Internal Medicine. [http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2796.2011.02467.x/epdf ] (Consulté le 26 septembre 2017).

• DECEUNINCK, Geneviève, et autres. No increase in Guillain-Barre Syndrome hospitalisations after HPV vaccination program implementation. An administrative database analysis in Québec, Canada, [Fichier PDF], [Québec],
  Institut national de la santé publique du Québec [2016], p. [894]-895
  [https://www.eurogin.com/content/dam/Informa/eurogin/previous/EUROGIN-2016.pdf ] (Consulté le 29 mai 2018).

• GEE, Julianne, et autres. Monitoring the safety of quadrivalent human papillomavirus vaccine: findings from the Vaccine Safety Datalink, [En ligne], 2011. Vaccine. [https://www.ncbi.nlm.nih.gov/pubmed/21907257 ] (Consulté le 26 septembre 2017).

• GRIMALDI-BENSOUDA, Lamiae, et autres. Risk of autoimmune diseases and human papilloma virus (HPV) vaccines: Six years of case-referent surveillance, [En ligne], 2017. Journal of Autoimmunity. [http://www.sciencedirect.com/science/article/pii/S0896841116302141 ] (Consulté le 26 septembre 2017).

• KLEIN, Nicola P, et autres. Safety of quadrivalent human papillomavirus vaccine administered routinely to females, [En ligne], 2012. The Journal of the American Medical Association (JAMA). [http://jamanetwork.com/journals/jamapediatrics/fullarticle/1363509 ] (Consulté le 26 septembre 2017).

• OJHA, Rohit P, et autres. Guillain-Barre syndrome following quadrivalent human papillomavirus vaccination among vaccine-eligible individuals in the United States, [En ligne], 2014. Human Vaccines & Immunotherapeutics. [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4181024/ ] (Consulté le 26 septembre 2017).

• SLADE, Barbara A, et autres. Postlicensure safety surveillance for quadrivalent human papillomavirus recombinant vaccine, [En ligne], 2009. Journal of the American Medical Association (JAMA). [http://jamanetwork.com/journals/jama/fullarticle/184421 ] (Consulté le 26 septembre 2017).