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, 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 an 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.

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.

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 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) 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.

• MOREIRA, Edson, & al. Safety Profile of the 9-Valent HPV Vaccine: A Combined Analysis of 7 Phase III Clinical Trials, 2016. Pediatrics. (Accessed on September 26^th, 2017).
• ORGANISATION MONDIALE DE LA SANTÉ. Relevé épidémiologique hebdomadaire, Vaccin contre les papillomavirus humain : note de synthèse de l’OMS, May 2017. World Health Organization. (Accessed on September 26^th, 2017).
• ORGANISATION MONDIALE DE LA SANTÉ. Relevé épidémiologique hebdomadaire, Réunion du comité consultatif mondial pour la sécurité des vaccins, June 2017. World Health Organization. (Accessed on September 26^th, 2017).
  This reference was also used for the sections on Pregnancy, Circulatory Disorders, Complex Regional Pain Syndrome and Postural Orthostatic Tachycardia Syndrome, and Guillain-Barré Syndrome (GBS).
• R. DE VINCENZO, Rosa, & al. Long-term efficacy and safety of human papillomavirus vaccination, 2014. International Journal of Women’s Health. (Accessed on September 26th, 2017).
• VICHNIN, Michelle, & al. An Overview of Quadrivalent Human Papillomavirus Vaccine Safety: 2006 to 2015, 2015. The Pediatric Infectious Disease Journal. (Accessed on September 26^th, 2017).

• SCHELLER, Nikolai, & al. Quadrivalent HPV Vaccination and the Risk of Adverse Pregnancy Outcomes, 2017. The New England Journal of Medicine. (Accessed on September 26^th, 2017).

• SCHELLER, Nikolai, & al. Quadrivalent HPV Vaccination and Risk of Multiple Sclerosis and Other Demyelinating Diseases of the Central Nervous System, 2015. The Journal of the American Medical Association (JAMA). (Accessed on September 26^th, 2017).

• YIH, W. Katherine, & al. Evaluation of the risk of venous thromboembolism after quadrivalent human papillomavirus vaccination among US females, 2016. Vaccine. (Accessed on September 26^th, 2017).

• EUROPEAN MEDICINES AGENCY. EMA to further clarify safety profile of human papillomavirus (HPV) vaccines, 2015. (Accessed on September 26^th, 2017).
• EUROPEAN MEDICINES AGENCY. Review concludes evidence does not support that HPV vaccines cause CRPS or POTS, 2015. (Accessed on September 26^th, 2017).

• ANDREWS, Nick, Julia STOWE & Elizabeth MILLER. No increased risk of Guillain-Barré syndrome after human papilloma virus vaccine: A self-controlled case-series study in England, 2017. Vaccine. (Accessed on September 26^th, 2017).
• ANGELO, Maria-Genalin, & al. Post-licensure safety surveillance for human papillomavirus-16/18-AS04-adjuvanted vaccine: more than 4 years of experience, 2014. Pharmacoepidemiology and drug safety. (Accessed on September 26^th, 2017).
• ARNHEIM-DAHLSTRÖM, Lisen, & al. Autoimmune, neurological, and venous thromboembolic adverse events after immunization of adolescent girls with quadrivalent human papillomavirus vaccine in Denmark and Sweden: cohort study, 2013. BMJ. (Accessed on September 26^th, 2017).
• CHAO, Chun, & al. Surveillance of autoimmune conditions following routine use of quadrivalent human papillomavirus vaccine, 2012. Journal of Internal Medicine. (Accessed on September 26^th, 2017).
• DECEUNINCK, Geneviève, & al. No increase in Guillain-Barre Syndrome hospitalisations after HPV vaccination program implementation. An administrative database analysis in Québec, Canada [PDF], [Québec],
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  (Accessed on May 29^th, 2018).
• GEE, Julianne, & al. Monitoring the safety of quadrivalent human papillomavirus vaccine: findings from the Vaccine Safety Datalink, 2011. Vaccine. (Accessed on September 26^th, 2017).
• GRIMALDI-BENSOUDA, Lamiae, & al. Risk of autoimmune diseases and human papilloma virus (HPV) vaccines: Six years of case-referent surveillance, 2017. Journal of Autoimmunity. (Accessed on September 26^th, 2017).
• KLEIN, Nicola P, & al. Safety of quadrivalent human papillomavirus vaccine administered routinely to females, 2012. The Journal of the American Medical Association (JAMA). (Accessed on September 26^th, 2017).
• OJHA, Rohit P, & al. Guillain-Barre syndrome following quadrivalent human papillomavirus vaccination among vaccine-eligible individuals in the United States, 2014. Human Vaccines & Immunotherapeutics. (Accessed on September 26^th, 2017).
• SLADE, Barbara A, & al. Postlicensure safety surveillance for quadrivalent human papillomavirus recombinant vaccine, 2009. Journal of the American Medical Association (JAMA). (Accessed on September 26^th, 2017).