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Human papillomavirus (HPV) vaccines: Canadian Immunization Guide

For health professionals

Last complete chapter revision: July 2024

This chapter was updated based on the following guidance from the National Advisory Committee on Immunization (NACI):

New recommendations:

  • Individuals 9 to 20 years of age, unless immunocompromised, should receive 1 dose of HPV vaccine.
  • Individuals 21 to 26 years of age, unless immunocompromised, should receive 2 doses of HPV vaccine.
  • Individuals 27 years of age and older, unless immunocompromised, may receive a 2-dose schedule of the HPV vaccine with shared decision making and discussion with a healthcare provider.
  • HPV vaccine can be offered in pregnancy. Routine questioning about last menstrual period and/or pregnancy is not required or recommended before offering HPV vaccine.
  • Nonavalent 9vHPV vaccine should be used as it provides protection against the greatest number of HPV types and associated diseases.

This information is captured in the table of updates.

On this page

Please note: The Public Health Agency of Canada (PHAC) recognizes that not all people giving birth or breastfeeding will identify as women or mothers. The writing in this chapter uses a gender additive approach where the term “woman” is used alongside gender neutral language. This is intended to demonstrate a commitment to redress the historic exclusion of trans and non-binary people, whilst avoiding the risk of marginalizing or erasing the experience of women within the health care environment. However, in line with best practice, it is recognized that when discussing or caring for individuals in a one-on-one capacity, language and documentation should reflect the gender identity of the individual. Finally, PHAC acknowledges the dynamic nature of language. It is likely that language deemed to be suitable or affirming in one context may not translate across others, and over the coming years will likely change and evolve with respect to appropriate representations.

Key information

What

  • Globally and in Canada, HPV-associated diseases are a significant public health problem.
  • Persistent infection with high-risk HPV types (e.g., 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59) can result in cervical, oropharyngeal, anal, vaginal, vulvar, and penile cancers.
  • Low-risk HPV types (e.g., 6 and 11) are generally non-oncogenic and cause conditions such as anogenital warts (AGW) and recurrent respiratory papillomatosis (RRP).
  • GARDASIL® 9 (9vHPV) vaccine provides protection against infection caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58. CERVARIX® (2vHPV) vaccine provides protection against infection caused by HPV types 16 and 18.
  • HPV vaccine prevents abnormal Pap smears and HPV-associated cancers, including cervical and anal cancers.
  • GARDASIL® (4vHPV) vaccine was authorized in 2006 in Canada and discontinued in 2019.
  • The most commonly reported adverse events following HPV vaccination are injection site pain, swelling or redness.

Who

  • 9vHPV vaccine is recommended for all individuals 9 to 26 years of age.
  • Individuals 27 years of age and older who are at ongoing risk of exposure to HPV may receive 9vHPV vaccine with shared decision making and discussion with a healthcare provider.
  • HPV vaccine can be offered in pregnancy. Routine questioning about last menstrual period and/or pregnancy is not required or recommended before offering HPV vaccine.
  • When recommended to receive HPV vaccine, individuals who are considered immunocompromised and/or living with HIV should receive a 3-dose schedule of 9vHPV vaccine.

How

  • Individuals 9 to 20 years of age, unless immunocompromised, should receive one dose of 9vHPV vaccine. A 2-dose schedule may be considered on an individual basis for individuals 9 to 20 years of age with shared decision-making with their healthcare provider.
  • Individuals 21 to 26 years of age, unless immunocompromised, should receive 2 doses of 9vHPV vaccine at least 24 weeks apart (6 months).
  • Individuals 27 years of age and older, unless immunocompromised, may receive a 2-dose schedule of 9vHPV administered at least 24 weeks apart (6 months).
  • When recommended to receive HPV vaccine, individuals who are considered immunocompromised and/or living with HIV should receive a 3-dose schedule of 9vHPV vaccine (months 0, 2, and 6).
  • Individuals who have received a different HPV vaccine may consider an additional dose of the 9vHPV vaccine for added protection against additional HPV types, following a discussion with their healthcare provider.
  • Although 2vHPV vaccine continues to be authorized in Canada, 9vHPV vaccine should be used due to its protection against a greater number of HPV types and associated diseases.
  • As syncope post-vaccination is common in younger people, vaccine recipients should be observed for 15 minutes after vaccine administration.

Why

  • If not immunized, it is estimated that 75% of Canadians will have an HPV infection at some time.
  • Vaccination before infection will provide the best protection against HPV diseases.
  • Individuals who missed routine HPV immunization remain at risk for HPV-associated diseases.
  • Even if an individual is already infected with one or more vaccine HPV type(s), the vaccine will provide protection against the other HPV type(s) contained in the vaccine.
  • Even 1 dose of HPV vaccine at all ages is expected to provide some benefit compared to no vaccination.

Epidemiology

Disease description

Infectious agent

Human papillomaviruses (HPV) are small, double-stranded DNA viruses from the family Papillomaviridae that infect the skin and mucosa. More than 200 HPV genotypes have been identified, including approximately 40 genotypes that affect the human anogenital and oropharyngeal sites. These HPV genotypes are categorized as low-risk for oncogenesis (for example, types 6 and 11) or high-risk for oncogenesis (for example, types 16, 18, 31, 33, 45, 52, 58). For additional information on HPV, refer to the Pathogen Safety Data Sheet.

Reservoir

Humans

Transmission

HPV infections are primarily transmitted through direct epithelial (skin or mucosa) contact including sexual activity, as well as vertically to an infant exposed to the virus in the maternal genital tract during delivery.

Risk factors

Due to the primary mode of transmission being direct epithelial contact (skin or mucosa) and high prevalence, most people are exposed to HPV at some point in their lifetime.

Unvaccinated individuals in direct contact with skin or mucous membranes of infected individuals are at high risk of HPV infection. Individuals with certain immunocompromising conditions, including HIV infection, are also at high risk for persistent HPV infections and associated diseases. Pregnant women and pregnant individuals are at risk of HPV infection. Epidemiological studies indicate that maternal HPV infection could increase the risk of pregnancy complications, including spontaneous abortion, preterm birth, preeclampsia, intrauterine growth restriction, premature rupture of membranes, and fetal death.

Spectrum of clinical illness

Most HPV infections are asymptomatic, self-limiting, and resolve within 24 months without treatment. Infection with one HPV type does not decrease the probability of being infected by other HPV types and co-infections do occur. Persistent infection with a high-risk HPV type is the major cause of cervical cancer and is also associated with cancers of the mouth, oropharynx, anus, vulva, vagina, and penis. Infection with low-risk HPV types can cause non-cancerous lesions, such as anogenital warts (AGW) and recurrent respiratory papillomatosis (RRP). HPV infection can be transmitted to the fetus before and during birth. As a result, newborns can develop juvenile-onset recurrent respiratory papillomatosis (JoRRP), which is associated with considerable morbidity and, in rare cases, can be fatal.

Disease distribution

Incidence and prevalence

Global

  • Five percent of all cancers worldwide are attributed to HPV infection.
  • Globally, it is estimated that 620,000 new cancer cases in women and 70,000 new cancer cases in men were caused by HPV in 2019.
  • Cervical cancer was the 4th leading cause of cancer and cancer deaths in women in 2022, with approximately 660,000 new cases and 350,000 deaths worldwide.

National

  • If not immunized, it is estimated that 75% of sexually active Canadians will have an HPV infection at some time in their lives.
  • Cervical cancer: In 2023, the cervical cancer incidence rate was estimated to be 8 cases per 100,000 women. Cervical cancer is the 14th most common cancer among Canadian women of all ages and the fourth most common among those aged 15 to 44 years. In 2023, there were approximately 1,550 new cases of cervical cancer and 400 deaths related to cervical cancer. Other HPV-associated cancers: The majority of HPV-related cancers, accounting for nearly two-thirds, are non-cervical. HPV is associated with 60 to 73% of oropharyngeal cancers, 90% of anal cancers, 40% of vaginal and vulvar cancers, and 40 to 50% of penile cancers. The incidence rates of HPV-associated anal and head and neck cancers have been increasing in both Canada and globally in recent decades. Vaginal, vulvar, and penile cancers typically peak at age 85 and above. In Canadian males and females, the onset of oropharyngeal and anal cancers usually occurs between 60 to 70 years of age.
  • Other HPV-related diseases: The prevalence AGW and RRP is not well studied in Canada. AGW remains one of the most common sexually transmitted infections globally, with HPV6 and HPV11 contributing to approximately 90% of AGW cases. Males experience higher rates of AGW compared to females, with rates of AGW peaking at 25 to 29 years for males and 20 to 24 years for females. JoRRP results from vertical transmission of HPV6 or HPV11 during pregnancy. Although severe, it is rare, with an annual incidence of 0.24 cases per 100,000 children 14 years and younger. Although Canadian data is limited, evidence from other jurisdictions suggests that the incidence of JoRRP has been declining since the implementation of routine HPV vaccination programs. Currently, data on the incidence of adult-onset RRP in Canada is limited.

Preparations authorized for use in Canada

HPV vaccines

  • GARDASIL® 9 (recombinant, nonavalent, human papillomavirus vaccine [types 6, 11, 16, 18, 31, 33, 45, 52, 58]), Merck Canada Inc. (9vHPV)
  • CERVARIX® (recombinant, bivalent, human papillomavirus vaccine [types 16, 18]), GlaxoSmithKline Inc. (2vHPV)

For complete prescribing information, consult the product leaflet or information contained within the product monograph available through Health Canada's Drug Product Database.

Refer to Contents of immunizing agents authorized for use in Canada in Part 1 for a list of vaccines and passive immunizing agents authorized for use in Canada and their contents.

Immunogenicity, efficacy and effectiveness

Immunogenicity

HPV vaccine is highly immunogenic. Clinical trials have shown that a 1-, 2-, or 3-dose series of the HPV vaccine elicits a strong immunological response to HPV vaccine-type antigens. Although a 2- or 3-dose schedule leads to significantly higher antibody titers than a 1-dose schedule, the response induced by a 1-, 2-, or 3-dose HPV vaccine schedule initially peaks and then remains relatively stable for up to 16 years.

Current evidence shows that a single dose of the HPV vaccine generates higher antibody titers than no vaccination. Randomized controlled trials (RCTs) have found that the antibody titers from a 2-dose schedule are generally non-inferior to those from a 3-dose schedule. The immune correlates of protection against HPV infection are unknown. Therefore, the clinical relevance of the reduced immune response associated with a single dose schedule is currently unclear.

Efficacy and effectiveness

Current HPV vaccines are highly effective for the prevention of HPV vaccine type-related persistent infection, as well as cervical cancer and its precursors. In women 16 to 26 years of age, the efficacy of 9vHPV vaccine against HPV types 16 and 18-related cervical disease is nearly 100%; efficacy against external genital lesions related to HPV types 6, 11, 16, or 18, including genital warts, is 95% to 99%; and efficacy against high grade disease related to HPV types 31, 33, 45, 52, and 58 contained in 9vHPV vaccine is over 96%.

Available evidence from randomized and non-randomized trials shows that a single dose of the HPV vaccine protects against HPV infection. Many trials assessing efficacy and effectiveness of one-dose HPV vaccine schedules are ongoing or anticipated; current RCT data is limited to 3 year follow up, with longer (6 to 11 year) follow up available from non-randomized trials. Studies comparing HPV schedules (e.g., number of doses) indicate a single dose schedule may provide similar protection from HPV infection as 2- or 3-dose schedules for at least 11 years. Based on limited evidence, a 1-dose HPV vaccine schedule may provide similar protection against early precursors to cervical cancer as well as anogenital warts.

HPV vaccine has no proven therapeutic effect on existing HPV infection. Prior infection with one or more vaccine HPV types does not diminish vaccine efficacy against other vaccine HPV types. A 2- or 3-dose HPV vaccine schedule is anticipated to confer long-term (e.g., lifelong) duration of protection. This is based on both clinical trial data and population level studies, with greatest evidence for 2vHPV and 4vHPV vaccines since the first HPV vaccines became available in 2007. While evidence on the clinical benefits of a 1-dose HPV vaccine schedule is substantial, longer-term follow up (e.g., beyond 11 years) is limited.

Recommendations for use

The current goal of the Canadian HPV immunization program is to reduce vaccine-preventable HPV-related morbidity and mortality across the Canadian population. Although 2vHPV vaccine continues to be authorized in Canada, 9vHPV vaccine should be used due to its protection against a greater number of HPV types and associated diseases. Individuals who have received a different HPV vaccine may consider one additional dose of the 9vHPV vaccine for added protection against additional HPV types, following a discussion with their healthcare provider. Refer to Risk factors for additional information.

Less than 9 years of age

There are no data on the use of HPV vaccine in children less than 9 years of age. HPV vaccine may be considered in children less than 9 years of age who are at risk of exposure to HPV or in whom long term immunosuppression is anticipated.

9 to 26 years of age

Individuals 9 to 20 years of age, unless immunocompromised, should receive one dose of 9vHPV vaccine. A 2-dose schedule may be considered on an individual basis for individuals 9 to 20 years of age in discussion with their health care provider. HPV vaccination prior to exposure to HPV is recommended to maximize the benefit of the vaccine.

Individuals 21 to 26 years of age, unless immunocompromised, should receive two doses of 9vHPV vaccine.

Although women with previous Pap test abnormalities, cervical cancer or genital warts may have had prior infection with one or more vaccine HPV types, they will benefit from receiving HPV vaccine for the HPV types to which they have not been exposed. HPV vaccine does not have any therapeutic effect on pre-existing cervical disease.

Refer to Other considerations for additional information.

27 years of age and older

Individuals 27 years of age and older may receive a two-dose schedule of 9vHPV vaccine with shared decision making and discussion with a healthcare provider. While peak risk for HPV infection is within 5 to 10 years of the first sexual experience, a second peak in HPV prevalence is observed in women 45 years and older. Although the second peak is not as high as the peak rates in younger women, it represents an increased risk. While the reason for this second peak is not yet fully understood, receipt of HPV vaccine by previously unimmunized adult women could reduce the risk of HPV infection occurring later in life.

Immunization after onset of sexual activity

HPV vaccination after the onset of sexual activity is beneficial because the vaccine recipient is very unlikely to be infected with all HPV types in the vaccine. Vaccine recipients who are already sexually active should be advised that they may already be infected with a vaccine HPV type(s) and should be informed that the vaccine will not have any therapeutic effect on pre-existing vaccine -type HPV infections.

Schedule

Refer to Table 1 for a summary of recommended immunization schedules and HPV vaccine for groups of vaccine recipients. For incomplete or interrupted vaccine schedules, refer to Incomplete or interrupted vaccine schedules.

9vHPV vaccine

  • Individuals 9 to 20 years of age, unless immunocompromised: 1-dose schedule. A 2-dose schedule may be considered. For a 2-dose schedule, doses should be administered at least 24 weeks apart (6 months).
  • Individuals 21 to 26 years of age, unless immunocompromised: 2-dose schedule. Doses should be administered at least 24 weeks apart (6 months).
  • Individuals 27 years of age and older, unless immunocompromised: 2-dose schedule. Doses should be administered at least 24 weeks apart (6 months).
  • Individuals 9 years of age and older who are immunocompromised and/or living with HIV: 3-dose schedule (months 0, 2 and 6).
Table 1: Recommended immunization scheduleTable 1 Footnote 1 with 9vHPV vaccine, by group
Groups Immunization ScheduleTable 1 Footnote 2Table 1 Footnote 3
Individuals 9 to 20 years of age 1-dose schedule. A 2-dose schedule may be considered on an individual basisTable 1 Footnote 4
Individuals 21 to 26 years of age 2-dose scheduleTable 1 Footnote 4
Individuals 27 years of age and older 2-dose scheduleTable 1 Footnote 4
Individuals who are immunocompromised and/or living with HIV, regardless of age 3-dose scheduleTable 1 Footnote 5
Table 1 Footnote 1

This table outlines recommendations specific to HPV immunization schedules. For detailed guidance on which populations are recommended to receive HPV vaccine, please refer to Recommendations for use and Vaccination of specific populations.

Table 1 Return to footnote 1 referrer

Table 1 Footnote 2

Recommended schedule is based on age at initiation of vaccination.

Table 1 Return to footnote 2 referrer

Table 1 Footnote 3

9vHPV vaccine should be used as it provides protection against the greatest number of HPV types and associated diseases.

Table 1 Return to footnote 3 referrer

Table 1 Footnote 4

For a 2-dose schedule, the doses should be administered at least 24 weeks apart (6 months).

Table 1 Return to footnote 4 referrer

Table 1 Footnote 5

When a 3-dose schedule is recommended for individuals who are immunocompromised and/or living with HIV, they should be administered at months 0, 2, and 6. For guidance on minimum intervals between doses, refer to Minimum intervals between doses of HPV vaccines.

Table 1 Return to footnote 5 referrer

Abbreviations

9vHPV = 9-valent human papillomavirus vaccine

Minimum intervals between doses of HPV vaccines

For either a 2-dose or 3-dose HPV vaccine schedule, the first and last doses of vaccine should be separated by a minimum interval of 24 weeks (6 months). In a 3-dose schedule, the minimum interval between the first and second doses of vaccine is 4 weeks (1 month), the minimum interval between the second and third doses of vaccine is 12 weeks (3 months), and the minimum interval between the first and last doses is 24 weeks (6 months). Refer to Timing of vaccine administration in Part 1 for additional information about delayed immunization schedules and accelerated immunization schedules.

Incomplete or interrupted vaccine schedules

An HPV vaccine series should be initiated, even if the series may not be completed according to schedule. If the vaccine schedule is interrupted, the vaccine series does not need to be restarted and 9vHPV vaccine should be used to complete the series regardless of which vaccine was given for previous dose(s) as it provides protection against the greatest number of HPV types and associated diseases. While NACI recommends a 2-dose HPV vaccination schedule for individuals 27 years of age and older without immunocompromise, even a single dose is expected to provide clinical benefit.

Refer to additional information contained within the product monographs available through Health Canada's Drug Product Database.

Booster doses and re-immunization

Re-immunization with HPV vaccine is not indicated at this time, given the long-lasting protection known for a 2 to 3 dose series and available evidence suggesting durable (up to 11 years) protection from a one dose series. Individuals who have completed immunization with a different HPV vaccine (2vHPV or 4vHPV vaccines) and are at ongoing risk, may benefit from one additional dose of the 9vHPV vaccine to receive protection offered by the additional types included in the 9vHPV vaccine.

Vaccination of specific populations

Pregnancy and breastfeeding

The 9vHPV vaccine can be offered in pregnancy, as pregnant women and pregnant individuals who are unvaccinated against HPV remain at risk of HPV infection and HPV-related morbidity during their pregnancy. Maternal HPV infection might increase the risk of pregnancy complications, such as spontaneous abortion, preterm birth, preeclampsia, intrauterine growth restriction, premature rupture of membranes, and fetal death. Current evidence suggests that there is no increased risk of adverse pregnancy or fetal outcomes linked to HPV vaccination during pregnancy. There is no known reason for anticipating an increased risk of adverse pregnancy or fetal outcomes associated with HPV vaccination during pregnancy. Routine questioning about last menstrual period or pregnancy is not required or recommended before offering HPV vaccine.

There are limited data on the effects on breastfed infants from HPV vaccination of their mothers; however, there have been no reported adverse events thought to be vaccine-related. Therefore, HPV vaccine can be administered to breastfeeding individuals.

Refer to Immunization in pregnancy and breastfeeding in Part 3 for additional information about vaccination of women or individuals who are pregnant or breastfeeding.

Immunocompromised persons

Immunization with a 3-dose schedule of the 9vHPV vaccine is recommended for immunocompromised individuals including individuals living with HIV. However, the immune response and vaccine efficacy may be less than that in persons who are immunocompetent. For complex cases, referral to a physician with expertise in immunization or immunodeficiency is advised. For example, HPV vaccination may be considered prior to surgery in a 7- or 8-year-old child who will be immunosuppressed following a solid organ transplant.

Refer to Immunization of immunocompromised persons in Part 3 for additional information about vaccination of people who are immunocompromised.

Serologic testing

Serologic testing is not indicated before or after receiving HPV vaccine. Unvaccinated individuals who have already been exposed to certain HPV types are still encouraged to receive the HPV vaccine, as it can provide protection against additional HPV types included in the vaccine.

Administration practices

Dose

Each dose of HPV vaccine is 0.5 mL.

Route of administration

HPV vaccine should be administered intramuscularly.

Post-immunization observation period

Vaccine recipients, particularly adolescents and young adults, should be observed for 15 minutes after immunization to prevent serious injury in the event of syncope.

Refer to Vaccine administration practices in Part 1 for additional information about pre-vaccination and post-vaccination counselling and observation.

Refer to Anaphylaxis and other acute reactions following vaccination in Part 2 for additional information about prevention of syncope and the management of anaphylaxis and syncope.

Interchangeability of vaccines

If the vaccine used for previously received doses was the formerly available 4vHPV vaccine, or 2vHPV vaccine, or the vaccine received is unknown, the 9vHPV vaccine should be used as it protects against the greatest number of HPV types. Individuals who have completed immunization with a different HPV vaccine (2vHPV or 4vHPV vaccines) and are at ongoing risk, may benefit from one additional dose of the 9vHPV vaccine to receive protection offered by the additional types included in the 9vHPV vaccine.

Refer to Principles of vaccine interchangeability in Part 1 for additional information about interchangeability of HPV vaccines.

Concurrent administration of vaccines

HPV vaccine may be administered concomitantly with other age-appropriate vaccines at different injection sites, using separate needles and syringes. HPV vaccine should be administered after other vaccines because it is known to cause more injection pain.

Refer to Timing of vaccine administration in Part 1 for additional information about concurrent administration of vaccines.

Storage requirements

HPV vaccines should be stored at +2°C to +8°C and should not be frozen. HPV vaccines should be protected from light. Refer to Storage and handling of immunizing agents in Part 1 for additional information and recommendations.

Safety and adverse events

HPV vaccines have been monitored post-market for over 15 years, and evidence continues to suggest that HPV vaccines are safe and well tolerated.

Common adverse events

Common adverse events occur in 1% to less than 10% of vaccinees. Very common adverse events occur in 10% or more of vaccinees.

Based on pre-licensure clinical trial data for 9vHPV, involving more than 15,000 subjects, the most common local adverse events in persons receiving HPV vaccines were: injection site pain, swelling and redness. The most common systemic adverse events were headache, fever (≥37.8°C), and nausea. These adverse events were observed significantly more often following HPV vaccine than following placebo controls. Additionally, female participants reported a higher frequency of adverse events after the third dose of 9vHPV compared to the initial two doses for all outcomes, except for any pain, which was highest following the second dose in females aged 16-26 years. In over 94% of subjects who received HPV vaccine, the reactions were mild to moderate in intensity, resolved over a few days, and did not prevent completion of the immunization schedule.

The most common local adverse events in female participants following vaccination with 2vHPV according to clinical trial data were pain, swelling, and redness at the injection site, while the most common systemic adverse events included fatigue, headache, and myalgia in females aged 10-25 years. Adverse events were more common following the third dose of 2vHPV vaccine compared to the first two doses for all outcomes except for any pain, which was highest following the first dose.

Since vaccine licensure, hundreds of millions of doses of HPV vaccine have been distributed worldwide. Data from post-licensure safety surveillance reporting systems including reports to the Canadian Adverse Events Following Immunization Surveillance System (CAEFISS) have consistently mirrored the pre-licensure data with the most frequently reported adverse events following immunization (AEFI) being vaccination site reactions and muscle pain.

Uncommon, rare, and very rare adverse events

Uncommon adverse events occur in 0.1% to less than 1% of vaccinees. Rare and very rare adverse events occur, respectively, in 0.01% to less than 0.1% and less than 0.01% of vaccinees.

Serious adverse events are rare following HPV immunization and, in most cases, data are insufficient to determine a causal association. Clinical trials have found no increase in the number or type of serious adverse events in recipients of HPV vaccine compared with those who received placebo. Anaphylaxis following vaccination with HPV vaccine may occur but is exceedingly rare. Syncope (fainting) can occur after immunization and is common among adolescents and young adults, likely due to immunization-related stress or anxiety. Therefore, observation for 15 minutes after administration is advisable. For information about post-vaccination observation and management of adverse events refer to Vaccine administration practices in Part 1 and Anaphylaxis and other acute reactions following vaccination in Part 2.

Other reported adverse events or conditions

The vaccine safety profile of HPV vaccines has been reviewed by national regulatory authorities both pre- and post-licensure, the World Health Organization (WHO) Global Advisory Committee on Vaccine Safety and the Institute of Medicine (IOM) of the National Academy of Sciences of the United States, as well as focused vaccine safety surveillance systems.

To date, there has been no evidence to support an association between HPV vaccines and any of the following conditions: new-onset autoimmune disease including Guillain-Barre Syndrome, multiple sclerosis, chronic fatigue syndrome (CFS), complex regional pain syndrome (CRPS), postural orthostatic tachycardia syndrome (POTS), primary ovarian insufficiency (POI), or infertility. Furthermore, findings from the IOM review affirm that there is no evidence linking HPV vaccination to conditions including transverse myelitis, acute disseminated encephalomyelitis, brachial neuritis, chronic inflammatory disseminated polyneuropathy, amyotrophic lateral sclerosis, neuromyelitis optica, pancreatitis, transient arthralgia or thromboembolic events.

Deaths following HPV vaccine that were observed in pre-licensure trials occurred no more frequently than in the placebo groups. While post-market AEFI reports have included reports with fatal outcome, reviews have not found that the risk of death was increased during the days following vaccination, and no deaths were found to be causally associated with vaccination.

Guidance on reporting adverse events following immunization (AEFI)

To ensure the ongoing safety of vaccines in Canada, reporting of AEFIs by vaccine providers and other clinicians is critical, and in some jurisdictions, reporting is mandatory under the law.

Vaccine providers are asked to report AEFIs through their local public health unit. Specific AEFI reporting requirements may vary by province or territory. In general, any serious or unexpected adverse event felt to be temporally related to vaccination should be reported.

Refer to Vaccine safety and pharmacovigilance and Adverse events following immunization in Part 2 for additional information on vaccine safety and for definitions of AEFIs, and reporting of AEFIs to public health.

Contraindications and precautions

HPV vaccine is contraindicated in persons with a history of anaphylaxis after previous administration of the vaccine and in persons with proven immediate or anaphylactic hypersensitivity to any component of the vaccine or its container. Individuals who develop symptoms indicative of hypersensitivity after receiving a dose of HPV vaccine should not receive further doses. Refer to Contents of immunizing agents authorized for use in Canada in Part 1 for a list of vaccines authorized for use in Canada and their contents.

Refer to Contraindications and precautions in Part 2 for additional general information.

Other considerations

HPV testing

HPV DNA testing is available in Canada but access varies across the country and is not part of regular preventive care visits or Pap tests. However, where recommended and available, Pap tests are currently used to determine if a woman is at risk of developing pre-cancerous and cancerous changes in the cervix thereby allowing these changes to be treated or closely followed and reduce the chances of developing cancer. Individuals are encouraged to follow their local provincial or territorial recommendations for appropriate HPV testing.

Cervical cancer screening in women who have received HPV vaccine

All women should be routinely monitored and screened for cervical cancer regardless of receipt of HPV vaccine. While HPV vaccine has been shown to be highly effective against cervical cancer caused by the HPV types contained within the vaccine, vaccine recipients remain susceptible to infection from other high-risk HPV types. In addition, sexually active women may have been infected with the HPV types contained within the HPV vaccine prior to receiving the vaccine. Appropriate precautions against sexually transmitted infections should continue to be used.

Chapter revision process

This chapter was updated to align with guidance in the National Advisory Committee on Immunization (NACI) Statement on Updated Recommendations on Human papillomavirus (HPV) Vaccines published on July 24, 2024.

Acknowledgements

This chapter was based on a NACI statement prepared by N Forbes, V Dubey, J Montroy, K Gusic, M Salvadori, A Howarth, A Tuite, R Harrison, and M Tunis on behalf of the NACI HPV Working Group. The chapter was prepared by N Mohamed, N Forbes, M Salvadori, J Montroy, R Pless, A Howarth and reviewed by V Dubey and C Jensen.

NACI gratefully acknowledges the contribution of: N Haddad, S Kelly, and J Daniel.

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