|Gardasil was the first HPV vaccine approved in Canada. It is a quadrivalent vaccine that protects against 4 different HPV types: HPV- 6, HPV-11, HPV-16 and HPV-18.
Gardasil helps protect females between 9 and 45 years of age against:
- precancerous conditions of the cervix, vagina and vulva
- cervical, vaginal and vulvar cancer
In females and males between 9 and 26 years of age, Gardasil also helps prevent:
- precancerous conditions of the anus (anal epithelial neoplasia or AIN)
- anal cancer
Gardasil also helps protect females (9–45 years of age) and males (9–26 years of age) against anogenital warts.
||Cervarix is a bivalent vaccine that protects against 2 high-risk HPV types: HPV-16 and HPV-18.
Cervarix helps protects females between 10 and 25 years of age against:
- precancerous conditions of the cervix
- cervical cancer
Cervarix does not protect against genital warts.
How the vaccines work
Both vaccines work by stimulating the body to produce antibodies against the types of HPV they target. The aim of the vaccines is to prevent HPV infections and therefore the diseases associated with these HPV types (prophylactic vaccines). The HPV vaccines do not treat HPV infections, diseases or cancers related to HPV infections.
The vaccines work best when given to young people before they become sexually active (which includes sexual intercourse, genital skin-to-skin contact and oral sex). The goal is to protect young people before they are exposed to the HPV types that the vaccines cover.
The vaccines are not live (they do not contain the active virus), so a person cannot get HPV from the vaccine.
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Effectiveness of the vaccines
Studies have shown that Gardasil and Cervarix are both highly effective in preventing infection with the types of HPV they target. Evidence from many clinical trials shows that the vaccines are highly effective in preventing persistent infection from HPV-16 and HPV-18, as well as precancerous cervical lesions associated with these types of HPV.
In clinical trials, researchers have found that Gardasil is effective in preventing precancerous conditions of the vagina, vulva and anus. It is also very effective in preventing anal and genital (anogenital) warts caused by HPV-6 and HPV-11. At this time, Cervarix is not approved for preventing precancerous conditions of the vagina, vulva or anus.
Some research shows that both vaccines may also provide partial protection against other high-risk types of HPV, such as HPV-31, HPV-33 and HPV-45, which are similar to HPV-16 and HPV-18. This is called cross protection. However, more research is needed to determine the degree of effectiveness and the duration of protection against these other HPV types. Also, researchers are working on new HPV vaccines that protect against more HPV types.
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National Advisory Committee on Immunization (NACI) recommendations
Both HPV vaccines have been approved and recommended by Health Canada and Canada’s National Advisory Committee on Immunization (NACI). Health Canada approves vaccines based on their effectiveness and safety, while NACI makes recommendations for the use of vaccines including identifying groups of people at risk for diseases that can be prevented with vaccines. The most recent NACI recommendations on HPV vaccination were made in 2012.
Vaccination of girls and women
NACI recommends that either HPV vaccine (Gardasil or Cervarix) be given to prevent cervical cancer and precancerous cervical changes in:
- females 9–26 years of age
- The vaccines are most effective when given to females before they are sexually active.
- females 14–26 years of age who have been sexually active, have had genital warts or previous abnormal Pap tests, including cervical cancer
- Vaccination could still help these females because they may not have been infected with all the HPV types covered by the vaccine.
- females over 26 years of age
- Gardasil is effective in females 27–45 years of age.
- The effectiveness of Cervarix has not been directly tested in this age group, but there is some evidence from immune responses in younger women to suggest that the vaccine would have similar effectiveness in older women.
Only Gardasil is approved for girls and women aged 9–45 to prevent vaginal and vulvar cancer and the precancerous conditions associated with these cancers, as well as anal and genital (anogenital) warts. Gardasil is also the only vaccine approved for girls and women ages 9–26 to prevent anal cancer and the precancerous condition associated with this cancer.
Vaccination of boys and men
Only Gardasil is approved for boys and young men to prevent anal cancer, its precancerous condition and anogenital warts. The vaccine is most effective when given to males before they become sexually active. NACI recommends that Gardasil be used for:
- males between 9 and 26 years of age
- males 9 years of age and older who have sex with other males
There is some evidence that Gardasil may also prevent penile, perianal and perineal precancerous conditions (intraepithelial neoplasias) and their associated cancers, although it is currently not approved for this use.
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How the vaccines are given
Gardasil and Cervarix are given by an injection into an arm muscle. The manufacturers of both vaccines recommend the injections be given 3 times over a 6-month period. The schedule of doses makes sure the vaccines are as effective as possible. If all 3 doses of the vaccine are not given, or they are not given at the right time, you may not get the full benefit of the vaccine.
- first injection on day 1
- second dose 2 months after the first injection
- last injection 6 months after the first dose
- first injection on day 1
- second dose 1 month after the first dose
- last injection 6 months after the first dose
In the last ten years there has been an explosion of oral/head and neck cancer. Studies are showing a
high association with the HPV virus (possibly associated with oral/genital sexual practices) More
research is being done in this area and whether immunization with HPV Vaccines will reduce the
incidence of these types of cancer .As always,much is to be learned.
HPV Vaccination Does Not Lead to Increased Sexual Activity
For Release: October 15, 2012
In 2006, the U.S. Centers for Disease Control (CDC) Advisory Committee on Immunization Practices recommended that all girls ages 11 to 12 receive the human papillomavirus vaccine (HPV). The American Academy of Pediatrics (AAP) also recommends the HPV vaccine for both boys and girls at ages 11 to 12. HPV strains are the most common sexually transmitted viruses, and HPV causes a large number of cancers of the mouth and throat, cervix and genital organs. In the study, “Sexual Activity-Related Outcomes after Human Papillomavirus Vaccination of 11- to 12-Year-Olds,” published in the November 2012 issue of Pediatrics (published online Oct. 15), HPV vaccination of girls at the recommended ages was not associated with increased markers of sexual activity, as measured by pregnancy, sexually transmitted disease infections and/or contraceptive counseling for up to three years after vaccination. While early onset of sexual activity and multiple sexual partners are risk factors for HPV infection, the study authors say these findings are the first to validate surveys where young women say they do not plan to modify their sexual behaviors after HPV vaccination
About the HPV vaccine
The HPV vaccine Gardasil is the vaccine used in Ontario’s HPV immunization program. The vaccine protects against four types of HPV — types 6, 11, 16 and 18. Two of these cause 70% of cervical cancers and the other two cause 90% of genital warts.
Three doses of the vaccine are required for complete protection.
In Ontario,the Grade 8 HPV vaccination program was introduced in September 2007 and, since then, almost 700,000 doses of Gardasil have been distributed.
The HPV vaccine has been approved for use in over 100 countries, and over 40 million doses of vaccine have been distributed worldwide.
HPV vaccine safety
The HPV vaccine is safe. It has been approved by Health Canada and recommended for use by the National Advisory Committee on Immunization. Before obtaining approval for use in Canada, the vaccine went through rigorous testing and evaluation. The HPV vaccine is approved for use in over 100 countries, and over 40 million doses have been given worldwide. After a vaccine is approved for use, ongoing monitoring is conducted to ensure its continued safety.
You cannot become infected with HPV from the vaccine.
The HPV vaccine does not contain any preservatives, antibiotics, thimerosal or mercury.
It’s important to know what goes into each injection. The Gardasil vaccine contains proteins of HPV Types 6, 11, 16 and 18, amorphous aluminum hydroxyphosphate sulfate (aluminum salts), yeast protein, sodium chloride, L-histidine, polysorbate 80, sodium borate, and water for injection. The vaccine does not contain any antibiotics or preservatives, including mercury or thimerosal.
The vaccine contains aluminum salts, a common substance (called an adjuvant) added to a vaccine to enhance the immune response. Adjuvants make it possible to reduce the amount of antigens (particles that mimic HPV in the vaccine) needed to achieve immunity. Aluminum salts have been safely used for over 70 years. They are found in other vaccines, such as the tetanus, diphtheria and hepatitis B immunizations.
The vaccine was thoroughly tested in order to meet Health Canada’s standards for safety and efficacy. Clinical trials for Gardasil involved around 33,000 people worldwide. Safety information was collected on over 13,000 individuals who received the HPV vaccine. These studies were large enough to detect reactions occurring as infrequently as one in several thousand. The reported reactions to this vaccine are typical reactions seen with most vaccines. These typical reactions include redness, soreness and swelling at the injection site. Gardasil is safe and effective, and it continues to be the HPV vaccine used in Ontario’s publicly funded Grade 8 program.
Canadian vaccine safety standards
Vaccine safety is a high priority. Health Canada thoroughly tests vaccines using the highest standards for safety and efficacy. Each new vaccine must pass a rigorous licensing process by the government before it is introduced and, once in use, it continues to be monitored for safety and quality.
Vaccines are continually monitored through the Canadian Adverse Events Following Immunization Surveillance System (CAEFISS). Timely information is provided to the public about any side effects.
Ongoing vaccine monitoring
Ontario monitors vaccine safety by reviewing reports of side effects — referred to as adverse events following immunization (AEFIs) — submitted by healthcare providers or parents to local Public Health Units. Between 2007 and 2011, almost 700,000 HPV vaccine doses were distributed in Ontario. During this same period, there were 133 confirmed adverse event reports. The most commonly reported events were rashes, allergic skin reactions and local pain or redness at the injection site. Ten serious AEFIs were reported (7.5% of all reports), which included two seizures, one case of thrombocytopenia (abnormal bleeding) and one death. Further review found that the reported death was because of a preexisting cardiac condition. Overall, these findings are consistent with HPV vaccine safety data from the United States and Australia.
In addition, the Ministry of Health and Long-Term Care, in collaboration with Public Health Ontario (PHO), considers new scientific information about HPV as it becomes available.
Vaccine side effects
The HPV vaccine has side effects similarly seen with most other vaccines. These include redness, tenderness and swelling at the injection site and, less commonly, dizziness, nausea, headache and fever.
Severe allergic reactions are rare. However, as with any vaccine or drug, severe allergic reactions may occur with symptoms such as difficulty breathing, swelling of the face or mouth, wheezing and hives or rashes. Public health nurses administer the vaccine and are present at school clinics at all times. They are trained to recognize and manage side effects, including any severe allergic reactions.
Who should not get the HPV vaccine?
The HPV vaccine should not be given to anyone who
- has been fully immunized with the HPV vaccine;
- has had a serious reaction to a previous dose of the HPV vaccine;
- has an allergy or hypersensitivity to any ingredients of the vaccine; or
- is pregnant.
It’s also recommended not to give the vaccine to those with a fever or anything more serious than a minor cold on the day the vaccine is to be given.