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The page below is a sample from the LabCE course Human Papillomavirus (HPV) and Molecular Testing for Cervical Cancer. Access the complete course and earn ASCLS P.A.C.E.-approved continuing education credits by subscribing online.

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HPV Vaccines

The CDC strongly recommends the HPV vaccine. It recommends vaccination of preteen boys and girls at age 11 or 12 so they are protected before ever being exposed to the virus. HPV vaccine also produces a higher immune response in preteens than in older adolescents. The vaccines that are discussed on this page have been approved by the FDA for the prevention of HPV infections.
CDC Recommendations:
  • All children who are 11 or 12 years old should get two shots of HPV vaccine six to twelve months apart. Adolescents who receive their two shots less than five months apart will require a third dose of HPV vaccine. If a child is older than 14 years, three shots are recommended over a six-month period. In addition, three doses are recommended for individuals with certain immunocompromising conditions aged 9 through 26 years. Through age 26, vaccination is also recommended for young men who have sex with men including men who identify as gay, or bisexual, or who are transgender.
  • Two dose or three dose vaccinations?: Since 2006, HPV vaccines have been recommended in a three-dose series given over six months. In 2016, CDC changed the recommendation to two doses for persons starting the series before their 15th birthday. The second dose of HPV vaccine should be given six to twelve months after the first dose. Adolescents who receive their two doses less than five months apart will require a third dose of HPV vaccine. Teens and young adults who start the series at ages 15 through 26 years still need three doses of HPV vaccine
  • The CDC recommends that women who have an HPV infection and/or an abnormal Pap test result that may indicate an HPV infection should still receive HPV vaccination if they are in the appropriate age group. The reason is the vaccine may protect them against high-risk HPV types that they have not yet acquired. However, these women need to be informed that the vaccination will not cure them of current HPV infections or treat the abnormal results of their Pap test. HPV vaccines provide maximum benefit only if a person receives them before he or she is sexually active.
  • Currently, women vaccinated will still have to be screened for cervical cancer because HPV vaccines do not protect against all HPV types. Cervical cancer screening is important in order to detect precancerous changes in the cervical cells before cancer can develop.
Source: National Cancer Institute, HPV vaccine fact sheet, available at https://www.cancer.gov/about-cancer/causes-prevention/risk/infectious-agents/hpv-vaccine-fact-sheet
Three HPV vaccines have been given FDA approval: Cervarix®, Gardasil®, and Gardasil® 9. All three vaccines went through years of extensive safety testing before they were licensed by the FDA. Cervarix® was studied in clinical trials with more than 30,000 females. Gardasil® trials included more than 29,000 females and males, and Gardasil® 9 trials included more than 15,000 females and males. Since 2014, only Gardasil 9 and Cervarix are available in the U.S. The following is a summary of the HPV vaccines available in the U.S.:
Gardasil®
Approved in 2006, this vaccine contains HPV types 6,11,16 and 18. It is used for the prevention of cervical, anal, vulvar, and vaginal cancer, as well as precancerous lesions in these tissues. It also can prevent genital warts caused by HPV infection. The Gardasil vaccine is no longer available in the U.S because it has been replaced by the more recently FDA approved Gardasil 9 vaccine.
Cervarix®
Approved in 2009, this vaccine is used for the prevention of cervical cancer and precancerous cervical lesions caused by HPV infection. Cervarix HPV vaccine contains only two HPV types, 16 and 18. Infection with either of these types is responsible for the majority of cervical carcinoma. It is approved for vaccination of women and girls ages 10-25 years and is highly effective in preventing infections with HPV types 16 and 18. It has not been approved for prevention of penile or oropharyngeal cancers.
Gardasil® 9
As mentioned, Gardasil was approved by the FDA in 2006 as a vaccine against the four HPV types, however, it is no longer distributed in the U.S. Instead, in 2014, the FDA approved Gardasil 9 which covers the same four HPV types as Gardasil as well as five additional HPV types (a total of 9 HPV types). Gardasil 9 is approved as a vaccine for cervical, vulvar, vaginal and anal cancer caused by seven HPV types (16,18,31,33,45,52, and 58) and for genital warts caused by two HPV types (6 and 11). It is approved for use in both males and females aged 9 through 26 years. In October 2018, the FDA expanded the approval of Gardasil 9 for use as a vaccine in women and men aged 27 through 45 years.