Human Papillomavirus Vaccine Recommendations and Safety

Human Papillomavirus (HPV) Vaccination Recommendations

HPV vaccine should be administered at the target age of 11-12 years in both females and males. ACIP also recommends vaccination for females through age 26 years and for males through age 21 years who were not adequately vaccinated previously

On December 16, 2016 the MMWR article, "Use of a 2-Dose Schedule for Human Papillomavirus Vaccination- Updated Recommendations of the Advisory Committee on Immunization Practices" was published, detailing updated HPV vaccination recommendations. The new recommendation is for use of a 2-dose schedule for girls and boys who initiate the vaccination series at ages 9 through 14 years. Three doses remain recommended for persons who initiate the vaccination series at ages 15 through 26 years and for immunocompromised persons.

Human Papillomavirus (HPV) Vaccines

The U.S. Food and Drug Administration (FDA) has approved three vaccines shown to be effective at preventing HPV infection.

The bivalent HPV vaccine has FDA approval for administration to females aged 9–25 years for the prevention of cervical cancer, cervical intraepithelial neoplasia (CIN) 2 or worse and adenocarcinoma in situ, and CIN 1 caused by oncogenic HPV genotypes 16 and 18.

The quadrivalent HPV vaccine is indicated to prevent cancers and intraepithelial neoplasias of the cervix, anus, vulva, and vagina and genital warts associated with HPV genotypes 6, 11, 16, and 18. The FDA has approved administration of the quadrivalent three-dose vaccine to females and males aged 9–26 years.

The 9-valent HPV vaccine, approved by the FDA on December 10, 2014 for the prevention of cervical, vulvar, vaginal and anal cancers caused by HPV types 16, 18, 31, 33, 45, 52 and 58, and for the prevention of genital warts caused by HPV types 6 or 11

Sexually Active Adolescents and Young Women

Sexually active adolescents and young women can receive either the quadrivalent or bivalent HPV vaccine. These patients should be counseled that the vaccine may be less effective in individuals who have been exposed to HPV before vaccination than in individuals who were HPV naive at the time of vaccination. However, sexually active individuals can receive some benefit from the vaccination because exposure to all HPV types prevented by the vaccines is unlikely in persons aged 13 years through 26 years. The need for ongoing cervical cytology screening should be emphasized in all women aged 21 years and older, even those vaccinated before the onset of sexual activity.

Adolescents and Young Women With Previous Cervical Intraepithelial Neoplasia or Genital Warts

The HPV vaccines can be given to patients with previous CIN or genital warts. Health care providers need to emphasize that the benefits may be limited and cervical cytology screening and corresponding management based on College recommendations must continue. The HPV vaccines are not intended to be treatment for cervical cytologic abnormalities, genital warts, or a positive HPV DNA test result. Patients with these conditions should undergo the appropriate evaluation and treatment.

Pregnant and Lactating Women

Both the quadrivalent and bivalent HPV vaccines have been classified by the FDA as pregnancy category B. Although HPV vaccination in pregnancy is not recommended, neither is routine pregnancy testing before vaccination. Currently, there are few data on HPV vaccine administration in pregnancy; however, the available safety data regarding the inadvertent administration of the vaccine during pregnancy are reassuring. In clinical studies, the proportion of pregnancies with adverse outcomes was comparable in women who received the HPV vaccine and in women who received a placebo.

However, it is wise to remind patients to use contraception during the period when they are receiving the vaccination series. The manufacturer should be contacted if pregnancy is detected during the vaccination schedule. Completion of the vaccine series should be delayed until pregnancy is completed. Lactating women can receive either HPV vaccine because inactivated vaccines, such as these vaccines, do not affect the safety of breastfeeding for mothers or infants.

Immunosuppressed Patients

The presence of immunosuppression, like that experienced in patients with HIV infection or organ transplantation, is not a contraindication to HPV vaccination. However, the immune response may be less robust in the immunocompromised patient.

Women Older Than 26 Years

Human papillomavirus vaccines are not currently licensed in the United States for women older than 26 years. Off-label use may be indicated on a case-by-case basis because vaccination may provide some marginal benefit.

Current ACIP Vaccine Recommendations: Human Papillomavirus

Human Papillomavirus (HPV) Vaccine Safety

Safety data for both HPV vaccines are reassuring. According to the Vaccine Adverse Events Reporting System, more than 57 million doses of HPV vaccine have been distributed, and there are no data to suggest that there are any severe side effects or adverse reactions linked to vaccination. Ongoing surveillance of HPV vaccine side effects—which include syncope, nausea, headache, dizziness, and local pain and redness—shows no new, unexpected adverse reactions. Although there was an observed increase of venous thromboembolism in those vaccinated, on review it was determined that this finding was not statistically significant because all five patients had prior known risks of venous thromboembolism. The CDC continues to consider HPV vaccines safe.

A Vaccine Information Statement (VIS) is a document, produced by CDC, that informs vaccine recipients - or their parents or legal representatives - about the benefits and risks of a vaccine they are receiving. You can access the VIS statements for the following HPV vaccines:

Contraindications

Individuals who develop symptoms indicative of hypersensitivity to the active substances or to any of the components of either vaccine after receiving a dose of vaccine should not receive further doses of the product. Safety and effectiveness of the two formulations have not been established in pregnant women. Any exposure to it during pregnancy should be reported to the manufacturer by calling 1-877-888-4231 for the quadrivalent vaccine and 1-888-452-9622 for the bivalent vaccine.

Precautions

As with any vaccine, vaccination may not protect all vaccine recipients. Neither vaccine is intended to be used for treatment of active disease (ie, genital warts, cervical cancer, cervical intraepithelial neoplasia, vulvar intraepithelial neoplasia, or vaginal intraepithelial neoplasia). Human papillomavirus (HPV) vaccines can be administered simultaneously or at any time before or after a different inactivated or live vaccine administration. Because vaccinated individuals may develop syncope, sometimes resulting in falling with injury, health care providers should consider observing patients for 15 minutes after vaccine administration.

Sources:

1. Meites E, Kempe A, Markowitz LE. Use of a 2-Dose Schedule for Human Papillomavirus Vaccination — Updated Recommendations of the Advisory Committee on Immunization Practices. MMWR Morb Mortal Wkly Rep 2016;65:1405–1408. DOI: http://dx.doi.org/10.15585/mmwr.mm6549a5

2. Centers for Disease Control and Prevention. Vaccine safety: human papillomavirus (HPV) vaccine. Available at:http://www.cdc.gov/vaccinesafety/vaccines/HPV/index.html. Retrieved November 4, 2013.

3.Gee J, Naleway A, Shui I, Baggs J, Yin R, Li R, et al. Monitoring the safety of quadrivalent human papillomavirus vaccine: findings from the Vaccine Safety Datalink. Vaccine 2011;29:8279–84.

 

 

 

Updated 3/22/17

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