The past decade has seen the development of two vaccines to prevent HPV infection.
- In 2006, a quadrivalent HPV vaccine (Gardasil®) was approved by the Food and Drug Administration (FDA) for use in the United States, followed in 2009 with the approval of a bivalent vaccine (Cervarix®).
- Both are nearly 100% protective against HPV 16 and 18, which cause about 70% of cervical cancers.17
- The quadrivalent vaccine also is approximately 100% effective in preventing infection with HPV 6 and 11, which together are responsible for nearly all instances of genital warts.17
HPV Vaccine Indications
The quadrivalent vaccine is approved by the Food and Drug Administration (FDA) for use in the United States in:
- Girls and young women aged 9 to 26 years for the prevention of cervical, vulvar, and vaginal cancers and precancers caused by HPV types 16 and 18.2
- Males and females aged 9 to 26 years to prevent genital warts (condyloma acuminata) associated with HPV types 6 and 1118
- Males and females aged 9 to 26 years to prevent anal cancers, precancers, and dysplasia caused by HPV types 6, 11, 16, and 18. 19
The bivalent vaccine is approved by the FDA for use in the United States in:
- Females aged 10 to 25 years for the prevention of cervical cancers and precancers associated with HPV 16 and HPV 18.17
The emphasis on preteen and teenage groups is intended to maximize protection, because many HPV infections are acquired soon after onset of sexual activity.9
HPV Vaccination Recommendations
Recommendations of the Advisory Committee on Immunization Practices (ACIP) for use of HPV vaccines in males and females2,17,18:
- Routine vaccination with either the quadrivalent or bivalent vaccine for all females aged 11 and 12. ACIP also recommends vaccination for girls and young women aged 13 to 26 years who have not previously been vaccinated
- Routine vaccination with the quadrivalent vaccine for all boys aged 11 and 12. ACIP also recommends vaccination for boys and young men aged 13 to 21 years who have not previously been vaccinated
Dosing schedules with the vaccines are at 0, 1 to 2 months, and 6 months. Minimum intervals are 4 weeks between doses 1 and 2, 12 weeks between doses 2 and 3, and 24 weeks between the first and third doses. It is likely that variations in scheduled doses do not seriously impair the vaccines’ effectiveness; therefore, the vaccine series should not be restarted if the schedule is interrupted.
Safety and Side Effects
In studies with tens of thousands of males and females worldwide, HPV vaccines have been shown to be effective, safe, and well tolerated. Adverse events (AEs) are no greater in those receiving an HPV vaccine than background rates of other vaccines for this age group. There is no difference between vaccine and control groups in serious AEs, new onset chronic disease and autoimmune disorders, or deaths.20
The most common local symptoms reported are pain, swelling, and redness at the injection site. The most common general symptoms include headache, nausea, and fever.17 To avoid syncope (fainting), patients should sit or lie down for 15 minutes after the vaccine has been administered and before leaving the office or clinic.17
- Those with a severe allergic reaction (e.g., anaphylaxis) after previous dose
- With the quadrivalent vaccine, a history of immediate hypersensitivity to yeast
- Prefilled syringes of the bivalent vaccine are contraindicated for those with anaphylactic latex allergy (single-dose vials of the bivalent vaccine have no latex)