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Am Fam Physician. 2007;76(4):573-574

Author disclosure: Nothing to disclose.

The quadrivalent human papillomavirus (HPV) recombinant vaccine (Gardasil) is the first vaccine developed to prevent cervical cancer, precancerous genital lesions, and genital warts caused by HPV types 6, 11, 16, and 18.1 These four types are responsible for 70 percent of cervical cancers and 90 percent of genital warts.2 The Advisory Committee on Immunization Practices recommends that females 9 to 26 years of age receive the vaccine.3

NameDoseDose formApproximate cost*
Quadrivalent human papillomavirus recombinant vaccine (Gardasil)A series of three intramuscular 0.5-mL doses, with the second dose given at least two months after the initial dose and the third dose given at least six months after the initial dose.0.5-mL single-dose vial or 0.5-mL single-dose prefilled syringe$147 per dose ($441 for the three-dose series)


Clinical trials have not identified serious safety issues with the HPV vaccine. The vaccine may be administered concomitantly (at separate injection sites) with hepatitis B recombinant; tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis; and meningococcal vaccines. Coadministration with other vaccines has not been studied.1,3 The HPV vaccine is U.S. Food and drug Administration pregnancy category B, although the manufacturer does not recommend its use in pregnant women.1


The HPV vaccine is well tolerated, and less than 0.1 percent of patients stop the series because of adverse effects. Minor injection site reactions are common, including pain (83.9 percent), swelling (25.4 percent), and erythema (24.6 percent). In approximately 5,000 patients receiving the vaccine, 10 to 13 percent experienced fever and less than 7 percent reported nausea or dizziness.1


The HPV vaccine will protect against genital warts caused by HPV types 6, 11, 16, and 18 in 99 percent of women.1,3,4 It also decreases the risk of developing cervical dysplasia; however, the effect on cervical cancer, because of its low incidence, is not known. Four studies enrolling more than 20,000 females 16 to 26 years of age who were free of HPV infection showed that only four of the 7,858 patients who received all three doses of the HPV vaccine developed cervical intraepithelial neoplasia (CIN) grades 1, 2, or 3, or adenocarcinoma in situ (AIS) because of one of the four strains of HPV; this was compared with 83 of 7,861 patients receiving placebo (0.05 percent versus 1.1 percent, respectively).1 In other words, for every 100 persons who receive the HPV vaccine, one case of cervical dysplasia will be prevented over a two-year period (number needed to treat [NNT] = 100; 95% confidence interval [CI], 79 to 127). In a study of more than 16,000 females with unknown HPV status, fewer cases of CIN 1, 2, or 3, or AIS were reported in those who received the HPV vaccine than in those who did not during two years of follow-up (1.9 percent versus 3.6 percent; NNT = 60; 95% CI, 47 to 85).1 The vaccine's duration of protection is unknown, but protective antibodies have persisted for at least four years.4,5


The cost for the three-dose series of HPV vaccine is $441. Many insurance plans will cover this vaccine for females who are within the recommended age group.


The recommended dosing schedule for the HPV vaccine is a series of three doses, with the second dose given at least two months after the initial dose and the third dose given at least six months after the initial dose. The patient's HPV status does not need to be determined before vaccination,5 and women who already have a documented strain of HPV can still receive the vaccine.3 If the vaccination series is interrupted, it should be continued without restarting the entire series.3,4

The HPV vaccine is administered intra-muscularly into the deltoid or the upper anterolateral thigh. The vaccine should be refrigerated, and the suspension should be shaken before administration.1 Current recommendations do not change guidelines for cervical cancer screening in vaccinated females.3

Bottom line

The HPV vaccine is safe and effective in preventing genital warts and cervical changes that may lead to cervical cancer, and it is recommended as part of the vaccination series in females 11 to 12 years of age. It can be given to females as young as 9 or 10 years of age, and catch-up vaccination is recommended for those who are 13 to 26 years of age.1,3

STEPS new drug reviews cover Safety, Tolerability, Effectiveness, Price, and Simplicity. Each independent review is provided by authors who have no financial association with the drug manufacturer.

This series is coordinated by Allen F. Shaughnessy, PharmD, assistant medical editor.

A collection of STEPS published in AFP is available at

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Copyright © 2007 by the American Academy of Family Physicians.

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