Review of Gardasil

Authors: Diane M Harper,1,* Stephen L. Vierthaler,2 and Jennifer A Santee3


Human papillomavirus (HPV) is necessary for the development of cervical cancer. Cervical cancer is the second most common cancer in women worldwide but 80% occurs in developing countries, not countries with Pap screening programs. Pap screening programs in industrialized countries have reduced the incidence of cervical cancer to 4–8/100,000 women. HPV vaccines may be a promising strategy for cervical cancer in women without access to screening programs. In industrialized countries, the benefit of HPV vaccines focuses on individual abnormal Pap test reduction not cancer prevention.

The focus of this review is to cover the side effects of Gardasil in perspective with the limited population benefit cervical cancer reduction in countries with organized Pap screening programs. In addition, information about Gardasil benefits, risks and unknowns for individual patient decision making for vaccination is presented.

Gardasil offers protection against CIN 2+ lesions caused by HPV 16/18 and against genital warts caused by HPV 6/11 for at least 5 years. Combining Gardasil with repeated cytology screenings may reduce the proportion of abnormal cytology screens and hence reduce the associated morbidity with the subsequent colposcopies and excisional procedures.


The primary question to ask about the decision to vaccinate with Gardasil is, “Is there good evidence that this new vaccine is likely to make my patient live longer or better compared with the available alternatives?” [74]. We do not know how long the vaccine will last, the HPV types covered by the vaccine are limited, and the very safe alternative of Pap screening with early detection and treatment is a proven successful program. Gardasil is not likely to extend a woman’s life in countries with cytology screening, but it may allow her to experience fewer abnormal Pap tests and their subsequent workup.

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