The Food and Drug Administration (FDA) has approved Gardasil, the first vaccine developed to prevent cervical cancer, precancerous genital lesions and genital warts due to human papillomavirus (HPV) types 6, 11, 16, and 18. The vaccine is approved for use in females 9-26 years of age. Gardasil was evaluated and approved in six months under FDA's priority review process--a process for products with potential to provide significant health benefits.
HPV is the most common sexually-transmitted infection in the US. The Centers for Disease Control and Prevention (CDC) estimates that about 6.2 million Americans become infected with genital HPV each year and that over half of all sexually active men and women become infected at some time in their lives. On average, there are 9,710 new cases of cervical cancer and 3,700 deaths attributed to it in the US each year. Worldwide, cervical cancer is the second most common cancer in women; it is estimated to cause over 470,000 new cases and 233,000 deaths worldwide each year.
Gardasil is a recombinant vaccine (contains no live virus) that is given as three injections over a six-month period. Immunization is expected to prevent most cases of cervical cancer due to HPV types included in the vaccine. However, females are not protected if they have been infected with these HPV type(s) prior to vaccination, indicating the importance of immunization before potential exposure to the virus. The vaccine also does not protect against less common HPV types not included in the vaccine. Therefore, routine and regular pap screening remain critically important to detect precancerous changes in the cervix to allow treatment before cervical cancer develops.
