CDC Finalizes Advisory Panel Recommendations for Mercks Cervical Cancer Vaccine

WHITEHOUSE STATION, N.J. -- The Centers for Disease Control and Prevention (CDC) has adopted the unanimous recommendation of its Advisory Committee on Immunization Practices (ACIP) for the use of GARDASIL® [Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine] in girls and women ages 11 through 26. GARDASIL is indicated to help prevent cervical cancer, precancerous and low-grade cervical lesions, vulvar and vaginal precancers and genital warts caused by human papillomavirus (HPV) types 6, 11, 16 and 18.

The vaccination guidelines, published in the CDCs Morbidity and Mortality Weekly Report (MMWR), and now available to physicians, finalize the provisional recommendations issued by the ACIP in June 2006.

The guidelines state that routine vaccination with GARDASIL (referred to in the guidelines as Quadrivalent HPV Vaccine) is recommended for 11- and 12-year-old females and for females ages 13 to 26 who have not previously been vaccinated or who have not completed the full series, and that vaccination with GARDASIL can be started at nine years of age. Additionally, the guidelines highlight that GARDASIL can be administered to females even if they have or previously had an abnormal or unclear Pap test, a positive HPV test or genital warts. Pap testing and screening for HPV DNA or HPV antibody are not needed before vaccination at any age. GARDASIL can help protect females against disease due to vaccine HPV types not already acquired. Females should be advised that data from clinical trials do not indicate the vaccine will have any therapeutic effect on existing cervical lesions, genital warts or HPV infection.

The CDCs decision to adopt the vaccination recommendations put forth by the ACIP is an important milestone in cervical cancer prevention, said Margaret G. McGlynn, president of Merck Vaccines. We look forward to continuing to work with the public health community, physicians, parents and others to support the implementation of this broad recommendation for GARDASIL to help achieve our common public health goal of reducing the burden of cervical cancer and HPV-related diseases for as many females as possible, as quickly as possible.

In the United States, approximately 20 million people are infected with HPV, and approximately 80 percent of females will have acquired HPV by age 50. For most people, HPV goes away on its own; however in some, certain high-risk types of HPV, if unrecognized and untreated, can lead to cervical cancer. Cervical cancer is the second most common cause of cancer death in women worldwide, resulting in nearly a half-million diagnoses and 240,000 deaths each year. It is estimated that in 2007, there will be approximately 11,150 new cases of cervical cancer and 3,700 deaths in the United States. In addition, certain low-risk types of HPV cause genital warts and can lead to abnormal Pap results. Approximately one million cases of genital warts occur each year in the United States and an estimated 32 million cases occur worldwide. Additionally, there are an estimated 4.7 million abnormal Pap results that require follow-up each year in the United States. At least 3 million of these results are caused by some type of HPV.

Source: Merck & Co., Inc.