CDC Finalizes Advisory Panel Recommendations for GARDASIL®, Merck's Cervical Cancer Vaccine

Business Wire, March 22, 2007

WHITEHOUSE STATION, N.J. -- The U.S. 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([R]) [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 CDC's 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 CDC's decision to adopt the vaccination recommendations put forth by the ACIP is an important milestone in cervical cancer prevention," said Margaret G. McGlynn, president, 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."

GARDASIL helps protect against the four HPV types that cause the most HPV disease

GARDASIL has been studied for more than a decade in more than 25,000 individuals, including 1,124 adolescent girls ages 9 to 15. Approved by the Food and Drug Administration (FDA) on June 8, 2006, for girls and women ages 9 to 26, GARDASIL is the world's first and only cervical cancer vaccine. GARDASIL is indicated for the prevention of HPV types 16- and 18-related cervical cancer, cervical pre-cancers (CIN 2/3 and AIS), vulvar pre-cancers (VIN 2/3) and vaginal pre-cancers (VaIN 2/3) and for the prevention of genital warts and low-grade cervical lesions (CIN 1) caused by HPV types 6, 11, 16 and 18. HPV types 16 and 18 account for approximately 70 percent of cases of cervical cancer, non-invasive cervical cancer (CIN 3, AIS), VIN 2/3 and VaIN 2/3, and account for 50 percent of CIN 2 lesions. HPV 6 and 11 cause approximately 90 percent of genital wart cases. These four types of HPV also cause approximately 35 to 50 percent of all low-grade cervical, vulvar and vaginal lesions (CIN I, VIN I and VaIN I).

Dosage and administration for GARDASIL

GARDASIL is a ready-to-use, three-dose, intramuscular vaccine. GARDASIL should be administered in three separate intramuscular injections in the upper arm or upper thigh over a six-month period. The following dosage schedule is recommended: first dose at elected date, second dose two months after the first dose and the third dose six months after the first dose.

Selected important information about GARDASIL

GARDASIL is contraindicated in individuals who are hypersensitive to the active substances or to any of the excipients of the vaccine.

The health care provider should inform the patient, parent or guardian that vaccination does not substitute for routine cervical cancer screening. Women who receive GARDASIL should continue to undergo cervical cancer screening per standard of care.

Vaccination with GARDASIL may not result in protection in all vaccine recipients. GARDASIL is not intended to be used for treatment of active genital warts; cervical cancer; CIN, VIN, or VaIN. GARDASIL has not been shown to protect against disease due to non-vaccine HPV types.

Vaccine-related adverse experiences that were observed in clinical trials at a frequency of at least 1.0 percent among recipients of GARDASIL and also greater than those observed among recipients of placebo, respectively, were pain (83.9 percent vs. 75.4 percent), swelling (25.4 percent vs. 15.8 percent), erythema (24.6 percent vs. 18.4 percent), fever (10.3 percent vs. 8.6 percent), nausea (4.2 percent vs. 4.1 percent), pruritis (3.1 percent vs. 2.8 percent) and dizziness (2.8 percent vs. 2.6 percent).

Access to GARDASIL

There is broad private and public health insurance coverage for GARDASIL. Health plans covering approximately 96 percent of privately-insured lives in the U.S. (currently more than 120 insurance plans) have implemented coverage for GARDASIL; however, individual benefit coverage and rates provided by health plans may vary.