CDC Finalizes Advisory Panel Recommendations for GARDASIL, Cervical Cancer Vaccine

Cervical Cancer Vaccine and Gardasil

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 [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 to15. 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).

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.

GARDASIL was also added to the Vaccines for Children (VFC) Program on November 1, 2006, providing coverage for many who do not have private health insurance. To date, 53 out of 55 immunization projects (which cover 94 percent of the public sector birth cohort in the U.S.) have adopted GARDASIL and many have already begun to accept provider orders.

Merck has also initiated a new patient assistance program for vaccines. Through this program, currently available in private physicians' offices and private clinics, Merck is making available, free of charge, GARDASIL and other Merck vaccines indicated for use in individuals ages 19 and older who are uninsured and who are unable to afford vaccines.

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.

GARDASIL (sold in some countries as SILGARD ) has been approved in 60 countries including the United States, the 27 countries of the European Union, Mexico, Australia, Taiwan, Canada, New Zealand and Brazil. Additional applications for GARDASIL are currently under review with regulatory agencies in more than 50 countries around the world.

In 1995, Merck entered into a license agreement and research collaboration with CSL Limited of Australia relating to technology used in GARDASIL. GARDASIL also is the subject of other third-party licensing agreements.