Merck & Co., Inc. announced that the U.S. Centers for Disease Control and Prevention (CDC) has added Merck’s cervical cancer vaccine, GARDASIL? [Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine] to the CDC’s Vaccines for Children (VFC) contract for girls and women aged 9 to 18. GARDASIL was approved on June 8 by the Food and Drug Administration (FDA) for use in girls and women ages 9 to 26 years. GARDASIL is the world’s first and only vaccine available 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.
“The addition of GARDASIL to the VFC program is a very positive step towards protecting the future health of girls and young women in this country against cervical cancer caused by HPV types 16 and 18,” said Mark Feinberg, M.D., Ph.D., vice president, Policy, Public Health and Medical Affairs in the Merck Vaccine Division. “Inclusion of GARDASIL in the VFC program, coupled with private insurance coverage and Merck’s Vaccine Patient Assistance Program, represent important means to facilitate broad and equitable access to GARDASIL.”
Health insurers covering approximately 94 percent of privately insured lives in the US (currently more than 95 insurance plans) have decided to reimburse GARDASIL. Many lives not covered by Managed Care will now be covered under the VFC Program. Merck has also initiated a new patient assistance program for vaccines. Through this new program, currently available in private physicians’ offices, Merck is making available, free of charge, GARDASIL and other Merck vaccines indicated for use in individuals aged 19 and older who are uninsured and who are unable to afford vaccines.
Since 1994, the VFC program has provided vaccines to children through age 18 who are Medicaid-eligible, uninsured, underinsured or Native American. After the CDC’s Advisory Committee for Immunization Practices (ACIP) has made a recommendation for the use of a given vaccine, the ACIP votes on whether the vaccine should be included in the VFC program. At the June 2006 meeting of the ACIP, the committee voted unanimously to recommend GARDASIL to the VFC program. Eligible adolescents may receive recommended vaccines through VFC once the CDC contracts for the purchase of the vaccine, a process that is now complete.
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.
As with any vaccine, 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.
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.
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).
Other Information about GARDASIL
In 1995, Merck entered into a license agreement and collaboration with CSL Limited relating to technology used in GARDASIL. GARDASIL also is the subject of other third-party licensing agreements.
About HPV Disease
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 2006, there will be approximately 9,700 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 1 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.
Worldwide Availability of GARDASIL
GARDASIL has been approved in more than 30 countries including those in the European Union, Mexico, Malaysia, 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. Additionally, Merck is actively working to accelerate the availability of GARDASIL in the developing world: Merck has announced a partnership with India’s Council of Medical Research to study GARDASIL. Merck is also working with PATH to develop HPV vaccination programs that will facilitate the introduction of GARDASIL to the most impoverished nations. Merck will make our new vaccines, including GARDASIL, available at dramatically lower prices to developing world countries.
Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck currently discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs. The Company devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but help deliver them to the people who need them. Merck also publishes unbiased health information as a not-for-profit service. For more information, visit www.merck.com.