WHITEHOUSE STATION, N.J., Aug. 20, 2008 -
The analysis conducted by the Harvard School of Public Health's J. Kim and S. Goldie underscores the impact that HPV vaccination can have on reducing the burden of cervical cancer and HPV diseases in the United States. As the authors note, more than 11,000 women each year are diagnosed with cervical cancer in the United States and 3,700 women die; that is, 10 women a day will die from cervical cancer. Worldwide, 233,000 women die from cervical cancer each year. Merck's goal, along with many leaders in the global health care community is to eradicate cervical cancer through education, screening and vaccination against the HPV types that cause 70 percent of cervical cancer cases.
While we are pleased that GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant] has been used widely among 11- to 12- year old girls in the United States, more than 60 percent of them have not yet been vaccinated. As it is "back to school" season, it is a critical time of year for parents to talk to their doctor about vaccination against HPV and other diseases caused by HPV types 6, 11, 16 and 18.
The authors' Health Economic Model and conclusion validates what the Advisory Committee on Immunization Practices (ACIP) and other policy making and professional bodies recommend today: universal vaccination with pre-adolescent girls together with a "catch up" program for older females who have not been vaccinated. Data show that GARDASIL is very effective in women through the age of 26 and most effective when given before exposure to HPV types 6, 11, 16 and 18.
Because women remain at risk for HPV infection throughout their lifetime and because the women in the catch-up cohort of 13 to 26 years old are not likely to have been infected with all four vaccine HPV types, catch up vaccination can benefit many women.
Many of the potential concerns raised in the editorial by C.J. Haug have been considered and largely dismissed by the medical community. As with many diseases for which vaccines have been discovered and developed, there was no long-term evidence on reduction of disease at the time of introduction and yet large-scale vaccination programs were implemented and positively affected the lives of millions. Merck remains committed to evaluating the duration of immunity provided by GARDASIL and updating the medical community on our findings. At this time, we have demonstrated long-term duration of protection without breakthrough due to waning immunity through five years.
In 2006, GARDASIL became the first approved vaccine to prevent cervical cancer, precancerous or dysplastic lesions, and genital warts caused by HPV types 6, 11, 16 and 18 in girls and women 9 through 26 years of age.
Additional 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. GARDASIL is not recommended for use in pregnant women.
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, vulvar interepithelial neoplasia (VIN), or vaginal interepithelial neoplasia (VaIN). GARDASIL has not been shown to protect against disease due to other HPV types.
In clinical studies for GARDASIL, vaccine-related adverse experiences that were observed 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, swelling, erythema, fever, nausea, pruritis and dizziness. In addition, common post-marketing reports include vomiting and syncope.
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 anterior 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.
About Merck
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.
Forward-Looking Statement
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations and involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential or financial performance. No forward-looking statement can be guaranteed and actual results may differ materially from those projected. Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Merck's business, particularly those mentioned in the risk factors and cautionary statements in Item 1A of Merck's Form 10-K for the year ended Dec. 31, 2007, and in any risk factors or cautionary statements contained in the Company's periodic reports on Form 10-Q or current reports on Form 8-K, which the Company incorporates by reference.
|
Printer Friendly Page
