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Submitted by: Merck & Co., Inc.
Posted: Sep 04, 2012 – 08:30 AM EST
The Republic of Uganda through the Ministry of Health (MoH), supported by Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the launch of a national vaccination program with GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant] for appropriate girls 9 to 13 years of age in 12 districts throughout the country. Cervical cancer is the most frequent cancer diagnosed among women in Uganda, and incidence rates of the disease in the country are about three times the global average. An estimated 3,500 women in Uganda are diagnosed with cervical cancer each year.
"Cervical cancer is a serious health concern in Uganda as it represents the most common cancer diagnosed in women of all ages," said Dr. Gerald Mutungi, Program Manager for Non-Communicable Diseases Prevention and Control Program-Ministry of Health. "It is our hope that this important collaboration with Merck, GAVI, PATH, and other partners will help to reduce the burden of cervical cancer in Uganda."
Through an agreement with Merck, the vaccination program will be implemented with 460,000 doses of GARDASIL donated to 12 districts in Uganda over a two year period, enough to vaccinate approximately 140,000 eligible girls in 12 districts. The program represents the first phase of Uganda's national roll out plan for human papillomavirus (HPV) vaccination.
"The launch of this program in Uganda is another important step in helping to support our goal of reducing the incidence of cervical cancer around the world, and particularly in sub-Saharan Africa where the burden of cervical cancer is significant," said Colleen McGuffin, vice president, Merck Vaccines. "We are pleased to donate GARDASIL to support the Ugandan Ministry of Health's cervical cancer prevention efforts."
GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant] is indicated in the United States for use in girls and young women 9 through 26 years of age for the prevention of cervical, vulvar, vaginal and anal cancers caused by HPV types 16 and 18; genital warts caused by HPV types 6 and 11; and precancerous or dysplastic lesions caused by HPV types 6, 11, 16 and 18. GARDASIL is also approved for use in boys and men 9 through 26 years of age for the prevention of anal cancer caused by HPV types 16 and 18; genital warts caused by HPV types 6 and 11; and precancerous or dysplastic lesions caused by HPV types 6, 11, 16 and 18.
Important information about GARDASIL
GARDASIL does not eliminate the necessity for women to continue to undergo recommended cervical cancer screening. Recipients of GARDASIL should not discontinue anal cancer screening if it has been recommended by a health care provider.
GARDASIL has not been demonstrated to provide protection against diseases from vaccine and non-vaccine HPV types to which a person has previously been exposed through sexual activity.
GARDASIL is not intended to be used for treatment of active external genital lesions; cervical, vulvar, vaginal and anal cancers; cervical intraepithelial neoplasia, vulvar intraepithelial neoplasia, vaginal intraepithelial neoplasia, or anal intraepithelial neoplasia.
GARDASIL has not been demonstrated to protect against disease due to HPV types not contained in the vaccine.
Not all vulvar, vaginal and anal cancers are caused by HPV, and GARDASIL protects only against those vulvar, vaginal and anal cancers caused by HPV types 16 and 18.
Select safety information for GARDASIL
GARDASIL is contraindicated in individuals with hypersensitivity, including severe allergic reactions to yeast, or after a previous dose of GARDASIL.
Because vaccinees may develop syncope, sometimes resulting in falling with injury, observation for 15 minutes after administration is recommended. Syncope, sometimes associated with tonic-clonic movements and other seizure-like activity, has been reported following vaccination with GARDASIL. When syncope is associated with tonic-clonic movements, the activity is usually transient and typically responds to restoring cerebral perfusion.
GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant] is not recommended for use in pregnant women.
The most common adverse reaction was headache. Common adverse reactions that were observed among recipients of GARDASIL at a frequency of at least 1.0 percent and greater than placebo were: fever, nausea, dizziness; and injection-site pain, swelling, erythema, pruritus and bruising.
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 deltoid region of the upper arm or in the higher anterolateral area of the thigh. 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.
GARDASIL is approved for use in more than 125 countries. As of July 2012, more than 95 million doses of GARDASIL have been distributed worldwide; however, it is not known how many doses have been administered.
Other Merck access efforts for GARDASIL in the developing world
Merck is pursuing a systematic and thoughtful approach to improve access to GARDASIL in the developing world through four key pillars: innovation, partnerships, pricing and implementation. The initiative in Uganda follows the launch in April 2011 of a comprehensive cervical cancer prevention program in Rwanda incorporating both HPV vaccination and HPV testing, the first program of its kind in Africa. In its initial year, an estimated 93 percent of eligible girls 12 to 15 years of age in Rwanda were vaccinated with three doses of GARDASIL. Also, in 2010 Merck partnered with the Royal Government of Bhutan and Australian Cervical Cancer Foundation to launch a six-year national vaccination program with GARDASIL for appropriate girls and young women between the ages of 12 and 18 in Bhutan. Merck provided GARDASIL to the program partners at no cost in the first year and for the remaining five years is providing it at an access price at which Merck will not profit. In 2009 Merck also announced a partnership with QIAGEN N.V. focused on increasing access to HPV vaccination and HPV DNA testing in some of the most resource-poor areas of the world. This initiative was the first time a vaccine manufacturer and a molecular diagnostics company collaborated to help address the burden of cervical cancer with a comprehensive approach.
About HPV and cervical cancer
HPV is a widespread virus that is transmitted through sexual contact. For most people, HPV will clear on its own. However, for those who don't clear certain types, HPV can cause cervical, vaginal and vulvar cancers in women and anal cancer and genital warts in men and women. There is no way to predict who will or will not clear the virus.
It is estimated that approximately 500,000 women develop cervical cancer annually around the world, with about 85 percent of cases occurring in developing countries. Cervical cancer is considered the third most common cancer found in women. The World Health Organization estimates that only about five percent of women in the developing world have been screened for cervical disease in the previous five years compared to 75 percent in the developed world.
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Please see Prescribing Information for GARDASIL at http://www.merck.com/product/usa/pi_circulars/g/gardasil/gardasil_pi.pdf and Patient Information for GARDASIL at http://www.merck.com/product/usa/pi_circulars/g/gardasil/gardasil_ppi.pdf.
GARDASIL® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, N.J., U.S.A.
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