Republic of Uganda and MSD Launch Cervical Cancer Vaccination Program
• Cervical cancer is the most common cancer among women in Uganda
• MSD will donate 460,000 doses of GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant] over two years
JOHANNESBURG, South-Africa, September 4, 2012/African Press Organization (APO)/ – The Republic of Uganda through the Ministry of Health (MoH), supported by MSD (http://www.msd.com) known as Merck in 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 eligible 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 MSD, GAVI, PATH, and other partners will help to reduce the burden of cervical cancer in Uganda.”
Through an agreement with MSD, 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.”
“At MSD we are committed to work with health officials and other stakeholders in sub-Saharan Africa to advance human health and to protect future generations of Africans from potentially devastating diseases,” says Henrik Secher, managing director, MSD Africa. “Being part of the Cervical Cancer Vaccination program in Uganda is a great example of how – in close cooperation with local governments – we can help improve access to much needed vaccines.”
Distributed by the African Press Organization on behalf of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
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Important information about GARDASIL
GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant] is indicated in females aged 9 to 26 years* for the prevention of cervical, vulvar, and vaginal cancer, precancerous or dysplastic lesions, genital warts, and persistent infection caused by Human Papillomavirus (HPV) Types 6, 11, 16, and 18 (which are included in the vaccine).
GARDASIL is indicated in males aged 9 to 15 years for the prevention of infection caused by Human Papillomavirus (HPV) Types 6, 11, 16, and 18 (which are included in the vaccine).
GARDASIL also provides protection in girls and women 9 through 26 years of age against HPV 31-, 33-, 52- and 58-related CIN (grades 1, 2, 3) or AIS.
*Immunogenicity studies have been conducted to link efficacy in females aged 16 to 26 years to the younger populations.
As for any vaccine, vaccination with GARDASIL may not result in protection in all vaccine recipients. This vaccine is not intended to be used for treatment of active external genital lesions; cervical, vulvar, or vaginal cancers; CIN, VIN, or VaIN related to HPV vaccine types or non-vaccine serotypes.
This vaccine will not protect against diseases that are not caused by HPV. Routine cervical screening and detection and removal of cervical lesions should be continued in individuals who receive the vaccine.
As with all injectable vaccines, appropriate medical treatment should always be readily available in case of rare anaphylactic reactions following the administration of the vaccine.
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 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 [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant] 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.
About GARDASIL
GARDASIL is approved for use in more than 125 countries. To date, more than
95 million doses have been distributed worldwide; however, it is not known how many doses have been administered.
Other MSD access efforts for GARDASIL in the developing world
MSD 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 MSD partnered with the Royal Government of Bhutan and Australian Cervical Cancer Foundation to launch a six-year national vaccination program with GARDASIL for girls and young women between the ages of 12 and 18 in Bhutan. MSD 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 MSD will not profit. In 2009 MSD 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.
About MSD
Today’s MSD is a global healthcare leader working to help the world be well. MSD is a tradename of Merck & Co., Inc., with headquarters in Whitehouse Station, N.J., U.S.A. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit http://www.msd.com or and connect with us on Twitter, Facebook and YouTube.
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Please see WHO Prescribing Information for GARDASIL at
http://www.who.int/immunization_standards/vaccine_quality/PQ_179_HPV_Merck/en/index.html
GARDASIL® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, N.J., U.S.A.
SOURCE
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
