MSD (http://www.merck.com), known as Merck in the United States and Canada, has announced that the company has been awarded a significant portion of the UNICEF human papillomavirus (HPV) vaccine tender, and will provide sustained supply of GARDASIL? [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant] to GAVI-eligible countries. This agreement follows the GAVI Alliance?s earlier announcement that HPV vaccines would be included in its portfolio for the first time. GAVI is expected to support the introduction of HPV vaccination in 28 countries by the end of 2017.
Through this initial tender award, MSD expects to supply approximately 2.4 million doses of GARDASIL to GAVI-eligible countries between 2013 to 2017 to help meet vaccine demand for countries already approved or recommended for approval by GAVI for HPV vaccine demonstration projects and national introductions. Additional awards by UNICEF are anticipated as vaccine demand increases.
?It is essential that every young girl around the world has access to HPV vaccines. Today?s decision by UNICEF is an important step forward,? said Henrik Secher, managing director, MSD Africa. ?This partnership highlights MSD?s commitment to working closely with GAVI to ensure broad and sustained access to GARDASIL in the world?s poorest countries, where the burden of HPV diseases, such as cervical cancer, is greatest.?
Following a 2009 report, the World Health Organization (WHO) recommended that routine HPV vaccination be included in national immunization programs to help prevent cervical cancer and other HPV-related diseases. 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 the third most common type of cancer among women worldwide. High-risk HPV types 16 and 18 cause about 75 percent of cervical cancers, 70 percent of vaginal cancers, 40 to 50 percent of vulvar cancers and 80 percent of anal cancers.
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).
*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.
GARDASIL is approved for use in more than 125 countries. To date, more than
111 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. Key efforts include:
? In September 2012, MSD announced it will donate 460,000 doses of GARDASIL over a two-year period to the Republic of Uganda to help the Ministry of Health launch a HPV vaccination program in 12 districts in the country. The program represents the first phase of Uganda?s national rollout plan for HPV vaccination;
? In April 2011, the Government of Rwanda, MSD and QIAGEN launched 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;
? 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 appropriate 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;
? MSD has also donated more than one million doses of GARDASIL through the GARDASIL Access Program, which was established in 2007 to help enable organizations and institutions in eligible lowest income countries to gain operational experience designing and implementing HPV vaccination projects.
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MSD undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in MSD?s 2012 Annual Report on Form 10-K and the company?s other filings with the Securities and Exchange Commission (SEC) available at the SEC?s Internet site (http://www.sec.gov).
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
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