Republic of Uganda and Merck Launch Cervical Cancer Vaccination Program


September 4, 2012 7:08 am ET

— Cervical cancer is the most common cancer among women in Uganda

— Merck will donate 460,000 doses of GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant] over two years

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

“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)

“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

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

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

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.

About Merck

Today’s Merck is a global healthcare leader working to help the world be
well. Merck is known as MSD outside the United States and Canada.
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
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GARDASIL® is a registered trademark of Merck Sharp & Dohme Corp., a
subsidiary of Merck & Co., Inc., Whitehouse Station, N.J., U.S.A.

Please see Prescribing Information for GARDASIL® at
and Patient Information for GARDASIL® at

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