GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18)
Vaccine, Recombinant], Merck’s HPV Vaccine, Available to Developing
Countries through UNICEF Tender
WHITEHOUSE STATION, N.J. -- May 9, 2013
Merck (NYSE: MRK), known as MSD outside the United States and Canada,
announced today 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, Merck 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
“It is essential that every young girl around the world have access to HPV
vaccines. Today's decision by UNICEF is an important step forward,” said Julie
L. Gerberding, M.D., president, Merck Vaccines. “This partnership highlights
Merck’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
cervical cancer is greatest.”
“A vast gap currently exists between girls in rich and poor countries. With
today's announcement of GAVI's programmes we can begin to bridge that gap to
help protect girls against cervical cancer no matter where they are born,”
said Dr. Seth Berkley, CEO of the GAVI Alliance. “By 2020 we hope to reach
more than 30 million girls in more than 40 countries. This is a
transformational moment for the health of women and girls across the world. We
thank the manufacturers for working with us to help make this happen.”
Following a 2009 report, the World Health Organization 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.
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
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 vaccines 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
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 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. Key efforts include:
*In September 2012, Merck 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, Merck 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 Merck partnered with the Royal Government of Bhutan and the
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.
*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.
*Merck has also donated more than one million doses of GARDASIL [Human
Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant]
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
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Please see Prescribing Information for GARDASIL^® at
Patient Information for GARDASIL at
Pamela Eisele, 908-423-5042
Imraan Munshi, 215-652-0059
Carol Ferguson, 908-423-4465
Justin Holko, 908-423-5088
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