GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant], Merck’s HPV Vaccine, Available to Developing Countries through UNICEF Tender
May 9, 2013 6:20 am ET
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 increases.
“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 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 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
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
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 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
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
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 projects.
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well. Merck is known as MSD outside the United States and Canada.
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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
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Please see Prescribing Information for GARDASIL®
and Patient Information for GARDASIL at http://www.merck.com/product/usa/pi_circulars/g/gardasil/gardasil_ppi.pdf.
Pamela Eisele, 908-423-5042
Imraan Munshi, 215-652-0059
Carol Ferguson, 908-423-4465
Justin Holko, 908-423-5088