GARDASIL® is First Cervical Cancer Vaccine to Receive WHO Pre-qualification

WHO Pre-qualification Will Help to Facilitate Expanded Global Access and Implementation of HPV Vaccination Programs

WHITEHOUSE STATION, N.J. - GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant], Merck’s cervical cancer vaccine, has been awarded World Health Organization (WHO) pre-qualification. GARDASIL is the first cervical cancer vaccine to receive WHO pre-qualification.

WHO pre-qualification means that GARDASIL is now eligible for procurement by the United Nations Children’s Fund (UNICEF) and other United Nations (UN) agencies including the Pan American Health Organization (PAHO), for use in national immunization programs.

“Merck is committed to ensuring access to GARDASIL,” said Margaret G. McGlynn, president, Merck Vaccines and Infectious Diseases. “WHO pre-qualification is an important step to enable more women in countries throughout the world to benefit from this significant advance in women’s health.”

WHO pre-qualification aims to ensure that vaccines meet WHO standards of quality, safety and efficacy, which in conjunction with other criteria, is used by the UN and other agencies to make purchasing decisions.

“Cervical cancer is a significant burden in developing countries. WHO pre-qualification of an HPV vaccine signifies a move to help protect young women and improve access to better health care, particularly in the poorest countries,” comments Graça Machel, Founder and President of the Foundation for Community Development (FDC), Mozambique and a passionate advocate for women’s health.

In the United States, GARDASIL is currently indicated for use in girls and young women 9 through 26 years of age for the prevention of cervical, vulvar and vaginal 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.

HPV types 16 and 18 are responsible for approximately 70 percent of cervical cancer cases, and HPV types 6 and 11 are responsible for approximately 90 percent of genital warts and about 10 percent of low-grade cervical changes/lesions/dysplasias.

GARDASIL is contraindicated in individuals with hypersensitivity, including severe allergic reactions to yeast, or after a previous dose of GARDASIL.

About access to GARDASIL in the developing world
WHO pre-qualification is a significant part of Merck’s approach to accelerating access to GARDASIL in the developing world through four key pillars: innovation, partnerships, pricing and implementation. This development follows the recent WHO position paper on the use of HPV vaccines.

Merck will offer GARDASIL to the public sectors of GAVI-eligible countries at a price at which we do not profit. Additionally, Merck is exploring several ways to further reduce product cost for the developing world, including manufacturing efficiencies and reduction of royalties paid out to licensors on GARDASIL doses sold in the developing world.

In 2007, Merck made a commitment to donate at least 3 million doses of GARDASIL over five years to help address the problem of HPV infection in under-resourced communities through the GARDASIL Access Program which is managed by Axios Healthcare Development. In February 2009, the first doses of donated GARDASIL were shipped.

Additionally, Merck is partnering with PATH, an international non-profit organization, to conduct demonstration projects of GARDASIL in the developing world by providing vaccine and technical support at no cost. These demonstration projects are designed to support the accelerated availability of cervical cancer vaccines in the world’s least-developed countries. The projects are complete in Peru and ongoing in Vietnam and India.

Merck is also sharing clinical data on GARDASIL, HPV epidemiology and cervical cancer rates from studies done in 41 countries and more than 38,000 patients with health authorities, governments, non-governmental organizations and physicians around the world.

Additional important information about GARDASIL
The health care provider should inform the patient, parent or guardian that vaccination does not substitute for routine cervical cancer screening. Women who receive GARDASIL should continue to undergo cervical cancer screening.

GARDASIL is not recommended for use in pregnant women.

GARDASIL is not intended to be used for treatment of active genital warts, cervical, vaginal and vulvar cancers, cervical intraepithelial neoplasia (CIN), vulvar intraepithelial neoplasia (VIN) or vaginal intraepithelial neoplasia (VaIN).

GARDASIL has not been demonstrated to provide protection against disease from vaccine and non-vaccine HPV types to which a woman has previously been exposed through sexual activity. GARDASIL has not been shown to protect against diseases due to HPV types not contained in the vaccine.

Not all vulvar and vaginal cancers are caused by HPV and GARDASIL protects only against those vulvar and vaginal cancers caused by HPV 16 and 18. Vaccination with GARDASIL may not result in protection in all vaccine recipients.

In clinical studies for GARDASIL, headache was the most commonly reported adverse reaction. Common adverse reactions that were observed at a frequency of at least 1 percent among recipients of GARDASIL and also greater than those observed among recipients of control group, respectively, were pain, swelling, erythema, fever, nausea, pruritis, dizziness and bruising.

In addition, syncope has been reported following vaccination with GARDASIL, sometimes resulting in falling with injury: observation for 15 minutes after administration is recommended.

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 human papillomavirus
Human papillomavirus (HPV) is estimated to cause about half a million new cervical cancer cases every year, with a majority affecting women in developing countries. For most women, HPV goes away on its own, however, for some, certain high-risk types of HPV, if unrecognized and untreated, can lead to cervical cancer. Cervical cancer is the second most common cancer among women worldwide. Almost 80 percent of cervical cancer cases occur in developing countries, where, in many regions, it is the most common cancer among women. HPV types 16 and 18 cause approximately 70 percent of cervical cancer cases. Not all vulvar and vaginal cancers are caused by HPV and the exact number of cases caused by HPV types 16 and 18 is unknown. However, it is estimated that HPV types 16 and 18 account for 40-50 percent of vulvar cancers and about 70 percent of vaginal cancer. Genital warts are abnormal skin growths caused by HPV, particularly types 6 and 11, which cause more than 90 percent of genital warts.

GARDASIL is approved in 111 countries
GARDASIL has been approved in 111 countries, 23 of which are GAVI-eligible, and additional applications are currently under review with regulatory agencies in more countries around the world.