Four-type HPV Vaccine Receives WHO Pre-qualification

Main Category: Cervical Cancer / HPV Vaccine
Article Date: 02 Jun 2009 - 5:00 PDT

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The four-type (6, 11, 16, 18) human papillomavirus (HPV) vaccine, Gardasil® has been awarded World Health Organization (WHO) pre-qualification. It is the first cervical cancer vaccine to receive WHO pre-qualification.

WHO pre-qualification means that the four-type HPV vaccine 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 immunisation programmes.

"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.

Gardasil® is the only four-type (6,11,16,18) HPV vaccine and is licensed for the prevention of premalignant genital lesions (cervical, vulval and vaginal), cervical cancer and external genital warts (condyloma acuminata) causally related to human papillomavirus (HPV)-types 6, 11, 16 and 18. The vaccine has been developed by Merck & Co., Inc. and Sanofi Pasteur MSD. In Western Europe, the vaccine is marketed by Sanofi Pasteur MSD.

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 the vaccine to the public sectors of GAVI (Global Alliance for Vaccines and Immunization)-eligible countries at a price without 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 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 Programme which is managed by Axios Healthcare Development. In February 2009, the first donated doses were shipped.

Additionally, Merck is partnering with PATH (Program for Appropriate Technology in Health), an international not-for-profit organisation, to conduct demonstration projects 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 carried out in 41 countries involving more than 38,000 patients, with health authorities, governments, non-governmental organisations and physicians around the world.

Notes

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.

Indication of Gardasil®

Gardasil® is a vaccine for the prevention of premalignant genital lesions (cervical, vulvar and vaginal), cervical cancer and external genital warts (condyloma acuminata) causally related to human papillomavirus (HPV) types 6, 11, 16 and 18. The indication is based on the demonstration of efficacy of Gardasil® in adult females 16 to 26 years of age and on the demonstration of immunogenicity of Gardasil® in 9- to 15-year old children and adolescents. Protective efficacy has not been evaluated in males. The use of Gardasil® should be in accordance with official recommendations.

Source
Sanofi Pasteur MSD