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 Gra?a 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.
Source: Merck & Co., Inc., USA