Merck Sharp & Dohme's Gardasil vaccine for cervical cancer has been awarded WHO pre-qualification. It 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 programmes.
"We recognize the significant impact cervical cancer has on women and families, especially in the developing world, which is why MSD is committed to improving access to innovative vaccines like Gardasil," said Margaret G McGlynn, president, MSD. "WHO pre-qualification is an important step in helping to ensure greater global access to Gardasil and to help protect against cervical cancer and other HPV-related diseases caused by HPV types six, 11, 16 and 18 in more countries throughout the world," he said.
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," commented Graça Machel, founder and president of the Foundation for Community Development (FDC), Mozambique and a passionate advocate for women's health.
Gardasil is currently indicated for use in girls and young women nine through 26 years of age for the prevention of cervical cancers, vulvar and vaginal pre-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 six, 11, 16 and 18. HPV types 16 and 18 are responsible for approximately 70 per cent of cervical cancer cases, and HPV types six and 11 are responsible for approximately 90 per cent of genital warts and about 10 per cent of low-grade cervical changes/lesions/dysplasias.