MSD's cervical cancer vaccine gets WHO pre-qualification

WHITEHOUSE STATION, New Jersey — MSD’s human papillomavirus quadrivalent (Types 6, 11, 16 and 18) vaccine 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 MSD’s HPV quadrivalent vaccine is now eligible for procurement by the United Nations Children’s Fund (UNICEF) and other UN agencies, including the Pan American Health Organization (PAHO), for use in national immunization programs. 

“MSD is committed to ensuring access to its vaccine,” 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,” said Graça Machel, founder and president of the Foundation for Community Development (FDC), Mozambique and a passionate advocate for women’s health.  

MSD’s HPV quadrivalent vaccine is currently indicated for use in girls and young women nine through 45 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. 

WHO pre-qualification is a significant part of MSD’s approach to accelerating access to the quadrivalent vaccine 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. 

MSD will offer the vaccine to the public sectors of the Global Alliance for Vaccines and Immunization (GAVI)-eligible countries at no profit. Additionally, MSD 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 vaccine doses sold in the developing world.