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Vaccine against human papillomavirus receives US approval

The first vaccine capable of preventing cervical cancer recently received approval and licensure by the US Food and Drug Administration (FDA) for use in females ages 9-26. Gardasil, the quadrivalent vaccine manufactured by Merck, also prevents the development of precancerous genital lesions and genital warts caused by four types of the human papillomavirus (HPV), which is one of the most common sexually-transmitted infections in the world (see February 2006 Spotlight article, Cervical cancer vaccines).

The efficacy of the vaccine, administered through 3 immunizations over a period of 6 months, was illustrated in 4 Phase III trials conducted in 21,000 women in several countries. The greatest need for the vaccines lies in developing countries, where the majority of the 250,000 deaths from cervical cancer occur each year. On June 5, the Bill " Melinda Gates Foundation awarded the Seattle-based not-for-profit organization Program for Appropriate Technology in Health (PATH) a US$27.8 million grant to conduct a five-year effort to ensure that this vaccine is made available to women and girls in developing countries. PATH is collaborating with Merck and GlaxoSmithKline, which also manufactures a cervical cancer vaccine that is expected to receive a license for use in the European Union, as well as officials in Peru, India, Uganda, and Vietnam to establish mechanisms for financing purchase of these vaccines and to ease introduction efforts.

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All articles written by Kristen Jill Kresge