An experimental vaccine to protect young people against human papilloma virus (HPV), which causes cervical cancer in women, will be presented for approval to the US Food and Drug Administration by the end of this year and is expected to be put on the market in 2006. Called Gardasil, the vaccine is partially an Israeli story, as the clinical research director at Merck & Co. laboratories in the US that is responsible for its development is an Israeli citizen, Dr. Eliav Bar.
The genetically engineered vaccine was successfully tested on adolescent women and men and found to provide "100% protection" against four common HPV types - 16, 18, 6 and 11 - and related cervical cancer, cervical pre-cancers and genital warts. These data from a Phase III study of Gardasil were presented for the first time at the annual meeting of the European Society of Pediatric Infectious Diseases.
"It is important to consider the role of both sexes when talking about the public-health impact of HPV," said Prof. Terry Nolan, a public health expert at the University of Melbourne, one of the study's lead investigators.
"HPV types 6 or 11 are not linked to cervical cancer, but they can cause abnormal Pap smears, which then lead to additional tests - and unnecessary worries about cancer," said Barr, a co-author of the study. "Gardasil was purposefully designed to target the HPV types most commonly associated with cervical cancer, as well as the types that cause genital warts and many abnormal Pap smears, to reduce the burden from HPV-related diseases as much as possible. We expect that the vaccine will help dramatically reduce the costs associated with cervical cancer screening, which in the US is approximately $6 billion per year."
An estimated 20 million men and women are infected with HPV in the US alone. In most cases, the virus appears to go away on its own, but in some, it leads to cervical cancer, abnormal Pap tests and genital warts. Because men can become infected and unintentionally spread the virus, they contribute to the risk of cervical cancer and are at risk of developing genital warts and, rarely, some cancers. Worldwide, 250,000 women die of cervical cancer every year.
The benefit of the vaccine, whose price has not yet been determined by Merck, could be even greater in the developing world, says Barr, as few women there even get tested for cervical cancer. But to be fully effective, adolescents would need to be vaccinated before they are sexually active, and it's not only children and parents who are embarrassed to discuss sexuality. Selling the vaccine to all who need it requires an educational campaign, as 70% of the public have never even heard of HPV.
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