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Landmark vaccine against cervical cancer gets US FDA approval

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  • US Federal drug officials announced the approval of a vaccine against cervical cancer that could eventually save thousands of lives each year in the US and hundreds of thousands in the rest of the world.

    The vaccine, called Gardasil, guards against cancer and genital warts caused by the human papillomavirus, the most common sexually transmitted disease. It is the culmination of a 15-year effort that began at the National Cancer Institute and a research center in Australia, and health officials described the vaccine as a landmark.

    Federal vaccine experts are widely expected to recommend that all 11-to-12-year-old girls get the vaccine, but its reach could be limited by its high price and religious objections to its use. Merck, Gardasil’s maker, said a full, three-shot course would cost $360, making Gardasil among the most expensive vaccines ever made.

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    “This is a huge advance,” said Dr Jesse Goodman, director of the Food and Drug Administration’s biologics center. “It demonstrates that vaccines can work beyond childhood diseases to protect the health of adults.”

    The vaccine prevents lasting infections with two human papilloma virus strains that cause 70 per cent of cancers and another two strains that cause 90 per cent of genital warts. But if girls have already been exposed to those strains, the vaccine has no effect, so health experts want the vaccine given before girls have sex. The median age at which girls have sex is 15.

    A Merck spokeswoman said Gardasil, which was approved for girls and women ages 9 to 26, would be available in doctors’ offices by the end of June.

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