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Cervical Cancer Vaccine Seeks FDA Approval

Posted on: Thursday, 18 May 2006, 18:06 CDT

Merck Research Laboratories in West Point, Pa., is seeking approval for the first cervical cancer vaccine for use by women and girls ages 9 to 26.

If the pharmaceutical company receives approval from the Food and Drug Administration, Gardasil could become legal quickly as next month, the Philadelphia Inquirer reported. Merck told a federal panel that the drug might prevent as many as 350,000 incidents of cancer within 20 years.

Gardasil prevents infection by two types of human papillomavirus linked to cervical cancer and blocks infections related to genital warts.

The drug could be worth billions of dollars, Wall Street analysts said. Sales of Gardasil are projected at $1.9 billon by 2010. GlaxoSmithKline is developing a similar drug.

Merck reported that five women who participated in clinical trials later had children with birth defects.

The overall assessment is that this was highly unlikely to be related to Gardasil and the findings were due to chance, said Eliav Barr, Merck's head of clinical development for the vaccine.

Conservative groups initially concerned about effects on sexual activity have said they support the vaccine, as long as it is taken by personal choice.

Source: United Press International

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