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Merck's Gardasil Cleared by FDA

Updated from 1:59 p.m. EDT

The Food and Drug Administration approved Merck's (MRK - Get Report) Gardasil, the first vaccine against a virus that causes cervical cancer and genital warts.

The agency gave the product broad approval Thursday, saying that the vaccine is appropriate for treating girls as young as 9 years old and women as old as 26.

The vaccine is approved for two types of human papillomavirus, or HPV, that Merck says accounts for 70% of cervical cancers. The vaccine also prevents two types of HPV that account for 90% of genital warts.

FDA approval for a product that many analysts say could eventually produce $1 billion or more in annual sales came three weeks after a group of outside medical experts unanimously endorsed the vaccine .

Shares of Merck were little changed, gaining 1 cent to $33.97.

The agency's action gives Merck a head start against GlaxoSmithKline (GSK), which is developing the HPV vaccine called Cervarix. GlaxoSmithKline expects to file an application with the FDA by the end of the year .

"This vaccine is a significant advance in the protection of women's health in that it strikes at the infections that are the root cause of many cervical cancers," said Dr. Andrew C. von Eschenbach, acting commissioner of the FDA.

"Use of Gardasil can help significantly reduce the human and economic burden of cervical cancer, precancerous or low-grade lesions and genital warts," said Dr. Kevin Ault, associate professor in the department of gynecology and obstetrics at Atlanta's Emory University School of Medicine, in a press release issued by Merck. Ault was the clinical study investigator for Gardasil.

The vaccine is now available for ordering. The Gardasil regimen requires three injections over six months. Merck is charging $120 per dose. The company has created a new program in which it will provide free vaccines to adults who are uninsured and can't afford vaccines. Merck vaccines, including Gardasil, will be covered by this program in the third quarter.
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