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FDA OKs first cervical cancer vaccine

From Christy Feig
CNN

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WASHINGTON (CNN) -- The U.S. Food and Drug Administration on Thursday approved the first vaccine for cervical cancer -- Gardasil, manufactured by Merck and Co.

Studies show virtually all cases of cervical cancer are caused by a virus known as human papillomavirus, or HPV. It is transmitted sexually and most of the time human immune systems can get rid of it, but in about 10,000 women a year it develops into cervical cancer.

There are more than 70 different types of HPV. Dr. Kevin Ault of Emory University School of Medicine, who led one of the clinical trials, said this vaccine protects against four of them, but they are the four most significant.

"These are the four medically most important types," he said. "Two of the types -- 16 and 18 -- are responsible for about 70 percent of cervical cancer and then the other two -- six and 11-- are responsible for about 90 percent of genital warts," Ault said.

Every year cervical cancer kills nearly 4,000 women in the United States. Ault says this could change that. (Watch one woman's brush with cancer -- 2:53)

"If everyone would get the vaccine and the vaccine would work as well as it has in the trials, you might get up to a 70 percent reduction in cervical cancer," he said.

The American Cancer Society hailed the approval as "one of the most important advances in women's health in recent years." If the federal vaccine advisory panel recommends Gardasil's regular use, the ACS said, it will work to promote public awareness and encourage women to continue getting regular Pap tests.

Gardasil is expected to be available late this summer, according to Merck.

The vaccine does not protect against existing HPV infections but will protect against future infections.

The FDA is approving the vaccine for women between the ages of 9 and 26. It was not tested in women older than 26. Later this month an advisory committee to the Centers for Disease Control and Prevention will decide on its recommendation for who should get the vaccine.

The vaccine is made up of three shots to be given over a six-month period. Merck says it will cost $120 per dose. The company says it has created a program to provide the shots for free to adults who are uninsured or unable to afford them.

Analysts' estimates for annual sales range from $1.6 billion to $4 billion, with the high estimate assuming that some states will require mandatory vaccination.

While some conservatives have indicated reservations about the vaccine -- in part because it might lead some teens to think it makes sex "safe" -- others, such as the Family Research Council, have said they welcome the vaccine so long as it is presented honestly.

In a statement issued last October, the FRC said it, "will seek to ensure that there is full disclosure to the public of what these vaccines can and cannot achieve, their efficacy, and their risks (including side effects) and benefits. We believe that adults must be provided with sufficient information to make an informed, free choice whether to vaccinate either themselves or their children for HPV."

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