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What a shock...FDA may expand cervical cancer vaccine age

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" racked up 1 billion in sales since June of 2006 " ...cha-ching baby!!!!

http://www.cnn.com/2008/HEALTH/03/19/fda.gardasil.ap/index.html

WASHINGTON (AP) -- The Food and Drug Administration will consider

whether to expand use of a vaccine intended to prevent cervical

cancer to women aged 27 to 45, the vaccine maker said Wednesday.

The four types of HPV prevented by Gardasil account for more than 70

percent of cervical cancers.

Gardasil, made by Merck & Co., currently is approved for use in

girls and women aged 9 through 26 to block four types of human

papilloma virus, which can cause cervical cancer and genital warts.

A decision is expected this summer.

There are dozens of different types of HPV, but those targeted by the

vaccine -- types 6, 11, 16 and 18 -- account for more than 70 percent

of all cases of cervical cancer.

In asking the FDA to expand the use of Gardasil, Merck noted that

women remain at risk of becoming infected with HPV throughout their

lives. The government estimates that more than 6 million Americans

get a new infection of HPV each year.

Gardasil is given in three shots over a six-month period.

Experts emphasize that the vaccine is purely preventive. It does not

cure an existing HPV infection, but can prevent future infections.

That's one reason it is recommend that girls get the vaccine before

they are sexually active.

Merck spokeswoman Kelley Dougherty said that an advisory committee

would consider whether to urge testing for HPV infection before

getting the vaccine.

However, she noted that commercially available tests do not

differentiate between the types of HPV.

She said researchers found that few adult women were infected with

all four HPV types, so getting the vaccine would protect them from

any of the four they had not contracted.

Currently Gardasil is the only cervical cancer vaccine on the market.

It has racked up about $1 billion in sales since its June 2006 U.S.

launch. GlaxoKline PLC is awaiting approval of its own vaccine,

Cervarix

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