FDA to consider approving expanded use of Gardasil
Wed, 19 Mar 2008 15:38:17 GMT —
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.
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. GlaxoSmithKline PLC is awaiting approval of its own vaccine, Cervarix.