FDA Approves Cervical Cancer Vaccine

(CBS/AP)  The first vaccine to protect against most cervical cancer won federal approval Thursday.

The vaccine Gardasil, approved for use in girls and women ages 9 to 26, prevents infection by four strains of the human papillomavirus, or HPV, Merck & Co. Inc. said. The virus is the most prevalent sexually transmitted disease.

Gardasil protects against the two types of HPV responsible for about 70 percent of cervical cancer cases. The vaccine also blocks infection by two other strains responsible for 90 percent of genital wart cases.

Last month, an FDA advisory committee voted 13-0 on five separate times to endorse Gardasil.

However, the vaccine should not be considered a replacement for the standard screening test: the pap smear, CBS News correspondent Elizabeth Kaledin reported.

HPV is the most common sexually transmitted disease. It affects more than 50 percent of sexually active adults. The cervical cancer it can cause kills each year about 290,000 women worldwide, including 3,500 women in the United States, where regular pap smears often detect precancerous lesions and early cancer.

Making their case for approval, Merck officials suggested that development could make Gardasil the biggest advance in preventing cervical cancer since the pap test.

Early opposition to Gardasil was based on concerns it could encourage sexual activity in the young. But that largely faded away because of vaccine's potential for reducing cancer.

Merck is expected to market Gardasil as a cancer, rather than an STD, vaccine. It remains unclear how widespread will be the use of the three-shot series, in part because of its $360 list price. Conservative opposition to making the vaccine mandatory for school attendance may also curb its adoption.

The target age for receiving Gardasil is low because the vaccine works best when given to girls before they begin having sex and run the risk of HPV infection. The vaccine may not protect people already infected and may increase their risk of the kind of lesions that can lead to cervical cancer, the FDA has said.

The national Advisory Committee on Immunization Practices will decide June 29 whether to endorse routine vaccination with Gardasil. That endorsement is critical if a vaccine is to become a standard of care.
It then will be up to individual states to decide whether to add the vaccine to the list of others required before students may attend public schools.

Conservative groups like Focus on the Family support availability of the vaccine, but oppose making it mandatory, saying the decision to vaccinate should rest with a child's parents or guardians. It promotes abstinence as the best way of warding off infection by HPV and other STDs.