FDA Approves Cervical Cancer Vaccine
Handout  /  Getty Images file
The Merck & Co manufactured Gardasil, approved by the FDA on June 8, prevents cervical cancer by blocking two forms of the human papillomavirus which cause 70 percent of all cervical cancer cases.
updated 10/13/2006 11:49:42 AM ET 2006-10-13T15:49:42

An influential government advisory panel Thursday recommended that 11- and 12-year-old girls be routinely vaccinated against the sexually transmitted virus that causes cervical cancer.

The Advisory Committee on Immunization Practices also said the shots can be started for girls as young as 9, at the discretion of their doctors.

The committee’s recommendations usually are accepted by federal health officials, and influence insurance coverage for vaccinations.

Gardasil, made by Merck & Co., is the first vaccine specifically designed to prevent cancer. Approved earlier this month by the Food and Drug Administration for females ages 9 to 26, it protects against strains of the human papilloma virus, or HPV, which causes cervical, vulvar and vaginal cancers and genital warts.

Some health officials had girded themselves for arguments from religious conservatives and others that vaccinating youngsters against the sexually transmitted virus might make them more likely to have sex. But the controversy never materialized in the panel’s public meetings.

Earlier this year, the Family Research Council, a conservative group, did not speak out against giving the HPV shot to young girls. The organization mainly opposes making it one of the vaccines required before youngsters can enroll in school, said the group’s policy analyst, Moira Gaul.

Health officials estimate that more than 50 percent of sexually active women and men will be infected with one or more types of HPV in their lifetimes. Vaccine proponents say it could dramatically reduce the nearly 4,000 cervical cancer deaths that occur each year in the United States.

Boys next?
The vaccine comes as a $360 series of three shots, and in tests has been highly effective against HPV. The vaccine is formulated to address the subtypes of HPV responsible for 70 percent of cervical cancer cases and 90 percent of genital warts.

Scientists say the vaccine is most effective when given to girls before they become sexually active, and some girls become active before their teens. About 7 percent of children have had sexual intercourse before age 13, and about a quarter of boys and girls have had sex by age 15, according to government surveys.

In a public comment session at Thursday’s meeting, all nine speakers supported recommending the vaccine to females 9 to 26, the broadest possible group under FDA license. The speakers included a state senator from Maryland and the chief medical officer of AmeriChoice, a UnitedHealth Group company that manages state Medicaid programs.

The panel focused on 11- to 12-year-olds in part because children that age already routinely get two other shots.

Several speakers also called for the immunization of boys, as soon as studies are completed on the vaccine’s safety and effectiveness for males. HPV has been linked to penile, anal, and head and neck cancers and a tumor-like condition of the respiratory tract.

Merck officials said clinical effectiveness studies in males should be completed by 2008.

Merck officials also said they can provide the more than 19 million doses that health officials expect would be used in the next year.

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