Monday, July 10, 2006

U.S. Panel Endorses Cervical Cancer Vaccine for Girls

THURSDAY, June 29 (HealthDay News) -- A U.S. advisory panel recommended Thursday that 11- and 12-year-old girls be routinely vaccinated against the virus that causes cervical cancer.

The National Advisory Committee on Immunization Practices also recommended that the vaccine, called Gardasil, be administered to girls as young as 9, at the provider's discretion, and for women up to age 26 who have not previously been vaccinated against the sexually transmitted human papillomavirus (HPV).

"The Advisory Committee on Immunization Practices made a historic vote today to recommend routine use of HPV vaccine for girls aged 11 to 12," Dr. Anne Schuchat, director of the National Center for Immunizations and Respiratory Diseases at the U.S. Centers for Disease Control and Prevention, said at a Thursday news conference. "It's a very important day -- a breakthrough for women's health."

Some religious conservatives and other critics have expressed concern that giving the vaccine to children could encourage underage sex. But, according to Schuchat, no controversy arose at the panel's recent public meetings.

The panel's recommendation was hailed by health experts.

"It's a wonderful thing. It's good news all around," said Dr. Connie L. Trimble, associate professor of gynecology and obstetrics and pathology at Johns Hopkins' Sidney Kimmel Comprehensive Cancer Center, in Baltimore. Trimble is working on a therapeutic vaccine for people already infected with the virus.

The advisory committee also recommended that the vaccine be included in the Vaccines for Children Program, which provides free vaccines for children up to age 18 who are eligible for Medicaid, are uninsured or are Native American or Alaskan Native.

The recommendations will be passed along to the head of the CDC and to the U.S. Department of Health and Human Services for review, and are expected to be accepted.

Gardasil, manufactured by Merck & Co., is the first vaccine to protect against HPV, known to cause most cervical cancers.

The U.S. Food and Drug Administration approved Gardasil earlier this month for girls and women aged 9 to 26. An FDA advisory panel had signed off on the vaccine in May.

Cervical cancer is the second most common malignant disease in women globally, causing an estimated 290,000 deaths worldwide each year. In the United States, some 10,400 new cases will be diagnosed this year, and 3,700 women will die from the disease.

The main cause of cervical cancer is continuous infection with HPV, especially HPV 16 and 18, which are spread by sexual contact. The virus also causes precancerous and benign cervical lesions and genital warts, and may be implicated in some anal and oral cancers. An estimated 20 million men and women in the United States are infected with HPV but, for most, the virus shows no symptoms and goes away on its own.

In a two-year study involving more than 12,000 women, Gardasil was found to be 100 percent effective against four types of human papillomavirus: 16 and 18, which are responsible for about 70 percent of cervical cancer cases, and 6 and 11, which cause 90 percent of genital wart cases.
Merck has said the vaccine has the potential to reduce the annual number of new cervical cancer cases around the world from 500,000 to about 150,000, and cut deaths by more than two-thirds, to about 90,000.

At the annual meeting of the American Society of Clinical Oncology earlier this month in Atlanta, scientists reported that the Gardasil vaccine was also 100 percent effective against vulvar and vaginal precancerous lesions caused by HPV types 16 and 18.

Like many other vaccinations, Gardasil will require three shots over six months. Even with the vaccine, women would still need to be screened for cervical cancer caused by other types of HPV, experts noted. This is most often accomplished by having a Pap test, which is still a very accurate indicator of a woman's cervical condition.

In fact, Schuchat stressed, the vaccine "will not replace other prevention strategies, such as cervical cancer screening for women or protective sexual behaviors. Women should continue to get Pap tests as a safeguard against cervical cancer."

It's unclear whether insurance providers will pay for the cost of the vaccine -- estimated to be $120 -- for children not covered under the Vaccines for Children Program.

"We are hopeful that managed care will pick this up," Schuchat said. "Working on ensuring access is very important."

More information
Visit the National Immunization Program for more on childhood immunizations.

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