- The Washington Times - Thursday, May 18, 2006

An advisory panel to the U.S. Food and Drug Administration yesterday recommended approval of a vaccine to protect women and girls as young as 9 years old against a sexually transmitted virus that causes cervical cancer.

By a 13-0 vote, the panel endorsed marketing of Gardasil, a genetically engineered vaccine manufactured by Merck & Co. that targets the types of human papillomavirus (HPV) that cause most cases of cervical cancer and genital warts. It is being recommended for girls and women ages 9 to 26, Merck said.

The Vaccines and Related Biological Products Advisory Committee unanimously “voted in favor of the vaccine, concluding that data supported its safety and efficacy” in women and girls of that age, said Julie Zawisza, an FDA spokeswoman.

Recommendations of advisory committees to the FDA are not binding, but the agency usually follows them.

If approved, Gardasil would be the first vaccine designed to prevent a form of cancer.

Clinical trial data involving more than 12,000 sexually active women from 13 countries, presented at an international conference last fall, found the experimental vaccine “100 percent effective” in blocking two strains of HPV (types 16 and 18) that cause 70 percent of cervical cancer cases in women not previously infected with HPV.

Half the women in the study received three doses of Gardasil over six months. The other half received dummy shots.

Gardasil also protects against HPV types 6 and 11, which are responsible for 90 percent of all cases of genital warts.

“We’re thrilled,” Rick Haupt, executive medical director for Merck, said in an interview after the meeting. The achievement comes at a time when the New Jersey-based pharmaceutical firm has been hammered by slumping revenues and profits and thousands of lawsuits since it voluntarily withdrew its popular arthritis painkiller Vioxx because of safety concerns.

Initially, there was concern Gardasil might become a political issue because of Merck’s desire to use the vaccine in young girls.

“The risk of infection with the HPV types this vaccine prevents occurs rapidly once a youngster becomes sexually active. So it is important to immunize young adolescents before they have sexual activity, so you capture them before they are exposed,” Mr. Haupt said.

As part of its message to get young people protected against HPV, Merck is also advising that they “avoid sexual contact of any type,” he said, adding that “counseling adolescents [not to engage in any type of sex] is the only way to prevent infection.”

But FDA reviewers cautioned that Gardasil does not always protect against HPV in people already infected before they get the vaccine.

Because of the firm’s medical and morality message and also because of the prevalence of HPV, he said, “many of the socially conservative” religious groups who initially had reservations about Gardasil “have come to recognize the vaccine will have great public health value.”

In an interview last week with the Baltimore Sun, Dr. Gene Rudd, associate executive director of the Christian Medical and Dental Associations, said that “where there are diseases out there, the only reasonable way you can protect individuals and society is to be immunized.”

In endorsing Gardasil yesterday, the FDA advisory committee unanimously answered yes to five questions concerning the product. One of those questions asked whether Merck “has enough data to give the vaccine to girls 9 to 15 years old,” said Mr. Haupt.

About 20 million U.S. men and women are infected with HPV. As for cervical cancer, the federal Centers for Disease Control and Prevention report an estimated 10,000 new cases in the United States annually and nearly 4,000 deaths.

“There are no data to suggest that getting the vaccine will increase someone’s sexual behavior,” Mr. Haupt said.

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