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CORRECTED: Young girls should get cancer vaccine, panel says

Posted on: Thursday, 29 June 2006, 16:50 CDT

Corrects spelling of vaccine name in first paragraph to Gardasil, from Gardisil.

By Maggie Fox, Health and Science Correspondent

WASHINGTON (Reuters) - Girls as young as nine and young women up to age 26 should be able to get Merck and Co.'s Gardasil vaccine aimed at preventing a sexually transmitted virus that can cause cancer, a panel of U.S. experts said on Thursday.

In a complicated vote, the Advisory Committee on Immunization Practices agreed to recommend the vaccine for three groups -- all young girls aged 11 and 12; girls and women aged 13 to 26 who have not received the vaccine yet; and women who have had abnormal pap smears, genital warts, or certain other conditions.

At their discretion, physicians could vaccinate as young as nine, the panel decided. The group also voted to include the vaccine in the federal Vaccines for Children Program, under which the government buys vaccines for uninsured or poor schoolchildren.

The Advisory Committee on Immunization Practices advises the U.S. Centers for Disease Control and Prevention, which in turn advises school districts and other authorities.

The U.S. Food and Drug Administration licensed Gardasil for use in women and girls nine to 26 years of age earlier this month. It protects against four types of human papilloma virus, also known as HPV or human wart virus.

The idea is to vaccinate girls before they ever get infected with the virus. About 15 percent of U.S. 15-year-old girls are already infected with at least one strain of HPV, said Dr. Carol Baker of the National Foundation for Infectious Disease, who was at the meeting.

The approval could make for blockbuster sales for Merck, with some analysts predicting annual sales of more than $3 billion within the next few years.

"Merck has already been shipping Gardasil since its approval. We model Gardasil sales of $3.2 billion in 2010," said Dr. Tim Anderson, Senior Pharmaceutical Analyst at Prudential Equity Group.

"I think this is going to be a great cancer prevention tool but it is not going to be effective for about 10 years," said Baker.

This is because genital wart infection takes a while to cause cancer.

PROTECTING GIRLS EARLY

Clinical trials have shown that a three-dose course of the vaccine can prevent close to 100 percent of the lesions that can become cervical cancer, and genital warts. Women get regular Pap smears in most developed countries to detect these lesions before they turn into tumors.

The virus also can cause much rarer penile cancer in men. The HPV 16 and 18 strains of virus are responsible for about 70 percent of cervical cancer cases.

The CDC says more than 50 percent of sexually active women and men will be infected with one or more genital HPV types during their lifetimes.

Cervical cancer kills about 300,000 women worldwide each year, including about 4,000 in the United States.

The CDC has no enforcement powers. It will be up to insurers to decide whether to pay for the $125-a-dose vaccine, school districts and universities to require or recommend it and individuals themselves to decide whether to get it.

Dr. Cynthia Rand of the University of Rochester in New York said she believed most people would get the vaccine. She has started a series of studies on how many people would take the vaccine if offered.

"The minority of parents we interviewed didn't think their children wouldn't be needing it because their children wouldn't be having sex. But they thought it would be needed in the general community," she said in a telephone interview.

At least one state legislative group, Women In Government, will be supporting the vaccine.

GlaxoSmithKline also has a slightly different HPV vaccine in development.

Insurer WellPoint Inc. said on Thursday it would reimburse patients for Gardasil.

"We believe this vaccine is a medical breakthrough that will benefit adolescents and young women throughout the country," the insurer said in a release.

(Additional reporting by Ransdell Pierson)

Source: REUTERS

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