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Thumbs Up for Cervical Cancer Vaccine

FDA Advisory Panel Recommends Approval of Vaccine Called Gardasil
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Limited Effectiveness

FDA scientists said their analysis showed that vaccination of unscreened women in doctors’ offices would likely cut the rate of precancerous lesions by 40%, since many are likely to already carry infections with one or more HPV types.

While praising its potential, several experts expressed concern that overconfidence in the vaccine could undo years of progress in promoting cervical cancer screening in women using Pap tests. The tests are the only reliable way to detect the presence of abnormal cervical cells that may be cancerous or precancerous.

Eliav Barr, MD, Merck’s senior director for vaccines and biologics, pledged that the company would not promote Gardasil as an alternative to Pap testing. “This vaccine is not a replacement for cervical cancer screening, and I think that that’s clear,” Barr said.

Lasting Immunity?

Experts also urged Merck and the FDA to conduct longer-term studies on Gardasil, because researchers still don’t know how long immunity will last.

“There are going to be questions of what lays down the line in the way of boosting requirements,” said Pamela McInnes, director of the Center for Integrative Biology and Infectious Diseases at the National Institutes of Health and a member of the FDA panel.

Barr said that the company planned to track thousands of Norwegian women who received the vaccine.

Merck is seeking to market the drug for HPV prevention in girls as young as 9 years old. The Advisory Committee on Immunization Practices, which advises the federal government on vaccination policies, is set to meet next month. The panel will likely consider whether HPV vaccine should be added to list of recommended and required childhood immunizations, Barr said.

News of the vaccine’s development has also prompted conservative Christian groups to question its potential to undermine abstinence messages by making sex less risky.

Peter S. Sprigg, vice president of the Family Research Council, called the potential marketing of Gardasil a “positive development.”

“But we would be concerned if this were administered with a message that, ‘Hey, it’s now save for you to have sex,’” he tells WebMD.

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