Panel OKs Merck Vaccine

Merck also has submitted Gardasil applications to the EU and to Australia, New Zealand, Mexico, Brazil, Argentina, Singapore and Taiwan. Merck licenses the technology used in Gardasil from CSL Ltd., an Australian drug and vaccine company.

Public Health Impact

The FDA says there will be nearly 10,000 new cervical cancer cases and 3,700 cervical cancer deaths in the U.S. this year. Merck estimates that 20 million American men and women are infected with HPV, although the virus goes away on its own for most people. Worldwide, cervical cancer kills about 300,000 a year.

"Infection with high-risk HPV types increases the chance that mild abnormalities will progress to more severe abnormalities or cervical cancer," says the National Cancer Institute. Having many unprotected sex with many partners raises the risk of getting HPV.

"Studies suggest that whether a woman develops cervical cancer depends on a variety of factors acting together with high-risk HPVs," the institute says. "The factors that may increase the risk of cervical cancer in women with HPV infection include smoking and having many children."

The advisory committee's vote came one day after an FDA staff report said Gardasil was generally safe and effective. FDA staff members routinely issue report before advisory panels meet, providing data analyses and suggesting questions for panelists to ask during the hearings.

The advisory reviewed an experimental vaccine whose late-stage clinical trial results encouraged physicians, analysts and investors when Merck released data in October. Merck said Gardasil prevented 100% of high-grade precancerous lesions of the cervix as well as non-invasive cervical cancers.

The study compared Gardasil vs. placebo among women who weren't infected with HPV when they enrolled in the test and remained free of infection while they were vaccinated. They were followed for an average of two years after enrolling. This study tested women ages 16 to 26. They were given three injections of Gardasil or placebo over six months.