FDA urged to approve cervical-cancer vaccine

A federal advisory panel Thursday unanimously recommended that the Food and Drug Administration (FDA) approve a vaccine that has been shown to prevent cervical cancer, the second most common cancer among women worldwide.

The FDA almost always follows the recommendations of its advisory panels and is expected to in this case, probably by June 8.

Tests in more than 17,000 girls and women have shown that the vaccine, Gardasil, is nearly 100 percent effective in blocking cervical cancers caused by the sexually transmitted human papilloma virus.

Guardasil prevents against four strains of human papilloma virus. Two strains are thought to be responsible for 70 percent of the 15,000 cervical cancers diagnosed and the 4,000 deaths caused by it in the U.S. each year. Worldwide, 400,000 women are diagnosed with cervical cancer each year and 200,000 die of it. The other two strains are behind about 50 percent of genital-wart cases.

Human papilloma virus, or HPV, is the most common sexually transmitted disease in the United States, with about 20 million people infected.

Dr. Monica Farley of the Emory University School of Medicine, acting chair of the advisory panel, said the vaccine's maker, Merck, had submitted "impressive data" about the vaccine's efficacy and that FDA approval would be a "wonderful good step" toward controlling cervical cancer.

Dr. Laura Koutsky, a University of Washington epidemiologist who chaired the steering committee that coordinated the testing of the vaccine, said, "It's basically the first step in eradicating HPV-related cancers."

She predicted that in five to 10 years, the vaccine would make "a huge difference" in cervical-cancer rates, and within five years would decrease precancerous lesions, genital warts and the earliest form of cervical cancer.

A vaccine-utilization committee of the Centers for Disease Control and Prevention (CDC) is scheduled to meet June 29, at which time it could vote on whether to recommend universal use of Gardasil in females. A draft proposal recommends vaccinating all girls ages 11 and 12. Requirements for its use, however, can be mandated only by individual states.

Even if it should become a requirement, added Wendy Wright, president of Concerned Women of America, all states allow children to opt out of mandatory vaccinations for medical or other reasons. Some conservative religious groups have expressed concerns about the vaccine, saying it may send an implicit message to girls that sex is OK.

The FDA panel stressed that Gardasil does not eliminate the need for cervical-cancer screening, such as the Pap test, because the vaccine does not protect against all HPV strains.

Some experts had reservations about the practicality of the vaccine because it is expected to cost up to $500 and must be administered in three separate injections over the course of six months.

"Cost is really going to present public health agencies with a significant challenge," said Dr. Jeffrey Duchin, head of immunizations for Public Health — Seattle & King County. The CDC committee could recommend federal subsidies to make Gardasil available to low-income families.

If approved, Gardasil would be the second vaccine to protect against cancer. Hepatitis B vaccines have previously been shown to protect against liver cancer.

Seattle Times staff writer Warren King contributed to this report.