FDA backs cervical-cancer vaccine

The Food and Drug Administration (FDA) on Thursday approved the first vaccine to prevent cervical cancer, the second leading cause of cancer death among women worldwide.

The vaccine, Gardisil, can prevent up to 70 percent of the 10,000 cases of cervical cancer diagnosed in the United States each year. It was approved for use in females ages 9 through 26.

Drug maker Merck set a price of $120 a shot, making it one of the costliest vaccines available. The vaccine is administered in three doses over six months.

The FDA decision was expected, given an advisory committee's unanimous endorsement last month and the lack of strong opposition to the vaccine from conservative groups that expressed concern the shots could encourage sexual activity.

The focus now moves to the federal Centers for Disease Control and Prevention (CDC), which is scheduled to meet June 29 to consider a recommendation that all girls ages 11 and 12 be vaccinated.

An endorsement by the CDC committee would clear the way for private insurance coverage of the vaccine. But it is up to individual states to mandate the shots.

The shots block four types of the sexually transmitted human papillomavirus, or HPV.

Two of those are responsible for the majority of cervical-cancer cases in the United States. The remaining two types cause 50 percent of the 1 million genital-warts cases reported annually.

Tests in 17,000 girls and women showed Gardisil blocked 100 percent of cervical cancer in women not previously exposed to the two HPV types in the vaccine.

Gardisil is most effective when given to girls before they become sexually active.

"We can now include the worst types of HPV and most cervical cancer among the diseases that no one need suffer and die from," said Alex Azar, deputy Health and Human Services secretary.

The vaccine does not eliminate the need for regular cancer screening and Pap smears, because it does not protect against all types of HPV.

Merck is seeking approval for the vaccine elsewhere in the world. Each year, cervical cancer kills an estimated 240,000 women worldwide, including 3,700 in the United States.

The price of $360 for all three doses of vaccine could be burdensome for public-health agencies and might discourage uninsured patients from obtaining it, some doctors and public-health advocates said.

"Cost will definitely be a barrier," said Dr. Mark Einstein of Montefiore Medical Center in New York and member of the Society of Gynecologic Oncologists vaccine committee. Total costs to each patient would approach $500 with physician fees, he said.

Many on Wall Street judged the vaccine could become a $3 billion-a-year product for Merck.

That would be welcome news for Merck, which has suffered a financial hit as a result of its Vioxx debacle.

While GlaxoSmithKline has a rival vaccine, Cervarix, the company has said it will not seek FDA approval until the end of this year.

Material from Newsday and The Associated Press is included in this report.