Cervical cancer vaccine OK’d

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

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

Drug maker Merck & Co. set a price of $120 per 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 that the shots could encourage sexual activity.

With the FDA’s approval, the focus now moves to the federal Centers for Disease Control and Prevention, 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 the mandate 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 U.S. The remaining two types cause 50 percent of the 1 million genital warts cases reported in the U.S. annually.

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.

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 a member of the Society of Gynecologic Oncologists vaccine committee. Total costs to each patient would approach $500 with physician fees, he said.

“The vaccine is a tremendous breakthrough,” said Marilyn Keefe, of the National Family Planning and Reproductive Health Association. “But I don’t think anyone would consider $360 a bargain.”

Merck said the vaccine was cost-effective when pitted against the $5 billion annual cost of HPV-related diseases in the U.S. The company said that vaccination of 12- to 24-year-old females with Gardisil would result in lower total costs than no vaccination at all.

“It’s not appropriate to compare the prices for Gardisil to any other vaccine, as there is no other vaccine for HPV and cervical cancer,” Merck spokeswoman Janet Skidmore said.

Merck said it plans a patient assistance program to make the vaccine available to uninsured, low-income women.