Cervical Cancer Vaccine Approved

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 Merck & Co. vaccine, called Gardasil, can prevent up to 70% 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.

A three-shot treatment, administered over six months, costs about $360, making it one of the most expensive vaccines available.

The FDA’s decision was expected given an advisory committee’s unanimous endorsement last month and a lack of strong opposition to the vaccine from conservative groups concerned the shots might 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 mandate the shots.

The vaccine blocks 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 other two cause many of the genital warts cases reported in the U.S. annually.

Tests in 17,000 girls and women showed Gardasil blocked 100% of cervical cancers in those not previously exposed to the two cancer-causing HPV types in the vaccine. Gardasil is most effective when given to females 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 Health and Human Services Deputy Secretary Alex M. Azar II.

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

The vaccine’s price 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, a member of the Society of Gynecologic Oncologists vaccine committee.

With physician fees, total costs to each patient would approach $500, he said.

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

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

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 vaccination of 12- to 24-year-old females with Gardasil would result in lower total costs than no vaccination at all.

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

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