WASHINGTON -- Women for the first time have a vaccine to protect themselves against cervical cancer.
The Food and Drug Administration on Thursday licensed the vaccine, Gardasil, for use in girls and women ages 9 to 26. The vaccine works by preventing infection by four of the dozens of strains of the human papillomavirus, or HPV, the most prevalent sexually transmitted disease.
By age 50, some 80 percent of women have been infected.
Gardasil protects against the two types of HPV responsible for about 70 percent of cervical cancer cases. The vaccine also blocks infection by two other strains responsible for 90 percent of genital wart cases. The vaccine will be available by the end of the month, with a three-shot series costing $360.
Its manufacturer, Merck & Co. Inc., seeks similar approval elsewhere around the world. Each year, cervical cancer kills an estimated 240,000 women worldwide, including 3,700 in the United States.
"FDA approval of the HPV vaccine, the first vaccine targeted specifically to preventing cancer, is one of the most important advances in women's health in recent years," said Dr. Carolyn Runowicz, president of the American Cancer Society. The vaccine developed for hepatitis B has been shown to protect against liver cancer.
Clinical trials showed Gardasil prevented 100 percent of cervical cancer related to the two HPV strains in women who had not been previously infected, Merck said. It also prevented 99 percent of the cases of genital warts caused by the two other strains.
"Fortunately, we can now include the worst types of HPV and most cervical cancer in the list of diseases that no one need suffer or die from ever again," said Alex Azar, deputy Health and Human Services secretary.
Research presented earlier suggests an added bonus to Gardasil: It also protects against vaginal and vulvar cancers linked to the four types of HPV.
Gardasil works best when given to girls before they begin having sex and run the risk of HPV infection. The vaccine does not protect those already infected.
The FDA said that Gardasil appeared very safe. It remains unclear if its effect is long-lasting or if women will need booster shots later in life. Merck will monitor its long-term effectiveness. The company also continues to study whether the vaccine is safe and effective in males.
Merck intends to market Gardasil as a cancer, rather than an STD, vaccine. Its cost, along with conservative opposition to making the vaccine mandatory for school attendance, may curb its widespread use.
The national Advisory Committee on Immunization Practices will decide June 29 whether to endorse routine vaccination with Gardasil. That endorsement is critical if a vaccine is to become a standard of care.
Sen. Frank Lautenberg, D-N.J., urged the panel to put "science and women's health ahead of ideological opposition" in considering a recommendation.
It then will be up to individual states to decide whether to add the vaccine to the list of others required before students may attend public schools.
Conservative groups like Focus on the Family support availability of the vaccine but oppose making it mandatory, saying the decision to vaccinate should rest with a child's parents or guardians. It promotes abstinence as the best way to prevent infection by HPV and other STDs.
Inda Blatch-Geib, an Akron, Ohio mother of four, said she'd consider vaccinating her daughters, ages 9 and 16. Blatch-Geib, 41, doesn't think it would signal a parental OK for her girls to have sex.
"Giving the vaccine goes with a conversation. We are pretty open with our children, so it wouldn't be an issue. It would lead to conversations," Blatch-Geib said.
The vaccine does not eliminate the need for regular Pap tests, which can detect precancerous lesions and early cancer. Merck has said Gardasil could cut the number of abnormal Pap results due to HPV infection.
Analysts believe Gardasil sales could top $1 billion a year for Merck. The Whitehouse Station, N.J. company is battling thousands of lawsuits over its withdrawn painkiller Vioxx. Eventually, it could face competition from GlaxoSmithKline PLC, which is also developing its own HPV vaccine.
The cost of Gardasil and the difficulty of getting young girls in to see a doctor three times in six months to receive the vaccine could pose problems, said Cynthia Dailard, senior public policy analyst at the Guttmacher Institute, which focuses on sexual and reproductive health. Ensuring its availability to poor and minority girls and women -- and others less likely to receive regular Pap exams -- also will be difficult. Merck plans to provide Gardasil for free to the poor and uninsured.
"This is an incredibly exciting breakthrough, but at the same time, it presents some major challenges, some the likes of which we have never confronted before," Dailard said.
On the Net:
Government HPV fact sheet: http://www.cdc.gov/std/HPV/STDFact-HPV.h...