WASHINGTON -- A vaccine shown to prevent most cases of cervical cancer won approval from federal drug regulators yesterday in a move that could save the lives of thousands of women in the United States every year.
As expected, the Food and Drug Administration allowed Merck & Co. to start selling the vaccine, Gardasil, for females ages 9 to 26.
Studies showed that the three-shot series was nearly 100 percent effective in protecting against the two dominant strains of the sexually transmitted human papillomavirus, HPV.
That virus causes more than two-thirds of cervical cancer cases.
The approval was hailed because of the vaccine's potential for eliminating a form of cancer expected to afflict 9,700 women and kill 3,700 in the United States this year. In Maryland, cervical cancer strikes about 200 women annually and kills 80.
Dr. Neal Halsey, a vaccine specialist at the Johns Hopkins University and chair of the immunization working group at the Infectious Diseases Society of America, described the drug as "the most exciting new vaccine to come along in years."
"Although we've made strides treating cancer, we haven't made much progress protecting against cancer," Halsey said.
While cervical cancer deaths occur far less frequently in the United States than in other countries because of widespread Pap screening, the vaccine offers the potential to nearly eradicate the disease while helping women avoid invasive surgeries due to false test results.
Robert Rose, a University of Rochester researcher who helped develop the HPV vaccine, said 15 percent of Pap results are false positives resulting in unnecessary procedures to confirm the presence of lesions.
He said the vaccine won't eliminate the need for Pap exams but, if taken widely, would lead to a "significant reduction" in surgeries.
Despite its medical promise, the vaccine has become embroiled in a debate between women's health groups who see the opportunity to revive adolescent gynecological care and social conservatives worried about the government's indirectly encouraging sex.
Conservative opponents, who did not resist FDA approval, have instead targeted anticipated regulatory steps that could lead to states including Gardasil among the mandatory vaccinations for school admission.
A national immunization panel is expected to recommend this month the ages at which girls should receive the HPV vaccine. Then states would determine whether to require it.
One conservative group, Focus on the Family, has begun rousing members through the Internet and radio to oppose mandatory vaccination as a violation of parental authority.
Linda Klepacki, the Colorado Springs organization's sexual health analyst, said Gardasil shouldn't be required like other vaccines because it targets a sexually transmitted disease.
"Because it is purely sexually transmitted, it can be prevented by making the healthiest decision about your sexuality: abstinence," Klepacki said.
But women's health groups say the vaccine should be among the list of routine vaccinations for girls because it is effective only before exposure to the virus, which is common once sexual activity begins.
The groups also emphasize the continued need for Pap screening to detect any infections caused by strains of the virus not covered by the vaccine.
Surveys indicate that parents want the vaccine for their children upon learning of the benefits, said Deborah Arrindell, vice president for health policy at the American Social Health Association, which receives funding from industry and government agencies.
The association, as well as women's health groups, have been offering information about the value of HPV vaccination on their Web sites. "If states don't opt for making this mandatory, mandatory education as an entry requirement to school would be a nice runner-up because I think parents will make the right decision," Arrindell said.
Yet with Merck charging $120 for each of the three injections, other health experts worry that vulnerable populations, such as the poor and immigrants, won't get the vaccination if it isn't required.
Members of those groups are less likely to have Pap exams, which have drastically reduced the incidence of cervical cancer in the United States.
"The science is not the question. It's all these social issues," said Dr. Connie Trimble, a professor at Hopkins. "If the virus was transmitted by sneezing, I don't think there would be a question."
Some local health officials are thinking about securing the funding to pay for distributing the vaccine to the poor, especially women and girls who aren't covered by the federal Vaccines for Children program. The program would not pay for vaccinations for 60 percent of children and adolescents, federal health officials estimate.
Baltimore's health commissioner, Dr. Joshua Sharfstein, said the agency would move quickly to raise awareness of the vaccine through staff visits with pediatricians, parent education and public service announcements.
The city Health Department would begin providing vaccinations after federal funding becomes available.
"This is an intervention with a high public-health impact, so we would really want to make it accessible," he said.
Deaths from cervical cancer occur at a significantly higher rate in Baltimore and on the Eastern Shore than they do in Maryland and across the country. The state's mortality rate is slightly lower than the nation's.
Maryland health officials won't decide whether to require the vaccine, a spokeswoman said, until the national immunization panel makes its recommendation.
Gardasil is the first HPV vaccine to receive FDA approval, and another is close behind. At the end of this year, GlaxoSmithKline expects to ask the FDA for permission to sell its vaccine, Cervarix.
The company, based in England, has sought approval in Asia, Australia, Europe and Latin America.
HPV vaccines may have their biggest impact in the developing world, where cervical cancer is the second-leading cause of death among women, killing a quarter-million every year. Many victims can't afford or don't have access to Pap exams, which would detect infections early enough for doctors to prevent the onset of cervical cancer.
The HPV vaccine is expected to cost less than Pap screening in the developing world, and private foundations have begun donating tens of millions of dollars to make it available.