THURSDAY, May 18, 2006 (HealthDay News) -- A vaccine that protects against the virus known to cause most cervical cancers was given the blessing of a U.S. Food and Drug Administration advisory panel Thursday.
The vaccine, Gardasil, is expected to get full FDA approval on June 8, and the national Advisory Committee on Immunization Practices will then decide whether to include the vaccine in routine vaccination schedules. Gardasil, which is manufactured by Merck & Co., would then become the first vaccine to be approved for the prevention of cervical cancer.
Experts noted the development of this type of vaccine is unquestionably a good thing.
"This will be a very important advance for public health for women," said Dr. Jay Brooks, chairman of hematology/oncology at the Ochsner Clinic Foundation, in Baton Rouge, La.
"It's a very positive thing. There's no negative that I can think of," echoed Dr. Nicholas Klein, director of obstetrics and gynecology at Nyack Hospital, in Nyack, N.Y. "It's a great step forward in possibly preventing cervical cancer."
There are, however, some important remaining questions.
"This can have a tremendous effect on women's health," said Dr. Daniel H. Smith, chief of the gynecologic oncology division at Hackensack University Medical Center's Cancer Center, in New Jersey. "Having said that, to me, the real issue is who should be treated, and when."
At Thursday's hearing, Merck officials told members of the FDA's Vaccines and Related Biological Products advisory committee that the vaccine could be used for females between 9 and 26 years old but would work best when given to girls before they become sexually active.
"It will be most effective when administered prior to entry in the risk period, and that is the age group 15 and below," Merck's Dr. Eliav Barr told the panel, according to an Associated Press report.
The FDA panel voted 13-0 to recommend the vaccine, AP reported.
The main cause of cervical cancer is continuous infection with human papilloma viruses (HPV), especially HPV 16 and 18, which are spread by sexual contact. The virus also causes precancerous and benign cervical lesions and genital warts, and may be implicated in some anal and oral cancers. An estimated 20 million men and women in the United States are infected with HPV but, for most, the virus shows no symptoms and goes away on its own.
Cervical cancer is the second most common malignant disease in women globally, causing an estimated 290,000 deaths worldwide each year. In the United States, some 10,400 new cases will be diagnosed this year, and 3,700 women will die from the disease.
In a two-year study involving more than 12,000 women, the vaccine was found to be 100 percent effective against four types of human papilloma virus: 16 and 18, which are responsible for about 70 percent of cervical cancer cases, and 6 and 11, which cause 90 percent of genital wart cases.
Merck has said the vaccine has the potential to reduce the annual number of new cervical cancer cases around the world from 500,000 to about 150,000, and cut deaths by more than two-thirds, to about 90,000.
The vaccination will require three shots over six months, which experts said is normal.
"Polio, for example, has to be taken more than once. Some other vaccines have a limited lifespan and they have to be renewed every 10 years or so. That's not something new; I believe that it's very positive for women's health," Klein said.
And many experts agreed that the earlier the vaccine is given, the better.
"There is a potential that individuals will feel that taking this shot means that the recipient will be sexually active," Brooks said. "We should completely remove that stigma, and we should simply vaccinate like we would against any other diseases. We're not making any moral judgments as to individuals being vaccinated."
"If you vaccinate early enough and widely enough, you would cut down on the ravages of HPV," he added. "It should be done before sexual activity begins."
Experts also felt the vaccine should eventually be given to boys as well as girls, given that boys transmit the virus.
"Why don't we give it to boys?" Smith asked.
Even with the vaccine, women would still need to be screened for cervical cancer caused by other types of HPV, experts noted.
And, according to an AP report, FDA reviewer Dr. Nancy Miller told panel members that Gardasil would not necessarily protect against any of the four viruses in people who already have been infected and even increases their
risk for precursors to cancer.
A second experimental cervical cancer vaccine, Cervarix, which would protect against HPV 16 and 18, is being developed by GlaxoSmithKline.
More information
To learn more about cervical cancer, visit the National Cancer Institute.
