THURSDAY, June 8, 2006 (HealthDay News) -- U.S. health officials approved on Thursday the first vaccine that protects against the human papillomavirus (HPV), known to cause most cervical cancers.
The U.S. Food and Drug Administration approved Merck & Co.'s Gardasil for girls and women aged 9 to 26. An FDA advisory panel had signed off on the vaccine in May.
The National Advisory Committee on Immunization Practices will now decide whether to include the vaccine in routine vaccination schedules.
The FDA action was hailed by experts.
"It's huge," said Dr. Michael A. Bookman, director of medical gynecologic oncology at Fox Chase Cancer Center, in Philadelphia. "The thing that is incredible is the global possibilities. In the U.S., we have done a good job of implementing screening and testing. In the rest of the world, this is a much more serious problem."
"Today is an important day for public health and for women's health, and for our continued fight against serious life-threatening diseases like cervical cancer," U.S. Department of Health and Human Services Deputy Secretary Alex Azar said in a prepared statement Thursday.
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.
The main cause of cervical cancer is continuous infection with 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.
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 papillomavirus: 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.
At last weekend's annual meeting of the American Society of Clinical Oncology (ASCO) in Atlanta, scientists reported that the Gardasil vaccine was also 100 percent effective against vulvar and vaginal precancerous lesions caused by HPV types 16 and 18.
"This study shows that the prophylactic vaccine developed to prevent cervical cancer could actually also prevent vulvar and vaginal cancer as well," study author Dr. Jorma Paavonen, chief physician in the department of obstetrics and gynecology at the University of Helsinki in Finland, said at an ASCO press briefing on Monday.
Most experts feel that the earlier the vaccine is given, the better.
"Young kids respond better to vaccines. They're immunologically poised to respond better," Bookman explained. "You also want to get the vaccine into girls and boys before they are sexually active, not just intercourse but oral sex and any way the virus might spread."
Merck officials have said 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.
However, some critics have expressed concern that giving the vaccine to children could encourage underage sex.
Like many other vaccinations, Gardasil will require three shots over six months.
Even with the vaccine, women would still need to be screened for cervical cancer caused by other types of HPV, experts noted. This is most often accomplished by having a Pap test, which is still a very accurate indicator of a woman's cervical condition.
Phase III results of a second experimental cervical cancer vaccine, Cervarix, were presented Monday at the ASCO meeting. In this trial, 100 percent of women across all age groups represented (15 to 55) had an antibody response against HPV 16 and 18. This vaccine, made by GlaxoSmithKline, is similar to Gardasil.
"This is an opportunity to get in and educate people at an early age, have them accept the vaccine as part of their culture," Bookman said.
For more on cervical cancer, visit the U.S. National Cancer Institute.