Cervical cancer vaccine wins FDA approval
Immunization against HPV infection recommended for girls 9 to 26
Girls and women for the first time have a vaccine to protect themselves against the viral infection that leads to cervical cancer.
On June 8, the Food and Drug Administration approved use of the vaccine, Gardasil, for use in girls and women ages 9 to 26. It works by preventing infection by four strains of the human papillomavirus, or HPV, the most prevalent sexually transmitted disease.
The cancer kills hundreds of thousands of women each year worldwide. Dr. Jane Siegel, an infectious diseases expert on the medical staff at Children’s, said the vaccine will have “a dramatic effect” on the health of women around the world.
Gardasil, manufactured by Merck and Co. Inc., 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 for use by the end of June.
Safe, highly effective
Clinical trials showed that Gardasil prevents 100 percent of cervical cancer related to the two HPV strains in women who had not been previously infected, according to Merck. The vaccine also prevented 99 percent of the cases of genital warts caused by the two other strains.
“Fortunately, we now can 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 Dr. Siegel.
According to the FDA, the vaccine appears to be “very safe.” How long its protection will last or if women will have to receive booster shots later in life remains unknown. Merck has agreed to monitor the vaccine’s long-term effectiveness.
Target ages
The target age for receiving Gardasil is young because the vaccine works best when given to girls before they begin having sex and run the risk of HPV exposure and infection. The vaccine may not protect people already infected and may increase their risk of the kind of lesions that can lead to cervical cancer.
“By incorporating this vaccine into the 11- to 12-year-old adolescent visit, we can assure that young women will be protected at a later time in life when they may be exposed. It is not a required vaccine. It is up to each family to choose whether or not they want that protection for their daughters,” Dr. Siegel said.
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. The decision whether to add the vaccine to the list of others required before students may attend public schools will be up to individual states.
HPV affects more than 50 percent of sexually active adults at some point in their lives. The cervical cancer it can cause kills about 290,000 women worldwide each year, including 3,700 in the United States. In the U.S., regular Pap smears often detect.
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