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FDA waves HPV vaccine through.(Gynecology)
The vaccine that provides protection against infection from four types of human papillomavirus, including the two that cause about 70% of cervical cancers, has been approved by the Food and Drug Administration for vaccinating females 9-26 years of age.
The recombinant vaccine, which is being marketed as Gardasil, is approved for the prevention of the following conditions caused by HPV types 6, 11, 16, and 18: cervical cancer, condyloma acuminatum, cervical adenocarcinoma in situ, vulvar intraepithelial neoplasia grades 2 and 3, vaginal intraepithelial neoplasia grades 2 and 3, and cervical intraepithelial neoplasia (CIN) grades 1, 2, and 3.
Recommendations on how and for what age groups the vaccine may be used is on the agenda of the next meeting of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices later this month.
The approval follows the unanimous endorsement of the vaccine as safe and effective in 9- to 26-year-old females by the FDA's Vaccine and Related Biological Products Advisory Committee 3 weeks before the approval. In combination with regular screening, the vaccine will be a good step "toward hopefully eradicating cervical cancer," said Dr. Monica Farley, professor of medicine at Emory University, Atlanta, and acting chair of the panel.
"Immunization with Gardasil is expected to prevent most cases of cervical cancer due to HPV types included in the vaccine," the FDA said in a statement. The vaccine does not protect against disease in women infected with HPV before they are vaccinated, a finding in the clinical trials that underlines "the importance of immunization before potential exposure to the virus."
In addition, because Gardasil does not include other less common HPV types, routine Pap screening remains "critically important to detect precancerous changes in the cervix to allow treatment before cervical cancer develops," the FDA said in the statement.
HPV 16 and 18 cause 70% of cervical cancers and other HPV-related cancers, 65% of high-grade precancerous lesions, and 25% of CIN 1 cases. HPV types 6 and 11 cause 90% of genital warts (in both men and women), 90% of recurrent respiratory papillomatosis lesions (in both men and women), and 10% of CIN 1 cases.
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Source: HighBeam Research, FDA waves HPV vaccine through.(Gynecology)