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COPYRIGHT 2006 International Medical News Group
GAITHERSBURG, MD. -- The vaccine that provides protection against the human papillomavirus types that cause 70% of cervical cancers moved closer to approval when it was unanimously endorsed as safe and effective for females aged 9-26 years by the Food and Drug Administration's Vaccine and Related Biological Products Advisory Committee last month.
The quadrivalent vaccine covers HPV 16 and 18, which in women cause 70% of cervical cancers and other HPV-related cancers, 65% of high-grade precancerous lesions, and 25% of cervical intraepithelial neoplasia (CIN) type 1 cases. The other two components of the vaccine are HPV types 6 and 11, which 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 in women.
Administered in three doses on a 0-, 2-, and 6-month schedule, the Merck vaccine was close to 100% effective in protecting against the disease caused by the four HPV types in females aged 16-26 years who had not been previously exposed. The proposed indication for the vaccine, called Gardasil, is for "prevention of cancer, precancerous or dysplastic lesions, genital warts, and infection caused by the HPV...
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