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news.Merck & Co's Gardasil, the first ever vaccine to prevent cervical cancer, has been approved by the FDA to be given to girls and women aged nine to 26. The vaccine prevents infection with certain types of human papillomavirus which cause most cervical cancer as well as genital warts.
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Gardasil is designed to prevent the majority of human papillomavirus (HPV)-related clinical diseases, those caused by HPV 6, 11, 16 and 18. HPV types 16 and 18 account for approximately 70% of cases of cervical cancer, whilst HPV 6 and 11 cause approximately 90% of genital wart cases.
In clinical studies, Gardasil prevented 100% of HPV 16- and 18 -related cervical cancer in women not previously exposed to the relevant HPV types.
“Use of Gardasil can help significantly reduce the human and economic burden of cervical cancer, precancerous or low-grade lesions and genital warts caused by HPV 6, 11, 16 and 18 in the US, and the rest of the world, in this generation and future generations,” said Dr Kevin Ault, associate professor, Department of Gynecology and Obstetrics, Emory University School of Medicine, and clinical study investigator for Gardasil.
The efficacy of Gardasil, which includes results from an HPV-16 prototype of Gardasil, was evaluated in four placebo-controlled, phase II and phase III clinical studies. Together, the phase II and III studies evaluated 20,541 women aged 16 to 26 years. Study participants were followed for up to five years after enrollment.