Merck & Co., Inc. announced that the US Food and Drug Administration (FDA) has approved Gardasil [Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine, the first and only vaccine to prevent cervical cancer and vulvar and vaginal pre-cancers caused by HPV types 16 and 18 and to prevent low-grade and pre-cancerous lesions and genital warts caused by HPV types 6, 11, 16 and 18.

In the United States, approximately 10,000 women are diagnosed with cervical cancer every year, and an average of 10 women die each day from the disease.


The FDA approved Gardasil for the prevention of cervical cancer; cervical pre-cancers [cervical intraepithelial neoplasia (CIN) 2/3 and adenocarcinoma in situ (AIS)]; vulvar pre-cancers [vulvar intraepithelial neoplasia (VIN) 2/3]; and vaginal pre-cancers [vaginal intraepithelial neoplasia (VaIN) 2/3] caused by HPV types 16 and 18. Gardasil is also approved for the prevention of genital warts and low-grade cervical lesions (CIN 1) caused by HPV types 6, 11, 16 and 18. Gardasil is approved for 9 to 26-year-old girls and women.

"Merck is proud to be the leader in cervical cancer vaccine research and development," said Richard T. Clark, chief executive officer and president, Merck & Co., Inc. "Bringing forward this life-saving scientific advance is yet another testament to Merck's long-standing mission to research and develop novel vaccines and medicines that can greatly improve public health."

Gardasil is designed to prevent the majority of HPV-related clinical diseases, those caused by HPV 6, 11, 16 and 18. HPV types 16 and 18 account for approximately 70 per cent of cases of cervical cancer, AIS (non-invasive cervical cancer), CIN 3, VIN 2/3 and VaIN 2/3, and account for 50 percent of CIN 2 lesions. HPV 6 and 11 cause approximately 90 per cent of genital wart cases. These four types of HPV also cause approximately 35 to 50 per cent of all low-grade cervical, vaginal and vulvar lesions (CIN I, VIN I and VaIN I). There are an estimated 4.7 million abnormal Pap results that require follow-up each year in the United States. At least 3 million of these results are caused by some type of HPV. All four types cause abnormal Pap test results; the lesions caused by types 6 and 11 are clinically indistinguishable from pre-cancerous lesions caused by types 16 and 18.

"Gardasil is a major health breakthrough - the first vaccine specifically designed to prevent cancer - and is approved to prevent not only cervical cancer but also genital warts," said Kevin Ault, associate professor, Department of Gynecology and Obstetrics, Emory University School of Medicine, and clinical study investigator for Gardasil. "Use of Gardasil can help significantly reduce the human and economic burden of cervical cancer, pre-cancerous or low-grade lesions and genital warts caused by HPV 6, 11, 16 and 18 in the United States, and the rest of the world, in this generation and future generations."