Quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine (Gardasil®): a guide to its use in the EU

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Abstract

The quadrivalent human papillomavirus (HPV) [types 6, 11, 16, 18] recombinant vaccine (Gardasil®) is approved in the EU for use from the age of 9 years for the prevention of premalignant anogenital lesions and cervical and anal cancers, and genital warts caused by the vaccine HPV types. In clinical trials, quadrivalent HPV vaccine provided high-level protection against infection or disease caused by the vaccine HPV types in females aged 15–45 years who are negative for the vaccine types. Quadrivalent HPV vaccine also provided high-level protection against genital warts, anogenital precancerous lesions and persistent infection caused by the vaccine HPV types in males aged 16–26 years who are negative for the vaccine types in clinical trials. In addition, bridging studies show robust immune responses in young girls and boys aged from 9 years, allowing extrapolation of the efficacy results seen in clinical trials and approval of quadrivalent HPV vaccine for use from the age of 9 years. The prophylactic efficacy of HPV vaccination was also shown in real-world settings. Quadrivalent HPV vaccine is generally well tolerated. Thus, quadrivalent HPV vaccine offers an effective means, in combination with screening programmes, to substantially reduce the burden of cervical cancer. In addition, it is effective in reducing the burden of HPV-related anogenital disease, including anal cancers and genital warts, in females and males.

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