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9-Valent human papillomavirus recombinant vaccine (Gardasil® 9): a guide to its use in the EU

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Abstract

The 9-valent human papillomavirus (HPV) [types 6, 11, 16, 18, 31, 33, 45, 52, 58] recombinant vaccine (Gardasil® 9) provides an extended coverage of protection against HPV-related infection and disease relative to available (first generation) HPV vaccines. It is approved in the EU from the age of 9 years for the prevention of HPV-related premalignant lesions and cancers affecting the cervix, vulva, vagina and anus caused by vaccine HPV types, and genital warts caused by specific HPV types. In females negative for vaccine HPV types, the 9-valent HPV vaccine prevented cervical, vulvar and vaginal disease and persistent infection related to HPV types 31, 33, 45, 52 and 58 in women aged 16–26 years, and elicited an immune response to HPV types 6, 11, 16 and 18 that was noninferior to that elicited by the quadrivalent HPV vaccine in females aged 9–26 years. In addition, protective efficacy for each of the 9 HPV types in the vaccine can be inferred in girls and boys aged 9–15 years and men aged 16–26 years based on the robust immune response in bridging studies. The vaccine is generally well tolerated and is predicted to be cost effective relative to current HPV vaccination strategies.

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Acknowledgments

The article was reviewed by: S. Majewski, Medical University of Warsaw, Warsaw, Poland; S.-E. Olsson, Karolinska Institute at Danderyd Hospital, Stockholm, Sweden; M. Petras, Charles University in Prague, Prague, Czech Republic. During the peer review process, the manufacturer, as well as the marketing authorisation holder in the EU, of 9-valent HPV vaccine was offered an opportunity to review this article. Changes resulting from comments received were made on the basis of scientific and editorial merit.

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    Kate McKeage & Katherine A. Lyseng-Williamson

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  1. Kate McKeage
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  2. Katherine A. Lyseng-Williamson
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Correspondence to Katherine A. Lyseng-Williamson.

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The preparation of this review was not supported by any external funding.

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K. McKeage and K.A. Lyseng-Williamson are contracted/salaried employees of Adis/Springer, are responsible for the article content and declare no conflicts of interest.

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McKeage, K., Lyseng-Williamson, K.A. 9-Valent human papillomavirus recombinant vaccine (Gardasil® 9): a guide to its use in the EU. Drugs Ther Perspect 32, 414–421 (2016). https://doi.org/10.1007/s40267-016-0337-y

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