An Overview of Quadrivalent Human Papillomavirus Vaccine Safety 2006 to 2015
Michelle Vichnin, Paolo Bonanni, Nicola P Klein, Suzanne M Garland, Stan L Block, Susanne K Kjaer, Heather L Sings, Gonzalo Perez, Richard M Haupt, Alfred J Saah, Fabio Lievano, Christine Velicer, Rosybel Drury, Barbara J Kuter
The Pediatric Infectious Disease Journal | LIPPINCOTT WILLIAMS & WILKINS | Published : 2015
BACKGROUND: A quadrivalent human papillomavirus (HPV4) type 6/11/16/18 vaccine (GARDASIL/SILGARD®) has been licensed in many countries around the world for the prevention of cervical, vulvar, vaginal, and anal cancers and precancers, as well as external genital warts causally related to HPV types 6/11/16/18. Across 7 phase 3 clinical trials involving more than 29,000 males and females ages 9-45 years, vaccination was generally well tolerated. Because of its expected public health benefit in reducing cervical cancer and other HPV-related diseases, the vaccine has been implemented in the national vaccination programs of several countries, with over 178 million doses distributed worldwide. METH..View full abstract
The authors declare the following: Paolo Bonanni reports having received grant support from Sanofi Pasteur MSD and GlaxoSmithKline; reimbursements, advisory boards, consultancy and lecture fees from Sanofi Pasteur MSD and GlaxoSmithKline. Nicola P. Klein reports having received research support from Merck, GlaxoSmithKline, Pfizer, Novartis, Sanofi Pasteur, MedImmune and Nuron Biotech. Suzanne M. Garland reports having received grant support from Merck, GlaxoSmithKline and CSL; reimbursement fare for attending a global advisory board from Merck, and lecture fees from Sanofi Pasteur. Stan Block reports having received grant support, and speaker fees from Merck and research grants from GlaxoSmithKline. Susanne K. Kjaer reports having received scientific advisory board and speaker's fees and unrestricted research grants through her institution from Sanofi Pasteur MSD and Merck, and scientific advisory board fee from Roche. Michelle Vichnin, Heather L Sings, Gonzalo Perez, Richard M. Haupt, Alfred Saah, Fabio Lievano, Christine Velicer, and Barbara J. Kuter are current or former Merck employees and hold stock/stock options. Rosybel Drury is an employee of Sanofi Pasteur MSD.