Prevention of cervical cancer: journey to develop the first human papillomavirus virus-like particle vaccine and the next generation vaccine

In 2006, the first human papillomavirus (HPV) virus-like particle (VLP) vaccine was licensed. Gardasil®, the quadrivalent HPV 6, 11, 16 and 18 recombinant VLP vaccine (4vHPV), developed by Merck demonstrated remarkable efficacy in prevention of important clinical pre-cursors to cervical cancer and genital warts. The vaccine was designed to protect against HPV 16 and 18 that cause ∼70% of cervical cancers and HPV 6 and 11 that cause ∼90% of genital warts. Initially, Gardasil® was indicated in the United States for women 9-26 years of age for the prevention of HPV 16 and 18-related cervical, vulvar and vaginal cancer, HPV 6, 11, 16 and 18-related genital intraepithelial neoplasia and the prevention of HPV 6 and 11-related genital warts. Subsequently, a bivalent HPV 16 and 18 VLP vaccine, Cervarix (2vHPV) developed by GlaxoSmithKline was licensed. Since the original licensures, the indications for Gardasil® have been expanded to include males and a vaccine with extended HPV coverage, Gardasil 9 (9vHPV), licensed in 2014.