The next generation of HPV vaccines: nonavalent vaccine V503 on the horizon.

HPV infection with 'high-risk' genotypes is associated with ano-genital and oropharyngeal cancers. Two currently licensed prophylactic HPV vaccines designed to prevent disease associated with HPV 16 and 18 are in use around the world. Both vaccines have very high efficacy for prevention of vaccine type-associated cervical precancers, preventing approximately 70% of these lesions. Quadrivalent HPV vaccine has also been shown to prevent HPV16/18-associated vaginal, vulvar and anal precancers, and HPV6/11-associated ano-genital warts. To broaden protection against HPV genotypes not in the current vaccines, 'second-generation' vaccines with additional genotypes are under development. Merck, Sharp and Dohme has submitted a Biologics License Application for its investigational nonavalent HPV vaccine V503 to the US FDA, with standard review being granted. The nonavalent HPV vaccine appears to be safe and effective in preventing persistent infection and precancerous lesions associated with HPV types 16/18/31/33/45/52/58, as well as genital warts related to HPV types 6 and 11.