A Comprehensive Clinical and Public Health Review of the Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9)

I. Introduction and Product Characterization

Overview of Human Papillomavirus (HPV) as a Public Health Concern

Human Papillomavirus (HPV) represents the most prevalent sexually transmitted viral infection globally and is the etiological agent for a significant spectrum of human diseases, ranging from benign lesions to invasive malignancies.[1] While the majority of HPV infections are transient and immunologically cleared by cell-mediated immune responses within several years, a subset of infections with high-risk oncogenic HPV types can persist.[2] This persistence is the primary causal factor for the development of precancerous intraepithelial neoplasias and subsequent invasive cancers.[2] The public health burden of HPV is substantial, encompassing cervical, anal, oropharyngeal, vulvar, vaginal, and penile cancers.[3] In the United States, HPV-attributable oropharyngeal cancer has now surpassed cervical cancer as the most common HPV-related malignancy, underscoring the evolving epidemiology of the disease and the need for comprehensive prevention strategies that address multiple anatomical sites in both sexes.[6] Beyond malignancy, low-risk HPV types, primarily 6 and 11, are responsible for approximately 90% of cases of anogenital warts (condyloma acuminata) and recurrent respiratory papillomatosis, conditions that cause significant morbidity and psychological distress.[4] The management of HPV-related diseases also imposes a considerable economic burden on healthcare systems, involving costs associated with screening, diagnostic procedures like colposcopy, and treatments for precancerous and cancerous lesions.[2]

Development and Composition of the 9-valent Recombinant Vaccine