FDA Approves Nine-Valent HPV Vaccine for Prevention of Certain Cancers Caused by Five Additional Types of HPV
The U.S. Food and Drug Administration (FDA) today approved recombinant nine-valent human papillomavirus vaccine (Gardasil 9) for the prevention of certain diseases caused by nine types of HPV. The nine-valent vaccine covers five more HPV types than the previously approved quadrivalent vaccine (Gardasil) and has the potential to prevent approximately 90% of cervical, vulvar, vaginal, and anal cancers.
The new HPV vaccine is approved for use in females ages 9 through 26 and males ages 9 through 15. It is approved for the prevention of cervical, vulvar, vaginal, and anal cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58, and for the prevention of genital warts caused by HPV types 6 or 11. The vaccine adds protection against five additional HPV types—31, 33, 45, 52 and 58—that cause approximately 20% of cervical cancers and are not covered by previously FDA-approved HPV vaccines.
“Vaccination is a critical public health measure for lowering the risk of most cervical, genital and anal cancers caused by HPV,” said Karen Midthun, MD, Director of the FDA’s Center for Biologics Evaluation and Research. “The approval of [the nine-valent HPV vaccine] provides broader protection against HPV-related cancers.
Clinical Study Details
A randomized, controlled clinical study was conducted in the United States and internationally in approximately 14,000 females ages 16 through 26 who tested negative for vaccine HPV types at the start of the study. Study participants received either quadrivalent or nine-valent HPV vaccine 9. The nine-valent vaccine was determined to be 97% effective in preventing cervical, vulvar, and vaginal cancers caused by the five additional HPV types (31, 33, 45, 52, and 58). In addition, the nine-valent vaccine is as effective as the quadrivalent form for the prevention of diseases caused by the four shared HPV types (6, 11, 16, and 18) based on similar antibody responses in participants in clinical studies.
Due to the low incidence of anal cancer caused by the five additional HPV types, the prevention of anal cancer is based on the quadrivalent vaccine’s demonstrated effectiveness of 78% and additional data on antibodies in males and females who received the nine-valent HPV vaccine.
Safety and Efficacy
The effectiveness of nine-valent vaccine in females and males ages 9 through 15 was determined in studies that measured antibody responses to the vaccine in approximately 1,200 males and 2,800 females in this age group. Their antibody responses were similar to those in females 16 through 26 years of age. Based on these results, the vaccine is expected to have similar effectiveness when used in this younger age group.
The nine-valent HPV vaccine is administered as three separate shots, with the initial dose followed by additional shots given 2 and 6 months later. For all of the indications for use approved by the FDA, the vaccine’s full potential for benefit is obtained by those who are vaccinated prior to becoming infected with the HPV strains covered by the vaccine.
The safety of the nine-valent HPV vaccine was evaluated in approximately 13,000 males and females. The most commonly reported adverse reactions were injection site pain, swelling, redness, and headaches.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
