New vaccine version approved for cancers caused by additional HPV types
A new vaccine, human papillomavirus (HPV) 9-valent vaccine, recombinant (Gardasil 9, Merck Sharp & Dohme), has been approved by FDA for the prevention of diseases caused by 9 HPV types. It is effective against 5 additional strains of the virus than is the previous FDA-approved version of the vaccine (Gardasil).
The broader protection afforded by this vaccine may mean that it will be able to prevent about 90% of cervical, vulvar, vaginal, and anal cancers. It has been approved for the prevention of such cancers that are caused by HPV types 16, 18, 31, 33, 45, 52, and 58. It also has been approved for the prevention of genital warts that are caused by HPV types 6 and 11. The added protection of this new vaccine includes the 5 additional HPV types 31, 33, 45, 52, and 58, which have been determined to cause about 20% of cervical cancers.
Its effectiveness was assessed in a randomized, controlled clinical study including about 14,000 females aged 16 through 26 years testing negative for vaccine HPV types at the beginning of the trial. Findings from the study indicated that the HPV 9-valent vaccine was 97% effective in the prevention of cervical, vulvar, and vaginal cancers resulting from exposure to the 5 additional types of HPV. The new vaccine versus the older version is also equally effective in preventing diseases caused by HPV types 6, 11, 16, and 18.
Further, through studies measuring antibody responses to the vaccine in about 2,800 females and 1,200 males aged 9 through 15 years, these responses were found to be similar to those seen in females aged 16 through 26 years. The conclusion is that the new vaccine will result in an effectiveness that is also the same in this younger cohort of patients.
FDA approved use of the new vaccine in females aged 9 to 26 years and males aged 9 to 15 years. The vaccine is administered as 3 separate shots, including an initial dose and then the other 2 shots given at 2 and 6 months later, respectively.