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FDA announced the approval of Gardasil 9 for the prevention of certain diseases caused by nine types of HPV, five more than the previously FDA-approved Gardasil.
FDA announced on Dec. 10, 2014 that it had approved Gardasil 9, manufactured by Merck Sharp & Dohme for the prevention of nine different types of the human papillomavirus (HPV). The vaccine is now approved for the prevention of cervical, vulvar, vaginal, and anal cancers caused by HPV types 16, 18, 31, 33, 45, 52, 58, and genital warts caused by HPV 6 or 11. The previously-approved vaccine, Gardasil, protected against only four HPV types: 6, 11, 16, and 18. The new vaccine prevents an additional five types of HPV, which account for 20% of cervical cancers.
Gardasil 9 is approved for use in females ages 9 to 26 and males ages 9 to 15. The clinical study was conducted in the US and internationally in approximately 14,000 females aged 16 to 26 who tested negative for vaccine HPV types at the start of the study. Gardasil 9 was found to be 97% effective in preventing cervical, vulvar, and vaginal cancers caused by the additional five HPV types, but just as effective as the previously-approved Gardasil for the prevention of diseases caused by 6, 11, 16, or 18.
Effectiveness of the vaccine was determined in studies that measured antibody responses to the vaccine in approximately 1200 males and 2800 females ages 9 to 15. Similar antibody responses to that of females ages 16 to 26 indicated similar effectiveness of the vaccine when used on the age group of 9 to 15. The safety of the vaccine was evaluated in approximately 13,000 males and females with adverse side effects including injection site pain, swelling, redness, and headaches. The vaccine is administered in three separate shots; one separated by two months and then six months.