FDA approves Gardasil 9 to prevent certain cancers caused by five additional HPV types

WASHINGTON - Dec. 10, 2014 - PRLog -- Gardasil 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) has been approved by the U.S. Food and Drug Administration for the prevention of certain diseases caused by nine types of Human Papillomavirus (HPV), according to a press release issued today.

The vaccine is approved for the HPV types 16, 18, 31, 33, 45, 52 and 58 for the prevention of cervical, vulvar, vaginal and anal cancers and for the prevention of genital warts caused by HPV types 6 or 11 in females ages 9 through 26 and males ages 9 through 15. The five additional types  31, 33, 45, 52 and 58 cause approximately 20 percent of cervical cancers.

FDA approval was based on a randomized, controlled clinical study assessing 14,000 females ages 16 through 26 who tested negative for vaccine HPV types at the start of the study. Gardasil 9 had a 97% efficacy rate for the prevention of cervical, vulvar and vaginal cancers caused by the five additional HPV types (31, 33, 45, 52, and 58).  During the trial, antibody responses revealed that Gardasil 9 is just as effective against the prevention of diseases caused by HPV types (6, 11, 16, and 18) as the original Gardasil vaccine. Similar antibody responses were also observed in approximately 1,200 males and 2,800 females in the 9 through 15 age group.

“Vaccination is a critical public health measure for lowering the risk of most cervical, genital and anal cancers caused by HPV,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research. “The approval of Gardasil 9 provides broader protection against HPV-related cancers.

Gardasil 9 is manufactured by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

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