publication date: Dec. 12, 2014

Gardasil 9 Vaccine Covers Five Additional HPV Types

 

FDA approved Gardasil 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) for the prevention of certain diseases caused by nine types of Human Papillomavirus.

Covering five more HPV types than the version of Gardasil previously approved by the FDA, Gardasil 9 has the potential to prevent approximately 90 percent of cervical, vulvar, vaginal and anal cancers.

Gardasil 9 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 five additional HPV types—31, 33, 45, 52 and 58—cause approximately 20 percent of cervical cancers and are not covered by previously FDA-approved HPV vaccines.

A randomized, controlled clinical study was conducted in the U.S. 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 Gardasil or Gardasil 9. Gardasil 9 was determined to be 97 percent effective in preventing cervical, vulvar and vaginal cancers caused by the five additional HPV types (31, 33, 45, 52, and 58).

In addition, Gardasil 9 is as effective as Gardasil 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 Gardasil’s demonstrated … Continue reading 40-46 Gardasil 9 Vaccine Covers Five Additional HPV Types

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