GARDASIL 9, Human Papillomavirus 9-valent Vaccine, Recombinant, is a non-infectious recombinant 9-valent vaccine prepared from the purified virus-like particles (VLPs) of the major capsid (L1) protein of HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58.
06/2006 - Merck’s first licensed HPV vaccine, GARDASIL, was approved
2008 - new indication in (STN 125126/419) added
2009 - use in males and prevention of genital warts were added to the indication in (STN 125126/1297),
2010 - prevention of anal cancer and AIN in men and women was added to the indications and usage in (STN 125126/1895).
2014 - GARDASIL 9 was licensed with indications to prevent diseases related to the HPV types covered by the vaccine in girls and women 9 through 26 years of age, and boys 9 through 15 years of age.
2015 - GARDASIL 9 indications applicable to males were extended to include men 16 through 26 years of age (STN 125508/15).
10/06/2018 - PDUFA Goal Date
06/12/2020 - FDA approval date
This submission was not discussed at a Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting because review of this supplemental application did not identify concerns or issues which would have benefitted from an advisory committee discussion.