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Proper Name
Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant
Prevention of vulvar and vaginal cancer.

GARDASIL, Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant, is a non-infectious recombinant quadrivalent vaccine prepared from the purified virus-like particles (VLPs) of the major capsid (L1) protein of HPV Types 6, 11, 16, and 18. The L1 proteins are produced by separate fermentations in recombinant Saccharomyces cerevisiae and self-assembled into VLPs.

Key Regulatory Milestones

Gardasil was first licensed for use in the U.S. on June 8, 2006 with subsequent approvals of supplements in 2008, 2009, and 2010.

04/24/2015 - FDA approval date

04/26/2015 - PDUFA Goal Date

Advisory Committee

This submission was not discussed at a Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting because review of this submission did not identify concerns which would have benefitted from an advisory committee discussion.

Advanced Facts