Gardasil Pediatric Utilization and Safety Review for the Pediatric Advisory Committee Meeting —

Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research

December 7, 2010

Date: October 29, 2010
From: Michael Nguyen, MD Medical Officer, Vaccine Safety Branch
To: STN 125126
Through:
David Martin, MD, MPH Vaccine Safety Branch Chief
Rickey Wilson, MD, JD, MS Division of Epidemiology Director

Subject: Gardasil Pediatric Utilization and Safety Review for the Pediatric Advisory Committee Meeting — December 7, 2010

Sponsor: Merck & Co., Inc.

Product: Gardasil, Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant

Pharmaceutical form: 0.5mL sterile liquid suspension for intramuscular injection in a vial or prefilled syringe, containing approximately:
20 mcg of HPV types 6 and 18 L1 proteins 40 mcg of HPV types 11 and 16 L1 proteins 225 mcg aluminum hydroxyphosphate sulfate adjuvant 9.56 mg sodium chloride 35 mcg sodium borate 0.78 mg L-histidine 50 mcg polysorbate 80

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