Gardasil 9 Description

Chemistry: HUMAN PAPILLOMAVIRUS 9-VALENT (TYPES 6, 11, 16, 18, 31, 33, 45, 52, 58) RECOMBINANT VACCINE (GARDASIL 9), 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. The L1 proteins are produced by separate fermentations using recombinant Saccharomyces cerevisiae and self-assembled into VLPs. The fermentation process involves growth of S. cerevisiae on chemically-defined fermentation media which include vitamins, amino acids, mineral salts, and carbohydrates. The VLPs are released from the yeast cells by cell disruption and purified by a series of chemical and physical methods. The purified VLPs are adsorbed on pre-formed aluminum-containing adjuvant (Amorphous Aluminum Hydroxyphosphate Sulfate or AAHS). The 9-valent HPV VLP vaccine is a sterile liquid suspension that is prepared by combining the adsorbed VLPs of each HPV type and additional amounts of the aluminum-containing adjuvant formulation and the final purification buffer.
Composition: Active Ingredients: HUMAN PAPILLOMAVIRUS 9-VALENT (TYPES 6, 11, 16, 18, 31, 33, 45, 52, 58) RECOMBINANT VACCINE (GARDASIL 9) is a sterile preparation for intramuscular administration. Each 0.5-mL dose contains approximately 30 mcg of HPV 6 L1 protein, 40 mcg of HPV 11 L1 protein, 60 mcg of HPV 16 L1 protein, 40 mcg of HPV 18 L1 protein, 20 mcg of HPV 31 L1 protein, 20 mcg of HPV 33 L1 protein, 20 mcg of HPV 45 L1 protein, 20 mcg of HPV 52 L1 protein, and 20 mcg of HPV 58 L1 protein.
Vaccine is prepared from fermentation cultures of a recombinant strain of yeast Saccharomyces cerevisiae containing the genes for the human papillomavirus L1 protein of each type (6, 11, 16, 18, 31, 33, 45, 52, 58).
HUMAN PAPILLOMAVIRUS 9-VALENT (TYPES 6, 11, 16, 18, 31, 33, 45, 52, 58) RECOMBINANT VACCINE (GARDASIL 9) is available as a 0.5 mL single-dose prefilled syringe. A one-inch 23 gauge and one-inch 25 gauge sterile needles are provided separately in the package.
Inactive Ingredients (List of excipients): Each 0.5-mL dose of the vaccine contains approximately 500 mcg of aluminum (as Amorphous Aluminum Hydroxyphosphate Sulfate adjuvant), 9.56 mg of sodium chloride, 0.78 mg of L-histidine, 50 mcg of polysorbate 80, 35 mcg of sodium borate, and water for injection. The product does not contain a preservative or antibiotics.
Prior to agitation, HUMAN PAPILLOMAVIRUS 9-VALENT (TYPES 6, 11, 16, 18, 31, 33, 45, 52, 58) RECOMBINANT VACCINE (GARDASIL 9) may appear as a clear liquid with a white precipitate. After thorough agitation, HUMAN PAPILLOMAVIRUS 9-VALENT (TYPES 6, 11, 16, 18, 31, 33, 45, 52, 58) RECOMBINANT VACCINE (GARDASIL 9) is a white, cloudy liquid.