Date shown reflects the date that the evidence was documented
2022-01-19
Human-Papillomavirus-Vaccine-Package-Insert-Gardasil-9-0
"GARDASIL 9 is a sterile suspension for intramuscular administration. Each 0.5-mL dose contains
approximately 30 mcg of HPV Type 6 L1 protein, 40 mcg of HPV Type 11 L1 protein, 60 mcg of HPV Type
16 L1 protein, 40 mcg of HPV Type 18 L1 protein, 20 mcg of HPV Type 31 L1 protein, 20 mcg of HPV Type
33 L1 protein, 20 mcg of HPV Type 45 L1 protein, 20 mcg of HPV Type 52 L1 protein, and 20 mcg of HPV
Type 58 L1 protein.
Each 0.5-mL dose of the vaccine also contains approximately 500 mcg of aluminum (provided as
AAHS), 9.56 mg of sodium chloride, 0.78 mg of L-histidine, 50 mcg of polysorbate 80, 35 mcg of sodium
borate, <7 mcg yeast protein, and water for injection. The product does not contain a preservative or
antibiotics.
After thorough agitation, GARDASIL 9 is a white, cloudy liquid.
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
HPV only infects human beings. Animal studies with analogous animal papillomaviruses suggest that
the efficacy of L1 VLP vaccines may involve the development of humoral immune responses. Efficacy of
GARDASIL 9 against anogenital diseases related to the vaccine HPV types in human beings is thought to
be mediated by humoral immune responses induced by the vaccine, although the exact mechanism of
protection is unknown.
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
GARDASIL 9 has not been evaluated for the potential to cause carcinogenicity, genotoxicity or
impairment of male fertility. GARDASIL 9 administered to female rats had no effects on fertility [see
Pregnancy (8.1)]."
https://www.fda.gov/media/90064/download
Human-Papillomavirus-Vaccine-Package-Insert-Gardasil-9-0
"GARDASIL 9 is a sterile suspension for intramuscular administration. Each 0.5-mL dose contains
approximately 30 mcg of HPV Type 6 L1 protein, 40 mcg of HPV Type 11 L1 protein, 60 mcg of HPV Type
16 L1 protein, 40 mcg of HPV Type 18 L1 protein, 20 mcg of HPV Type 31 L1 protein, 20 mcg of HPV Type
33 L1 protein, 20 mcg of HPV Type 45 L1 protein, 20 mcg of HPV Type 52 L1 protein, and 20 mcg of HPV
Type 58 L1 protein.
Each 0.5-mL dose of the vaccine also contains approximately 500 mcg of aluminum (provided as
AAHS), 9.56 mg of sodium chloride, 0.78 mg of L-histidine, 50 mcg of polysorbate 80, 35 mcg of sodium
borate, <7 mcg yeast protein, and water for injection. The product does not contain a preservative or
antibiotics.
After thorough agitation, GARDASIL 9 is a white, cloudy liquid.
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
HPV only infects human beings. Animal studies with analogous animal papillomaviruses suggest that
the efficacy of L1 VLP vaccines may involve the development of humoral immune responses. Efficacy of
GARDASIL 9 against anogenital diseases related to the vaccine HPV types in human beings is thought to
be mediated by humoral immune responses induced by the vaccine, although the exact mechanism of
protection is unknown.
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
GARDASIL 9 has not been evaluated for the potential to cause carcinogenicity, genotoxicity or
impairment of male fertility. GARDASIL 9 administered to female rats had no effects on fertility [see
Pregnancy (8.1)]."
https://www.fda.gov/media/90064/download