Trade name: GARDASIL®9
Generic names: Human Papillomavirus 9-valent Vaccine, Recombinant Suspension for intramuscular injection.
Indication and Usage | The FDA has approved this vaccine:
- In girls and women 9 through 45 years of age for the prevention of the following diseases:
- Cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by Human Papillomavirus (HPV) types 16, 18, 31, 33, 45, 52, and 58.
- Genital warts (condyloma acuminata) caused by HPV types 6 and 11.
- And the following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58:
- Cervical intraepithelial neoplasia (CIN) grade 2/3 and cervical adenocarcinoma in situ (AIS).
- Cervical intraepithelial neoplasia (CIN) grade 1.
- Vulvar intraepithelial neoplasia (VIN) grade 2 and grade 3.
- Vaginal intraepithelial neoplasia (VaIN) grade 2 and grade 3.
- Anal intraepithelial neoplasia (AIN) grades 1, 2, and 3.
- In boys and men 9 through 45 years of age for the prevention of the following diseases:
- Anal, oropharyngeal and other head and neck cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58.
- Genital warts (condyloma acuminata) caused by HPV types 6 and 11.
- And the following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58:
- Anal intraepithelial neoplasia (AIN) grades 1, 2, and 3.
- The oropharyngeal and head and neck cancer indication is approved under accelerated approval based on effectiveness in preventing HPV related anogenital disease. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
Limitations of Use and Effectiveness: Vaccination with GARDASIL 9 does not eliminate the necessity for vaccine recipients to undergo screening for cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers as recommended by a health care provider. GARDASIL 9 has not been demonstrated to provide protection against disease caused by:
- HPV types not covered by the vaccine
- HPV types to which a person has previously been exposed through sexual activity.
- Not all vulvar, vaginal, anal, oropharyngeal and other head and neck cancers are caused by HPV, and GARDASIL 9 protects only against those vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by HPV 16, 18, 31, 33, 45, 52, and 58.
- GARDASIL 9 is not a treatment for external genital lesions; cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers; CIN; VIN; VaIN; or AIN.
Ingredients: 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. 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.
Manufacturer-listed adverse reactions: HPV vaccine (Gardasil 9) can cause: Vomiting, Urticaria (hives), Autoimmune hemolytic anemia, Idiopathic thrombocytopenic purpura, Lymphadenopathy, Pulmonary embolus, Pancreatitis, Asthenia (weakness), Chills, Death, Malaise (discomfort), Autoimmune diseases, Hypersensitivity reactions including anaphylactic/anaphylactoid reactions, Bronchospasm, Arthralgia (joint pain), Myalgia (muscle pain), Acute disseminated encephalomyelitis, Guillain-Barré syndrome, Motor neuron disease, Paralysis, Seizures, Transverse myelitis, Cellulitis, Deep venous thrombosis.
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