GARDASIL

What it is

GARDASIL 9 is a non-infectious recombinant 9-valent vaccine prepared from 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 purified VLPs are adsorbed on a pre-formed aluminium-containing adjuvant (Amorphous Aluminium Hydroxyphosphate Sulfate or AAHS). GARDASIL 9 is available in 0.5-mL single-dose vials and prefilled syringes for intramuscular administration.

Approved indications

— Prevention of cervical, vulvar, vaginal and anal cancer, precancerous or dysplastic lesions, genital warts, and infection caused by Human Papillomavirus (HPV) types 6, 11, 16, 18, 31, 33, 45, 52 and 58 in females aged 9 to 45 years. — Prevention of anal cancer, precancerous or dysplastic lesions, external genital lesions, and infection caused by Human Papillomavirus (HPV) types 6, 11, 16, 18, 31, 33, 45, 52 and 58 in males aged 9 to 45 years.

Dosing overview

GARDASIL 9 should be administered intramuscularly as 3 separate 0.5-mL doses according to the following schedule: first dose at elected date; second dose 2 months after the first dose; third dose 6 months after the first dose. The second dose should be administered at least 1 month after the first dose and the third dose should be administered at least 3 months after the second dose, with all three doses given within a 1-year period. Alternatively, in individuals 9 to 14 years of age, GARDASIL 9 can be administered according to a 2-dose schedule; the second dose should be administered between 5 and 13 months after the first dose.

Key safety warnings

Syncope (fainting) may follow any vaccination, especially in adolescents and young adults. Syncope, sometimes associated with falling, has occurred after vaccination with GARDASIL 9. Therefore, vaccinees should be carefully observed for approximately 15 minutes after administration of GARDASIL 9. Vaccination with GARDASIL 9 may not result in protection in all vaccine recipients. This vaccine is not intended to be used for treatment of active external genital lesions; cervical, vulvar, vaginal or anal cancers; CIN, VIN, VaIN, or AIN. Routine cervical screening and detection and removal of cervical lesions should be continued in individuals who receive the vaccine. This vaccine should be given with caution to individuals with thrombocytopenia or any coagulation disorder because bleeding may occur following an intramuscular administration in these individuals.

Contraindications

Hypersensitivity to the active substances of GARDASIL 9 or GARDASIL or to any of the inactive ingredients of either vaccine. Individuals who develop symptoms indicative of hypersensitivity after receiving a dose of GARDASIL 9 or GARDASIL should not receive further doses of GARDASIL 9.

PBS listing

GARDASIL 9 was recommended by PBAC in November 2017 for prevention of human papillomavirus (HPV) related diseases, including cervical, vulvar, vaginal, and anal cancers, and genital warts, caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58.

Regulatory history

GARDASIL 9 was first listed on the ARTG on 2015-06-29 in both syringe (ARTG 224092) and vial (ARTG 224093) formulations. In November 2017, PBAC recommended GARDASIL 9 for the prevention of human papillomavirus (HPV) related diseases, including cervical, vulvar, vaginal, and anal cancers, and genital warts, caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58. An AusPAR was issued on 2023-04-06, approving GARDASIL 9 in males aged 9 to 45 years for the prevention of anal cancer, precancerous or dysplastic lesions, external genital lesions, and infection caused by the vaccine HPV types.