Gardasil 9 SSI Nov 2025
SELECTED SAFETY INFORMATION
▼This medicinal product is subject to additional monitoring in Australia. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events at https://www.tga.gov.au/reporting-problems.
▼This medicinal product is subject to additional monitoring in Australia. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events at https://www.tga.gov.au/reporting-problems.
GARDASIL 9 is listed on the National Immunisation Program (NIP). Refer to NIP Schedule.
Before prescribing, please review the Product Information available at www.msdinfo.com.au/gardasil9pi
INDICATIONS: GARDASIL 9 is indicated in females aged 9 to 45 years* for the 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. GARDASIL 9 is indicated in males aged 9 to 45 years* for the prevention of anal cancer, precancerous or dysplastic lesions, external genital lesions, and infection caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58.1
*Evidence of vaccine efficacy is based on the core efficacy population of females aged 16 to 26 years. Immunogenicity studies have been conducted to link efficacy to younger populations (females and males aged 9 to 15 years). Immunogenicity studies of GARDASIL 9 have been conducted relating to females over 26 years of age.1
SELECTED SAFETY INFORMATION1
CONTRAINDICATIONS: Hypersensitivity to active or inactive substances of GARDASIL 9 or GARDASIL. Individuals who develop symptoms indicative of hypersensitivity after a dose of GARDASIL 9 or GARDASIL should not receive further doses.
PRECAUTIONS:
Vaccination with GARDASIL 9 may not result in protection in all vaccine recipients. This vaccine is not intended to be used for active treatment and will not protect against diseases that are not caused by HPV or non-vaccine genotypes.
Routine cervical screening and detection and removal of cervical lesions should be continued in individuals who receive the vaccine.
Syncope (fainting), sometimes associated with falling, has occurred after HPV vaccination. Carefully observe vaccinees for ~15 minutes after administration.
The decision to administer or delay vaccination because of a current or recent febrile illness depends largely on the severity of the symptoms and their aetiology. Low-grade fever itself and mild upper respiratory infection are not generally contraindications to vaccination.
Caution giving this vaccine to individuals with thrombocytopenia or any coagulation disorder. Pregnancy category B2.
ADVERSE EFFECTS: Adverse reactions reported at a frequency of ≥1% from seven clinical studies included injection site pain, swelling, erythema, pruritus, and bruising, as well as vaccine-related systemic adverse reactions such as headache, pyrexia, nausea, dizziness, and fatigue. Four vaccine-related serious adverse events that occurred during the study period were pyrexia, allergy to vaccine, asthmatic crisis, and headache. See Product Information for other adverse effects.
Reference: 1. GARDASIL 9 Australian Approved Product Information, 14 February 2025.
AU-PVC-00092 v1. Issued November 2025.
▼This medicinal product is subject to additional monitoring in Australia. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events at https://www.tga.gov.au/reporting-problems.
GARDASIL 9 is listed on the National Immunisation Program (NIP). Refer to NIP Schedule.
Before prescribing, please review the Product Information available at www.msdinfo.com.au/gardasil9pi
INDICATIONS: GARDASIL 9 is indicated in females aged 9 to 45 years* for the 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. GARDASIL 9 is indicated in males aged 9 to 45 years* for the prevention of anal cancer, precancerous or dysplastic lesions, external genital lesions, and infection caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58.1
*Evidence of vaccine efficacy is based on the core efficacy population of females aged 16 to 26 years. Immunogenicity studies have been conducted to link efficacy to younger populations (females and males aged 9 to 15 years). Immunogenicity studies of GARDASIL 9 have been conducted relating to females over 26 years of age.1
SELECTED SAFETY INFORMATION1
CONTRAINDICATIONS: Hypersensitivity to active or inactive substances of GARDASIL 9 or GARDASIL. Individuals who develop symptoms indicative of hypersensitivity after a dose of GARDASIL 9 or GARDASIL should not receive further doses.
PRECAUTIONS:
Vaccination with GARDASIL 9 may not result in protection in all vaccine recipients. This vaccine is not intended to be used for active treatment and will not protect against diseases that are not caused by HPV or non-vaccine genotypes.
Routine cervical screening and detection and removal of cervical lesions should be continued in individuals who receive the vaccine.
Syncope (fainting), sometimes associated with falling, has occurred after HPV vaccination. Carefully observe vaccinees for ~15 minutes after administration.
The decision to administer or delay vaccination because of a current or recent febrile illness depends largely on the severity of the symptoms and their aetiology. Low-grade fever itself and mild upper respiratory infection are not generally contraindications to vaccination.
Caution giving this vaccine to individuals with thrombocytopenia or any coagulation disorder. Pregnancy category B2.
ADVERSE EFFECTS: Adverse reactions reported at a frequency of ≥1% from seven clinical studies included injection site pain, swelling, erythema, pruritus, and bruising, as well as vaccine-related systemic adverse reactions such as headache, pyrexia, nausea, dizziness, and fatigue. Four vaccine-related serious adverse events that occurred during the study period were pyrexia, allergy to vaccine, asthmatic crisis, and headache. See Product Information for other adverse effects.
Reference: 1. GARDASIL 9 Australian Approved Product Information, 14 February 2025.
AU-PVC-00092 v1. Issued November 2025.