Gardasil 9 Special Precautions

As for any vaccine, vaccination with GARDASIL 9 may not result in protection in all vaccine recipients.
The decision to vaccinate an individual should take into account the risk for previous HPV exposure and potential benefit from vaccination.
The vaccine is for prophylactic use only and has no effect on active HPV infections or established clinical disease. The vaccine has not been shown to have a therapeutic effect. 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. It is also not intended to prevent progression of other established HPV-related lesions.
GARDASIL 9 does not prevent lesions due to a vaccine HPV type in individuals infected with that HPV type at the time of vaccination.
Vaccination is not a substitute for routine cervical screening. Since no vaccine is 100% effective and GARDASIL 9 will not provide protection against every HPV type, or against HPV infections present at the time of vaccination, routine cervical screening remains critically important and should follow local recommendations.
This vaccine will not protect against diseases that are not caused by HPV.
As with all injectable vaccines, appropriate medical treatment should always be readily available in case of rare anaphylactic reactions following the administration of the vaccine.
Syncope (fainting) may follow any vaccination, especially in adolescents and young adults. Syncope, sometimes associated with falling, has occurred after HPV vaccination. Therefore, vaccinees should be carefully observed for approximately 15 minutes after administration of GARDASIL 9.
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 etiology. Low-grade fever itself and mild upper respiratory infection are not generally contraindications to vaccination.
Individuals with impaired immune responsiveness, whether due to the use of immunosuppressive therapy, a genetic defect, Human Immunodeficiency Virus (HIV) infection, or other causes, may have reduced antibody response to active immunization. [See Use with Systemic Immunosuppressive Medications under Interactions and Immunocompromised Individuals as follows.]
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.
Immunocompromised Individuals: The immunologic response to GARDASIL 9 may be diminished in immunocompromised individuals [see Use with Systemic Immunosuppressive Medications under Interactions].
Use in Children: The safety and efficacy of GARDASIL 9 have not been evaluated in children younger than 9 years.
Use in the Elderly: The safety and efficacy of GARDASIL 9 have not been evaluated in individuals aged 65 years and over.