Gardasil 9 Special Precautions

As for any vaccine, 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.
This vaccine will not protect against diseases that are not caused by HPV.
Vaccination does not substitute for routine cervical cancer screening. Women who receive GARDASIL 9 should continue to undergo cervical cancer screening per standard of care.
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, sometimes associated with tonic-clonic movements and other seizure-like activity, has been reported following HPV vaccination. When syncope is associated with tonic-clonic movements, the activity is usually transient and typically responds to restoring cerebral perfusion by maintaining a supine or Trendelenburg position. Vaccinees should be carefully observed for approximately 15 minutes after administration of GARDASIL 9 [see Post-marketing Experience under Adverse Reactions].
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.