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The decision to vaccinate an individual should take into account the risk for previous HPV exposure and potential benefit from vaccination.
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of rare anaphylactic reactions following the administration of the vaccine.
Syncope (fainting), sometimes associated with falling, can occur following, or even before, any vaccination, especially in adolescents as a psychogenic response to the needle injection. This can be accompanied by several neurological signs such as transient visual disturbance, paraesthesia, and tonic-clonic limb movements during recovery. Therefore, vaccines should be observed for approximately 15 minutes after vaccination. It is important that procedures are in place to avoid injury from fainting.
Vaccination should be postponed in individuals suffering from an acute severe febrile illness. However, the presence of a minor infection, such as a mild upper respiratory tract infection or low-grade fever, is not a contraindication for immunization.
As with any vaccine, vaccination with GARDASIL 9 may not result in protection in all vaccine recipients. The vaccine will only protect against diseases that are caused by HPV types targeted by the vaccine (see Pharmacology: Pharmacodynamics under Actions). Therefore, appropriate precautions against sexually transmitted diseases should continue to be used.
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. The vaccine is therefore not indicated for treatment of cervical, vulvar, vaginal and anal cancer, high-grade cervical, vulvar, vaginal and anal dysplastic lesions or genital warts. 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 (see Pharmacology: Pharmacodynamics under Actions).
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.
There are no data on the use of GARDASIL 9 in individuals with impaired immune responsiveness. Safety and immunogenicity of a qHPV vaccine have been assessed in individuals aged from 7 to 12 years who are known to be infected with human immunodeficiency virus (HIV) (see Pharmacology: Pharmacodynamics under Actions).
Individuals with impaired immune responsiveness, due to either the use of potent immunosuppressive therapy, a genetic defect, Human Immunodeficiency Virus (HIV) infection, or other causes, may not respond to the vaccine.
This vaccine should be given with caution to individuals with thrombocytopaenia or any coagulation disorder because bleeding may occur following an intramuscular administration in these individuals. Long-term follow-up studies are currently ongoing to determine the duration of protection. (See Pharmacology: Pharmacodynamics under Actions.)
There are no safety, immunogenicity or efficacy data to support interchangeability of GARDASIL 9 with bivalent or quadrivalent HPV vaccines.
Effects on ability to drive and use machines: GARDASIL 9 has no or negligible influence on the ability to drive or use machines. However, some of the effects mentioned under Adverse Reactions may temporarily affect the ability to drive or use machines.
