GARDASIL® 9 (Human Papillomavirus 9 valent Vaccine) (Recombinant, adsorbed) Safety Information

GARDASIL® 9 (Human Papillomavirus 9 valent Vaccine) (Recombinant, adsorbed)
Prescribing Information (Great Britain) & Prescribing Information (Northern Ireland) [External links]

Please refer to the Summary of Product Characteristics for full prescribing information.

Contraindications

Hypersensitivity to the active substances or to any of the excipients listed:

Sodium chloride
L-histidine
Polysorbate 80
Borax (Sodium borate)
Water for injections
Amorphous aluminium hydroxyphosphate sulfate (adjuvant)

Individuals with hypersensitivity after previous administration of GARDASIL® 9 or GARDASIL® Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed)/Silgard* should not receive GARDASIL® 9.

*Silgard (Human papillomavirus vaccine [types 6, 11, 16, 18] (recombinant, adsorbed)) is not licensed in the UK.

Special warnings and precautions for use

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, vaccinees 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 immunisation.

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. 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.

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).

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.

There are no safety, immunogenicity or efficacy data to support interchangeability of GARDASIL® 9 with bivalent or quadrivalent HPV vaccines.

Interaction with other medicinal products and other forms of interaction

Safety and immunogenicity in individuals who have received immunoglobulin or blood-derived products during the 3 months prior to vaccination have not been studied in clinical trials.

Use with other vaccines

GARDASIL® 9 may be administered concomitantly with a combined booster vaccine containing diphtheria (d) and tetanus (T) with either pertussis [acellular, component] (ap) and/or poliomyelitis [inactivated] (IPV) (dTap, dT-IPV, dTap-IPV vaccines) with no significant interference with antibody response to any of the components of either vaccine. This is based on the results from a clinical trial in which a combined dTap-IPV vaccine was administered concomitantly with the first dose of GARDASIL® 9.

Use with hormonal contraceptives

In clinical studies, 60.2% of women aged 16 through 26 years who received GARDASIL® 9 used hormonal contraceptives during the vaccination period of the clinical studies. Use of hormonal contraceptives did not appear to affect the type specific immune responses to GARDASIL® 9.

Pregnancy and Lactation

Pregnancy

Post-marketing data on pregnant women indicates no malformative nor foeto/neonatal toxicity of Gardasil 9 when administered during pregnancy.

Animal studies do not indicate reproductive toxicity.

A six-year pregnancy registry for Gardasil 9 prospectively followed 180 women of which there were 69 pregnancies with known outcomes. Frequencies of miscarriage and major birth defects were 4.3 % of pregnancies (3/69) and 4.5 % of live born infants (3/67), respectively. These frequencies were consistent with estimated background frequencies. These data support similar findings from a five year pregnancy registry for qHPV vaccine in which 1,640 pregnancies with known outcomes were included.

However, these data are considered insufficient to recommend use of Gardasil 9 during pregnancy. Vaccination should be postponed until completion of pregnancy

Breastfeeding

GARDASIL® 9 can be used during breastfeeding.
A total of 92 women were breastfeeding during the vaccination period of the clinical studies of GARDASIL® 9. In the studies, vaccine immunogenicity was comparable between breastfeeding women and women who did not breastfeed. In addition, the adverse experience profile for breastfeeding women was comparable to that of the women in the overall safety population. There were no vaccine-related serious adverse experiences reported in infants who were breastfeeding during the vaccination period.

Side effects

Refer to Summary of Product Characteristics for complete information on side-effects

Common side effects of GARDASIL® 9
Very common (≥1/10)	Common (≥1/100 to <1/10)
Headache	Dizziness
At the injection site: pain, swelling, erythema	Nausea
	Pyrexia
	Fatigue
	At the injection site: pruritus, bruising

Supporting documentation