Gardasil 9

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Prescribing Information

Therapeutic indications of GARDASIL 9®1

GARDASIL® 9 is indicated for active immunisation of individuals from the age of 9 years against the following HPV diseases:1

  • Premalignant lesions and cancers affecting the cervix, vulva, vagina and anus caused by vaccines HPV types.
  • Genital warts (Condyloma acuminata) caused by specific HPV types.

    • The use of GARDASIL 9 should be in accordance with official recommendations.

    GARDASIL 9® in Ireland2

    The HPV vaccine currently used in Ireland is called Gardasil 9. Over 100 million people have been fully vaccinated with Gardasil worldwide. This includes over 400,000 people in Ireland.

    GARDASIL 9® and HPV types1

    The indication of Gardasil 9 is based on:

  • Demonstration of efficacy of qHPV vaccine to prevent persistent infection and disease related to HPV types 6, 11, 16 and 18 in females aged 16 to 45 years and males aged 16 to 26 years.
  • Demonstration of non-inferior immunogenicity between Gardasil 9 and the qHPV vaccine for HPV types 6, 11, 16 and 18 in girls aged 9 to 15 years, women and men aged 16 to 26 years; efficacy for Gardasil 9 against persistent infection and disease related to HPV types 6, 11, 16, or 18 can be inferred to be comparable to that of the qHPV vaccine.
  • Demonstration of efficacy against persistent infection and disease related to HPV types 31, 33, 45, 52 and 58 in girls and women aged 16 to 26 years, and
  • Demonstration of non-inferior immunogenicity against the Gardasil 9 HPV types in boys and girls aged 9 to 15 years, men aged 16 to 26 years and women aged 27 to 45 years, compared to girls and women aged 16 to 26 years.

    • Posology and method of administration1

    Posology

    Individuals 9 to and including 14 years of age at time of first injection

    Gardasil 9 can be administered according to a 2-dose (0, 6 -12 months) schedule. The second dose should be administered between 5 and 13 months after the first dose. If the second vaccine dose is administered earlier than 5 months after the first dose, a third dose should always be administered.

    Gardasil 9 can be administered according to a 3-dose (0, 2, 6 months) schedule. The second dose should be administered at least one month after the first dose and the third dose should be administered at least 3 months after the second dose. All three doses should be given within a 1-year period.

    Individuals 15 years of age and older at time of first injection

    Gardasil 9 should be administered according to a 3-dose (0, 2, 6 months) schedule.

    The second dose should be administered at least one month after the first dose and the third dose should be administered at least 3 months after the second dose. All three doses should be given within a 1-year period.

    The use of Gardasil 9 should be in accordance with official recommendations. It is recommended that individuals who receive a first dose of Gardasil 9 complete the vaccination course with Gardasil 9. The need for a booster dose has not been established. Studies using a mixed regimen (interchangeability) of HPV vaccines were not performed for Gardasil 9.

    Subjects previously vaccinated with a 3-dose regimen of quadrivalent HPV types 6, 11, 16, and 18 vaccine (Gardasil), hereafter referred to as qHPV vaccine, may receive 3 doses of Gardasil 9. qHPV vaccine was also known as Silgard in some countries.

    Paediatric population (children <9 years of age)

    The safety and efficacy of Gardasil 9 in children below 9 years of age have not been established. No data are available.

    Method of administration

    The vaccine should be administered by intramuscular injection. The preferred site is the deltoid area of the upper arm or in the higher anterolateral area of the thigh. Gardasil 9 must not be injected intravascularly, subcutaneously or intradermally. The vaccine should not be mixed in the same syringe with any other vaccines and solution.

    Adverse Event Reporting

    Healthcare professionals are asked to report any suspected adverse reactions via

    HPRA Pharmacovigilance,
    Earlsfort Terrace,
    IRL – Dublin 2

    Tel: +353 1 6764971
    Fax: +353 1 6762517
    Website: www.hpra.ie
    E-mail: medsafety@hpra.ie

    1. Summary of Product Characteristics; Gardasil 9 suspension for injection in a pre-filled syringe: Gardasil 9 suspension for injection in a pre-filled syringe | SPC | MSD Ireland (Human Health) Limited | Medicines.ie (Accessed October 2022)

    2. HPV Vaccine – HSE.ie