0800 Immune

0800 466 863

Gardasil 9

Common name:

HPV9, nonavalent HPV vaccine

Protects against nine types of human papillomavirus.

tabs

Overview

Gardasil® 9 vaccine is funded on the National Immunisation Schedule for all aged 9 years to under 27 years. Gardasil 9 covers the same four human papillomaviruses (HPVs) as Gardasil plus an additional five types known to cause approximately 20% of cervical cancers and some other cancers (HPV 31, 33, 45, 52, 58). 

In New Zealand, the incidence of genital warts in men and women has more than halved since the introduction of the vaccine to girls in 2008. The vaccine is more than 83% effective in preventing persistent infection with HPV types 16 and 18 (precursors of cervical cancers). Fewer abnormal cervical smear results are being reported.

Responses to vaccine

Gardasil 9 (HPV9)

Common Responses

  • Fainting – more common in adolescent girls.
  • Mild pain, redness and swelling around injection site

Rare Responses

  • Severe pain and swelling at injection site

As with any medicine, very rarely a severe allergic reaction (anaphylaxis) can occur following immunisation.

References

In Depth

Other brands: None

Vaccine type: Subunit, recombinant

Schedule and administration

Schedule

On 1 January 2017 nonavalent Gardasil® 9 replaced quadrivalent Gardasil® on the National Immunisation Schedule. Gardasil 9 is being rolled out to primary care as stock of Gardasil is used up. The School-Based Immunisation Programme commenced the immunisation year with Gardasil 9. Gardasil and Gardasil 9 are fully interchangeable.

Eligibility for funded immunisation was extended to include all eligible males and females aged from 9 years–under 27 years*. 

* Non-resident males and females must be aged under 18 years to start a funded HPV vaccine course. They can go on to complete the course when aged 18 years or older.

* Males and females eligible for funded healthcare in New Zealand must be aged under 27 years to start a funded HPV vaccine course. They can go on to complete the course when aged 27 years or older.

Ideally the vaccine course is completed before the recipient becomes sexually active and is at risk of being exposed to HPV infection. However, those who are already infected with one or more types of HPV may still benefit from Gardasil 9 immunisation for the HPV types in the vaccine they have not been infected with. Immunisation will not make existing HPV infection worse. HPV vaccine is delivered to year 8 students through the School-based Immunisation Programme in most parts of NZ. It is funded, and may be delivered, from 9 years through primary healthcare providers.

    Males and females aged 27 years or older may still benefit from receiving a course of three Gardasil 9 vaccine doses. Individuals starting Gardasil 9 aged 27 years or older will need to purchase the vaccine doses through their family doctor or Family Planning Clinic.

    Males and females aged 9 years to 14 years inclusively:

    Not HIV-positive, or post-solid organ or stem cell transplantation

    • Two HPV vaccine doses

    • The standard schedule is 0 and 6–12 months.

      • If doses one and two are given at least 5 months apart, no further doses are required.

      • If doses one and two are given less than 5 months apart, a third HPV vaccine dose is required.

      • If dose two is not given until the child is aged 15 years or older, a third HPV vaccine dose is required.

    HIV-positive, or post-solid organ or stem cell transplantation

    • Three HPV vaccine doses

    • The standard schedule is 0, 2, 6 months, i.e. an interval of 2 months between doses one and two, and an interval of 4 months between doses two and three.

      • An alternate schedule can be followed, 0, 1, 4 months, on specialist advice.

    Males and females aged 15–26 years inclusively:

    • Three HPV vaccine doses

    • The standard schedule is 0, 2, 6 months, i.e. an interval of 2 months between doses one and two, and an interval of 4 months between doses two and three.

      • An alternate schedule can be followed, 0, 1, 4 months, i.e. a minimum interval of 1 month between doses one and two, and a minimum interval of 3 months between doses two and three.

    Administration

    • Gardasil 9 is administered by intramuscular injection.
      • The deltoid muscle or higher anterolateral area of the thigh are the recommended administration sites.
    • Gardasil® should be administered to adolescents and adults with thrombocytopenia or bleeding disorders, e.g. haemophilia, in accordance with their haematologist's instructions. The vaccine may be given subcutaneously if the person's haematologist has advised against intramuscular injection of immunisations. Firm pressure should be applied to the injection site (without rubbing) for at least ten minutes following either intramuscular or subcutaneous injection.
    • Fainting, with associated falling, has been observed following immunisation so consideration given to lying vaccine recipients down for immunisation.
    • Women who are breast feeding can safely have Gardasil 9. No adverse consequences for a breast feeding infant have been observed following vaccination of lactating women.
    • Gardasil 9 can be administered concurrently with other vaccines, including all the National Immunisation Schedule vaccines. Separate syringes and different injection sites should be used.

    Catch-up immunisation

    Gardasil and Gardasil 9 are fully interchangeable. When the vaccine course has been interrupted it may be resumed without repeating prior doses. Resume the standard schedule for the remaining doses.

    Storage and preparation

    Store between +2°C to +8°C. Protect from light. The expiry date of the vaccine is the last day of the month in the year indicated on the packaging.

    Vaccine safety

    Gardasil 9 can be administered concurrently with other vaccines, including all the National Immunisation Schedule vaccines. Separate syringes and different injection sites should be used.

    • The vaccine can be given to breastfeeding women without risk for the infant or mother.
    • Gardasil will not make existing HPV infection worse.
    • Gardasil does not cause infertility (sterility).

    For all vaccines, similar to most medications, an extremely rare allergic reaction called ‘anaphylaxis’ can occur. Anaphylaxis after immunisation occurs about 1–3 times in every one million vaccine doses. All vaccinators will have training and equipment to deal with this situation in the unlikely event of it occurring. No other serious responses to the vaccine have been identified.

    HPV vaccine should not be given to:

    • Anyone with a severe allergy (anaphylaxis) to a previous dose of this vaccine or a component of the vaccine.

    HPV immunisation should be postponed for:

    • Administration of Gardasil 9 should be postponed in individuals suffering from acute severe febrile illness (fever over 38°C).
      • The presence of a minor infection is not a contraindication.
    • The vaccine is not recommended during pregnancy however monitoring of women who have inadvertently received Gardasil during pregnancy has not identified any risks for the fetus or vaccine recipient.

    Vaccine effectiveness

    In clinical trials Gardasil vaccine demonstrated high efficacy against all endpoints in both males and females, as well as effectiveness in reducing the risk for subsequent HPV related disease.

    With the availability of effective vaccines, placebo-controlled trials are no longer an ethical approach for studying HPV vaccines. The efficacy of Gardasil 9 (HPV9) had to be assessed against Gardasil (HPV4).

    Efficacy was assessed in 14,215 women aged 16 to 26 years in a double-blind, phase IIb/III trial. Three doses of either Gardasil or Gardasil 9 were administered at 0, 2 and 6 months. In the per-protocol efficacy population, the incidence rate of high-grade disease related to HPV-31, 33, 45, 52, and 58 (i.e. serotypes in HPV9 vaccine only) was 0.1 per 1000 person-years in the HPV9 group and 1.6 per 1000 person years in the HPV4 group (1 case vs. 30 cases). HPV9 efficacy was 96.7%.

    Between January 2013 and June 2016 over 130 studies were published documenting HPV vaccine effectiveness and impact. Successful implementation of HPV vaccination programmes were associated with significant reductions in the prevalence of vaccine-type HPV, particularly among the cohorts eligible for vaccination, their sexual partners, and where coverage is highest. There were no changes observed in groups ineligible for funded HPV vaccine programmes.

    In countries with high HPV vaccine coverage, such as Australia and Denmark, there has been a profound reduction in the number of genital wart cases. Data from Australia suggest elimination is possible. Countries with more moderate coverage, such as NZ, have also observed significant reductions, For example, as of 2014, Ministry of Health data demonstrated a 47% reduction in genital warts cases presenting at family planning and sexual health clinics since Gardasil vaccination of females was introduced in 2008. By reducing the incidence of genital warts, fewer infants are at risk of contracting HPV infection during birth and developing recurrent respiratory papillomatosis.

    Effectiveness is optimum when the vaccine is given under 15 years of age, and prior to sexual interactions.

    Last updated: Nov 2017