On 1 January 2017 nonavalent Gardasil 9 replaced quadrivalent Gardasil on the National Immunisation Schedule. Gardasil and Gardasil 9 are fully interchangeable to complete a course of vaccination against serotypes 6, 11, 16 and 18.

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 from their primary healthcare vaccine provider.

Individuals who have completed a course of Gardasil (HPV4) and would like to broaden their protection against the additional five HPV serotypes in Gardasil 9 (HPV9) need to receive a full age-appropriate course of Gardasil 9. Individuals who were previously fully vaccinated with funded Gardasil are not eligible to receive funded Gardasil 9. This will need to be self-funded.

Unfunded doses should be purchased from Health Care Logistics and authorised vaccinators will need a prescription or standing order to administer them.  Pharmacist vaccinators can administer without a prescription between the ages of 9 and 45 years.

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 months.
• The minimum interval is 5 months between the two doses.
• There is no maximum interval between doses. It is not necessary to repeat the prior dose regardless of how long ago the dose was given.
• If two doses are given at least 5 months apart, no further doses are required even if the second dose is given when the individual is aged 15 years or older.
• If doses one and two are given less than 5 months apart, 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.
• A shortened schedule can be followed on specialist advice. Three doses can be given over a 5-month period, with a minimum interval of 4 weeks between any two doses.
• There is no maximum interval between doses. If the schedule has been interrupted, it is not necessary to repeat prior doses regardless of how long ago the doses were given.

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.
• If a shortened schedule is required, with an interval of 1 month between doses one and two and at least 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 9 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.

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:

• 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.

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). For serotypes 6, 11, 16 or 18, protection against precancerous vulval, vaginal and cervical lesions in women vaccinated when aged 16 years through 26 years ranged from 96–100% and for women vaccinated aged 24 years through 45 years when vaccinated 84.7–96.3%. In men vaccinated when aged 16 years through 26 years, protection against penile and anal cancers ranged from 73–100%. For the additional five HPV serotypes in Gardasil 9, types 31, 33, 45, 52 and 58, protection against persistent infection was around 96% and against precancerous vulval, vaginal and cervical lesions ranged from 92.9–98.9% in women vaccinated when aged 16 years through 26 years.

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, the incidence of genital warts in men and women has decreased by 75% since the introduction of the vaccine to girls 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.

In 2022, the WHO recommended “an off-label option, a single-dose schedule can be used in girls and boys aged 9–20 years” based on “comparable efficacy and duration of protection as a 2-dose schedule”. The WHO noted a “potential risk of a lower level of protection if efficacy wanes over time, although there is no current evidence of this.” A number of countries now have a one dose schedule for those without immunocompromise.

• Immunisation Advisory Centre. Antigen Literature Review for the New Zealand National Immunisation Schedule, 2016: Human papillomavirus. The University of Auckland, Auckland. Available from: https://www.immune.org.nz/publications/antigen-literature-review-for-the-new-zealand-national-immunisation-schedule-2016-human-papillomavirus
• Institute of Environmental Science and Research Ltd. STI epidemiology update. Porirua: Institute of Environmental Science and Research Ltd (ESR); 2019.
• Medical Advisory Committee of Haemophilia Foundation of New Zealand. National guidelines management of haemophilia - treatment protocols. Christchurch: Haemophilia Foundation of New Zealand; 2005.
• Medsafe. New Zealand data sheet: Gardasil 9 [Internet]. Wellington: New Zealand Medicines and Medical Devices Safety Authority; 2016 [updated 2020 March 4; cited 2020 July 2]. Available from: http://www.medsafe.govt.nz/profs/Datasheet/g/gardasil9inj.pdf
• U.S. Food and Drug Administration. Package insert: Gardasil 9 [Internet]. Silver Spring (MD): U.S. Food and Drug Administration; 2014 [updated 2020 June; cited 2020 July 2]. Available from: https://www.fda.gov/media/90064/download
• Ministry of Health. Immunisation handbook [Internet]. Wellington: Ministry of Health; 2020 [updated 2020 September 25; cited 2020 September 28]. Available from: https://www.health.govt.nz/publication/immunisation-handbook-2020