Gardasil®

Recommended and offered free on the New Zealand Immunisation Schedule to girls at 12 years of age (in year 8 at school).

Three vaccinations are required to complete the course.

All adolescent girls at 12 years of age.

Girls and young women, born in 1990 and 1991, who have not completed doses two and/or three of their course of three Gardasil® vaccinations.
Females outside of the funded age groups described above aged 9 through 45 years and males aged 9 through 26 years.
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® immunisation for the HPV types in the vaccine they have not been infected with.

Immunisation will not make existing HPV infection worse.

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

Administration of Gardasil® should be postponed in individuals suffering from a fever over 38°C.

The presence of a minor infection is not a reason to delay immunisation.

Gardasil® protects almost every young woman against infection with any of the four strains of human papillomavirus (HPV) in the vaccine.

Studies have followed large numbers of women who received the course of Gardasil® vaccine for five years and found they were still protected from the four HPV vaccine types.

Other studies have continued to follow smaller numbers of women for since 2002 and found they were still protected. The evidence suggests protection will last much longer without the need for booster immunisations.
Studies to confirm ongoing duration of protection are continuing.

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.

Gardasil® will not make existing HPV infection worse.

Gardasil® does not cause infertility (sterility).

Girls born in 1990 and 1991 had until 31 December 2012 to complete doses two and/or three of their course of Gardasil®. Girls in this age group can no longer have dose one of the vaccine for free.

Girls born after 1992, and aged 12 years or older, have until their 20th birthday to start their course of Gardasil®.

Young women born in 1990 and 1991 are eligible to complete doses two and/or three of their course of Gardasil® immunisations until 31 December 2012.

Girls born in 1991 or earlier are not eligible to a course of Gardasil® immunisation for free.

Gardasil® is indicated but not funded for groups in addition to those covered by the National Immunisation Schedule (i.e. in addition to girls aged 12 to 20 years and girls born in 1990 and 1991 as described above) .

The license includes females aged 9 through 45 years and males aged 9 through 26 years for the prevention of infection by HPV types 6 and 11 that cause anogenital warts and types 16 and 18 that cause precancerous lesions, mouth, throat, cervical, vaginal, vulvar, penile and anal cancers.

Gardasil®

The primary vaccination schedule consists of three doses of Gardasil® by intramuscular injection.
The recommended schedule is doses spaced at 0, 2 and 4 months (the third dose being 6 months after the first dose).

Where a shorter immunisation schedule is required doses can be spaced at 0, 1 and 3 months (the third dose being not less than 4 months after the first dose).

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®. No adverse consequences for a breast feeding infant have been observed following vaccination of lactating women.

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

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.

After three doses of Gardasil®, 95.8% of women aged 16-26 years and naive to infection with HPV types 6, 11, 16 and 18 at the commencement of vaccination were protected  against acquiring persistent infection with HPV types 6, 11, 16 or 18. None of the women in this same group developed disease related to infection with HPV types 6, 11, 16 or 18.

In women aged 24-45 years 83.1% of women were protected from persistent infection with HPV types 16 or 18 and any CIN disease. In this same group none of the women developed infection or disease from HPV types 6 or 11.

Women who were infected with one or more vaccine HPV types prior to vaccination have been shown to develop protection from clinical disease caused by the remaining vaccine HPV types.

• Gardasil® does not protect against infection or disease caused by every HPV type.
• Gardasil® will not treat HPV infection or disease present prior to vaccination.
• Vaccination with Gardasil® does not eliminate the necessity for women to continue to undergo recommended cervical cancer screening.

After three doses of Gardasil® men aged 16 through 26 years, and naive to infection with HPV types 6, 11, 16 and 18 at the commencement of vaccination, 85.6% were protected from persistent infection from the four HPV types (type 6 88%, type 11 93.4%, type 16 78.7% and type 18 96%). In the same group of males 90.4% of males were protected from external genital lesions, including condyloma and penile/perineal/perianal intraepithelial neoplasia (PIN), caused by HPV types 6, 11, 16 or 18.

When the vaccine course has been interrupted it may be resumed without repeating prior doses. Resume the standard schedule for the remaining doses.

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

Administration of Gardasil® 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.

The vaccine can be given to breastfeeding women without risk for the infant or mother.