THE JUNCTION HOT TOPICS

GARDASIL

HPV VACCINE

There are more than 40 types of human papillomavirus (HPV) and 15 of these have been proven to cause cervical cancer.  HPV types 16 & 18 account for 70% of cervical cancers and 50% of high grade cervical intraepithelial neoplasias (CIN 2 & CIN 3).  HPV types 6 & 11 are two of the lower risk types for causing abnormal paps but cause 90% of genital warts.

WHAT IS GARDASIL?

Gardasil is a vaccine that protects against disease caused by HPV types 6, 11, 16 & 18.

WHO SHOULD BE VACCINATED?

Gardasil is approved in Australia for females aged 9 to 26 years (and it is also indicated for males aged 9 to 15 years).

HOW IS IT ADMINISTERED?

Gardasil is administered intramuscularly as three separate doses.  According to the recommended dosing schedule, the second and third doses should be given two and six months after the initial dose.  Patients are encouraged to adhere to this schedule, but some flexibility is acceptable.  When it is necessary to use a different schedule, the second dose should be administered at least one month after the first and the third dose should be administered at least three months after the second.

SHOULD SEXUALLY ACTIVE WOMEN BE VACCINATED?

Although HPV is contracted through sexual contact, being sexually active does not always mean that a woman has been infected with the vaccine HPV types.  Therefore, prior sexual activity should not preclude vaccination.

WILL VACCINATION ELIMINATE THE NEED FOR PAP TESTING?

Vaccination with Gardasil offers protection against the high risk HPV types responsible for approximately 70% of cervical cancers.  However, at least 13 other genotypes are responsible for the remaining 30% of cases.  Also, some women who receive the vaccine will already be infected with one or more of the vaccine types.  The natural history of these already established infections will not be altered by administration of the vaccine.  All women must continue to have regular pap smears even after vaccination.

WHAT ARE THE COMMON SIDE EFFECTS?

Gardasil is generally well tolerated.  Reported side effects include injection site reactions such as pain and swelling and redness, although these were mostly mild to moderate in intensity.  Fever has also been reported.

As with any injectable vaccine, appropriate medical treatment should be available in case of rare anaphylactic reactions.

Gardasil may be administered at the same time (but at a different site) as Hepatitis B vaccine.

The vaccine may be given to lactating women, but women found to be pregnant before the completion of the 3 dose regime, should delay further injections until after the birth.

HOW EFFECTIVE IS GARDASIL?

Worldwide studies of Gardasil efficacy have involved approximately 20,000 women aged 16 to 26.  Vaccination with Gardasil was shown to prevent 100% of high grade cervical pre-cancers and non-invasive cancers associated with HPV types 16 and 18.  Gardasil also prevented 99% of external genital lesions (warts, vulvar intraepithelial neoplasia and vaginal intraepithelial neoplasia) related to the vaccine HPV types.

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(Last updated; June 2007)