Gardasil® now approved for women up to 45 years
The Therapeutic Goods Administration (TGA) has approved the use of Gardasil for women up to 45 years. This was based on efficacy data from a clinical study involving approximately 3,800 women.
Gardasil (Quadrivalent Human Papillomavirus [HPV] (Types 6, 11, 16, 18) Recombinant Vaccine) is now indicated in females aged 9 to 45 years for the prevention of cervical, vulvar, and vaginal cancer, pre-cancers, genital warts and infection caused by HPV types 6, 11, 16, and 18.
Gardasil works by causing the body to produce its own protection against HPV types 6,11,16 and 18. HPV types 16 and 18 cause up to 80% of cervical cancer cases as well as a significant proportion of cervical abnormalities.
HPV types 6 and 11 account for ~10% of low grade cervical abnormalities and over 90% of genital warts cases.
Associate Professor Jim Nicklin, Director of Gynaecologic Oncology, Royal Brisbane and Womens Hospital, said “Women remain at risk of acquiring HPV infection and developing HPV related disease throughout their lifetime.
The psychological burden of HPV disease is extensive, with investigations and treatments causing a great deal of anxiety for women.”
Vaccination is a primary prevention initiative and together with cervical screening offers women a prevention strategy against both cervical cancer and
pre-cancers.
Whilst Australia has one of the world’s most successful cervical screening programs, each year approximately 14,500 Australian women undergo surgical treatment for high grade cervical abnormalities.
Eighty percent of these high grade cervical abnormalities occur in women under the age of forty years.
Procedures to remove high grade abnormalities can have adverse effects on the ability to carry a child to term.
In the clinical study, Gardasil was generally well tolerated. The most common side effects were redness, swelling or pain at the injection site.
For women aged up to 45 years, Gardasil is available as a private prescription from their GP. A course of Gardasil consists of three doses given
over six months.
Dr Wendy Bissinger, Immunisation GP Advisor, states that “For women, the decision to vaccinate is an individual one, and most importantly, all women should continue with regular Pap smears.”
Women should talk to their GP for more information about Gardasil.
