A letter to healthcare professionals has announced the launch of Human Papillomavirus Vaccine (Gardasil®).
The vaccine is licensed for use in the prevention of high-grade cervical dysplasia (CIN 2/3), cervical carcinoma, high-grade vulvar dysplastic lesions (VIN 2/3) and external genital warts causally related to human papillomavirus types 6, 11, 16 and 18.
Based upon data from efficacy trials use is recommended only in adult females aged 16 to 26 years. Additionally, immunogenicity trials have been conducted successfully in 9 to 15 year old females.
Additionally, the product license states that the vaccine should only be used in accordance with official recommendations. According to the BBC, the Department of Health has requested expert advice from the Joint Committee on Vaccination and Immunisation (JCVI) on the "on the efficacy, safety and benefits that these new vaccines may offer".
Action: Clinicians should be aware of this new vaccine as patients may request more information. The product should not be prescribed on the NHS until the JCVI provide official recommendations regarding appropriate use.