Second human papillomavirus vaccine (Cervarix) included on the National Immunisation Program
Published in NPS RADAR
Date published: About this date
A second human papillomavirus (HPV) vaccine (Cervarix) has been accepted for use through the National HPV Vaccination Program. This Program allows free vaccination for girls aged 12 and 13 years, with a catch-up program for all females aged 13–26 years* through the National Immunisation Program (NIP) due to finish at the end of June 2009.1 Individual State or Territory Health Departments will decide which of the 2 approved HPV vaccines (Gardasil or Cervarix) to supply in the future.
Cervarix is a bivalent HPV vaccine that protects against infection with HPV types 16 and 18. These 2 types are responsible for 70% to 80% of cervical cancers and around 45% of high-grade cervical lesions in Australia.2,3
The Pharmaceutical Benefits Advisory Committee (PBAC) recommended listing Cervarix on the NIP on the basis of acceptable cost-effectiveness compared with Gardasil.4 The PBAC accepted that both vaccines provide similarly high levels of protection against persistent infection with HPV-16 and HPV-18 and related precancerous cervical lesions.
In clinical trials, Cervarix was highly effective (> 90%) in preventing infection with HPV-16 or HPV-18 in previously uninfected females, and in preventing cervical dysplasia caused by these subtypes.5–7 High levels of protection against infection were maintained in fully vaccinated females for up to 4.5 years after the first vaccine dose was administered.6
There is some evidence that Cervarix provides cross-protection against infection with other oncogenic HPV types not included in the vaccine.7 Unlike the quadrivalent HPV vaccine Gardasil (see NPS RADAR review), Cervarix does not protect against HPV-6 and HPV-11, which cause most cases of genital warts8, and it is not approved for use in males.9
A full course of vaccination consists of 3 doses (0, 1 and 6 months) administered intramuscularly into the deltoid region.9 Local injection-site symptoms (pain, redness, or swelling) are very common. These and other systemic symptoms (fatigue, headache, or myalgia) were more commonly reported with Cervarix in the 7-day post-vaccination period than with placebo.9
HPV vaccines do not protect against all oncogenic HPV types. Advise all females who have ever been sexually active, whether vaccinated or unvaccinated, to have regular Pap smears from the age of 18 years, or within two years of first intercourse, whichever is later.1
* Cervarix is TGA approved in females aged 10–45 years for the prevention of cervical cancer.9
- Australian Government Department of Health and Aging. National Human Papillomavirus (HPV) Vaccination Program Immunisation Provider Guidelines 2007. http://www.health.gov.au/
internet/ standby/ publishing.nsf/ Content/ BAB4FACE8645C02FCA2572990016D0F2/ $File/ gp-booklet.pdf
- Stevens M, Tabrizi S, Quinn M, et al. Human papillomavirus genotype prevalence in cervical biopsies from women diagnosed with cervical intraepithelial neoplasia or cervical cancer in Melbourne, Australia. Int J Gynecol Cancer 2006;16:1017–24. [PubMed]
- Brestovac B, Harnett G, Smith D, et al. Human papillomavirus genotypes and their association with cervical neoplasia in a cohort of Western Australian women. J Med Virol 2005;76:106–10. [PubMed]
- Australian Government Department of Health and Aging. November 2007 PBAC Outcomes — Positive Recommendations. 2007. http://www.health.gov.au/internet/main/publishing.nsf/Content/A008C4F78F359BF2CA2573A800032DBF/$File/11-07%20PBAC%20positive%20decisions%20for%20website.pdf
- Harper D, Franco E, Wheeler C, et al. Efficacy of a bivalent L1 virus-like particle vaccine in prevention of infection with human papillomavirus types 16 and 18 in young women: a randomised controlled trial. Lancet 2004;364:1757–65. [PubMed]
- Harper D, Franco E, Wheeler C, et al. Sustained efficacy up to 4.5 years of a bivalent L1 virus-like particle vaccine against human papillomavirus types 16 and 18: follow-up from a randomised control trial. Lancet 2006;367:1247–55. [PubMed]
- Paavonen J, Jenkins D, Bosch F, et al. Efficacy of a prophylactic adjuvanted bivalent L1 virus-like-particle vaccine against infection with human papillomavirus types 16 and 18 in young women: an interim analysis of a phase III double-blind, randomised controlled trial. Lancet 2007;369:2161–70. [PubMed]
- Brown DR, Schroeder JM, Bryan JT, et al. Detection of multiple human papillomavirus types in Condylomata acuminata lesions from otherwise healthy and immunosuppressed patients. J Clin Microbiol 1999;37:3316–22. [PubMed]
- GlaxoSmithKline Pty Ltd. Cervarix product information. 16 May 2007.