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GlaxoSmithKline (GSK) has announced that the European Commission has granted marketing authorisation for its cervical cancer vaccine Cervarix® [Human papillomavirus bivalent (types 16 and 18) vaccine, recombinant] as a two-dose schedule for girls aged 9 to 14. This is the first time a cervical cancer vaccine has been approved as a reduced dosing schedule and signifies potential for greater vaccination coverage rates and improved cervical cancer protection worldwide.
"GSK is delighted to receive approval for Cervarix as a 2-dose schedule. This new dosing schedule can make vaccination easier to implement and more affordable, which in turn creates the potential for higher vaccination coverage and more girls being protected against cervical cancer." said Thomas Breuer, Senior Vice-President and Lead Physician, GSK Vaccines.
Worldwide, cervical cancer claims an average of one life every two minutes with an estimated 275,000 deaths from the disease each year.1 Virtually all cases of cervical cancer are caused by a virus called human papillomavirus (HPV).2 There are more than 100 known types of HPV, 3 of which at least fifteen can cause cervical cancer.4 HPV 16 and 18 are the most common cancer-causing virus types and account for approximately 70% of all cer! vical cancer cases globally.5 Up to 80% of women worldwide will acquire an HPV infection in their lifetime and almost 40% of these infections will be with a cancer-causing virus type.2,6,7
The EU approval of Cervarix as a 2-dose schedule is based on the results of two clinical studies HPV 048 and HPV 070 which assessed both the immunogenicity and the safety of two doses of Cervarix.8,9 The findings from these two studies were consistent and demonstrated that two doses of Cervarix in 9 to 14 year old girls is comparable to three doses in 15 to 25 year old girls and women.8,9 This data looked not only at vaccine types 16 and 18 but also at non-vaccine types 31 and 45. In study HPV-048, these results were sustained for a total of four years.8,9
The vaccine is already approved in the EU for use in females from the age of 9 years, administered according to a three-dose schedule (vaccination at months 0,1 and 6) for the prevention of premalignant genital (cervical, vulvar and vaginal) lesions and cervical cancer causally related to certain oncogenic Human Papillomavirus (HPV) types. The two-dose schedule (0, 6 months) will apply to vaccination of girls aged 9-14. The three-dose schedule remains in the label for girls and women aged 15 years and above.
Outside of the EU, Cervarix two-dose schedule in girls aged 9-14 years is already approved in twelve countries (including Panama, Guatemala, Honduras, El Salvador, Haiti, Suriname, Chile, Guyana, Nigeria, Ghana, Pakistan and Bangladesh).
Cervarix is also approved in the US. For the full US Prescribing Information and EU Patient Information Leaflet, which includes information on the approved use of Cervarix™, please visit http://www.gsk.com/products.html.
1. GLOBOCAN 2008. Cervical Cancer Incidence and Mortality Worldwide in 2008 Summary. [Last accessed: December 2013]
2. Bosch FX, de Sanjose S. Chapter 1: Human papillomavirus and cervical cancer - burden and assessment of causality. Journal of the National Cancer Institute Monographs. 2003; 3-13
3. World Health Organization. Expert Committee on Biological Standardization. Guidelines to assure the quality, safety and efficacy of recombinant Human Papillomavirus virus-like particle vaccines. Available at: http://screening.iarc.fr/doc/WHO_vaccine_guidelines_2006.pdf [Last accessed: December 2013]
4. Muñoz N, Bosch FX, de Sanjose S, et al. Epidemiologic classification of human papillomavirus types associated with cervical cancer. N Engl J Med 2003; 348: 518-527
5. De Sanjose S et al. Human papillomavirus genotype attribution in invasive cervical cancer: a retrospective cross-sectional worldwide study. The Lancet Oncology. 2010. 11:1048-1056
6. Brown DR, Shew ML, Qadadri B et al. A longitudinal study of genital human papillomavirus infection in a cohort of closely followed adolescent women. Journal of Infectious Diseases. 2005; 191: 182-192
7. Gravitt PE, Jamshidi R. Diagnosis and management of oncogenic cervical human papillomavirus infection. Infectious Disease Clinics of North America. 2005;19:439-458
8. Puthanakit T, Schwartz T, Esposito S. Immune responses to a 2-dose schedule of the hpv-16/18 as04-adjuvanted vaccine in girls (9-14) versus 3 doses in women (15-25): a randomised trial. EUROGIN 2013. Available at: http://www.eurogin.com/2013/images/pdf/EUROGIN-2013-Abstracts-Part-2.pdf [Last accessed: December 2013]
9. Romanowski B, Schwartz T, Ferguson L. Immune response to the HPV-16/18 AS04-adjuvanted vaccine administered as a 2-dose or 3-dose schedule up to 4 years after vaccination. EUROGIN 2013. Available at: http://www.eurogin.com/2013/images/pdf/EUROGIN-2013-Abstracts-Part-2.pdf [Last accessed: December 2013]
10. Summary of Product Characteristics. Cervarix™. GlaxoSmithKline. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/000721/WC500024634.pdf [Last accessed: December 2013]
11. GSK Data on file 2013
12. GSK Data on file 2013
Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
Visit our Cervical Cancer / HPV Vaccine category page for the latest news on this subject.
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9 Mar. 2014. <http://www.medicalnewstoday.com/releases/270597>
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