The Four-type HPV Vaccine Gardasil(R) Demonstrates Real Life Benefits

Main Category: Cervical Cancer / HPV Vaccine
Article Date: 11 May 2009 - 5:00 PDT

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Results from an observational study in Australia establish that after only one year of a comprehensive vaccination programme with the four-type (6,11,16,18) human papillomavirus (HPV) Gardasil® major benefits are already being seen. The study results will be presented at the 25th International Papillomavirus Conference (IPV) in Malmö, Sweden.

The study compared the proportion of new genital warts diagnoses in the total number of diagnoses of sexually transmitted diseases at the Melbourne Sexual Health Centre before and after the introduction of vaccination with Gardasil® and documents a 48% decline in this proportion only one year after vaccination (in women younger than 28 years).1

"Our data suggest that a relatively rapid and marked reduction in the population prevalence of genital warts among vaccinated women may be achievable through an HPV vaccination program targeting women. Our data also supports some potential benefit being conferred to men. They seem to confirm the hypothesis that the vaccination of women reduces the transmission of the virus to men", says Professor Christopher Fairley at the University of Melbourne, Australia.

Australia has distributed Gardasil® since April 2007 to school girls between 12 and 18 years and since July 2007 to women less than 26 years of age outside of the school based programme. The coverage rate in the region where the study took place is between 65% and 75%.

"The reduction in genital warts diagnoses is already an important benefit in itself for both women and health authorities investing in HPV vaccination programmes with Gardasil®. In addition, it is a significant marker of the whole range of benefits that a vaccination programme with Gardasil® is expected to provide, including reduced cervical cancer and cervical, vulval and vaginal pre-cancers," says Bennett Lee, Director Medical Affairs for Gardasil® at Sanofi Pasteur MSD.

Gardasil® is the only four-type (6,11,16,18) HPV vaccine. In addition to sustained cervical cancer protection, Gardasil® can protect against cervical, vulval and vaginal pre-cancers, and against genital warts caused by HPV-types 6, 11, 16 and 18. These four types together cause the vast majority of HPV-related genital diseases.2,3,4

Gardasil® is now approved in 109 countries and 44 million doses have been distributed worldwide (by the end of March 2009). HPV vaccination is now recommended in 18 of the 19 European countries in which Sanofi Pasteur MSD markets Gardasil®, and is funded or due to be funded soon in 16 of them*.

HPV vaccination is also recommended and funded in the US, Australia, New Zealand and Canada.

Details about the study

This was a retrospective study comparing the proportion of new clients with genital warts at Melbourne Sexual Health Centre (MSHC) from January 2004 to December 2008. 36.055 patients attended MSHC between 2004 and 2008 and genital warts were diagnosed in 3.826 (10.6%). Clinical prevalence ratios and 95% confidence intervals were calculated for the proportion of new clients with genital warts and stratified by gender, age and risk group for the years 2004-2007 combined compared to 2008.

Gardasil® has demonstrated a good safety profile

Almost three years after the first launch and with 44 million doses distributed worldwide (by the end of March 2009) health care professional have extensive experience with the administration of Gardasil®. Authorities around the world† have confirmed the good safety profile of Gardasil®5,6 ,7,8 ,9,10. In January 2009, the Global Advisory Committee for Vaccine Safety (GACVS) of the World Health Organisation (WHO) stated: The safety profile is similar to that described in the clinical trials before its licensing. There is no evidence of new side effects not previously detected, in relation with the use of this vaccine.11 Large clinical studies that lasted a decade and included more than 25,000 women in 33 countries have not revealed an increased risk of serious adverse events compared to placebo12 13 14. In clinical trials the most often reported adverse events were injection site reactions and fever.

Indication of Gardasil®

Gardasil® is a vaccine for the prevention of premalignant genital lesions (cervical, vulvar and vaginal), cervical cancer and external genital warts (condyloma acuminata) causally related to Human Papillomavirus (HPV) types 6, 11, 16 and 18. The indication is based on the demonstration of efficacy of Gardasil® in adult females 16 to 26 years of age and on the demonstration of immunogenicity of Gardasil® in 9- to 15-year old children and adolescents. Protective efficacy has not been evaluated in males. The use of Gardasil® should be in accordance with official recommendations.

About Sanofi Pasteur MSD

Sanofi Pasteur MSD is a joint venture between sanofi pasteur, the vaccine division of sanofi-aventis, and Merck & Co., Inc. Combining innovation and expertise, Sanofi Pasteur MSD is the only company in Europe dedicated exclusively to vaccines. Sanofi Pasteur MSD is able to draw on the research expertise of sanofi pasteur and Merck & Co., Inc., together with their teams throughout the world, to focus on the development of new vaccines for Europe, which aim to extend protection to other diseases and perfect existing vaccines in order to improve the acceptability, efficacy and tolerability of vaccination.

* Austria, Belgium, Denmark, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxemburg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, United Kingdom; only Finland has not yet recommended HPV vaccination; only Austria, Ireland and Finland have not yet decided on funding.

† including the U.S. CDC and Food and Drug Administration (FDA), the European Medicines Agency (EMEA), the Australian Therapeutic Goods Administration (TGA), the French Agency for Sanitary Security of Health Products (AFSSAPS), the German Government and the Swiss regulatory agency (Swissmedic)

References

1. Fairley K Decline in presentations of genital warts one year after implementation of a quadrivalent Human Papillomavirus vaccination program in young women.

2. Smith JS et al. Human papillomavirus type distribution in invasive cervical cancer and highgrade cervical lesions: A meta-analysis update. Int J Cancer 2007; 121:621-632

3. Gardasil®, Summary of Product Characteristics 2009,

4. Gardasil®, European Product Assessment Report (EPAR), Scientific Discussion, http://www.emea.europa.eu/humandocs/PDFs/EPAR/gardasil/070306en6.pdf (Last accessed may 5th 2009)

5. http://www.cdc.gov/vaccinesafety/vaers/FDA_and_CDC_Statement.htm (Last accessed may 5th 2009)

6. http://www.emea.europa.eu/humandocs/PDFs/EPAR/gardasil/Gardasil_press_release.pdf (Last accessed may 5th 2009)

7. http://www.tga.gov.au/alerts/medicines/gardasil.htm (Last accessed may 5th 2009)

8. http://www.afssaps.fr/Infos-de-securite/Communiques-de-presse/Gardasil-R-premier-bilan-de-la-surveillance-des-risques-en-France/(language)/fre-FR (Last accessed may 5th 2009)

9. http://www.bundestag.de/aktuell/hib/2008/2008_173/11.html (Last accessed may 5th 2009)

10. http://www.swissmedic.ch/aktuell/00003/00559/index.html?lang=de (Last accessed may 5th 2009)

11. WHO Weekly epidemiological record, No 5,2009,84,37-40 http://www.who.int/wer/2009/wer8405.pdf (Last accessed may 5th 2009)

12. The Future II Study Group. N Engl J Med 2007; 356: 1928-43

13. Garland et al, The Future I Investigators. N Engl J Med 2007; 356: 1928-43

14. Barr E, Tamms G. Quadrivalent Human Papillomavirus Vaccine. Clinical Infectious Diseases 2007; 45:609-17

Source
Sanofi Pasteur MSD