Norway Chooses The Four-Type HPV Vaccine Gardasil(R) For The National Vaccination Programme

Main Category: Cervical Cancer / HPV Vaccine
Article Date: 02 Jun 2009 - 4:00 PDT

email to a friend   printer friendly   view / write opinions   rate article

The four-type (6,11,16,18) human papillomavirus (HPV) vaccine, Gardasil®, has been chosen by the Norwegian authorities for the national vaccination programme after the assessment of a variety of criteria, including efficacy in the prevention of cervical cancer, safety and evidence of long-lasting protection. All available data was considered, including new data presented during the 25th International Papillomavirus Conference (IPC) in May in Malmö, Sweden.

"We are very gratified to have been chosen to provide the world's leading HPV vaccine to the national vaccination programme in Norway. The choice made by the Norwegian authorities is a testament to the unique benefits provided by four-type HPV vaccination", says Didier Hoch, president of Sanofi Pasteur MSD.

Gardasil® is the only four-type (6,11,16,18) HPV vaccine. In addition to unsurpassed and sustained cervical cancer protection, Gardasil® can protect from cervical, vulvar and vaginal pre-cancer, and from genital warts caused by HPV types 6, 11, 16 and 18. These four types together cause the vast majority of HPV-related genital diseases.1,2,3

New data from Australia presented at IPC demonstrated a strong early impact of four-type HPV vaccination. Only one year after comprehensive vaccination of school girls and young women the diagnosis of genital warts dropped considerably.4 This is an important early benefit in itself and a significant marker of the whole range of benefits that four-type HPV vaccination is expected to provide in the long run.

All available clinical data suggest that Gardasil® will provide long-term protection. The vaccine has demonstrated to induce immune memory which experts consider a hall mark of long-term protection.*,5 New study results, also presented at IPC, further support this evidence by documenting sustained clinical efficacy up to 9,5 years for the one-type (16) HPV "Proof of Principle" (phase II) vaccine for Gardasil®.6

44 million doses of Gardasil® have been distributed worldwide+ and three years after the first launch health care professionals around the world have robust experience with the vaccine. Nine out of ten physicians in Western Europe choose Gardasil® when given a choice in prescribing HPV vaccination.7

Current EU 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 (see section 5.1). 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 (see section 5.1). 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.

* After vaccination the immune system has memorised the virus types targeted by the vaccine regardless of blood antibody levels and if the body reencounters these virus types it is capable to rapidly mount an immune response and should therefore prevent future disease caused by these virus types.
+ By the end of March 2009

References

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

2. Gardasil®, Summary of Product Characteristics 2009,

3. Gardasil®, European Product Assessment Report (EPAR), Scientific Discussion, http://www.emea.europa.eu/humandocs/PDFs/ EPAR/gardasil/070306en6.pdf (Last accessed 25th May 2009)

4. Australia has distributed Gardasil® since April 2007 free of charge to school girls between 12 and 18 years. Since July 2007 Gardasil® has been available reimbursed to women less than 26 years of age outside of the school based programme. The total coverage rate in the region where the study took place in these target groups is between 65 % and 75 %. Fairley K Decline in presentations of genital warts one year after implementation of a quadrivalent Human Papillomavirus vaccination program in young women. The 25th International Pappilomavirus Conference May 8-14 2009, Malmö, Sweden

5. Olsson SE et al. Induction of immune memory following administration of a prophylactic quadrivalent human papillomavirus (HPV) types 6/11/16/18 L1 virus-like particle (VLP) vaccine. Vaccine 2007; 25:4931-4939

6. Rowhani-Rahbar, A et al. Long-term efficacy of a prophylactic human papillomavirus type 16 vaccine. 25th International Papillomavirus Conference, May 8-14, Malmö, Sweden

7. Implied from 92.2% market share for Gardasil® in prescription markets in Western Europe (in value, year to date at end March 2009), MIDAS-IMS Health

Source
Sanofi Pasteur MSD