Gardasil® Applies For WHO Certification To Reinforce Global Access To The Vaccine - Approval Would Qualify Gardasil® For Procurement By United

Main Category: Cervical Cancer / HPV Vaccine
Also Included In: Sexual Health / STDs;  Women's Health / Gynecology;  Immune System / Vaccines
Article Date: 18 Jul 2007 - 1:00 PDT

email to a friend   printer friendly   opinions  

Sanofi Pasteur MSD's parent company, Merck & Co., Inc., has submitted an application to seek World Health Organisation (WHO) certification for the human papillomavirus vaccine Gardasil® as part of the commitment to make this vaccine available in the developing world. The application has been accepted by WHO and is being reviewed.

This certification, called "WHO prequalification", verifies that vaccines meet the qualifications of quality, safety and efficacy for procurement by United Nations (UN) agencies, including UNICEF* and PAHO†, and is an important step towards providing global access to vaccines.

"Merck is pursuing a systematic, thoughtful approach to the global introduction of Gardasil®: partnering with WHO, GAVI‡ and other international organisations, conducting global clinical trials and committing to making Gardasil® available at dramatically lower prices in GAVI-eligible countries§," said Margaret G. McGlynn, president of Merck Vaccines.

Gardasil® is the only vaccine that targets the four human papillomavirus types 6, 11, 16 and 18, which together cause the vast majority of genital human papillomavirus diseases1,2,3,4,5,6,7,8,9 including 70-75% of cervical cancer10.

In clinical studies, including more than 20,000 women, Gardasil® showed sustained prevention compared to placebo of up to 100% of pre-cancerous and potentially pre-cancerous cervical lesions, pre-cancerous vulvar and vaginal lesions and genital warts due to human papillomavirus virus types 6, 11, 16 and 18.11,12,13,14

Gardasil® provides wider and earlier benefit than the prevention of cervical cancer alone. Wider benefit because it also helps prevent cervical lesions, vulvar lesions and genital warts. Earlier benefit because significant proportions of these lesions, in particular early cervical lesions and genital warts, occur much faster than cervical cancer, often within just some months after exposure to the virus.

The vaccine has been approved in almost 80 countries, including the European Union (EU), the US, Canada, Australia and many countries in Africa and Asia and has met with broad acceptance. Approval was often granted under accelerated review times, for example in the US after a fast track review of six months, in the EU after nine months compared to a usual review time of 13 to 15 months. Additional applications are currently under review with regulatory agencies in many more countries around the world.

Global access: a continuous process

Merck is actively working to accelerate the availability of Gardasil® in the developing world. Clinical trials for its development have already included participants from 33 countries on five continents in a variety of settings. Clinical studies in developing world countries are being initiated to assess the efficacy of Gardasil® in other environments. Merck will provide Gardasil® and technical support to the international non-profit organisation PATH** to support demonstration studies designed to accelerate the availability of human papillomavirus vaccines in the most impoverished countries. Clinical trials with PATH are under way in India, Peru and Vietnam. Merck is working with India's Council of Medical Research to study Gardasil® in India.

RotaTeq®, Sanofi Pasteur MSD's rotavirus vaccine, has also applied for WHO prequalification status. It is the only five-type rotavirus vaccine offering direct and broad protection against the five predominant disease-causing rotaviruses in the world.15,16

Gardasil® and RotaTeq® have been developed by Merck & Co., Inc. and Sanofi Pasteur MSD. In Europe, the vaccines are marketed by Sanofi Pasteur MSD.

The burden of cervical cancer and other human papillomavirus genital diseases

Worldwide, cervical cancer is the second-most common cancer affecting women17 and the second-leading cause of cancer death in women18.Globally, approximately 500,000 women are diagnosed each year and almost 300,000 die from the disease18. The prevalence of cervical cancer is estimated to be 1.4 million cases worldwide.19

In addition, hundreds of thousands of women are diagnosed with other human papillomavirus genital diseases that start before cervical cancer and go beyond the cervix. These diseases include pre-cancerous and potentially pre-cancerous cervical lesions3,20, vulvar cancer1,2,21, pre-cancerous vulvar and vaginal lesions6,7,22,23, and genital warts24.

More about Gardasil®

According to the licence in the EU, Gardasil®, Human Papillomavirus Vaccine [Types 6,11,16,18] (Recombinant, adsorbed), can be given to children and adolescents 9 to 15 years and adult females 16 to 26 years of age and is indicated for the prevention of cervical carcinoma (cervical cancer), high grade cervical dysplasia (precancerous cervical lesions), high grade vulvar dysplastic lesions (precancerous vulvar lesions) and external genital warts (condyloma acuminata) caused by human papillomavirus types 6, 11, 16 and 18. http://www.gardasil.com

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. http://www.spmsd.com

* UNICEF: The United Nations Children's Fund
† PAHO: Pan American Health Organization
‡ GAVI: The Global Alliance for Vaccines and Immunization
§ GAVI eligible countries: the 75 poorest countries
** PATH: Program for Appropriate Technology in Health

References

1 Daling JR, Madeleine MM, Schwartz SM et al. A population-based study of squamous cell vaginal cancer: HPV and cofactors. Gynecol Oncol 2002;84:263-270.

2 Madeleine MM, Daling JR, Carter JJ et al. Cofactors with Human Papillomavirus in a population-based study of vulvar cancer. J Natl Cancer Inst 1997;89:1516-1523.

3 Clifford GM, Smith JS, Aguado T et al. Comparison of HPV type distribution in high-grade cervical lesions and cervical cancer: A meta-analysis. Br J Cancer 2003;89101-105.

4 Sotlar K, Diemer D, Dethleffs A et al. Detection and typing of Human Papillomavirus by E6 nested multiplex PCR. J Clin Microbiol 2004;42:3176-3184.

5 Clifford GM, Rana RK, Franceschi S et al. Human Papillomavirus genotype distribution in low-grade cervical lesions: Comparison by geographic region and with cervical cancer. Cancer Epidemiol Biomarkers Prev 2005;14:1157-1164.

6 Van Beurden M, ten Kate FJW, Smits HL et al. Multifocal intraepithelial neoplasia grade III and multicentric lower genital tract neoplasia is associated with transcriptionally active Human Papillomavirus. Cancer 1995;75:2879-2884.

7 Hording U, Junge J, Poulson H et al. Vulvar intraepithelial neoplasia III: A viral disease of undetermined progressive potential. Gynecol Oncol 1995;56:276-279.

8 Wieland U, Pfister H. papillomaviruses in human pathology: Epidemiology, pathogenesis and oncologic role.In:Gross,Barasso EDS.Human Papillomavirus Infection:A clinical atlas.Ullstein Mosby1997;p1-18.

9 Von Krogh G. Management of anogenital warts (condylomata acuminata). Eur J Dermatol 2001;11:598-603

10 Clifford GM, Smith JS, Plummer M et al. Human Papillomavirus types in invasive cervical cancer worldwide: A meta-analysis. Br J Cancer 2003;88:63-73.

11 Garland SM et al. Quadrivalent Vaccine against Human Papillomavirus to Prevent Anogenital Diseases. NEnglJMed 2007:356;19;1928-1943.

12 The FUTURE II study group. Quadrivalent Vaccine against Human Papillomavirus to Prevent High-Grade Cervical Lesions. NEnglJMed 2007:356;19;1915-1927.

13 Iversen OE et al. High Sustained efficacy of a Prophylactic Quadrivalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine: Reduction in Cervical Intraepithelial Neoplasia (CIN) 2/3 and Adenocarcinoma in situ (AIS) Risk, 5th International Conference on Cervical Cancer (ICCC) in Venice, oral presentation, 13th April 2007

14 Joura EA et al. High sustained efficacy of a quadrivalent HPV (types 6/11/16/18) L1 virus-like particle (VLP) vaccine against vaginal and vulvar pre-cancerous lesions: a combined analysis, Oral presentation and abstract, 18th International Congress on Anti Cancer Treatment, Paris, France, 7th February 2007.

15 Santos N and Hoshino Y. Global distribution of rotavirus serotypes/genotypes and its implication for the development and implementation of an effective rotavirus vaccine. Rev Med Virol 2005;15:29-56.

16 Van Damme.P et al., Distribution of Rotavirus Genotypes in Europe, 2004-2005: The REVEAL Study, J. Infect. Dis. 2007, 195[Suppl 1], S17-S25.

17 Bosch FX, de Sanjose S. Chapter 1: Human Papillomavirus and Cervical Cancer-Burden and Assessment of Causality. J Natl Cancer Inst Monogr. 2003;31:3-13.

18 World Health Organization. State of the art new vaccines research and development: Initiative for Vaccine Research. Geneva, Switzerland: World Health Organization; 2003:1-74.

19 Jansen KU, Shaw AR. Human Papillomavirus Vaccines and Prevention of Cervical Cancer, Annu Rev Med 2004;55:319-331.

20 Insinga RP, Glass AG and Rush BB. Diagnoses and outcomes in cervical cancer screening: A population-based study. Am J Obstet Gynecol 2004;191:105-113.

21 Parkin DM, Whelan SL, Ferlay J et al. Cancer incidence in five continents (GIS). Volume VIII. p606-611.

22 Dodge JA, Eltabbakh GH, Mount SL et al. Clinical features and risk of recurrence among patients with vaginal intraepithelial neoplasia. Gynecol Oncol 2001;83:363-369.

23 Jones RW. Vulval intraepithelial neoplasia: Current perspectives. Eur J Gynaecol Oncol 2001;22:393-402.

24 UK Health Protection Agency. CDR Weekly 2003;3(44)

• Additional
• References
• Citations