In its advice to the Danish Government, the Danish National Board of Health (NBH) specifically recommends using a vaccine that "also protects against condyloma" (genital warts) in addition to cervical cancer.
Last month the UK's Health Protection Agency published a modelling study showing that Gardasil® (Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed)) would prevent up to 70% of cervical cancer cases and 95% of cases of genital warts, stating that this model "should contribute to effective policies to prevent genital warts and cervical cancer."1
In Denmark, the NBH recommends that human papillomavirus (HPV) vaccination is offered to all girls around the age of 12 as part of the Danish Childhood Vaccination Programme. This is supplemented with a two-year catch-up programme targeted at girls of the age of 13, 14 and 15, who did not receive the vaccination at the age of 12. Screening of women will continue and NBH recommendations for the screening programme will be respected.2
"We are pleased that the Danish authorities recommend vaccination against cervical cancer and genital warts," says Didier Hoch, president of Sanofi Pasteur MSD. "We see an increasing interest from health authorities in widening and accelerating the benefits of cervical cancer vaccination through additional targeting of other human papillomavirus-related genital diseases."
Sanofi Pasteur MSD also welcomes the inclusion of free HPV vaccination in the vaccination calendar of the National Health System in Spain.
The Spanish recommendation targets a cohort of pre-adolescent girls between 11 and 14 years of age. The Inter-Territorial Board unanimously approved the recommendation made by the Public Health Commission of the national health system on 26 September 2007. Human papillomavirus vaccination will be included in the national vaccination calendar and implemented along with continued screening for early detection and education.3
Numerous other countries* have already recognised the benefits of preventing other HPV- related genital diseases.4,5,6,7,8,9,10,11,12
For instance, France recommends the prevention of genital warts in addition to cervical cancer. Belgium emphasises that the link between HPV and other anogenital tumours [such as vulvar and vaginal cancers] and genital warts is well established.
Australia currently reimburses only the cervical cancer vaccine Gardasil® within the vaccination programme for school girls because of its additional benefit to prevent genital warts.
The four-type (6, 11, 16, 18) cervical cancer vaccine Gardasil® provides wide-ranging and early benefits in addition to the prevention of cervical cancer due to human papillomavirus types 16 and 18. Wide-ranging benefits because it also helps prevent early cervical lesions, vulvar pre- cancerous lesions and genital warts due to types 6,11,16 and 18; early benefits because early cervical lesions and genital warts occur much faster than cervical cancer, often within a few months after exposure to the virus.
Sanofi Pasteur MSD has recently filed with the European Medicines Agency (EMEA) for an extension of the marketing authorisation for Gardasil® to include the prevention of vaginal cancers due to HPV types 16 and 18.
Since its first approval in 2006, Gardasil® has been approved in 85 countries worldwide and launched in 70 of them and has met with rapid adoption (more than 10 million doses distributed).
The German health authorities recommend the universal vaccination of girls aged 12 to 17 years, adding that girls and women who have not received vaccination during the recommended age period can still benefit from vaccination. Since December 2006, several German health insurance funds, together covering around 65% of the population, fully reimburse human papillomavirus vaccination. The remaining health insurance funds continue to follow this trend.
In Italy, the health authorities have recommended universal and free vaccination of 12-year- old girls. Vaccination in the first vaccination centres at regional level was anticipated to begin during April 2007 and currently 2 Regions are administering the Gardasil®. The remaining 18 Regions are expected to follow from 1st Jan 2008.
The French health authorities recommend the universal vaccination of 14-year-old girls and also recommend offering vaccination to girls and young women aged 15 to 23, who have not yet had sexual relations, or in the year following the start of their sexual activity at the latest. On 11 July, the National Social Security healthcare system in France announced reimbursement of human papillomavirus vaccination with Gardasil® for 14 year-old girls and catch up vaccination for teens and young women aged 15 to 23 years.
The High Counsel of Public Health in Luxembourg recommends universal vaccination of all 11-12-year- old girls and catch-up vaccination of girls between 13- and 18-years of age.
In Norway, the health authorities recommend the universal vaccination of 11-12-year-old girls and a catch-up vaccination programme for girls up to the age of 16 years.
In Austria a generic recommendation for HPV vaccination is in place for girls aged 9 to 15 years and women, preferably before sexual debut. The recommendation also includes boys aged 9 to 15 years providing a quadrivalent HPV vaccine is used.
On 15 May 2007, The Pharmaceutical Benefits Board in Sweden included the HPV vaccine Gardasil® in the National Pharmaceutical Benefits Scheme, the first vaccine ever granted such status by the Board. Reimbursement applies to girls aged 13 to 17 years.
Also in May through the ruling of the High Counsel of health (Conseil Supérior de la Santé, CSS), Belgium has a recommendation in place for universal HPV vaccination of one cohort of girls between 10- and 13-years old. An announcement on reimbursement is expected before the end of 2007. A catch-up programme for the remaining cohorts of girls up to the age of 15 years could further increase the economic benefits for the population and will be considered after ongoing health-economic evaluation.
In Switzerland on 18 June 2007, the Swiss Federal Office of Public Health (Bundesamt für Gesundheit) recommended human papillomavirus vaccination of 11 to 14 year-old girls to prevent cervical cancer and its precursors as well as other genital diseases and external genital warts caused by human papillomavirus types 6, 11, 16 and 18. The authorities also recommend a catch-up vaccination programme for girls aged 15 to 19 years for a period of five years. The vaccination of women aged 20 years and older should be decided on an individual basis.
In June 2006, the US health authorities recommended the routine vaccination of 11- and 12- year-old females and the vaccination of females aged 13 to 26 who have not previously been vaccinated; also 9- and 10-year-old females can be vaccinated at the discretion of their physicians. In November 2006, the authorities added Gardasil® to their Vaccines for Children (VFC) contract for eligible girls and women aged 9 to 18 providing coverage for many who do not have private health insurance. To date, 53 out of 55 immunisation projects (which cover 94 % of the public sector birth cohort in the U.S.) have adopted Gardasil®.
In November 2006, the Australian government announced the funding of Gardasil® for girls and women aged 12 to 26 years from 2007. Gardasil® will be put on the national immunisation programme for 12- to 13-year-old girls to be delivered through schools. The government will also fund a two year catch-up programme for 13- to 18-year-old girls in schools and 18- to 26-year-old women to be delivered through general practitioners. In August 2007 it was estimated that 77% - 90% of girls in Australian secondary schools have received Gardasil® .
The burden of cervical cancer and other human papillomavirus diseases
Despite screening for early detection, cervical cancer remains the second most common cause of death from cancer (after breast cancer) among young women (15-44 years) in Europe†.13 Around 33,500 women are diagnosed with, and 15,000 women die from cervical cancer each year.14
In addition, hundreds of thousands of women are diagnosed with other genital HPV diseases that start before the occurrence of cervical cancer and can touch other genital organs than the cervix. These diseases include pre-cancerous and early cervical lesions15,16,17, vulvar and vaginal cancer18,19,20, pre- cancerous vulvar and vaginal lesions21,22,23,24 and genital warts.25
It is estimated that HPV types 6, 11, 16 and 18 cause 75% of cervical cancer in Europe,26 75% of vulvar and vaginal cancers18,19, 70% of precancerous15,27 and 50% of potentially precancerous cervical lesions, a significant proportion of vulvar and vaginal cancers and their associated precancerous lesions18,19,21,22 and 90% of genital warts.28,29
Each year in Europe, HPV types 6 and 11 cause an estimated30 10% of early cervical lesions (80,000 cases) in addition to the 25% of early cervical lesions caused by types 16 and 18 (200,00 cases),; HPV types 6 and 11 also cause an estimated31 90% of genital warts (225,000 cases‡)28,32.
Though HPV type 6 and 11-related early cervical lesions usually do not progress to cancer, screening cannot distinguish them from type 16 and18-related lesions which may progress to cancer. They require the same follow up§ and may lead to the same anxiety in women.
Genital warts can cause anxiety which may impact personal relationships. Even if effective in the short term, physically ablative therapies are painful and recurrence rates can be high, as only the visible lesion is excised while the infection persists.33,34,35
Current EU indication of Gardasil®
Gardasil® , Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed), can be given to children and adolescents 9 to15 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 CIN 2/3 (precancerous cervical lesions), high grade vulvar dysplastic lesions VIN 2/3 (precancerous vulvar lesions) and external genital warts (condyloma acuminata) causally related to Human Papillomavirus (HPV) types 6, 11, 16 and 18.
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.
* such as Germany, France, Belgium, Switzerland, Sweden, as well as the United States, Canada and Australia
† European Union member states (except Romania and Bulgaria) plus Iceland, Norway & Switzerland
‡ In women alone, boys and men not yet considered.
§ Including repeated testing, colposcopy (visual examination of the cervix to determine the cause of abnormalities) and diagnostic biopsies (the removal of a sample of tissue (cells of the cervix) for examination under a microscope to assist in diagnosis).
2 http://www.sst.dk... (PDF)
5 http://www.sante.gouv.fr (follow >Thèmes > C > Conseil Supérieur d'Hygiène Publique de France • Accès aux avis et rapports > de la section des maladies transmissibles > Avis de la section des maladies transmissibles > Avis du 9 mars 2007 relatif à la vaccination contre les papillomavirus humains 6, 11, 16 et 18)
7 http://www.cfv.ch (1.0 Actualités)
11 http://www.phac-aspc.gc.ca... (PDF)
12 http://www.health.gov.au/internet/wcms/publishing... (PDF)
13 Ferlay J, Bray F, Pisani P et al, editors. Globocan 2000: Cancer incidence, mortality and prevalence worldwide. IARC Cancer Base No.5. version 1.0. IARC Press, Lyon 2001.
14 Ferlay J, Bray F, Pisani P et al, editors. Globocan 2002: Cancer incidence, mortality and prevalence worldwide. IARC Cancer Base No.5. version 2.0. IARC Press, Lyon 2004.
15 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.
16 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.
17 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.
18 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.
19 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.
20 Parkin DM, Whelan SL, Ferlay J et al. Cancer incidence in five continents (GIS). Volume VIII. p606-611.
21 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.
22 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.
23 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.
24 Jones RW. Vulval intraepithelial neoplasia: Current perspectives. Eur J Gynaecol Oncol 2001;22:393-402.
25 UK Health Protection Agency. CDR Weekly 2003;3(44)
26 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.
27 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.
28 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.
29 Von Krogh G. Management of anogenital warts (condylomata acuminata). Eur J Dermatol 2001;11:598-603.
30 Calculation based on 1998 US data and population data obtained from http://www.PopulationData.net. Calculation of HPV-related lesions is determined as follows: annual incidence of lesions multiplied by EU female population and prevalence of virus types.
31 Calculation based on 2002 UK data and population data obtained from http://www.PopulationData.net. Number of cases of genital warts in EU females is determined as follows: genital warts cases in UK female population multiplied by the EU female population divided by the UK female population.
32 Von Krogh G. Management of anogenital warts (condylomata acuminata). Eur J Dermatol 2001;11:598-603.
33 Beutner KR and Wiley DR. Recurrent external genital warts: A literature review. Papillomavirus Rep 1997;8:69-74.
34 Clinical Effectiveness Group (Association for Genitourinary Medicine and the Medical Society for the Study of Venereal Diseases. National guideline for the management of anogenital warts. (last visit 18.08.06).
35 McMillan A. The management of difficult anogenital warts. Sex Transm Dis 1999;75:192-194.
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