> HPV vaccination: testing of public health?

this Is a vaccine that canò defend indirectly by a tumor. But questions related to its use are numerous and complex.

WHAT to KNOW

80% of cancers of the neck of the uterus is concentrated in the countries of the più poor. 

You know, more than 100 genotypes of HPV and at least 35 of these infect the epithelium of the genital. There are low-risk HPV, that are associated with the appearance of condyloma slayer arises, and high-risk HPV responsible of the development of tumours. Types 16 and 18, against which is directed the vaccine, which correspond to 70% of the HPV oncogenes found worldwide12.

The infection affects about 75% of the women, but for the più (70-90%) de runs asymptomatic and is transient 2. If it persists, può evolving to carcinoma within 20-30 years, in the absence of diagnosis and treatment 1.

cervical cancer is the second tumor in women worldwide after breast, but the weight of the disease is almost all concentrated in the countries of the più poor: 80% of the 500,000 cases/year, according to estimates of the World Organization of the Sanità (WHO).

In the USA are reported approximately 10,000 cases per year with a letalità 30%. In Italy it is estimated that about 3500 new cases each year (period 1998-2002) and about 1000 deaths, with an incidence of 10 per 100,000 women and a letalità of 0.8%, which appear both in constant decline after the introduction of the scree ning (Pap-test)2.

THE VACCINE AND VACCINATION

there are still Many gaps knowledge on the vaccine and the vaccination strategy. 

vaccines against HPV: Gardasil, authorized by the Food and Drug Administration in June 2006 and a few months later by the EMEA – and Cervarix approval is pending. The first is a tetravalent against the HPV 16, 18 (high-risk), 6 and 11 (low-risk), the second is a bivalent against types 16 and 18. Both require the administration of 3 doses and were studied between the ages of 9 to 26 years of età.

The available data – reported at 5 years of follow-up – show that in women 16 to 26 years of age, never infected by HPV, the effectiveness on the dysplasias of moderate (CIN2) and if true (CIN3) associated with HPV 16 and 18 up to 100%3.

While in the women with previous infection, this value is; più than halved. To 9-15 years, the effectiveness is known, but the immune response è più high in the other età. The WHO has estimated that the best strategy is vaccination of girls before the beginning of sexual life4.

But not all share in the choice. A recent editorial in the JAMA5 highlights the many empty spaces of learning: the duration of immunityà, the possible needà of reminders, the security in the medium to long term and, finally, the protective efficacy on the tumor. And Diane Harper – u.s. researcher who has contributed to the studies on the vaccine – arrives to declare that vaccination of girls è «a huge experimentation of public health»6.

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Several countries have alreadyà introduced vaccination. At the beginning of 2007, the US chose a strategy extended from the 12enni up to women 26 years of age. Australia has made a choice similar to the distance of a few months. Germany, Austria, France and Italy have entered with diversified strategies, while in the rest of Europe are still in course evaluations on the alleged additional advantage of vaccination with respect to the implementation of the Pap-test7.

In the Netherlands, pending a decision by the end of 2007, doctors have been faced with a request abnormal vaccination, which has led to the formulation of the College of General Practitioners against the intense campaign to promote the industry outside of the official directions8.

The choice più interesting è that of Finland, which has undertaken a large trial of the population on a cohort of adolescents and deciderà the opportunityà to introduce vaccination based on the results expected by the end of 20209.

IN ITALIA

The effectiveness of the vaccine still needs to evidence a solid; the Pap-test is a tool for the prevention of proven effectiveness. 

last spring, our Ministry of Health has made available the vaccine – at a charge – in pharmacies and has announced plans to offer free 12enni, since 2008.

But the national plan to define the actions is still under discussion in the State-Regions Conference. In the meantime is growing demand hardly governable and uncontrolled by the private.

And we are still waiting for the national data on the prevalence of HPV-associated cancers, the evaluation of the impact of vaccination and screening, of the cost/benefìcio, feasibilityà and the acceptance of the vaccine strategy.

not to mention that this vaccination requires the networking of countless public and private players aimed at children, reproductive health of women, up to those who care for the cancer registry and the screening.

If the co-ordination is the cornerstone of any vaccine strategy, in this case, to govern the actions, information, training, supervision, presents a complexityà never-before-seen. Knowing the frailtyà organizational many areas of the country, there is something to worry about.

THE RUSH AND UNCERTAINTY

in Such a hurry is a little understandable given the characteristics of the disease and saw that there is another prevention tool with proven efficacy: Pap smear. Surprisingly, no one was ever scandalized that so many women cannot take advantage of the screening, even in many Italian regions, while it is considered unacceptable to not offer the vaccine, whose effectiveness on the tumor still needs to evidence a solid.

another problem are the very high cost of the vaccine, which acuiranno inequalities in the right to health. In the USA, the vaccination cycle costs 375$, in Italy 564€ in pharmacy, 376€ to public services. To these must be added the organisational costs of vaccination and surveillance, as it is said, are extremely demanding.

The analysis of cost/effectiveness have given different results depending on the basic assumptions and often do not have the essential variables for a proper assessment10. Facing so many uncertainties, the information takes on a crucial role both vis-à-vis doctors and women. Also not sarà easy to deal with the families and with the girls, a subject so delicate.

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CONCLUSIONI

The hypothesis that the HPV vaccine can help protect women from cancer is certainly of great interest. However, the many gaps of learning suggest that it is «a huge experimentation of public health», and then how such should be conducted and promoted vaccination.

The haste with which you è carried out in many parts of the world makes us reflect on the mechanisms and criteria of choice in sanità the public.

Luisella Grandori – Service Sanità the Public Region of Emilia Romagna, Responsible for the Prevention, Vaccination, ACP, Modena

taken from:

Research&Practice – Mario Negri Institute

Il Pensiero Scientifico Editore

IN ARGOMENTO

Hpv Papilloma virus

  • what causes HPV
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BIBLIOGRAPHY

1. WHO. WHO consultation onhuman papillomavirus vaccines.WER 2005; 35: 299-302.

2. Threads A, Verteranno R, we deem S,et al. HPV e carcinoma dellacervice. Epicentro, focus 2006 www.epicentro.iss.it/focus/hpv/hpv.asp

3. Villa LL, Costa RLR, Andrade RP,et al. High sustained efficacyof a prophylactic quadrivalent human papillomavirus types 6/11/16/18 LI virus like particle vaccine through 5 years of follow-up. Br J Cancer 2006; 95: 1459-66.

4. WHO, UNFPA. Preparing for thèintroduction of HPV vaccines:policy and programmeguidance for countries. WHO, 2006.

5. Gostin LO, DeAngelis CD.Mandatory HPV vaccination:public health vs private wealth.JAMA 2007; 297: 1921-3.

6. Bevington C. Researcher blastsHPV marketing.Fwdailynews.com March 14,2007. www.kpcnews.com/articles/2007/03/14/online_features/hpv_vaccine/hpv01 .prt

7. Kudjawu Y, Lévy-Bruhl D,Pastore Celentano L, et al.The current status of HPVand rotavirus vaccines innational immunisationschedules in thè EU -preliminary results of a VENICEsurvey. Euro Surveill 2007;12: E070426.1. Available from:www.eurosurveillance.org/ew/ 2007/070426.asp#1

8. Sheldon T. Drug companycampaign adds to pressureon Dutch doctors to vaccinateagainst HPV. BMJ 2007; 334: 819.

9. Lehtinen M, Apter D, Dubin G,et al. Enrolment of 22.000adolescent women to cancerregistry follow up for long-termhuman papillomavirus vaccineefficacy: guarding againstguessing. Int J STO & AIDS2006; 17: 517-21.

10. Newall A T, Beutels P, Wood JG, et al. Cost-effectiveness analysis of human papillomavirus vaccination. Lancet Infect Dis 2007; 7: 289-96.

A proposed test of HPV, it is useful to read also:

Prevention of cancer of the uterus?

page last updated on August 24, 2007

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