Aspectos bioéticos da vacinação em massa no Brasil / Bioethic aspects of mass vaccination in Brazil / Aspectos bioéticos de la vacunación en masa en Brasil

A vacinação em massa consiste na realização coletiva da prática vacinal, utilizando como estratégias as campanhas, mutirões e bloqueios, realizadas sem considerar os riscos epidêmicos e outras questões, implicando na perda da autonomia e vulnerabilidade dos indivíduos. Este estudo tem como objetivo realizar uma discussão referentes à prática da vacinação em massa sob a ótica da Bioética Principialista considerado o papel do Estado e os aspectos culturais relacionados a essa prática. Trata-se de uma revisão de literatura com recorte temporal de 1999 a 2013 em periódicos nacionais. Concluiu-se que ocorre desvalorização dos princípios éticos relacionados a autonomia, não-maleficência, beneficência e justiça, bem como uma desconsideração dos aspectos culturais dos vacinados por parte do Estado e dos profissionais de saúde. O Estado ainda é hoje o maior incentivador das práticas de vacinação em massa por serem medidas mais simples de prevenção das doenças uma vez que ainda existe uma precariedade nas infraestruturas sanitárias no país, no entanto, em contra partida, seria necessário estimular a conscientização da população e o aperfeiçoamento do controle sanitário que seriam a longo prazo opções necessárias para que em certos lugares se descontinuassem essa prática.

Mass vaccination is the collective achievement of immunization practice, using strategies such as campaigns, task forces and locks, made without considering the epidemic risks and other issues, resulting in the loss of autonomy and vulnerability of individuals. This study aims to conduct a discussion regarding the practice of mass vaccination from the perspective of bioethics principialist considered the role of the state and the cultural aspects of this practice. This is a review of literature with time frame 1999-2013 in national journals. It was concluded that occurs devaluation of ethical principles related to autonomy, non-maleficence, beneficence and justice, as well as a disregard of cultural aspects of vaccinees by the state and health professionals. The state is still the biggest supporter of mass vaccination practices by being simpler measures of disease prevention since there is still a precarious health infrastructure in the country, however, although, it would be necessary to stimulate public awareness and the improvement of sanitary control that would be long-term options needed for certain places if they stopped this practice.

La vacunación masiva es un logro colectivo de la práctica de la inmunización, utilizando estrategias como campañas, grupos de trabajo y aislamientos realizados, sin considerar los riesgos de epidemias y otras cuestiones, lo que resulta en la pérdida de la autonomía y la vulnerabilidad de los individuos. Este estudio tiene como objetivo llevar a cabo una discusión sobre la práctica de vacunación masiva desde la perspectiva de la bioética principialista, considerado el papel del Estado y los aspectos culturales de esta práctica. Se trata de una revisión de la literatura entre los años 1999 y 2013 en revistas brasileras. Se concluyó que hay una devaluación de principios éticos relacionados con la autonomía, no maleficencia, beneficencia y justicia, y una falta de respeto a los aspectos culturales de los vacunados por parte de los funcionarios de salud pública. El Estado sigue siendo el mayor encargado del mantenimiento de las prácticas de vacunación masiva, con medidas simples para prevenir la enfermedad, aunque todavía hay una deficiente infraestructura sanitaria en el país; sin embargo, sería necesario aumentar la conciencia pública y mejorar el control sanitario, y definir las medidas a largo plazo en ciertos lugares en caso de cese esta práctica.

Cost-effectiveness of the vaccine against human papillomavirus in the brazilian Amazon region / Custo-efetividade da vacina contra o papilomavírus humano na região Amazônica brasileira

OBJECTIVE: To assess the cost-utility of the human papillomavirus (HPV) vaccination on the prevention of cervical cancer in the Brazilian Amazon region. METHODS: AMarkov cohort modelwas developed to simulate the natural evolution of HPV and its progress to cervical cancer, considering the current preventive programs and treatment costs. The one-year transition probabilities were mainly based on empirical data of local and national studies. The model evaluated the addition of the vaccine to three cervical cancer-screening scenarios (0, 3 or 10 exams throughout life). RESULTS: The scenario of three Pap tests resulted in satisfactory calibration (base case). The addition of HPV vaccination would reduce by 35% the incidence of cervical cancer (70% vaccination coverage). The incremental cost-effectiveness ratio was US$ 825 for each quality-adjusted life year gained. The sensitivity analysis confirms the robustness of this result, and duration of immunity was the parameter with greater variation in incremental cost-effectiveness ratio. CONCLUSION: Vaccination has a favorable profile in terms of cost-utility, and its inclusion in the immunization schedule would result in a substantial reduction in incidence and mortality of invasive cervical cancer in the Brazilian Amazon region.

OBJETIVO: Avaliar a custo-efetividade da vacinação contra o papilomavírus humano (HPV) na prevenção do câncer de colo de útero na região Amazônica brasileira. MÉTODOS: Um modelo de coorte Markov foi desenvolvido para simular a história natural do HPV e seu progresso para câncer de colo de útero, considerando os atuais programas de prevenção e os custos de tratamento. As probabilidades de um ano de transição foram baseadas principalmente em dados empíricos de estudos locais e nacionais. O modelo avaliou a adição da vacina a três cenários de rastreio de câncer de colo de útero (0, 3 ou 10 exames ao longo da vida). RESULTADOS: O cenário de três exames de Papanicolau resultou em calibração satisfatória (caso base). A adição de vacinação contra o HPV reduziria em 35% a incidência de câncer de colo de útero (70% de cobertura de vacinação). A razão incremental de custo-efetividade foi US$ 825 para cada ano de vida ajustado para qualidade ganho. A análise de sensibilidade confirma a robustez deste resultado, e a duração de imunidade foi o parâmetro com maior variação na razão incremental de custo-efetividade. CONCLUSÃO A vacinação tem um perfil favorável em termos de custo-utilidade, e sua inclusão no calendário de imunização resultaria em redução substancial de incidência e de mortalidade relacionadas ao câncer de colo de útero na região Amazônica brasileira.

Varicella epidemiology and cost-effectiveness analysis of universal varicella vaccination program in Taiwan.

Varicella zoster virus is highly contagious and affects people worldwide. In this study, we collected local epidemiological data and evaluated the cost-effectiveness of varicella vaccination program in Taiwan. To examine the economical consequences of universal vaccination, a model of the incidence and the associated costs in a hypothetical cohort was created each year for 30 years. The incidence increased sharply after the infancy and peaked in children aged 5 years. The hospitalization rate among cases was the highest in infants, followed by adults 30 to 44 years old. The benefit-cost analysis showed that one dollar invested in the program would cost extra 46 cents in direct medical expense, but would save extra 45 cents considering the societal expenses. Substantial economical benefits can occur due to the averted unproductive days for parents. Sensitive surveillance of both varicella and zoster is essential in countries that have implemented or are about to implement varicella vaccination.

An economic evaluation of universal infant vaccination strategies against hepatitis B in Thailand: an analytic decision approach to cost-effectiveness.

To evaluate the cost-effectiveness of four infant vaccination strategies aimed at protecting the Thai population against hepatitis B virus (HBV) infection, vaccination and giving hepatitis B immunoglobulin (HBIg) to high-risk infants were compared with universal vaccination of infants and no vaccination. An analytic decision model was used to estimate the clinical and economic consequences of HBV for a hypothetical cohort of newborns for each of the immunization strategies. The model focused on the numbers and the costs of cases prevented. The decision model examined four different HBV management strategies: 1. screening for HBsAg, and vaccination; 2. screening for HBsAg, then HBeAg, and vaccination; 3. universal vaccination of all neonates; and 4. no vaccination. The cost-effectiveness per case prevented for Strategy 1 was 292.79 baht; for Strategy 2, 264.34 baht; for Strategy 3, 151.05 baht; and for Strategy 4, 0 baht. The incremental cost comparing Strategy 3 to Strategy 4 was 6,521 baht; comparing Strategy 2 to Strategy 3, 20,000 baht; and comparing Strategy 1 to Strategy 2, 95,000 baht. There is no socially acceptable threshold value for cost per case prevented to guide decisions on funding health care interventions. Strategy 3 should certainly be continued. Nevertheless, based on these results, Strategy 2 may be considered, despite the incremental cost being about 2 times that of Strategy 3, as it might represent a worthwhile investment of public funds.

The efficacy and effectiveness of influenza vaccination among Thai elderly persons living in the community.

OBJECTIVE: To determine the efficacy and cost-effectiveness of influenza vaccination in the Thai elderly living in an urban community. MATERIAL AND METHOD: The study design was a stratified, randomized, double blind, placebo-controlled trial. A total of 635 participants aged 60 years and older living in an urban community was randomized to receive an influenza vaccine or tetanus toxoid as a placebo injection. All participants were followed up 4-6 weeks in the community for influenza-like illness and treatment received, hospitalization and death for one year. A hemagglutination inhibition (HI) test for influenza virus antibody of all participants was done on the day of vaccination as well as 1 month, 5 months, and 12 months after the vaccination. Main outcome measures were immune response rate and protective titer, influenza-like illness, serological influenza, treatment received for influenza-like illness and their expenses, hospitalization and death during the study period. RESULTS: The immune response rate of vaccinations was 97.1% and protective titer for A (H1N1) and A (H3N2) strains were 96.4 and 98.6%, respectively. The incidence of influenza-like illness was 4.83% in the vaccine group compared with 10.88% in the placebo group. The relative risk reduction was 56% (95% CI = 14 to 77%). The survival analysis also showed that vaccinations significantly reduced the incidence of influenza (p = 0. 009). The number needed to prevent one episode was 17 persons (95% CI = 9 to 71 persons). The adverse reactions of vaccinations were mild and tolerable. However, the number of treatments received for influenza-like illness and their cost were not significantly different between the two groups. None of the subjects had pneumonia nor needed hospitalization during the study period. Seven participants died during the year of follow up, but not from influenza. CONCLUSION: In Thai elderly living in the community, influenza vaccination reduced the incidence of influenza-like illness by half, but not the number of treatments received for influenza-like illness, their cost, and its serious complications. In the year of the study, considering the cost of vaccines and the numbers needed to prevent one episode of infection from the provider's viewpoint, it may not be cost-effective to recommend that all Thai older persons living in the community should receive influenza vaccination annually. Vaccination recommendation for the elderly should be promptly implemented in expectation of a severe epidemic in Thailand.

Coverage and costs of mass immunization of an oral cholera vaccine in Vietnam.

The objective of this study was to describe a mass-immunization campaign of a locally-produced oral, killed whole-cell cholera vaccine in Hue city, Vietnam. Mass immunization with a 2-dose regimen of the vaccine was conducted in 13 communes in early 1998. The total, age- and sex-specific vaccine coverage was calculated using data from the vaccination records and the government census. The number of vaccine doses procured, administered, wasted, and left over, and the human and other resources required to prepare and conduct the vaccination campaign were systematically recorded. Government expenditure for planning, procurement, and delivery of the vaccine were documented. In total, 118,555 (79%) of the 49,557 targeted population were fully vaccinated during the mass-vaccination campaign. The total expenditure for the project was US dollar 105,447, resulting in a cost per fully-vaccinated person of US dollar 0.89. Mass immunization with this locally-produced oral, killed cholera vaccine was found to be feasible and affordable with attainment of high vaccination coverage.

H. influenzae type b (Hib) vaccine--controversies.

Hib vaccine is the 8th vaccine knocking at the door to be included in the EPI the world over. However there are some controversies that need to be addressed, especially when it comes to use of this vaccine in India. It is difficult to culture Hib unless one uses sheep blood enriched media for culture. There is a lack of good community based data on Hib burden in India. This makes many feel that Hib is rare in India. However this is not true. There are many studies that have looked at this closely. Hib is a common cause of meningitis and pneumonitis in children less than 5 years old in India. There is wide spread problem of multi-drug resistance by Hib in India. Mortality of meningitis is as high as 100% if third generation cephalosporins are not used in time. Of the survivors of meningitis, 60% develop long-term sequelae. Hib vaccine is very effective and can lead to 99% reduction with mass vaccination in just 2-3 years. It is also a very safe vaccine. Of the conjugated vaccines available in India all are equally effective and safe and there is nothing to choose one over the other. There is a need to give a booster dose at 15-18 months of age. Even UK, which never gave the booster dose, is seriously thinking of changing their practice and give a booster dose. Lastly the combination vaccines of Hib with IPV, DPwT/DPaT, and Hepatitis B are safe and effective and should be encouraged to improve the compliance. The use of Hib vaccine is recommended in India, for those who can afford the vaccine.

Se justifica economicamente la erradicacion de la poliomielitis en las Américas? / Is polio eradication in the Américas economically justified?

In 1985 the Pan Américan Health Organization launched a five-year campaign to eradicate poliomyelitis from the Américas. Through a cost/benefit analysis, this article seeks to answer the question: do savings in treatment and rehabilitation costs justify the cost of eradication? Although this question should never come up if the private market for vaccination functioned properly, its answer is a categorical yes. This analysis covers only economic savings, without considering savings in pain, suffering, and loss of productivity. Two different situations are analyzed: one where treatment covers all victims, and a second where it covers only a portion of them. In the first case, the article concludes that current levels of control of the disease have yet to absorb all potential benefits, and consequently, additional eradication efforts are justifiable. In the second, the analysis also finds that eradication is a justifiable investment, even when the only benefits considered are efective reduction in treatment cost- the cost of treating even a small portion of the affected individuals offsets the overal costs of prevention. Finally, the article compares strategies adopted by two hypothetical regions with equal incidence of paralytic poliomyelitis. In region A, the patients are treated but vaccination is only begun five years later because initially the treatment costs are not high enough

Analise economica das estrategias de vacinacao adotadas no Brasil em 1982 / Economic analysis of the vaccination strategies adopted by Brazil in 1982

This article presents an overview of a study carried out by the Public Health Special Service Foundation (Ministry of Health of Brazil) in association with the Pan Américan Health Organization; it compares the economic efficiency of the different vaccination strategies implemented by the National Immunization Program in Brazil in 1982. These strategies were classified in the following way: a) routine vaccination services, offered routinely by federal, state and municipal health service networks; b) mass vaccination campaigns; and c) intensified routine services, where scheduled vaccination services were provided in small villages in the interior of the country. These strategies were assessed by taking into account, on one hand, the costs of supplying the vaccines (in order words, of providing the services) and the costs of obtaining the vaccines (that is, transportation, costs, etc., which affect the user) and, on the other hand, the number of vaccinations and children completely vaccinated by means of each strategy. For this analysis, the study sample was the health units of differnt public institutions in 16 municipalities in the North and Northeast regions of Brazil. The results of the study show that, generally speaking, the mass campaign was the most efficient strategy, although in some municipalities the results of rutine services were almost as good