Análise crítica das recomendações do uso das vacinas meningocócicas conjugadas / A critical appraisal of the recommendations for the use of meningococcal conjugate vaccines

OBJETIVOS: Analisar a epidemiologia da doença meningocócica no Brasil e o impacto que as recentes evidências acumuladas com a incorporação das vacinas meningocócicas C conjugadas nos programas de imunização podem ter nas diferentes estratégias de uso dessas vacinas. FONTES DOS DADOS: Revisão nas bases de dados MEDLINE, SciELO e LILACS no período de 2000 a 2011. SÍNTESE DOS DADOS: No Brasil, a doença meningocócica é endêmica, com ocorrência periódica de surtos. Os maiores coeficientes de incidência ocorrem em lactentes, sendo o sorogrupo C responsável pela maioria dos casos, motivando a introdução da vacina meningocócica C conjugada no Programa Nacional de Imunizações, em 2010, para crianças menores de 2 anos. A introdução das vacinas meningocócicas C conjugadas nos programas de imunização na Europa, Canadá e Austrália mostrou-se efetiva, com dramática redução na incidência de doença causada pelo sorogrupo C, não apenas nos vacinados, mas também em não vacinados. A efetividade em longo prazo dessas vacinas mostrou-se dependente de uma combinação de persistência de anticorpos, memória imunológica e proteção indireta. Recentes evidências indicando que a persistência de anticorpos não é duradoura em crianças pequenas imunizadas e que a memória imunológica não é rápida o suficiente para protegê-las contra a doença enfatizam a importância da proteção indireta para manutenção da população protegida. CONCLUSÕES: A rápida queda de títulos de anticorpos em crianças vacinadas nos primeiros anos de vida sugere a necessidade de incorporarmos doses de reforço antes da adolescência, especialmente em locais como o Brasil, onde ainda não contamos com o efeito da proteção indireta da população.

OBJECTIVES: To assess the epidemiology of meningococcal disease (MD) in Brazil and the impact that recent evidence and lessons learned from the introduction of meningococcal C conjugate (MCC) vaccines into immunization programs may have on different strategies of vaccine use. SOURCES: Non-systematic review of the MEDLINE, SciELO and LILACS databases covering the period from 2000 to 2011. SUMMARY OF THE FINDINGS: Meningococcal disease is endemic in Brazil, with periodic occurrence of outbreaks. Most cases are associated with serogroup C and the highest incidence rates are observed in infants, encouraging the introduction of MCC vaccine in the National Immunization Program in 2010 for children under 2 years old. The introduction of MCC vaccines into immunization programs in Europe, Canada and Australia proved to be effective, with dramatic reduction in the incidence of serogroup C meningococcal disease, not only in the vaccinated, but also in the unvaccinated individuals. Long-term effectiveness of MCC vaccines was dependent on a combination of antibody persistence, immunologic memory and herd protection. Recent evidence indicating that antibody persistence is not long-lasting in young immunized children, and that immunologic memory is not fast enough to protect them against the disease, emphasize the importance of herd protection to maintain the population protected. CONCLUSIONS: The rapid decline of antibody titers in children vaccinated in the first years of life suggests the need to incorporate booster doses before adolescence, especially in locations like Brazil, where the immunization program did not incorporate catch-up campaigns including adolescents, lacking the herd immunity effect.

A critical appraisal of the recommendations for the use of meningococcal conjugate vaccines.

OBJECTIVES: To assess the epidemiology of meningococcal disease (MD) in Brazil and the impact that recent evidence and lessons learned from the introduction of meningococcal C conjugate (MCC) vaccines into immunization programs may have on different strategies of vaccine use. SOURCES: Non-systematic review of the MEDLINE, SciELO and LILACS databases covering the period from 2000 to 2011. SUMMARY OF THE FINDINGS: Meningococcal disease is endemic in Brazil, with periodic occurrence of outbreaks. Most cases are associated with serogroup C and the highest incidence rates are observed in infants, encouraging the introduction of MCC vaccine in the National Immunization Program in 2010 for children under 2 years old. The introduction of MCC vaccines into immunization programs in Europe, Canada and Australia proved to be effective, with dramatic reduction in the incidence of serogroup C meningococcal disease, not only in the vaccinated, but also in the unvaccinated individuals. Long-term effectiveness of MCC vaccines was dependent on a combination of antibody persistence, immunologic memory and herd protection. Recent evidence indicating that antibody persistence is not long-lasting in young immunized children, and that immunologic memory is not fast enough to protect them against the disease, emphasize the importance of herd protection to maintain the population protected. CONCLUSIONS: The rapid decline of antibody titers in children vaccinated in the first years of life suggests the need to incorporate booster doses before adolescence, especially in locations like Brazil, where the immunization program did not incorporate catch-up campaigns including adolescents, lacking the herd immunity effect.

Rubella vaccination of unknowingly pregnant women: the São Paulo experience, 2001.

BACKGROUND: Rubella vaccination is contraindicated during pregnancy. During mass immunization of women of childbearing age against rubella, women unknowingly pregnant may be vaccinated. To evaluate the effects of rubella vaccination during pregnancy, the Brazilian state of São Paulo conducted a follow-up study of pregnant women vaccinated during a rubella campaign in 2001. METHODS: Women vaccinated during pregnancy were reported to a national surveillance system. In the state of São Paulo, follow-up of vaccinated women included household interviews. Serum samples from vaccinated women were tested for antirubella antibodies to classify susceptibility to rubella infection. Children born to susceptible mothers were tested for evidence of congenital rubella infection and evaluated for signs of congenital rubella syndrome. RESULTS: The São Paulo State Health Department received 6473 notifications of women vaccinated during pregnancy. Serology performed for 5580 women identified 811 (15%) that were previously susceptible. Incidence of spontaneous abortion or stillbirth among previously susceptible vaccinated women was similar to women with prior immunity. Twenty-seven (4.7%) of 580 newborns tested had evidence of congenital rubella infection; none had congenital rubella syndrome. CONCLUSIONS: Mass rubella vaccination of women of childbearing age was not associated with adverse birth outcomes or congenital rubella syndrome among children born to women vaccinated during pregnancy.

Importance of background rates of disease in assessment of vaccine safety during mass immunisation with pandemic H1N1 influenza vaccines.

Because of the advent of a new influenza A H1N1 strain, many countries have begun mass immunisation programmes. Awareness of the background rates of possible adverse events will be a crucial part of assessment of possible vaccine safety concerns and will help to separate legitimate safety concerns from events that are temporally associated with but not caused by vaccination. We identified background rates of selected medical events for several countries. Rates of disease events varied by age, sex, method of ascertainment, and geography. Highly visible health conditions, such as Guillain-Barré syndrome, spontaneous abortion, or even death, will occur in coincident temporal association with novel influenza vaccination. On the basis of the reviewed data, if a cohort of 10 million individuals was vaccinated in the UK, 21.5 cases of Guillain-Barré syndrome and 5.75 cases of sudden death would be expected to occur within 6 weeks of vaccination as coincident background cases. In female vaccinees in the USA, 86.3 cases of optic neuritis per 10 million population would be expected within 6 weeks of vaccination. 397 per 1 million vaccinated pregnant women would be predicted to have a spontaneous abortion within 1 day of vaccination.

Clinical bioethics.

Clinical bioethics was born out of the need to introduce different ethical values involved in the relationships among physician, patient and health institutions which are outside the technical-scientific framework of routine medical practice. Physicians tend to adopt the norms and rules provided for in the Medical Ethics Code to guide the exercising of their professional practice. However, it has recently become challenging to apply these norms to all conduct since some issues faced in the professional practice are simply not provided for by such norms. Ethical consideration in practice drawing solely on the medical ethics code in Brazil has proved insufficient, both in the context of universal issues such as organ transplants, start and end-of-life, as well as in addressing specific issues such as allocation of funds for health. Clinical bioethics employs clinical cases and situations as an instrument for discussion. These discussions entail analysis of not only the facts and circumstances surrounding each case, but also the values which lead to patients, health teams and institutions opting to recommend, accept or refuse a given conduct.

Immunogenicity and safety of a new Vero cell rabies vaccine produced using serum-free medium.

The immunogenicity and safety of a new human rabies vaccine, produced in Vero cells by a process that does not require supplementation with human or animal derived components in production, were assessed. Thus, the objective is to produce a safer vaccine at a lower cost. A total of 296 volunteers was divided into two groups: Group 1, which received the study vaccine, and Group 2, which received the Vero cells vaccine produced by Sanofi Pasteur. Five doses were given on days 0, 3, 7, 14 and 28. Blood samples for determination of rabies virus neutralizing antibodies were collected on days 0, 14, 38 and 90. The geometric mean titers (GMT) were much higher than 0.5 IU/ml in both groups on days 14, 38 and 90, indicating seroconversion according to the World Health Organization. In Group 1, however, the GMTs were higher than in Group 2, the difference being statistically significant in the two last samples. There was no statistical difference between the groups in the ratio of individuals with titers > or =0.5 IU/ml in each sample. Pain at the injection site was the most common adverse reaction and occurred most often in Group 1 (p < 0.001). All cases had a favorable evolution. There were no severe adverse reactions. It was concluded that the new vaccine is safe and immunogenic.

Soroprevalência da hepatite B e avaliação da resposta imunológica à vacinação contra a hepatite B por via intramuscular e intradérmica em profissionais de um laboratório de saúde pública / Hepatitis B seroprevalence and evaluation of immune response to hepatitis B vaccination using intramuscular and intradermal routes in public health laboratory employees

OBJETIVOS: Determinar a prevalência dos marcadores da hepatite B (HBsAg e anti-HBs) e avaliar a resposta à vacinação contra hepatite B por via intradérmica (ID) em profissionais de saúde que não responderam à vacinação por via intramuscular (IM). MÉTODO: Todos os funcionários do Instituto Adolfo Lutz (IAL) foram convidados a participar do estudo. Amostras de soro foram colhidas no momento da administração da primeira dose de vacina (Engerix® B) e o HBsAg e o anti-HBs foram pesquisados, utilizando-se kits comerciais (Laboratórios Abbott®). Aos funcionários que não responderam à vacinação convencional (três doses por via IM) foram oferecidas doses de 5µg da mesma vacina por via ID. RESULTADOS: Foram envolvidos nesse estudo 404 funcionários do IAL, dos quais dois (0,5 por cento) eram HBsAg e 42 (10,5 por cento), anti-HBs reagentes. Dos 360 voluntários com sorologia negativa, 316 (87,8 por cento) receberam três doses de vacina (IM) e, desses, 259 colheram soros para avaliação pós-vacinal. Do total, 242 (93,4 por cento) apresentaram anticorpos acima de 10 UI/L após completarem o esquema inicial. Foram administradas duas doses de reforço, porém sete funcionários permaneceram sem resposta imunológica. A vacinação intradérmica foi realizada em cinco voluntários, e todos produziram anticorpos após a utilização dessa via de administração. CONCLUSÕES: A prevalência da hepatite B não foi maior nessa população do que na população geral. A vacinação por via intradérmica pode ser uma boa alternativa na imunização de pessoas que não respondem ao esquema convencional.

OBJECTIVES: To determine the prevalence of HBsAg and anti-HBs and to evaluate the response of intradermal hepatitis vaccination in healthcare workers non-responsive to previous repeated intramuscular vaccination. MATERIAL AND METHOD: All of the employees from Instituto Adolfo Lutz were invited to participate on this study. Serum samples were obtained and HBsAg and anti-HBs were detected using commercial kits (Abbott® Laboratories). Employees were submitted to the conventional three-dose vaccination by intramuscular route. To those employees who did not respond to intramuscular vaccination, 5 µg doses of Engerix® B were then administered by intradermal route up to nine doses. RESULTS: Four hundred and four healthcare workers were enrolled in this study. Initially, two (0.5 percent) and 42 (10.4 percent) were HBsAg and anti-HBs reagent, respectively. Among the 360 negative volunteers, 316 (87.8 percent) received three vaccine doses and in 259 of them, serum samples were collected to evaluate vaccine efficacy. Among them, 242 (93.4 percent) showed antibodies titer higher than 10 UI/l. Intradermal vaccination was carried out in five volunteers and all of them responded to this vaccine administration route. CONCLUSION: The prevalence of hepatitis B was not higher than in general population. Intradermal vaccine administration could be a good alternative in people that did not respond to previous intramuscular route.

Iniciação à bioética

Publicação que apresenta conceitos básicos e perspectivas da bioética. Aborda temas específicos relacionados com a bioética como, reprodução, aborto, eutanásia, pesquisa em humanos, saúde pública, biossegurança, direitos humanos, erro médico, confiabilidadee privacidade

Ethical aspects of brain death and end-of-life.

Ethical issues surrounding brain death and end-of-life have not been afforded in Brazil the same attention as in many developed countries. There appears to be reluctance on the part of Brazilian doctors to limit or suspend procedures or treatment which prolongs life of patients in terminal phases of severe incurable illness, or to suspend the artificial means of supporting vegetative functions in cases of brain death outside the context of organ and tissue donation for transplant. Fears grounded in possible administrative (Regional Medical Councils) or legal repercussions, as well as ambiguous interpretations of religious precepts, partially explain this reluctance which often results in unnecessary prolonging of patient suffering. A recent resolution by the Federal Medical Council on end-of-life may offer doctors some guidance and confidence in dealing with highly complex ethical situations.

Questões éticas relativas à morte encefálica e terminalidade da vida não têm ainda no Brasil o mesmo destaque que em países desenvolvidos. Os médicos brasileiros parecem ter resistência em limitar ou suspender tratamentos ou procedimentos de prolongamento da vida em pacientes em fase terminal de doença grave e incurável, ou em suspender os meios artificiais da manutenção de funções vegetativas em casos de morte encefálica fora do contexto de doação de órgãos e tecidos para transplante. Receio quanto a possíveis sanções administrativas (Conselhos Regionais de Medicina) ou legais, além de duvidosas interpretações de preceitos religiosos explicam, ao menos parcialmente, essa relutância, que freqüentemente resulta em prolongamento desnecessário do sofrimento dos pacientes. Uma recente Resolução do Conselho Federal de Medicina sobre terminalidade de vida oferece aos médicos orientação sobre como lidar com algumas dessas questões de grande complexidade ética.