Adverse events following immunization of measles,mumps and rubella,ormeasles and rubella combined attenuated live vaccine among8-month-old children in Jiaxing / 预防医学

Objective@#To analyze the surveillance of adverse event following immunization (AEFI) among 8-month-old children in Jiaxing who received measles, mumps and rubella combined attenuated live vaccine (MMR) or measles and rubella combined attenuated live vaccine (MR) , so as to provide support for the adjustment of vaccine immunization strategy.@*Methods @#The AEFI information of MR (December 1, 2016 to April 30, 2018) and MMR (December 1, 2018 to April 30, 2020) was collected through National AEFI Monitoring Information Management System to compare the incidence, clinical features, occurred time of AEFI as well as combined vaccination.@*Results@#Totally 94 287 doses of MR and 79 994 doses of MMR were administered, 145 and 156 cases of AEFI were reported, and the incidence rate was 15.38/10 000 after MR vaccination, which was lower than 19.50/10 000 after MMR vaccination (P<0.05). Most reported AEFI were abnormal reactions, with 93 cases (11.63/10 000) after MR vaccination and 101 cases (10.71/10 000) after MMR vaccination, among which 72 cases (7.64/10 000) and 76 cases (9.50/10 000) respectively had allergic rash. The AEFI cases mainly occurred less than one day after vaccination, with 113 cases (77.93%) after MR vaccination and 125 cases (80.13%) after MMR vaccination. Most cases of AEFI were vaccinated with Japanese encephalitis attenuated live vaccine (JEV), with 103 cases (71.03%) after MR vaccination and 102 cases (65.38%) after MMR vaccination.@*Conclusions@#The MMR is safety for 8-month-old children in Jiaxing. Most AEFI cases had abnormal reactions, occur within one day after vaccination, and are vaccinated with JEV.

Surveillance results of adverse events following immunization of enterovirus 71 inactvated vaccine / 预防医学

Objective@#To evaluate the safety of enterovirus 71（EV71）inactivated vaccines produced by Wuhan Institute of Bio Products through learning the incidence of adverse events following immunization（AEFI）in children aged 6 months to 3 years old after vaccination.@*Methods@#According to the national requirement for vaccine safety monitoring program，data of AEFI cases after inoculated EV71 vaccines from September 2017 to October 2018 in Zhejiang Province was collected by combining active and passive monitoring. Demographic characteristics，space distribution，dose and incidence of AEFI were analyzed.@*Results@#A total of 107 503 children were included in this study，of which 27 173 were actively monitored and 80 330 were passively monitored. The monitoring results showed that 288 cases of AEFI occurred after inoculated EV71 vaccines，the reported incidence rate was 267.90/100 000. Of 288 cases，266 cases had common reactions（247.43/100 000），14 cases had abnormal reactions（13.02/100 000）and 8 cases had complications（7.44/100 000）；145 cases were passively monitored（180.51/100 000）and 143 cases were actively monitored（526.26/100 000）；150 cases were males and 138 cases were females，with the males to females ratio of 1.09∶1. The AEFI of EV71 vaccines were reported in all the cities of Zhejiang Province，with Jinhua，Taizhou and Hangzhou ranking the top three and accounting for 50.69% of all the reported cases. About 202 cases of AEFI（70.14%）occurred after the first dose of EV71 vaccines，and 163 cases（56.60%）occurred on the day of inoculation.Most of common reactions were fever，swelling and sclerosis. The harm of the reported abnormal reactions was mild，with 8 cases of anaphylactic rash and no other serious abnormal reactions were found. @*Conclusion@#The reported incidence rate of AEFI of the domestic EV71 vaccine in children aged from 6 months to 3 years is 267.90/100 000，without serious abnormal reactions，suggesting that the EV71 vaccine is safe.

Avaliação da vigilância dos eventos adversos pós-vacinação contra sarampo, caxumba e rubéola, Espírito Santo, 2002 a 2006. / Evaluation of Vaccine Adverse Events Surveillance for Measles, Mumps and Rubella, Espírito Santo, Brazil, 2002 - 2006

Avaliou-se a Vigilância de EAPV (Eventos Adversos Pós-Vacinação) contra sarampo, caxumba e rubéola, no Espírito Santo, de 2002 a 2006, utilizando as diretrizes do CDC. O sistema de vigilância era simples. Apresentou boa aceitabilidade, estabilidade e flexibilidade. A qualidade dosdados e a oportunidade foram regulares. Sua representatividade e sensibilidade foram baixas e estava subutilizado. Nenhum dicionário de dados que relacionasse os nomes do campo da ficha de notificação de EAPV com o do sistema de informação (SI-EAPV) estava disponível. Asvariáveis não geravam dados necessários para a investigação do caso. Não estava claro que os casos de EAPV devessem ser notificados somente no SI-EAPV e não no Sinan de doenças exantemáticas (DE). Nenhum dos casos de EAPV identificados no SINAN/DE estava notificadono SI-EAPV. As principais recomendações são: criar dicionário de dados, incluir campos na ficha de notificação que permitam a completa investigação do caso no SI-EAPV, estabelecer o fluxo de informação entre os sistemas e orientar as equipes de saúde que o SI-EAPV é o sistema recomendado para a notificação.

We evaluated the post-vaccination adverse event surveillance (PVAES) for measles, mumps and rubella in the state of Espírito Santo, Brazil, from 2002 to 2006. We used CDC?s Updated Guidelines for Evaluating Disease Surveillance Systems. We found that the system is simple, itsacceptability, stability and flexibility were good. The data quality and opportunity is average. The system has low representativeness and sensitivity, and it is underutilized. The PVAES data form had no dictionary linking its names to the SI-EAPV (post-vaccination adverse eventsurveillance information system) database, and the variables did not generate the necessary data for case investigation. It was not clear that the adverse event cases should be reported only to SI-EAPV and not to the SINAN (Brazilian national communicable diseases informationsystem) for exanthematic diseases. None of the adverse event cases identified in SINAN were reported to the SI-EAPV. The main recommendations are: create data dictionaries, include sin the notification form to allow full case investigation, establish information flow between SINAN and SI-EAPV, and inform that adverse events after vaccination should be reported only to SI-EAPV.

Proposta de gestão on-line das informações de vigilância epidemiológica de eventos adversos pós-vacinação / Proposal for managing online information for epidemiological surveillance of adverse events following immunization

Hoje em dia, uma série de vacinas são capazes de proteger as pessoas, reduzindo drasticamente a incidência de doenças. Para gerenciar as ações de imunização em saúde pública, o Programa Nacional de Imunizações foi criado em 1973. Através dos seus mecanismos de trabalho, tais como, fornecimento de vacinas para toda a população, financiada pelo Governo Federal, sem custos diretos para os vacinados; armazenamento, transporte e suprimento de vacinas em redes de frio adequadas; sistemas de informações confiáveis, o Programa Nacional de Imunizações tem êxito em seus objetivos por controlar várias doenças evitáveis pela imunização. No entanto, sabemos que a ocorrência de eventos adversos pode surgir após a administração desses produtos imunizantes – EAPV. Para monitorar e controlar EAPV, a Vigilância Epidemiológica de Eventos Adversos Pós-Vacinação foi criado pelo Programa Nacional de Imunização, em 1992. Este serviço foi estruturado para reconhecer e identificar os casos de EAPV, subsidiar pesquisas, e assessorar os profissionais de saúde na vigilância de casos, entre outros objetivos que contribuem para o controle de vacinas, saúde e bem-estar da população. Para fazer o controle de eventos adversos, a Vigilância Epidemiológica de EAPV usa um formulário de notificação, manual de monitoramento com informações e instruções para notificar e investigar casos de EAPV e fornecer dados para o sistema de informação. Este último é fundamental para acompanhar os casos suspeitos e confirmados de EAPV, identificando os casos graves, os surtos e controlar os lotes de vacinas que podem causar eventos adversos à população vacinada. Desde 1998, o Programa Nacional de Imunizações tem administrado o Sistema de Informações de Eventos Adversos Pós-Vacinação, desenvolvido pela equipe técnica do Departamento de Informática do Ministério da Saúde – DATASUS. Com base nas diretrizes e critérios para avaliação de sistemas de vigilância,,,

Nowadays, a number of vaccines are able to protect people, reducing dramatically the incidence of diseases. To manage the immunizing actions in public health, the Brazilian National Immunization Program was created in 1973. Through its working mechanisms, such as, providing vaccines for the whole population, funded the FederalGovernment, without direct cost for vaccinees; storage, transportation and supply of vaccines in appropriate cold chain settings; reliable information systems, the National Immunization Program has succeed in its goal to control many diseases preventable byimmunization. However, we know that the occurrence of adverse events may follow the administration of immunizing products – AEFI. To monitor and control AEFI, the Epidemiological Surveillance of Adverse Events Following Immunization was created by National Immunization Program in 1992. This service was structured to recognizeand identify AEFI cases, subsidize research work, and support health professionals in surveillance, and other objectives that contribute to vaccines control, health and welfare of the population. To control adverse events, AEFI’s Epidemiological Surveillance use a notification form, monitoring manual with information and instructions to report and investigate AEFI’s cases and supply data to the information system. The latter is critical to follow up suspected and confirmed cases of AEFI,identifying severe cases, outbreaks and monitor vaccine lots that may cause adverse events to the vaccinated population. Since 1998, the National Immunization Program has managed the Adverse Events Following Immunization’s Informations System,developed by the technical staff in the Ministry of Health Department - DATASUS. Based on the guidelines and criteria for evaluation...

Acellular and "low" pertussis vaccines: adverse events and the role of mutations / Vacinas pertussis acelular e pertussis "low": eventos adversos e o papel das mutações

Objective: to discuss the current PAHO recommendation that does not support the substitution of traditional cellular DTP vaccine by acellular DTP, and the role of mutations, in humans, as the main cause of rare adverse events, such as epileptic-like convulsions, triggered by pertussis vaccine. Data review: the main components related to toxic effects of cellular pertussis vaccines are the lipopolysaccharide of bacterial cell wall and pertussis toxin. The removal of part of lipopolysaccharide layer has allowed the creation of a safer cellular pertussis vaccine, with costs comparable to the traditional cellular vaccine, and which may be a substitute for the acellular vaccine. Conclusion: The new methodology introduced by Instituto Butantan allows for the development of a new safer pertussis vaccine with low LPS content (Plow), and the use of the lipopolysaccharide obtained in the process in the production of monophosphoryl lipid A. This component has shown potent adjuvant effect when administered together with influenza inactivated vaccine, making possible to reduce the antigen dose, enhancing the production capacity and lowering costs.

Objetivo: Discutir as recomendações da WHO-OPAS que não consideram indicada a substituição da vacina DTP celular clássica pela DTP acelular e o papel de mutações, em humanos, como principal causa dos raros eventos de convulsões epileptiformes desencadeadas pela vacina pertussis. Revisão dos dados: Os principais componentes relacionados aos efeitos tóxicos da vacina pertussis celular são o lipopolissacarídio da parede celular da bactéria e a toxina pertussis. A remoção de parte da camada lipopolissacarídica permitiu a criação de uma vacina pertussis celular, mais segura e de custo comparável ao da vacina celular tradicional, podendo substituir a vacina pertussis acelular. Conclusão: A nova vacina pertussis, com baixo teor de LPS (Plow) desenvolvida pelo Instituto Butantan, além de oferecer uma vacina mais segura, permite o aproveitamento do lipopolissacarídeo para a produção de monofosforil lipídeo A. Esse componente mostrou-se potente como adjuvante e altamente eficiente quando administrado com a vacina de influenza, levando à possibilidade de se reduzir a dose de antígeno, aumentando a capacidade de produção e redução dos custos.

Associação entre meningite asséptica e uso da vacina tríplice viral(sarampo-caxumba-rubéola) durante campanha vacinal de 1997 / Association between aseptic meningitis and use of MMR vaccine, during the vaccination campaign, 1997

Em 1997 foi realizada uma campanha de vacinação em massa com a vacina tríplice víral (sarampo, caxumba, rubéola), em quatro Estados brasileiros: Rio Grande do Sul, Bahia, Piauí e Ceará. Três semanas após o principal dia de campanha, os diversos estados notificaram um aumento da incidência de casos de meningite asséptica (MA), especialmente nas capitais. Logo após, foi iniciada uma investigação desenvolvida pelos técnicos locais das Secretarias Estaduais de Saúde e por pesquisadores do Instituto de Saúde Coletiva e Faculdade de Medicina da Universidade Federal da Bahia, com apoio do Programa Nacional de Imunizações - PNI. Os resultados dessa investigação demonstram a existência de um surto de meningite asséptica que se iniciou de forma abrupta 2-3 semanas após a vacinação nas capitais estudadas, e persistiu por 4 semanas. Foi demonstrado que o maior risco após o uso da vacina correspondeu a 21-30 dias, quando comparado com o risco de MA antes da campanha. Apenas em Salvador o surto ocasionou um excessivo aumento da ocupação hospitalar. Esse texto discute os determinantes da ocorrência de um evento adverso na forma de um surto, as implicações sobre uma adequada assistência médica, e o impacto da informação sobre a adesão da população às vacinas empregadas pelo PNI

In 1997 a mass vaccination campaign with the measles, mumps and rubella vaccine was carried out in four Brazilian states: Rio Grande do Sul, Bahia, Piauí and Ceará. Three weeks after the special vaccination day, an increase was observed in the number of cases of aseptic meningitis in the capitals of the four states. An investigation was undertaken by health professionals from the State Health Secretaries, professionals from the Institute of Collective Health and the Medical School of the Federal University of Bahia with the support of the National Immunization Program. The results of the investigation demonstrated the occurrence of an outbreak of aseptic meningitis which initiated abruptly two to three weeks after the special vaccination day, with a total duration of four week. It was also shown that the risk of aseptic meningitis was greater 21-30 days after exposure to the vaccine when compared to the risk before the campaign. Only in Salvador the outbreak caused an excess of cases that extrapolated the admission capability of the reference hospital for infectious diseases. This work discusses the determinants of the outbreak, the implications for adequate medical assistance and the implications regarding societal credibility of the safety of the vaccines used in the routine vaccination calendar.