A rare skin reaction in an elderly woman after exposure to prophylaxis for rabies: A case report.

Introduction: Rabies is a zoonosis caused by viruses of the family Rhabdoviridae. Prophylaxis with the rabies vaccine and immunoglobulins, depending on the severity of the case, is recommended. After vaccination, mild, moderate, or severe adverse events (AE) are described. Although rare, severe skin reactions may occur, increasing the risk of anaphylaxis. Case report: An 84-year-old woman was attacked by a stray unknown cat, leaving her with bites and scratches in the neck region and multiple injuries. The case was classified as severe. About 3 h after the first dose of the rabies vaccine, disseminated purplish spots appeared on her lower limbs, worsening significantly after the second dose, requiring hospitalization for the application of the third dose under observation, dermatology evaluation, and collection of skin tissue for biopsy. She was discharged 24 h after the third vaccination, and the purple spots cleared gradually. The biopsy suggested an adverse reaction to the vaccine components. Immunohistochemistry of the rabies virus antigen in dermal nerve fillets was negative. The seroconversion post rabies vaccine showed IgG antibody values below the reference levels. Conclusion: Vaccination against rabies is extremely important; however, AEs may occur. Our patient developed an important AE and required hospitalization. After complete vaccination, the serum was not converted. A similar case was not previously described, and the case report is important for the creation of jurisprudence on rabies vaccination in elderly patients in Brazil.

Comprehensive landscape of neutralizing antibody and cell-mediated response elicited by the 1/5 fractional dose of 17DD-YF primary vaccination in adults.

The present study aimed at evaluating the YF-specific neutralizing antibody profile besides a multiparametric analysis of phenotypic/functional features of cell-mediated response elicited by the 1/5 fractional dose of 17DD-YF vaccine, administered as a single subcutaneous injection. The immunological parameters of each volunteer was monitored at two time points, referred as: before (Day 0) [Non-Vaccinated, NV(D0)] and after vaccination (Day 30-45) [Primary Vaccinees, PV(D30-45)]. Data demonstrated high levels of neutralizing antibodies for PV(D30-45) leading to a seropositivity rate of 93%. A broad increase of systemic soluble mediators with a mixed profile was also observed for PV(D30-45), with IFN-γ and TNF-α presenting the highest baseline fold changes. Integrative network mapping of soluble mediators showed increased correlation numbers in PV(D30-45) as compared to NV(D0) (532vs398). Moreover, PV(D30-45) exhibited increased levels of Terminal Effector (CD45RA+CCR7-) CD4+ and CD8+ T-cells and Non-Classical memory B-cells (IgD+CD27+). Dimensionality reduction of Mass Cytometry data further support these findings. A polyfunctional cytokine profile (TNF-α/IFN-γ/IL-10/IL-17/IL-2) of T and B-cells was observed upon in vitro antigen recall. Mapping and kinetics timeline of soluble mediator signatures for PV(D30-45) further confirmed the polyfunctional profile upon long-term in vitro culture, mediated by increased levels of IFN-γ and TNF-α along with decreased production of IL-10. These findings suggest novel insights of correlates of protection elicited by the 1/5 fractional dose of 17DD-YF vaccine.

[Brazilian Ministry of Health strategy to increase vaccination coverage at bordersEstrategia del Ministerio de Salud de Brasil para aumentar las tasas de cobertura de vacunación en las fronteras]. / Estratégia do Ministério da Saúde do Brasil para aumento das coberturas vacinais nas fronteiras.

Objective: Evaluate the implementation of the Ministry of Health's "Action Plan: Border Vaccination Strategy - Agenda 2022" in the Brazil's 33 twin cities and evaluate the increase in the country's vaccination coverage (VC). Methodology: Pre-post community clinical trial. Implementation of the strategy was analyzed, and pre- and post-intervention VC were compared in two stages: P1 (pre-intervention) and P2 (post-intervention). Based on statistical analyses of P1 and P2 coverage, calculations were made of municipal averages, standard deviation, and difference in VC between the two periods. Results: Integration was observed between the primary health care (PHC), surveillance, immunization, and special indigenous health district (DSEI) teams, although there were difficulties, for example, in relation to migratory flows. While immigration flows present challenges in the areas of immunization, PHC, and DSEI, the difficulties are compounded by the polarization of these services, which hinders intersectoral integration. After carrying out the workshops, a total of 50 977 doses were administered in the general population in the 33 twin cities. There was an increase in vaccination coverage in children up to 1 year of age in the locations evaluated after the intervention, which may be relevant in terms of increasing VC in Brazil. Conclusion: There was an increase in vaccination coverage in children up to 1 year of age in the locations evaluated after the intervention, helping to increase VC in Brazil.

Objetivo: Evaluar la aplicación de la Estrategia de Vacunación en las Fronteras - Agenda 2022, que forma parte del Plan de Acción del Ministerio de Salud en las 33 ciudades hermanas y evaluar el aumento de las tasas de cobertura de vacunación en Brasil. Métodos: Ensayo clínico comunitario realizado antes y después de la intervención correspondiente. Se analizó la aplicación de la estrategia y se compararon las tasas de cobertura de vacunación antes y después de la intervención en dos periodos: P1 (pre-intervención) y P2 (post-intervención). En los análisis estadísticos de la tasa de cobertura de vacunación en P1 y P2 se calcularon los valores de media y desviación estándar de los municipios y la diferencia entre las tasas de cobertura de los dos periodos. Resultados: Se observó una integración entre los equipos de Atención Primaria de Salud, Vigilancia, Inmunización y el Distrito Especial de Salud Indígena (DISEI), pero con dificultades, como las inherentes al flujo migratorio. Cabe destacar que el flujo migratorio es uno de los desafíos en el contexto de la inmunización, la atención primaria de salud y el DISEI, dificultad que se ve agravada por la polarización entre los servicios (inmunización, atención primaria de salud y el DISEI), lo que supone un reto para la integración de los sectores. Por lo que respecta al análisis de las tasas de cobertura de vacunación llevado a cabo después de realizar los talleres, se administró un total de 50 977 dosis a la población general en las 33 ciudades hermanas de Brasil. Hubo un aumento de las tasas de cobertura de vacunación de menores de hasta un año de edad en los lugares evaluados después de la intervención, lo que puede ser importante para aumentar las tasas de cobertura de Brasil. Conclusión: Después de la intervención hubo un aumento de las tasas de cobertura de vacunación de menores de hasta un año de edad en los lugares evaluados, lo cual influyó en el incremento de las tasas de cobertura de Brasil.

Immune response induced by standard and fractional doses of 17DD yellow fever vaccine.

The re-emergence of yellow fever (YF) urged new mass vaccination campaigns and, in 2017, the World Health Organization approved the use of the fractional dose (FD) of the YF vaccine due to stock shortage. In an observational cross-sectional investigation, we have assessed viremia, antibodies, soluble mediators and effector and memory T and B-cells induced by primary vaccination of volunteers with FD and standard dose (SD). Similar viremia and levels of antibodies and soluble markers were induced early after immunization. However, a faster decrease in the latter was observed after SD. The FD led to a sustained expansion of helper T-cells and an increased expression of activation markers on T-cells early after vaccination. Although with different kinetics, expansion of plasma cells was induced upon SD and FD immunization. Integrative analysis reveals that FD induces a more complex network involving follicular helper T cells and B-cells than SD. Our findings substantiate that FD can replace SD inducing robust correlates of protective immune response against YF.

Estratégia do Ministério da Saúde do Brasil para aumento das coberturas vacinais nas fronteiras / Brazilian Ministry of Health strategy to increase vaccination coverage at borders / Estrategia del Ministerio de Salud de Brasil para aumentar las tasas de cobertura de vacunación en las fronteras

[RESUMO]. Objetivo. Avaliar a implementação de estratégia do “Plano de Ação: Estratégia de Vacinação nas Fronteiras – Agenda 2022” do Ministério da Saúde nas 33 cidades gêmeas e avaliar o incremento das coberturas vacinais (CV) brasileiras. Métodos. Ensaio clínico comunitário, do tipo antes e depois. Analisou-se a realização da estratégia, bem como comparadas as CV pré e pós-intervenção em dois tempos: P1 (pré-intervenção) e P2 (pós-intervenção). Análises estatísticas sobre a CV, no P1 e P2, foram calculados os valores de média entres os municípios, desvio padrão e diferença entre as coberturas dos dois períodos. Resultados. Observou-se integração entre as equipes de Atenção Primária à Saúde (APS), Vigilância, Imunização e Distrito Sanitário Especial Indígena (DSEI), porém com dificuldades, como aquelas inerentes ao fluxo migratório. Ressalta-se que o fluxo imigratório é um dos desafios no contexto da imunização, APS e DSEI, entretanto, a esta dificuldade soma-se a polarização entre os serviços (imunização, APS e DISEI), ocasionando um desafio para a integração dos setores. Em relação à análise das CV, após a realização das oficinas, foram totalizadas 50 977 doses aplicadas na população geral nas 33 cidades-gêmeas do Brasil. Houve incremento das coberturas vacinais de crianças de até um ano de idade nos locais avaliados após a intervenção, o que pode ser importante para aumentar as CV no Brasil. Conclusão. Houve incremento das coberturas vacinais das crianças até um ano de idade nos locais avalia- dos após a intervenção e isso influenciou no aumento das CV no Brasil.

[ABSTRACT]. Objective. Evaluate the implementation of the Ministry of Health’s “Action Plan: Border Vaccination Strategy – Agenda 2022” in the Brazil’s 33 twin cities and evaluate the increase in the country’s vaccination coverage (VC). Methodology. Pre-post community clinical trial. Implementation of the strategy was analyzed, and pre- and post-intervention VC were compared in two stages: P1 (pre-intervention) and P2 (post-intervention). Based on statistical analyses of P1 and P2 coverage, calculations were made of municipal averages, standard deviation, and difference in VC between the two periods. Results. Integration was observed between the primary health care (PHC), surveillance, immunization, and special indigenous health district (DSEI) teams, although there were difficulties, for example, in relation to migratory flows. While immigration flows present challenges in the areas of immunization, PHC, and DSEI, the difficulties are compounded by the polarization of these services, which hinders intersectoral integration. After carrying out the workshops, a total of 50 977 doses were administered in the general population in the 33 twin cities. There was an increase in vaccination coverage in children up to 1 year of age in the locations evaluated after the intervention, which may be relevant in terms of increasing VC in Brazil. Conclusion. There was an increase in vaccination coverage in children up to 1 year of age in the locations evaluated after the intervention, helping to increase VC in Brazil.

[RESUMEN]. Objetivo. Evaluar la aplicación de la Estrategia de Vacunación en las Fronteras - Agenda 2022, que forma parte del Plan de Acción del Ministerio de Salud en las 33 ciudades hermanas y evaluar el aumento de las tasas de cobertura de vacunación en Brasil. Métodos. Ensayo clínico comunitario realizado antes y después de la intervención correspondiente. Se analizó la aplicación de la estrategia y se compararon las tasas de cobertura de vacunación antes y después de la intervención en dos periodos: P1 (pre-intervención) y P2 (post-intervención). En los análisis estadísticos de la tasa de cobertura de vacunación en P1 y P2 se calcularon los valores de media y desviación estándar de los municipios y la diferencia entre las tasas de cobertura de los dos periodos. Resultados. Se observó una integración entre los equipos de Atención Primaria de Salud, Vigilancia, Inmu- nización y el Distrito Especial de Salud Indígena (DISEI), pero con dificultades, como las inherentes al flujo migratorio. Cabe destacar que el flujo migratorio es uno de los desafíos en el contexto de la inmunización, la atención primaria de salud y el DISEI, dificultad que se ve agravada por la polarización entre los servicios (inmunización, atención primaria de salud y el DISEI), lo que supone un reto para la integración de los sectores. Por lo que respecta al análisis de las tasas de cobertura de vacunación llevado a cabo después de realizar los talleres, se administró un total de 50 977 dosis a la población general en las 33 ciudades hermanas de Brasil. Hubo un aumento de las tasas de cobertura de vacunación de menores de hasta un año de edad en los lugares evaluados después de la intervención, lo que puede ser importante para aumentar las tasas de cobertura de Brasil. Conclusión. Después de la intervención hubo un aumento de las tasas de cobertura de vacunación de menores de hasta un año de edad en los lugares evaluados, lo cual influyó en el incremento de las tasas de cobertura de Brasil.

Estratégia do Ministério da Saúde do Brasil para aumento das coberturas vacinais nas fronteiras / Brazilian Ministry of Health strategy to increase vaccination coverage at borders / Estrategia del Ministerio de Salud de Brasil para aumentar las tasas de cobertura de vacunación en las fronteras

RESUMO Objetivo. Avaliar a implementação de estratégia do "Plano de Ação: Estratégia de Vacinação nas Fronteiras - Agenda 2022" do Ministério da Saúde nas 33 cidades gêmeas e avaliar o incremento das coberturas vacinais (CV) brasileiras. Métodos. Ensaio clínico comunitário, do tipo antes e depois. Analisou-se a realização da estratégia, bem como comparadas as CV pré e pós-intervenção em dois tempos: P1 (pré-intervenção) e P2 (pós-intervenção). Análises estatísticas sobre a CV, no P1 e P2, foram calculados os valores de média entres os municípios, desvio padrão e diferença entre as coberturas dos dois períodos. Resultados. Observou-se integração entre as equipes de Atenção Primária à Saúde (APS), Vigilância, Imunização e Distrito Sanitário Especial Indígena (DSEI), porém com dificuldades, como aquelas inerentes ao fluxo migratório. Ressalta-se que o fluxo imigratório é um dos desafios no contexto da imunização, APS e DSEI, entretanto, a esta dificuldade soma-se a polarização entre os serviços (imunização, APS e DISEI), ocasionando um desafio para a integração dos setores. Em relação à análise das CV, após a realização das oficinas, foram totalizadas 50 977 doses aplicadas na população geral nas 33 cidades-gêmeas do Brasil. Houve incremento das coberturas vacinais de crianças de até um ano de idade nos locais avaliados após a intervenção, o que pode ser importante para aumentar as CV no Brasil. Conclusão. Houve incremento das coberturas vacinais das crianças até um ano de idade nos locais avaliados após a intervenção e isso influenciou no aumento das CV no Brasil.

ABSTRACT Objective. Evaluate the implementation of the Ministry of Health's "Action Plan: Border Vaccination Strategy - Agenda 2022" in the Brazil's 33 twin cities and evaluate the increase in the country's vaccination coverage (VC). Methodology. Pre-post community clinical trial. Implementation of the strategy was analyzed, and pre- and post-intervention VC were compared in two stages: P1 (pre-intervention) and P2 (post-intervention). Based on statistical analyses of P1 and P2 coverage, calculations were made of municipal averages, standard deviation, and difference in VC between the two periods. Results. Integration was observed between the primary health care (PHC), surveillance, immunization, and special indigenous health district (DSEI) teams, although there were difficulties, for example, in relation to migratory flows. While immigration flows present challenges in the areas of immunization, PHC, and DSEI, the difficulties are compounded by the polarization of these services, which hinders intersectoral integration. After carrying out the workshops, a total of 50 977 doses were administered in the general population in the 33 twin cities. There was an increase in vaccination coverage in children up to 1 year of age in the locations evaluated after the intervention, which may be relevant in terms of increasing VC in Brazil. Conclusion. There was an increase in vaccination coverage in children up to 1 year of age in the locations evaluated after the intervention, helping to increase VC in Brazil.

RESUMEN Objetivo. Evaluar la aplicación de la Estrategia de Vacunación en las Fronteras - Agenda 2022, que forma parte del Plan de Acción del Ministerio de Salud en las 33 ciudades hermanas y evaluar el aumento de las tasas de cobertura de vacunación en Brasil. Métodos. Ensayo clínico comunitario realizado antes y después de la intervención correspondiente. Se analizó la aplicación de la estrategia y se compararon las tasas de cobertura de vacunación antes y después de la intervención en dos periodos: P1 (pre-intervención) y P2 (post-intervención). En los análisis estadísticos de la tasa de cobertura de vacunación en P1 y P2 se calcularon los valores de media y desviación estándar de los municipios y la diferencia entre las tasas de cobertura de los dos periodos. Resultados. Se observó una integración entre los equipos de Atención Primaria de Salud, Vigilancia, Inmunización y el Distrito Especial de Salud Indígena (DISEI), pero con dificultades, como las inherentes al flujo migratorio. Cabe destacar que el flujo migratorio es uno de los desafíos en el contexto de la inmunización, la atención primaria de salud y el DISEI, dificultad que se ve agravada por la polarización entre los servicios (inmunización, atención primaria de salud y el DISEI), lo que supone un reto para la integración de los sectores. Por lo que respecta al análisis de las tasas de cobertura de vacunación llevado a cabo después de realizar los talleres, se administró un total de 50 977 dosis a la población general en las 33 ciudades hermanas de Brasil. Hubo un aumento de las tasas de cobertura de vacunación de menores de hasta un año de edad en los lugares evaluados después de la intervención, lo que puede ser importante para aumentar las tasas de cobertura de Brasil. Conclusión. Después de la intervención hubo un aumento de las tasas de cobertura de vacunación de menores de hasta un año de edad en los lugares evaluados, lo cual influyó en el incremento de las tasas de cobertura de Brasil.

Restoring High Vaccine Coverage in Brazil: Successes and Challenges

Facing the decline in vaccine coverage observed since 2016, the new Brazilian government committed to reversing this scenario. To achieve this, the Federal Government launched the National Vaccination Movement and the 'Health with Science' platform to combat vaccine misinformation, promoted Microplanning, providing tools for decision-making at the territorial level, allocated 30 million dollars to states and municipalities to implement innovative vaccination strategies, standardized the rules of the information systems for the registration of vaccine doses, and directed data to the National Health Data Network (RNDS). Reversing the declining trend of vaccination coverage in Brazil is challenging, but within just one year, it is possible to observe significant results from governmental actions. Out of the eight recommended vaccines by the age of one, seven showed an increase in vaccination coverage in 2023 compared to 2022: Most states showed improvements in vaccination coverage. Many challenges persist in advancing the vaccination agenda. However, there are reasons to celebrate the reversal of the declining trend in coverage of several vaccines in this first year of government and the increase in the number of municipalities that have fully achieved the vaccination coverage target. The National Vaccination Movement, with public opinion awareness, the resumption of regionalized communication campaigns, localized micro-planning actions including extramural vaccination strategies, and the integration of information systems, has been decisive in strengthening work in the territories and thus restoring a culture of immunization, a source of pride in the country and internationally recognized, throughout the 50 years of the National Immunization Program

Measles, mumps and rubella vaccine 12 months after hematopoietic stem cell transplantation

ABSTRACT The measles, mumps and rubella (MMR) vaccine is usually recommended from 24 months after a hematopoietic stem cell transplant (HSCT). Some authors have demonstrated that the MMR vaccination can be safe from 12 months post-HSCT in non-immunosuppressed patients, as recommended by the Brazilian National Immunization Program/Ministry of Health, since 2006. The objectives of this study were to evaluate when patients received MMR vaccine after an HSCT in our care service and if there were reports of any side effects. We retrospectively reviewed the records of HSCT recipients who received at least one MMR dose in our care service, a quaternary teaching hospital in Sao Paulo city, Brazil, from 2017 to 2021. We identified 82 patients: 75.6% (90.1% in the autologous group and 45.1% in the allogeneic group) were vaccinated before 23 months post-transplantation. None reported side effects following the vaccination. Our data support that the MMR vaccination is safe from 12 to 23 months after HSCT.

Hospitalizations for COVID-19 in a tertiary hospital in Brazil: a parallel with vaccination

ABSTRACT This study aimed to evaluate the COVID-19 hospitalizations in a tertiary hospital by age group and month, considering the introduction and the advance of the vaccination against the disease. The laboratory-confirmed COVID-19-associated hospitalizations among people aged 20 years or older, that occurred between March 2020 and June 2021, were distributed by month of symptom onset and age group. The proportion of hospitalizations by age group was calculated for the year 2021. The proportions were compared using the chi-square test for trends. The marks of vaccination advances among different age groups were taken from the official website LocalizaSUS. In 2020, hospitalizations among people aged 60-80 years old were the most frequent (39.1%). From January-June 2021, when the vaccination commenced, while hospitalizations of patients aged 20 to < 40 and 40 to 60 years old showed an increasing trend, the older age groups and those with vaccination recommendations (from 60 to < 80 and from 80 or over) showed a downward trend. As of June 2021, with widespread vaccination, a drop in hospitalizations was observed in > 60 years old. At 20 to <40 and 40 to < 60, an increase in hospitalizations was observed. It demonstrates the important role of vaccination in combating the COVID-19 pandemic.

Adverse event occurrence following use of tetanus, diphtheria and acellular pertussis adsorbed vaccine – Tdap –, São Paulo, SP, Brazil, 2015-2016 / Ocorrência de eventos adversos após o uso da vacina adsorvida difteria, tétano e pertussis (acelular) – dTpa –, São Paulo, SP, 2015-2016 / Aparecimiento de eventos adversos después del uso de la vacuna adsorbida difteria, tétanos y tosferina (acelular) – dTpa –, São Paulo, SP, Brasil, 2015-2016

Objective: to describe occurrence of adverse events following immunization (AEFI) with Tdap vaccine during pregnancy. Methods: this was a descriptive study using data from reports by participants in an effectiveness and immunogenicity study conducted in two hospitals in São Paulo, SP, Brazil, from 2015 to 2016. Results: of the 201 mothers included in the study, 48 (23.9%) had at least one AEFI; 60 symptoms related to Tdap use were identified – pain (22.4%), swelling (2.5%), fever (1.5%), somnolence (1.0%), redness (0.5%), vomiting (0.5%), headache (0.5%), local reaction (0.5%), and fatigue (0.5%); no rare, very rare, or extremely rare adverse events were reported; all events were considered to be expected, as they are described in the vaccine package insert; outcome of all events was recovery without sequelae. Conclusion: Tdap vaccine in the form adopted by the National Immunization Program is safe; no unexpected adverse events were identified among vaccinated pregnant women.

Objetivo: descrever a ocorrência de eventos adversos pós-vacinação (EAPV) com a vacina dTpa durante a gestação. Métodos: estudo descritivo, com dados de relatos das participantes de estudo de efetividade e imunogenicidade realizado em dois hospitais de São Paulo, SP, Brasil, entre 2015 e 2016. Resultados: das 201 mães incluídas no estudo, 48 (23,9%) apresentaram pelo menos um EAPV; foram identificados 60 sintomas relacionados ao uso da dTpa – dor (22,4%), inchaço (2,5%), febre (1,5%), sono (1,0%), vermelhidão (0,5%), vômito (0,5%), dor de cabeça (0,5%), reação local (0,5%) e cansaço (0,5%); não foram registrados eventos adversos raros, muito raros ou extremamente raros; todos os eventos foram considerados esperados e estão descritos em bula; todos tiveram desfecho para cura sem sequelas. Conclusão: a dTpa, na forma adotada pelo Programa Nacional de Imunizações (PNI), é segura; não foram identificados eventos adversos inesperados entre as gestantes imunizadas com a vacina.

Outbreak investigation in cargo ship in times of COVID-19 crisis, Port of Santos, Brazil / Investigação de surto em navio de carga em tempo de COVID-19, Porto de Santos, Brasil

ABSTRACT In February 2020, a Chinese cargo ship docked at the Port of Santos with reports of crew members with a feverish and respiratory condition. A team was gathered to verify the existence of suspected cases of COVID-19 inside the vessel and define its clearance. All 25 crew members were interviewed, and no suspected cases were found. The vessel was then cleared for port activities. The investigation resulted from the implementation of the contingency plan to face a public health emergency of international importance and several surveillance entities cooperated.

RESUMO Em fevereiro de 2020, um navio de carga vindo da China atracou no Porto de Santos com relato de tripulantes com quadro febril e respiratório. Uma equipe foi mobilizada para verificar a existência de casos suspeitos de COVID-19 dentro da embarcação e definir a liberação da embarcação no porto. Todos os 25 tripulantes foram entrevistados e não foram encontrados casos suspeitos. Então a embarcação foi liberada para atividades no porto. A investigação resultou da aplicação do plano de contingência diante de uma emergência de saúde pública de importância internacional e houve a colaboração de diversas entidades de vigilância.

Outbreak investigation in cargo ship in times of COVID-19 crisis, Port of Santos, Brazil

In February 2020, a Chinese cargo ship docked at the Port of Santos with reports of crew members with a feverish and respiratory condition. A team was gathered to verify the existence of suspected cases of COVID-19 inside the vessel and define its clearance. All 25 crew members were interviewed, and no suspected cases were found. The vessel was then cleared for port activities. The investigation resulted from the implementation of the contingency plan to face a public health emergency of international importance and several surveillance entities cooperated. DESCRIPTORS: Coronavirus Infections, epidemiology. Coronavirus Infections, prevention & control. Ships. International Health Regulations.

Ocorrência de eventos adversos após o uso da vacina adsorvida difteria, tétano e pertussis (acelular) - dTpa -, São Paulo, SP, 2015-2016 / Aparecimiento de eventos adversos después del uso de la vacuna adsorbida difteria, tétanos y tosferina (acelular) - dTpa -, São Paulo, SP, Brasil, 2015-2016 / Adverse event occurrence following use of tetanus, diphtheria and acellular pertussis adsorbed vaccine - Tdap -, São Paulo, SP, Brazil, 2015-2016

Objetivo: descrever a ocorrência de eventos adversos pós-vacinação (EAPV) com a vacina dTpa durante a gestação. Métodos: estudo descritivo, com dados de relatos das participantes de estudo de efetividade e imunogenicidade realizado em dois hospitais de São Paulo, SP, Brasil, entre 2015 e 2016. Resultados: das 201 mães incluídas no estudo, 48 (23,9%) apresentaram pelo menos um EAPV; foram identificados 60 sintomas relacionados ao uso da dTpa - dor (22,4%), inchaço (2,5%), febre (1,5%), sono (1,0%), vermelhidão (0,5%), vômito (0,5%), dor de cabeça (0,5%), reação local (0,5%) e cansaço (0,5%); não foram registrados eventos adversos raros, muito raros ou extremamente raros; todos os eventos foram considerados esperados e estão descritos em bula; todos tiveram desfecho para cura sem sequelas. Conclusão: a dTpa, na forma adotada pelo Programa Nacional de Imunizações (PNI), é segura; não foram identificados eventos adversos inesperados entre as gestantes imunizadas com a vacina.

Objetivo: describir el aparecimiento de eventos adversos posvacunación (EAPV) con la vacuna dTpa durante el embarazo. Métodos: estudio descriptivo con datos de relatos de las participantes del estudio de efectividad e inmunogenicidad realizado en dos hospitales de São Paulo, SP, Brasil, entre 2015 y 2106. Resultados: de las 201 madres del estudio, 48 (23,9%) tuvieron al menos un EAPV; se identificaron 60 síntomas relacionados al uso de dTpa - dolor (22.4%), hinchazón (2.5%), fiebre (1.5%), somnolencia (1.0%), enrojecimiento (0.5%), vómitos (0.5 %), dolor de cabeza (0.5%), reacción local (0.5%) y cansancio (0.5%) -; no se informaron eventos adversos raros, muy raros o extremadamente raros; todos los eventos se consideraron esperados y se describen en el prospecto; todos tuvieron resultados curativos sin secuelas. Conclusión: el estudio mostró que la vacuna dTpa utilizada por el Programa Nacional de Inmunización (PNI) es segura y no se identificaron eventos adversos inesperados entre las mujeres embarazadas vacunadas.

Objective: to describe occurrence of adverse events following immunization (AEFI) with Tdap vaccine during pregnancy. Methods: this was a descriptive study using data from reports by participants in an effectiveness and immunogenicity study conducted in two hospitals in São Paulo, SP, Brazil, from 2015 to 2016. Results: of the 201 mothers included in the study, 48 (23.9%) had at least one AEFI; 60 symptoms related to Tdap use were identified - pain (22.4%), swelling (2.5%), fever (1.5%), somnolence (1.0%), redness (0.5%), vomiting (0.5%), headache (0.5%), local reaction (0.5%), and fatigue (0.5%); no rare, very rare, or extremely rare adverse events were reported; all events were considered to be expected, as they are described in the vaccine package insert; outcome of all events was recovery without sequelae. Conclusion: Tdap vaccine in the form adopted by the National Immunization Program is safe; no unexpected adverse events were identified among vaccinated pregnant women.

Hospital-based surveillance of intussusception among infants / Vigilância hospitalar de intussuscepção entre neonatos

Abstract Objective: Intussusception surveillance was initiated after the nationwide introduction of live attenuated monovalent rotavirus vaccine (RV1). The objective is to assess the epidemiology of intussusception and compare the number of cases before and after the introduction of rotavirus vaccine. Methods: Cases of intussusception occurring between March 2006 and January 2008 were identified through a prospective enhanced passive surveillance system established in sentinel state hospitals. Retrospective review of medical records was used to identify cases, which occurred in sentinel hospitals between January 2001 and February 2006. Results: From 2001 to 2008, 331 intussusception cases were identified, 59.5% were male, with peak incidence among those 18–24 weeks of age. Overall <10% of cases were among infants 6–14 weeks of age (when the first dose of RV1 is administered). The most frequently observed signs or symptoms of intussusception included vomiting (89.4%), bloody stool (75.5%), and abdominal distention (71.8%). A majority (92.1%) of the case-patients required surgery for treatment; 31.8% of those who underwent surgery required bowel resection, and 13 (3.9%) died. Among the 21 hospitals that reported cases throughout the entire surveillance period (2001–2008), the number of intussusception events during 2007 (n = 26) and 2008 (n = 19) was not greater than the average annual number (n = 31, range 24–42) during baseline years 2001–2005. Conclusions: Although this analysis did not identify an increase in intussusception cases during the two years after RV1 introduction, these results support the need for special epidemiologic methods to assess the potential link between rotavirus vaccine and this very rare adverse event.

Resumo Objetivo: A vigilância da intussuscepção foi iniciada após a introdução da vacina monovalente viva atenuada contra rotavírus (RV1) em todo o país. O objetivo é avaliar a epidemiologia da intussuscepção e comparar a quantidade de casos antes e depois da introdução da vacina contra rotavírus. Métodos: Os casos de intussuscepção entre março de 2006 e janeiro de 2008 foram identificados por meio de um sistema de vigilância passivo prospectivo aprimorado estabelecido em hospitais-sentinela estaduais. A análise retrospectiva de prontuários médicos foi usada para identificar os casos que ocorreram em hospitais-sentinela entre janeiro de 2001 e fevereiro de 2006. Resultados: De 2001-2008, identificamos 331 casos de intussuscepção, 59,5% dos quais ocorreram em pacientes do sexo masculino, com pico de incidência entre aqueles com 18-24 semanas de idade. Em geral, < 10% dos casos ocorreram entre neonatos com 6-14 semanas de idade (quando a 1a dose de RV1 é administrada). Os sinais ou sintomas de intussuscepção observados com mais frequência incluíam vômito (89,4%), fezes com sangue (75,5%) e distensão abdominal (71,8%). A maioria (92,1%) dos pacientes precisou de cirurgia para o tratamento; 31,8% dos que se submeteram à cirurgia precisaram de ressecção intestinal e 13 (3,9%) vieram a óbito. Entre os 21 hospitais que relataram casos durante todo o período de vigilância (2001-2008), a quantidade de casos de intussuscepção em 2007 (n = 26) e 2008 (n = 19) não foi maior do que a quantidade média anual (31, faixa de 24-42) durante os anos-base de 2001-2005. Conclusões: Embora esta análise não tenha identificado um aumento nos casos de intussuscepção nos dois anos após a introdução da RV1, esses resultados justificam a necessidade de métodos epidemiológicos especiais para avaliar a possível associação entre a vacina contra rotavírus e esse evento adverso muito raro.