Vaccination in pregnancy. Consensus document of the CAV-AEP and the SEGO.

During pregnancy, physiological changes in the immune response make pregnant women more susceptible to serious infection, increasing the risk for the mother as well as the foetus, newborn and infant. All women should be correctly and fully vaccinated as they enter their reproductive years, especially against diseases such as tetanus, hepatitis B, measles, rubella and varicella. In addition to the recommended vaccines, in risk situations, inactivated vaccines could be administered to women who were not correctly vaccinated before, while attenuated vaccines are contraindicated. Despite the fact that vaccination during pregnancy is a very important preventive measure and the existing recommendations from public health authorities, scientific societies and health professionals, the vaccination coverage could clearly be improved, especially against influenza and SARS-CoV-2, so any health professional involved in the care of pregnant women should proactively recommend these vaccines. The Spanish Association of Pediatrics (AEP), through its Advisory Committee on Vaccines, and the Spanish Society of Gynaecology and Obstetrics (SEGO) recommend vaccination against the following diseases during pregnancy: against influenza and COVID-19, in any trimester of pregnancy and during the postpartum period (up to 6 months post birth) in women not vaccinated during pregnancy; against pertussis, with the Tdap vaccine, between weeks 27 and 36 of gestation (in the CAV-AEP recommendations, preferably between weeks 27 and 28); and against RSV, with RSVPreF, between weeks 24 and 36 of gestation, preferably between weeks 32 and 36.

Effectiveness of influenza vaccine in preventing severe cases of influenza: Season 2022/2023.

INTRODUCTION: Influenza poses a significant burden in terms of morbidity and mortality, with vaccination being one of the most effective measures for its prevention. Therefore, the aim of this study is to determine the effectiveness of the influenza vaccine in preventing cases of severe influenza in patients admitted to a tertiary hospital during the 2022/23 season. METHODS: Case-control study. All hospitalised patients with a positive result in an RT-PCR for influenza were included. Those who met the criteria for a severe case (pneumonia, sepsis, multi-organ failure, admission to ICU or exitus) were considered cases. Those who did not meet these criteria were considered controls. Vaccine effectiveness (VE) to prevent severe cases and its 95% confidence interval were calculated. RESULTS: A total of 403 patients were admitted with confirmed influenza. Of these, 98 (24.3%) developed severe influenza. Of the total, 50.6% were men and 47.1% were over 65 years of age. VE adjusted for influenza type, age and certain comorbidities was 40.6% (-21.9 to 71.1). In a segmented analysis, influenza vaccine was effective in preventing severe cases in all categories. It was particularly relevant in the 65+ age group (VEa = 60.9%; -2.0 to 85.0) and in patients with influenza A (VEa = 56.7%; 1.5-80.9). CONCLUSION: Influenza vaccination markedly reduced the occurrence of severe cases of influenza in hospitalised patients, therefore, it remains the main strategy to reduce morbidity and mortality and associated costs.

Respiratory syncytial virus infection in adults: Differences with influenza.

INTRODUCTION: Respiratory syncytial virus (RSV) causes an acute respiratory illness similar to influenza, although there are few data comparing both of them in adults. The existence of clinical differences between these two infections could have implications for their management. MATERIALS AND METHODS: Retrospective observational cohort study including 63 adults with positive PCR for RSV and 221 for influenza during winter 2018-2019. Epidemiological, clinical characteristics and outcomes were contrasted between both groups. RESULTS: Compared to influenza, RSV-positive patients presented a higher association with active neoplasia (OR=2.9; 95% CI: 1.2-6.9), dependence for basic activities of daily living (OR=3.4; 95% CI: 1.4-8.2) and immunosuppression due to chronic glucocorticoid administration (OR=7.6; 95% CI: 1.6-36.1). At diagnosis, fever was less common (OR=0.3; 95% CI: 0.2-0.7), and C-reactive protein level ≥100mg/l was more frequent (OR=2.1; 95% CI: 1.0-4.5). They developed bacterial co-infection by Staphylococcus aureus in a higher proportion (OR=8.3; 95% CI: 1.5-46.9) and presented a greater need for admission to the intensive care unit (OR=5.4; 95% CI: 1.4-19.2). CONCLUSION: RSV is an important cause of respiratory illness in adults during the influenza season. It especially affects vulnerable patients with chronic underlying diseases, and has a higher morbidity than influenza. For all these reasons, specific detection, prevention and treatment of RSV is necessary in order to reduce the consumption of health care resources due to RSV disease in adults.

[Adaptation and validation of the MoVac-flu scale on motivation towards the flu vaccine]. / Adaptación y validación de la escala MoVac-flu sobre motivación hacia la vacuna de la gripe.

OBJECTIVE: To translate, adapt and validate the psychometric properties of MoVac-flu scale in order to be used in Spanish. METHOD: The present research was an analytical observational study of cross-cultural adaptation and validation into Spanish of the MoVac-flu scale. It has been carried out between the months of March and July 2022. The sample size was 142 people who were obtained by consecutive sampling. The processes used for the adaptation have been translation, validation by a committee of experts, back-translation and pilot test. For validation, the psychometric properties of reliability, internal consistency, appearance validity, content validity, utility and ceiling-floor effect have been verified. RESULTS: The internal consistency of the MoVac-flu scale in its version translated into Spanish was high, showing a McDonald's ω of 0.914. CONCLUSIONS: The MoVac-flu scale in Spanish allows to measure the degree of motivation towards vaccination against influenza in the adult population.

Vaccination trends in people with HIV infection participanting in the hospital-based survey of patients infected with HIV, 2006-2021.

OBJECTIVE: To assess the trend in hepatitis A, hepatitis B, pneumococcal, tetanus and seasonal influenza vaccination in people with HIV infection and to analyse associated factors. METHODS: The Hospital Survey of Patients with HIV, an annual cross-sectional study conducted on a fixed day (2006-2021), was used. Inpatients and outpatients were included. Trends in vaccination and associated factors were analysed using logistic regression. RESULTS: A total of 8643 participants were included. Vaccination rates increased to 65.3% for hepatitis A, 83.7% for hepatitis B, 49.3% for tetanus, 68.9% for pneumococcal and 74.5% for seasonal influenza in 2021. Factors positively associated with vaccination were older age for pneumococcal and influenza vaccination; higher educational level for hepatitis A and tetanus; living in a closed institutions or prison for tetanus, pneumococcal and influenza; and having acquired HIV through sex between men for hepatitis A, B and pneumococcal. In addition, being on antiretroviral treatment and having a high CD4 count were positively associated with vaccination for all these diseases. Factors inversely associated with vaccination were being older (hepatitis A, B and tetanus), being an immigrant (tetanus and seasonal influenza) and being an injection drug user/ex-user for hepatitis A and B. CONCLUSIONS: Vaccination in people with HIV has increased in the study period. The results are in line with the recommendations in this population, although there is still room to reach the established vaccination indicators.

Old and new aspects of influenza. / Nuevos y viejos aspectos de la gripe.

Influenza is a classic infectious disease that, through the continuous variation of the viruses that produce it, imposes new challenges that we must solve as quickly as possible. The COVID-19 pandemic has substantially modified the behavior of influenza and other respiratory viruses, and in the coming years we will have to coexist with a new pathogen that will probably interact with existing pathogens in a way that we cannot yet glimpse. However, knowledge prior to the pandemic allows us to focus on the aspects that must be modified to make influenza an acceptable challenge for the future. In this review, emphasis is placed on the most relevant aspects of epidemiology, disease burden, diagnosis, and vaccine prevention, and how scientific and clinical trends in these aspects flow from the previously known to future challenges.

O lampejo dos rastros nos intervalos da montagem: notas metodológicas sobre a incursão em arquivos concernentes à febre amarela e à gripe espanhola / The flash of traces in the montage intervals: methodological notes on the incursion into Yellow Fever and Spanish Flu archives / El destello de los rastros en los intervalos del montaje: apuntes metodológicos sobre la incursión en archivos concernientes a la fiebre amarilla y a la gripe española

No presente artigo, tecemos reflexões e apresentamos conceitos que têm orientado uma pesquisa nos registros de arquivos sobre a febre amarela e a gripe espanhola, nos acervos da Fundação Oswaldo Cruz, da Biblioteca Nacional e do Arquivo Nacional. A pesquisa é centrada na busca dos rastros e das ruínas desses eventos epidêmicos, mediante o método da montagem e com a perspectiva do limiar. Buscamos, por meio dessas materialidades, criar intervalos, experimentar e tecer brechas que prefiguram outros possíveis. Defendemos que, ao manejar, por meio da fabulação crítica, as formas como uma epidemia se faz aparecer, habilitamos a elaboração de uma imaginação política capaz de conferir ao futuro outras possibilidades e outros agenciamentos que não sejam a catástrofe e a melancolia

In this article we reflect on the presented concepts that have guided research in the archival records of Yellow Fever and Spanish Flu in the collections of the Fundação Oswaldo Cruz (Oswaldo Cruz Foundation), the Biblioteca Nacional (National Library), and the Arquivo Nacional (National Archive). The research is centered on the search for the traces and ruins of those epidemic events, through the method of montage and from the perspective of the threshold. We seek, by means of these materialities, to create intervals, to experiment, and to weave gaps that prefigure other possibilities. We argue that, by coping with, through critical fabulation, the ways in which an epidemic makes itself appear, we enable the elaboration of a political imagination capable of giving the future other possibilities and arrangements that are not the catastrophe and the melancholy

En el presente artículo hacemos reflexiones y presentamos conceptos que han guiado una investigación sobre los registros archivísticos de la fiebre amarilla y la gripe española en los acervos de la Fundação Oswaldo Cruz (Fundación Oswaldo Cruz), de la Biblioteca Nacional (Biblioteca Nacional y del Arquivo Nacional (Archivo Nacional). La investigación se centra en la búsqueda de los rastros y las ruinas de esos eventos epidémicos, mediante el método del montaje y la perspectiva del umbral. Buscamos, por medio de estas materialidades, crear intervalos, experimentar y tejer brechas que prefiguren otras posibilidades. Argumentamos que manejando, a través de la fabulación crítica, las formas en que se hace aparecer una epidemia, posibilitamos la elaboración de una imaginación política que dé al futuro otras posibilidades y disposiciones que no sean la catástrofe y la melancolía

[Evaluation of a community-based intervention to increase influenza vaccination coverage in pregnant women]. / Evaluación de una intervención comunitaria para incrementar la cobertura vacunal de la gripe en mujeres embarazadas.

OBJECTIVE: To know the impact of the educational intervention carried out on the professionals of a basic health area and their community participation group, which make up the intervention group (IG), and to analyze its repercussion on the vaccination coverage achieved for influenza in the risk group (pregnant and puerperal women) comparing it with its neighboring basic zone, which makes up the control group (CG), during the 2019/20 vaccination season. DESIGN: Quasi-experimental study of community intervention. SITE: Two basic health zones belonging to the Elche-Crevillente health department, Spain. PARTICIPANTS: Pregnant and postpartum women from 2 basic health areas and the community participation group. Health professionals directly related to the flu vaccination campaign. INTERVENTIONS: Training session for the IG prior to the 2019/20 flu campaign. MAIN MEASUREMENTS: Attitudes towards influenza vaccination in health professionals through the validated CAPSVA questionnaire and the vaccination coverage of pregnant and postpartum women through the Nominal Vaccine Registry and their acceptance of the vaccine in the midwife's office. RESULTS: The influenza vaccination coverage data recorded in Nominal Vaccine Registry for pregnant and puerperal women was 26.4% (n=207) in the IG and 19.7% (n=144) in the CG (p=0.001), with an incidence ratio of 1.34, thus achieving 34% more vaccination in the IG. Acceptance for vaccination in the midwife's office was also high, with 96.5% immunization in IG vs. 89.0% in CG, with a RR=1.09 (95% CI 1.01-1.62). CONCLUSIONS: Joint training strategies for professionals and community assets improve the results of vaccination coverage.

Executive summary - Diagnosis, treatment and prophylaxis of influenza virus infection - Consensus statement of the Spanish Society of Infectious Diseases and Clinical Microbiology (SEIMC), the Spanish Society of Pediatric Infectious Diseases (SEIP), the Spanish Association of Vaccinology (AEV), the Spanish Society of Family and Community Medicine (SEMFYC) and the Spanish Society of Preventive Medicine, Public Health and Health Management (SEMPSPGS).

The influenza virus has accompanied humans since time immemorial, in the form of annual epidemics and occasional pandemics. It is a respiratory infection with multiple repercussions on people's lives at an individual and social level, as well as representing a significant burden on the health system. This Consensus Document arises from the collaboration of various Spanish scientific societies involved in influenza virus infection. The conclusions drawn are based on the highest quality evidence available in the scientific literature and, failing that, on the opinion of the experts convened. The Consensus Document addresses the clinical, microbiological, therapeutic, and preventive aspects (with respect to the prevention of transmission and in relation to vaccination) of influenza, for both adult and pediatric populations. This Consensus Document aims to help facilitate the clinical, microbiological, and preventive approach to influenza virus infection and, consequently, to reduce its important consequences on the morbidity and mortality of the population.

Efecto de la vacunación contra la influenza en pacientes con enfermedad cardiovascular: un metaanálisis actualizado de ensayos clínicos controlados aleatorizados / Effect of Influenza Vaccination in Patients with Cardiovascular Disease: An Updated Meta- Analysis of Randomized Controlled Trials

RESUMEN Introducción : La influenza es una causa importante de morbilidad y mortalidad en pacientes con enfermedades cardiovasculares (ECV). El objetivo de esta revisión sistemática actualizada y metaanálisis fue evaluar los efectos de la vacunación contra la influenza (VI) sobre la mortalidad y morbilidad en pacientes adultos con ECV. Métodos : Se realizó una revisión sistemática y un metaanálisis (PubMed, Cochrane Library, International Clinical Trials Registry Platform, y búsqueda manual en presentaciones en congresos de la especialidad), de ensayos clínicos aleatorizados publicados hasta abril de 2022 que investigaron si la VI reduce la mortalidad por todas las causas en pacientes adultos con ECV, incluyendo insuficiencia cardíaca (IC) y enfermedad de las arterias coronarias (EAC), en comparación con pacientes que no fueron vacunados. Resultados : Se analizaron un total de seis ensayos clínicos, que incluyeron 9316 pacientes. Cinco ensayos incluyeron pacientes con EAC, y uno con IC. El seguimiento medio fue de 16 ± 9,7 meses. La VI se asoció con una reducción de la mortalidad en comparación con el control, cociente de riesgos (RR) 0,67, intervalo de confianza del 95% (IC95%) 0,47-0,95; p = 0,03; I2 = 53%; y con una reducción de la mortalidad cardiovascular en comparación con el control, RR 0,64, IC95% 0,44-0,94; p = 0,02; I2 = 54%. El uso de la VI se asoció con una reducción no estadísticamente significativa de infarto de miocardio en comparación con el control, RR 0,82, IC95% 0,60-1,12; p = 0,57; I2 = 0%. Conclusión : En este metaanálisis de seis ensayos controlados aleatorizados, la VI se asoció con una reducción del riesgo relativo del 33% y del 36% de la mortalidad por todas las causas y cardiovascular, respectivamente, en pacientes con ECV. Intentamos promover un consenso con respecto a los beneficios persistentes de la vacuna contra la influenza en pacientes con ECV, incluyendo dos nuevos ensayos clínicos en EAC e IC, donde se confirma la asociación de la vacunación con la reducción de riesgo en sujetos con ECV.

ABSTRACT Background : Influenza is a major cause of morbidity and mortality in patients with cardiovascular disease (CVD). The aim of this updated systematic review and meta-analysis was to evaluate the effect of influenza vaccination (IV) on morbidity and morbidity in adult patients with CVD. Methods : We conducted a systematic review and meta-analysis (PubMed, Cochrane Library, International Clinical Trials Registry Platform, and manual search of conference presentations) of randomized clinical trials published up to April 2022 analyzing whether IV reduced all-cause mortality in adult patients with CVD, including heart failure (HF) and coronary artery disease (CAD), compared with patients who were not vaccinated. Results : A total of six clinical trials comprising 9316 patients were analyzed. Five trials included CAD patients, and one trial included HF patients. Mean follow-up was 16 ± 9.7 months. Influenza vaccine was associated with a reduction of mortality compared to controls: relative risk (RR) 0.67 (95% CI, 0.47-0.95), p = 0.03; I2 = 53%, and with reduction of cardiovascular mortality compared to controls: RR 0.64 (95% CI, 0.44-0.94), p = 0.02; I2 = 54%. There was a non-statistically significant reduction in myocardial infarction compared to control: RR 0.82 (95% CI, 0.60-1.12), p = 0.57; I2 = 0%. Conclusion : In this meta-analysis of six randomized controlled clinical trials, IV was associated with a 33% and 36% relative risk reduction of all-cause mortality and cardiovascular mortality, respectively, in patients with CVD. We sought to promote consensus about the persistent benefits of influenza vaccination in patients with CVD by including two new clinical trials in CAD and HF, confirming the association of vaccination with risk reduction in subjects with CVD.

COVID-19, Virtual Engagement and the Psychoid Imagination.

The impact of the COVID-19 pandemic on analytic training and the delivery of educational content is explored here. The proliferation of Zoom therapy and teaching is creating a post-human platform to which nearly everyone in contemporary society has had to adapt. Looking at the possible meanings of the pandemic, a psychoid factor (the virus) engaging the imagination has come to the fore as a response to climate change. The striking similarity to the H1N1 viral pandemic ("Spanish flu") is noted, especially in the context of C. G. Jung having had a case in 1919 during which he experienced a number of visions and dreams. The imagery produced can be seen as an implicit attempt at "re-enchanting the world" found in The red book. Finally, a reconsideration of pedagogy in response to the pandemic is discussed with an eye to the archetypal aspects of internet communications.

Cet article étudie l'impact de la pandémie de COVID-19 sur la formation des analystes et sur la manière dont le contenu éducatif est dispensé. La prolifération de thérapie et de formation par Zoom crée une plateforme post-humaine à laquelle quasiment toute personne dans la société contemporaine a eu à s'adapter. En regardant les sens possibles que l'on peut donner à la pandémie, un facteur psychoïde (le virus) qui mobilise l'imagination a pris le devant de la scène en tant que réponse au changement climatique. L'article souligne la similarité frappante avec la pandémie virale H1N1 (la grippe espagnole), particulièrement dans le contexte où C.G. Jung l'a attrapée en 1919 et a fait l'expérience d'un certain nombre de visions et de rêves. L'imagerie produite peut être vue comme une tentative implicite de « ré-enchanter le monde ¼ telle qu'on la trouve dans le Livre Rouge. En conclusion, une reconsidération de la pédagogie issue de la pandémie est discutée en tenant compte des aspects archétypaux des communications par internet.

Se exploran aquí las repercusiones de la pandemia de COVID-19 en la formación analítica y en la transmisión de contenidos educativos. La proliferación de la terapia y la enseñanza vía Zoom está creando una plataforma posthumana a la que casi todo el mundo en la sociedad contemporánea ha tenido que adaptarse. En cuanto a los posibles significados de la pandemia, un factor psicoide (el virus) que atrae la imaginación ha pasado a primer plano como respuesta al cambio climático. Se observa la sorprendente similitud con la pandemia viral H1N1 ("gripe española"), especialmente en el contexto de un caso que C.G. Jung tuvo en 1919 durante el cual experimentó una serie de visiones y sueños. La imaginería producida puede verse como un intento implícito de "reencantar el mundo" que se encuentra en El Libro Rojo. Por último, se plantea una reconsideración de la pedagogía en respuesta a la pandemia, teniendo en cuenta los aspectos arquetípicos de las comunicaciones por Internet.

Executive summary. Diagnosis, treatment and prophylaxis of influenza virus infection. Consensus statement of the Spanish Society of Infectious Diseases and Clinical Microbiology (SEIMC), the Spanish Society of Pediatric Infectious Diseases (SEIP), the Spanish Association of Vaccinology (AEV), the Spanish Society of Family and Community Medicine (SEMFYC) and the Spanish Society of Preventive Medicine, Public Health and Health Management (SEMPSPGS).

The influenza virus has accompanied humans since time immemorial, in the form of annual epidemics and occasional pandemics. It is a respiratory infection with multiple repercussions on people's lives at an individual and social level, as well as representing a significant burden on the health system. This Consensus Document arises from the collaboration of various Spanish scientific societies involved in influenza virus infection. The conclusions drawn are based on the highest quality evidence available in the scientific literature and, failing that, on the opinion of the experts convened. The Consensus Document addresses the clinical, microbiological, therapeutic, and preventive aspects (with respect to the prevention of transmission and in relation to vaccination) of influenza, for both adult and pediatric populations. This Consensus Document aims to help facilitate the clinical, microbiological, and preventive approach to influenza virus infection and, consequently, to reduce its important consequences on the morbidity and mortality of the population.

Executive summary. Diagnosis, treatment and prophylaxis of influenza virus infection. Consensus statement of the Spanish Society of Infectious Diseases and Clinical Microbiology (SEIMC), the Spanish Society of Pediatric Infectious Diseases (SEIP), the Spanish Association of Vaccinology (AEV), the Spanish Society of Family and Community Medicine (SEMFYC) and the Spanish Society of Preventive Medicine, Public Health and Health Management (SEMPSPGS).

The influenza virus has accompanied humans since time immemorial, in the form of annual epidemics and occasional pandemics. It is a respiratory infection with multiple repercussions on people's lives at an individual and social level, as well as representing a significant burden on the health system. This Consensus Document arises from the collaboration of various Spanish scientific societies involved in influenza virus infection. The conclusions drawn are based on the highest quality evidence available in the scientific literature and, failing that, on the opinion of the experts convened. The Consensus Document addresses the clinical, microbiological, therapeutic, and preventive aspects (with respect to the prevention of transmission and in relation to vaccination) of influenza, for both adult and pediatric populations. This Consensus Document aims to help facilitate the clinical, microbiological, and preventive approach to influenza virus infection and, consequently, to reduce its important consequences on the morbidity and mortality of the population.

Efficacy and effectiveness of influenza vaccination in healthy children. A review of current evidence.

Influenza is common in healthy children and adolescents and is associated with a high rate of hospitalization in this group, especially for those <5 years. Although the WHO has recommended vaccination in children under 5 years of age since 2012, it is really implemented in few countries today. The aim of this paper was to review the available evidence on the efficacy/effectiveness of influenza vaccination in healthy children <18 years of age through a non-systematic search of studies conducted between 2010 and 2020. Despite the high variability in results due to differences in design, vaccine type and season included in the 41 selected studies, statistically significant studies show efficacy values for the influenza vaccine of between 25.6% and 74.2%, and effectiveness from 26% to 78.8%. Although a systematic review would be necessary to corroborate the evidence, this review suggests that paediatric vaccination is generally an effective measure for preventing influenza in healthy children in line with international organisms' recommendations.

The new generation of messenger RNA (mRNA) vaccines against influenza.

Today there are multiple types of flu vaccines. The emergence of nucleic acid technology used in vaccines against SARS-CoV-2 suggests its future application against this infection. Against influenza, two types of vaccines have been developed based on messenger RNA (mRNA): conventional or non-replicative and self-amplifying or replicative (auRNA), both included in lipid nanoparticles. Animal studies carried out with the former have shown their strong capacity to induce Th-1 antibodies and cellular immunity against influenza haemagglutinin (HA) with few side effects. Human trials have shown 87% seroconversion and 100% seroprotection. The auRNA vaccines have obtained similar results in animals but at a concentration 64 times lower than the conventional one. Vaccines based on mRNA platforms meet the WHO requirements for next generation influenza vaccines.

Impact and characteristics of hospital-acquired influenza over 10 seasons in a third-level university hospital.

OBJECTIVES: To analyze the characteristics of patients with nosocomial flu, to compare them with patients with community-acquired influenza to study possible differences and to identify possible risk factors associated with this type of flu. PATIENTS AND METHODS: Observational, cross-sectional and retrospective study of hospitalized patients with a microbiological confirmation of influenza in a third-level university hospital over 10 seasons, from 2009 to 2019. Nosocomial influenza was defined as that infection whose symptoms began 72h after hospital admission, and its incidence, characteristics and consequences were further analyzed. RESULTS: A total of 1260 hospitalized patients with a microbiological diagnosis of influenza were included, which 110 (8.7%) were nosocomial. Patients with hospital-acquired influenza were younger (71.74±16.03 years, P=0.044), had a longer hospital stay (24.25±20.25 days, P<0.001), had more frequently a history of chronic pulmonary pathologies (P=0.010), immunodeficiency (P<0.001), and were associated with greater development of bacterial superinfection (P<0.001), respiratory distress (P=0.003), and admission to the intensive care unit (ICU) (P<0.001). In the multivariate logistic regression analysis, the following characteristics were identified as independent risk factors: immunodeficiency (ORa=2.33; 95% CI: 1.47-3.60); ICU admission (ORa=4.29; 95% CI: 2.23-10.91); bacterial superinfection (ORa=1.64; 95% CI: 1.06-2.53) and respiratory distress (ORa=3.88; 95% CI: 1.23-12.23). CONCLUSIONS: Nosocomial influenza is more common in patients with a history of immunodeficiency. In addition, patients with hospital-acquired influenza had an increased risk of bacterial superinfection, admission to the ICU, and development of respiratory distress.

Adverse events in pregnant women with the tetravalent influenza vaccine obtained from cell cultures.

Influenza vaccination in pregnant women shows a clear benefit/risk ratio. Influenza vaccines are currently being developed using new platforms. It is essential to analyse the safety of these new vaccines in this population group, underrepresented in clinical trials. In the 2019-2020 season, a vaccine obtained in cell culture was recommended to pregnant women in two autonomous communities. Information is collected from the vaccination and pharmacovigilance centres of both communities. The reporting rate of adverse events (AEs) after vaccination in pregnant women was 4.02/100,000 doses administered, and in non-pregnant women aged 18-64 years it was 5.9/100,000 doses administered. The rate of AE reported was 8.04 and 17.74 respectively. No spontaneous abortions, prematurity or foetal malformations were reported. This analysis suggests the safety in pregnant women of the influenza vaccine obtained from cell cultures.

O trem e a "senhorita espanhola": a epidemia de gripe em Diamantina, 1918 / The train and the "Spanish señorita": the flu epidemic in Diamantina, 1918

Resumo O artigo analisa a epidemia de gripe de 1918 em Diamantina, no interior de Minas Gerais. A partir de fontes bibliográficas e documentais, discute como o ramal ferroviário da Estrada de Ferro Vitória a Minas, inaugurado em 1914, contribuiu para a chegada da doença à cidade que, até então, era representada no discurso de suas elites como isolada e salubre. Aborda as imbricadas relações entre a expansão dos sistemas de transportes pelo interior do Brasil, o meio ambiente, o conhecimento científico e os processos saúde/doença.

Abstract The article analyzes the influenza epidemic in 1918 in Diamantina, a town in the Brazilian state of Minas Gerais. Bibliographic and documental sources are used to investigate the influence of the Vitória-Minas railroad (Estrada de Ferro Vitória a Minas), opened in 1914, on the arrival of the disease in the town, which had until then been represented in the discourse of its elites as insalubrious and isolated. The interrelations between the spread of transportation systems across Brazil, the environment, scientific knowledge, and health-disease processes are discussed.

Ethical considerations on placebo-controlled vaccine trials in pregnant women / Consideraciones éticas sobre los ensayos de vacunas controlados con placebo en mujeres embarazadas / Considerações éticas sobre estudos de vacina controlada com placebo em gestantes

Abstract Placebo use in clinical trials, whenever a proven effective treatment exists, is one of the most debated topics in contemporary research ethics. This article addresses the ethical framework for placebo use in clinical trials assessing vaccine efficacy in pregnant women. Vaccine trial participants are healthy at the outset and some must be infected during the study to demonstrate the product's efficacy, meaning that placebo-treated participants are under risk of serious and irreversible harm. If effective vaccines exist, such risk precludes placebo use. This interdiction should be extended to any clinical trial of vaccine efficacy in pregnant women, because a demonstration of clinical efficacy in nonpregnant individuals and comparable immunogenic responses in pregnant women are predictors of efficacy in pregnancy as well. Moreover, product effectiveness in real-world use scenarios can be ascertained by observational studies conducted after its inclusion in vaccination campaigns.

Resumen El uso de placebo en ensayos clínicos es uno de los principales temas debatidos sobre la ética en investigación contemporánea cuando existe un tratamiento eficaz probado. Este artículo aborda la ética en el uso de placebo en ensayos clínicos sobre la eficacia de vacuna en mujeres embarazadas. Las participantes en los ensayos de vacunas estaban sanas al inicio del estudio, y algunas fueron vacunadas durante el estudio para demostrar la eficacia del producto. Las participantes tratadas con placebo corren el riesgo de sufrir daños graves e irreversibles. Si existen vacunas efectivas, este riesgo impide el uso de placebo. Este impedimento debe extenderse a cualquier ensayo clínico de eficacia de vacuna en embarazadas, pues la eficacia clínica demostrada en mujeres no embarazadas y las respuestas inmunogénicas comparables con las embarazadas son predictores de eficacia en el embarazo. Además, la efectividad del producto se constata en estudios observacionales realizados tras las campañas de vacunación.

Resumo O uso de placebo em ensaios clínicos, quando um tratamento comprovadamente eficaz existe, é um dos principais tópicos debatidos na ética em pesquisa contemporânea. Este artigo aborda o quadro ético para o uso de placebo em ensaios clínicos que avaliam a eficácia de vacina em gestantes. Participantes em ensaios de vacina são saudáveis no início e alguns devem ser inoculados durante o estudo para demonstrar a eficácia do produto. Ou seja, participantes tratados com placebo estão sob risco de danos graves e irreversíveis. Se existirem vacinas eficazes, esse risco impede o uso de placebo. Essa interdição deve ser estendida a qualquer ensaio clínico de eficácia de vacina em gestantes, pois a demonstração de eficácia clínica em não gestantes e as respostas imunogênicas comparáveis em gestantes também são preditoras de eficácia na gravidez. Ademais, a eficácia do produto em cenários reais de uso pode ser verificada por estudos observacionais realizados após sua inclusão em campanhas de vacinação.