Vigilancia de los eventos adversos a la vacunación en Camagüey (2018)

Objetivo: Evaluar la vigilancia de los eventos adversos a la vacunación en Camagüey en 2018. Métodos: Investigación en servicios y sistemas de salud de tipo operacional, con diseño evaluativo, que abarcó desde el 1ro. de enero hasta el 31 de diciembre de 2018. La población de estudio quedó constituida por 355 trabajadores (149 médicos de la familia, 161 enfermeras de familia, 16 enfermeras vacunadoras y 29 gerentes del programa de vacunación). La información se obtuvo mediante observación, revisión documental y entrevistas. Para evaluar los componentes: estructura, procesos y resultados, se definieron diferentes criterios, indicadores y estándares. Resultados: La estructura se evaluó como definida. El 90,9 % de los indicadores relacionados con cobertura y capacitación de los recursos humanos obtuvo la puntuación máxima, y en los recursos materiales, solo en el 81,2 % de los vacunatorios se disponía del conjunto de modelos necesario para el trabajo y control. Los atributos de sensibilidad, simplicidad, flexibilidad, aceptabilidad, integralidad, oportunidad y capacidad de autorespuesta, se evaluaron satisfactoriamente (70 % o más del estándar propuesto); la sensibilidad alcanzó solo el 34,2 %. Se obtuvo una tasa de 150 eventos adversos por 105dosis aplicadas, pero sin eventos graves, y los resultados se consideraron útiles. Conclusiones: El sistema de vigilancia de eventos adversos a la vacunación en Camagüey cumplió con los estándares establecidos para la confiabilidad del programa de vacunación y la toma de decisiones: una estructura bien definida, procesos con buen funcionamiento y resultados muy útiles.

Objective: To evaluate the surveillance for adverse events to vaccination in Camagüey in 2018. Methods: Operational research in health services and systems, with an evaluative design, which covered from January 1 to December 31, 2018. The study population comprised 355 workers (149 family physicians, 161 family nurses, 16 nurse vaccinators, and 29 vaccination program managers). Information was obtained through observation, documentary review, and interviews. Different criteria, indicators, and standards were established for evaluating the structure, process and outcome components. Results: The structure was evaluated as defined. The maximum score was obtained in 90.9% of the indicators related to coverage and training of human resources. Regarding material resources, only 81.2% of the vaccination centers had the necessary set of templates to carry out the work and control. The attributes of sensitivity, simplicity, flexibility, acceptability, comprehensiveness, timeliness, and self-response capacity were evaluated satisfactorily (70% or more of the proposed standard); sensitivity reached only 34.2%. A rate of 150 adverse events per 105doses applied was obtained; severe events were not evidenced, and the results were considered useful. Conclusions: The surveillance system for adverse events to vaccination in Camagüey met the standards established for the reliability of the vaccination program and decision-making: a well-defined structure, well-functioning processes, and very useful outcomes.

Brote de transmisión comunitaria de COVID-19 en un municipio de La Habana (marzo-abril, 2021)

Introducción: Una oportuna investigación de los eventos epidemiológicos de la COVID-19 garantiza minimizar la propagación de la enfermedad en la población. Objetivos: Caracterizar el brote de transmisión comunitaria de COVID-19 en un municipio de La Habana. Métodos: Estudio transversal de casos positivos de infección por SARS-CoV-2 del brote Catedral en La Habana Vieja, en 2021. Las variables analizadas fueron: edad, sexo, manzana de residencia, fecha de inicio de síntomas, fecha de diagnóstico, forma clínica, tipo de caso. Se utilizó la metodología para el estudio de brotes. Se calcularon porcentajes, diferencias de proporciones, tasas, número reproductivo efectivo y parámetro de dispersión con intervalos de confianza de 95 %. Resultados: Se notificó el brote el 23 de marzo y se cerró el 22 de abril con 106 casos (tasa de ataque 4,51 %), el pico en la notificación se produjo el 29 de marzo con 40 casos (37,73 %). La edad media fue de 43 años. Resultaron más afectados los adultos de 60 y más años (30,18 %), las mujeres (58,49 %) y la manzana 0024 (45,28 % de los casos). El 77,3 % no presentó síntomas, entre ellos dos superdispersores; los sintomáticos fueron leves y no hubo fallecidos. El número reproductivo efectivo global fue de 0,94 (IC: 0,70-1,21); superior en los asintomáticos (11,43 versus 4,00); y el parámetro de dispersión de 0,89 (IC: 0,51-2,09), superior en los sintomáticos (1,06 versus 0,69). Conclusiones: El control epidemiológico oportuno ante cada caso permitió la corta duración del brote y que no hubiesen fallecidos.

Introduction: A timely investigation of COVID-19 epidemiological events guarantees to minimize the spread of the disease in the population. Objective: To characterize the COVID-19 outbreak of community transmission in a municipality in Havana. Methods: Cross-sectional study of positive cases of SARS-CoV-2 infection of the "Cathedral" outbreak in Old Havana in 2021. The variables analyzed were: age, sex, city block of residence, date of symptom onset, date of diagnosis, clinical manifestations, and type of case. The methodology for the study of outbreaks was used. Percentages, differences in proportions, rates, effective reproductive number, and dispersion parameter with 95% confidence intervals were calculated. Results: The outbreak was reported on March 23 and closed on April 22 with 106 cases (attack rate of 4.51%). The peak was notified on March 29 with 40 cases (37.73%). The mean age was 43 years. Adults aged 60 years and older (30.18%), women (58.49%), and block 0024 (45.28% of cases) were most affected. A total of 77.3% were asymptomatic, including two superspreaders; symptomatic cases were mild and there were no deaths. The overall effective reproductive number was 0.94 (CI: 0.70-1.21); higher in asymptomatic cases (11.43 versus 4.00); and the dispersion parameter was 0.89 (CI: 0.51-2.09), higher in symptomatic cases (1.06 versus 0.69). Conclusions: Timely epidemiological control of each case ensured the short duration of the outbreak and no deaths.

Asymptomatic SARS-CoV-2 Infection in Havana, Cuba, March-June 2020: Epidemiological Implications.

INTRODUCTION: The percentage of asymptomatic COVID-19 cases worldwide is estimated at 18-50%; 53% in Cuba specifically, and 58% in Havana, the Cuban capital and the 2020 epicenter of the country's COVID-19 epidemic. These figures, however, do not represent the transmission capacity or behavior of asymptomatic cases. Understanding asymptomatic transmission's contribution to SARS-CoV-2 spread is of great importance to disease control and prevention. OBJECTIVE: Identify the epidemiological implications of asymptomatic SARS-CoV-2 infection in Havana, Cuba, during the first wave of the epidemic in 2020. METHODS: We carried out a cross-sectional study of all confirmed COVID-19 cases diagnosed in Havana, Cuba, from March 16 through June 30, 2020. The information was obtained through review of the standardized form for investigation of suspected and confirmed cases. Examined variables included age, sex, occupation, case type and source of infection. Cases were divided into asymptomatic and symptomatic groups, and transmission was characterized through the creation of a contact matrix. Analysis was carried out in Epidat and R. RESULTS: We studied 1287 confirmed cases, of which 57.7% (743) were asymptomatic, and 42.3% (544) were symptomatic. Symptomatic presentation was the most common for both imported and introduced cases, while asymptomatic presentation was more common in autochthonic cases and infections from an undetermined source. Asymptomatic infection was more common in groups aged ⟨20 and 20-59 years, while symptomatic infection was more common in those aged ⟩60 years. In the contact matrix, 34.6% of cases (445/1287) were not tied to other cases, and 65.4% (842/1287) were infectious-infected dyads, with symptomatic-symptomatic being the most common combination. The majority of primary cases (78.5%; 1002/1276) did not generate secondary cases, and 85.6% (658/743) of asymptomatic cases did not lead to other cases (although one asymptomatic superspreader led to 90 cases in a single event). However, 63.2% (344/544) of symptomatic primary cases generated secondary cases, and 11 symptomatic superspreaders spawned 100 secondary cases in different events. CONCLUSIONS: Asymptomatic SARS-CoV-2 infection was the most common form of COVID-19 in Havana during the study period, but its capacity for contagion was lower than that of symptomatic individuals. Superspreader events under specific conditions played an important role in sustaining the epidemic.

Clinical-Epidemiological Characteristics of the First Patients Diagnosed with COVID-19 in Cuba.

INTRODUCTION: COVID-19 is caused by the novel coronavirus SARS-CoV-2 and was declared a pandemic on March 11, 2020, the same day that the first cases in Cuba were diagnosed. In Cuba, all confirmed cases of COVID-19 were hospitalized from this point forward. OBJECTIVE: Characterize the first patients diagnosed with COVID-19 in Cuba. INTRODUCTION: METHODS We carried out a descriptive, cross-sectional study of 415 suspected cases of COVID-19 admitted to the Pedro Kourí Tropical Medicine Institute in Havana, Cuba, from March 11, 2020 through April 10, 2020. (In Cuba, all patients suspected of being COVID-19-positive were admitted to hospitals or isolation centers for observation and treatment.) Of these 415 individuals, 63 (15.2%) tested positive for SARS-CoV-2. Information was obtained from the Institute's databases as well as a standardized interview form for cases confirmed or suspected as infected with the novel coronavirus. We considered the following variables: age, sex, occupation at the time of interview, national origin, personal health history, time elapsed between symptom onset and hospital admission, signs and symptoms, diagnosis and status at discharge. We based our analysis on frequency distributions and double-entry contingency tables. RESULTS: The mean age was 50 years (range: 16-94 years). The 45-54 age group represented the largest share of cases (25.4%; 16/63); persons aged ≥65 years were 20.6% (13/63); there were more men than women (55.6% vs. 44.4%). Cubans represented 52.4% (33/63) of patients while 47.6% (30/63) were from 14 countries where COVID-19 had already been identified. All foreigners and Cubans who arrived from abroad were considered imported cases (54.0%; 34/63). Health personnel (10 doctors and 1 nurse) represented 17.5% (11/63) of cases. Cough (50.8%), fever (46.0%), sore throat (22.2%) and headache (19.0%) were the most frequently reported symptoms. Asymptomatic patients represented 25.4% (16/63) of cases. Hypertension was the most frequently associated chronic disease (28.6%), followed by asthma (25.0%) and diabetes (17.9%). Patients who were admitted to hospital ≥3 days after symptom onset represented 66.7% (42/63) of cases. Mean hospital stay was 13.7 days (range: 1-27 days). Factors associated with a higher risk of contracting the disease included occupation as a healthcare worker (OR: 1.85; 95%, CI: 0.88-3.87) and aged ≥65 years (OR: 1.68; 95% CI: 0.85-3.34). Five individuals died, for a fatality rate of 7.9% (three foreigners and two Cubans; four men and one woman). Four of these patients were infected outside of Cuba and one was identified as a contact of a confirmed case. All patients who died had significant comorbidities (diabetes, asthma and hypertension). Age of deceased patients ranged from 54 to 87 years. CONCLUSION: The first patients diagnosed with COVID-19 in Cuba were admitted to the Pedro Kourí Tropical Medicine Institute in Havana. They share characteristics with those reported by other countries: more men than women were affected, and comorbidities including hypertension, diabetes and asthma were all important risk factors, as was age ≥65 years. More than half of all cases were imported, and autochthonous patients were all contacts of confirmed cases.

Characterization of Adverse Events Following Childhood Immunizations in Pinar del Río, Cuba.

INTRODUCTION: The Cuban national program for childhood immunizations began in 1962 and has included a surveillance system for monitoring adverse events following immunization since 1999. The expected rate of adverse events following childhood immunization in Cuba is 50 per 100,000 vaccine doses administered. In 2017, Pinar del Río Province reported higher-than-expected rates of adverse events, which motivated this study on their frequency and types. OBJECTIVE: Characterize adverse events following immunization reported in children in Pinar del Río Province in 2017. METHODS: We examined reports of adverse events following immunization in children from 2 months through 14 years of age in Pinar del Río Province, Cuba, from January 1, 2017 through December 31, 2017. We found 487 adverse events that met the criteria established by the national surveillance system. Information was obtained from epidemiological surveys of adverse events following immunization in Pinar del Río Province municipalities. Recorded were age, municipality, signs and symptoms, vaccine type, number of doses, anatomical site and route of vaccine administration, and the institution where the child was vaccinated. We estimated proportions for intensity and frequency related to vaccination, and calculated rates for 100,000 vaccine doses administered. We then compared the rates of observed adverse events with those of expected events. RESULTS: The overall rate of adverse events was 305.6 per 100,000 doses administered. Highest rates were reported in children aged ⟨1 year (580.9 per 100,000 doses administered); in Guane Municipality (610 per 100,000 doses), for the pentavalent (DTwP-HB-Hib) vaccine (1567.7 per 100,000 doses), and in applications to the anterolateral quadrant of the thigh (772.5 per 100,000 doses). Symptoms classifi ed as moderate, common, and general occurred more often, with fever being the most frequent. Severe induration, hypotonic and hyporesponsive episodes, persisten crying and rashes were observed more frequently than expected. CONCLUSIONS: The rate of adverse events following childhood immunization is similar to that reported in other provinces and elsewhere in the world. Of all childhood vaccines, the pentavalent vaccine is the most reactogenic. The absence of serious adverse events demonstrates the safety of childhood immunization in Cuba.

La sostenibilidad de la vacunación y los movimientos antivacunas en tiempos del nuevo coronavirus / Vaccination Sustainability and Anti-Vaccine Movements in the Times of the New Coronavirus

Estimado editor: En la lucha contra las enfermedades infecciosas, la vacunación como herramienta indispensable de la salud pública ha permitido ganar diversas batallas en la erradicación y eliminación de enfermedades como la viruela y la poliomielitis, así como controlar otras, entre las que figuran el sarampión, la tosferina y el tétanos. Anualmente, la inmunización evita una cifra estimada de 2,5 millones de muertes entre niños menores de cinco años a nivel mundial, de ahí que la eficacia y seguridad de las vacunas sea incuestionable.1,2,3) En la medida que estos logros representan importantes avances, nos convertimos en "víctimas de nuestros éxitos".4 Hoy, en el contexto de la pandemia de la COVID-19, los programas de vacunación están sufriendo importantes caídas y demoras. De ahí la importancia de mantener altas coberturas de vacunación, para evitar la emergencia y reemergencia de estas enfermedades, algunas potencialmente graves o mortales. La Directora de la Organización Panamericana de la Salud (OPS), Dra. Carissa F. Etienne expresó: "Las vacunas salvan vidas y deben mantenerse incluso durante la pandemia de COVID-19. Las personas más vulnerables no deben sufrir las consecuencias de no recibir las vacunas que necesitan". De ahí, que se insta a los países a que durante la pandemia mantengan los programas de vacunación contra la gripe y el sarampión y así evitar...(AU)

Cultura de la salud en los familiares de niños sobre la vacunación. Policlínico "5 de Septiembre", enero-junio 2015 / Culture of health in family members of children about vaccination. Polyclinic "5 de Septiembre", January-June 2015

Objetivo: conocer desde la perspectiva social, los conocimientos y creencias de la población a partir del significado que las personas le atribuyen a las vacunas preventivas y al proceso de vacunación. Métodos: Se realizó un estudio exploratorio con familiares de niños de 0 a 24 meses pertenecientes al Policlínico 5 de Septiembre, municipio Playa, La Habana, que abarcó de enero a junio de 2015. Se utilizó un diseño mixto convergente o por triangulación de datos. Para la recolección de datos se utilizó la entrevista-cuestionario, entrevista a expertos y entrevista a informantes claves. Se elaboró una base de datos en Excel, la que se exportó al programa SPSS versión 19.0. En un primer momento, se realizó un análisis descriptivo, en el que se calcularon frecuencias absolutas y relativas para las variables de estudio. Para establecer las relaciones entre el nivel de conocimiento y algunas variables sociodemográficas, para el análisis de los datos cualitativos, se realizaron lecturas reiteradas de las transcripciones de las entrevistas a expertos e informantes claves y de las respuestas a las preguntas abiertas del cuestionario para la familiarización con el contenido de estos. Resultados: Se puso de manifiesto la vía institucional en la cultura de la salud que poseen los familiares con relación a las vacunas y el proceso de vacunación. Los familiares presentaban en su mayoría conocimientos insuficientes acerca de las vacunas y las enfermedades que protegen estas. No presentaban conocimientos sobre los eventos adversos graves o severos. El proceso de vacunación mostró gran significado para los familiares, asociados a experiencias positivas con este. Conclusiones: Se inicia un acercamiento a la cultura de la salud, poseída por un grupo de familiares, relativos a las vacunas preventivas y el proceso de vacunación en Cuba. Las madres refuerzan la responsabilidad de vacunar al niño/a como parte del cuidado de la salud de este. La cultura de la salud en los familiares de niños/as no incluye información distorsionada sobre las vacunas preventivas y su efectividad. Se nutre exclusivamente de la cultura científica, aunque no la reproduce en su totalidad. El proceso de vacunación es altamente valorado por los familiares, dada la importancia que le atribuyen, la confianza que tienen en el Programa Nacional de Inmunización, la satisfacción que muestran con la organización del servicio y la atención del personal de salud(AU)

Objective: to know, from the social perspective, the population´s knowledge and beliefs based on the meaning that people attribute to preventive vaccines and the vaccination process. Methods: An exploratory study was carried out with relatives of children from 0 to 24 months from "5 de Septiembre" community clinic in Playa municipality, Havana, from January to June 2015. A mixed convergent or triangulation design was used. Data collection was completed by questionnaire interview, expert interview and interview to key informants. A database was created in Excel, which was exported to the SPSS program version 19.0. Initially, a descriptive analysis was performed, in which absolute and relative frequencies were calculated for the study variables. Repeated readings were made of the transcripts of the interviews with experts and key informants and for the answers to the open questions of the questionnaire, to establish the analysis of the qualitative data, and for familiarization with their content. Results: It was shown the institutional pathway in health culture that family members have in relation to vaccines and the vaccination process. Most family members had poor knowledge about vaccines and the diseases they prevent. They did not show knowledge about serious or severe adverse events. The vaccination process showed great significance for family members, associated with positive experiences with it. Conclusions: This study initiates an approach to the health culture a group of family members had related to preventive vaccines and the vaccination process in Cuba. Mothers reinforce the responsibility of vaccinating the child as part of their child's health care. The health culture in family members of children does not include distorted information about preventive vaccines and their effectiveness. Their knowledge is fed exclusively by scientific culture, although it is entirety not reproduce. The vaccination process is highly valued by family members, given the importance they attach to it, the confidence they have in the National Immunization Program, the satisfaction they show with the organization of the service and the care of health personnel(AU)

A Cuban Perspective on the Antivaccination Movement.

Vaccination is one of the most cost-effective interventions for control of communicable diseases. This health achievement could flounder if measures are not taken by health systems to prioritize immunization, increase vaccination rates and educate health professionals to address public concerns about vaccine safety and efficacy. Parents' refusal to vaccinate their children directly affects public health, because it puts both individual and group immunity in danger; immunization coverage is effective only when high population coverage is attained. The growing number of antivaccination (antivaxxer) groups around the world is alarming, contributing to falling vaccination rates. Troubling consequences include disease outbreaks in several countries globally and in our hemisphere. This article looks at the history and features of antivaxxer movements around the world and proposes ways the Cuban health system, through its National Immunization Program, can address dangers for the population associated with potentially negative infiuences of social-network antivaxxer campaigns. The paper underscores the role of mass and social media, health professional training and sustained competence, and the importance of a vaccine-related adverse events surveillance system. KEYWORDS Vaccination, immunization, antivaccination move-ment, antivaccine groups, primary health care, society, communi-cations media, social media, Cuba.

Experiencia cubana en inmunización, 1962–2016

[RESUMEN]. El Programa de Inmunización de Cuba se creó en 1962 como resultado de las transformaciones políticas, económicas y sociales iniciadas en 1959, cuando las enfermedades transmisibles — entre ellas las prevenibles por vacunas— eran la principal causa de morbilidad y mortalidad en la población infantil. Su organización y ejecución ininterrumpida han permitido que seis enfermedades, dos formas clínicas graves y dos complicaciones graves estén eliminadas, y las restantes mantengan tasas de incidencia y mortalidad que no constituyen un problema de salud. Anualmente, en Cuba se administran, en promedio, 4 800 000 dosis de vacunas simples o combinadas que protegen contra 13 enfermedades, incluida una pentavalente cuyos cinco componentes se producen en el país. La vacunación antipoliomielítica oral en la campaña de 1962 fue la primera experiencia en la Región de las Américas con participación comunitaria e intersectorial y Cuba, el primer país en eliminar la enfermedad. Resultados recientes de investigaciones cubanas han incidido en el Programa Mundial de Erradicación. La vacunación universal antihepatitis B a las 24 horas después del nacimiento se cumplió 19 años antes de la meta fijada por la OMS empleando una vacuna nacional. En Cuba, la vacunación es gratuita, de acceso universal, está integrada en la atención primaria de salud, y el compromiso y la voluntad política con la salud de la población se vehiculizan mediante un sistema de salud integral. La información y la vigilancia epidemiológica son sistemáticas, confiables y sensibles. Se alcanzan coberturas de vacunación por encima de 98% en todas las vacunas y la población tiene un nivel inmunitario alto.

[ABSTRACT]. The Immunization Program of Cuba was created in 1962 as a result of the political, economic and social transformations initiated in 1959, when communicable diseases —among them those preventable by vaccines— were the main cause of morbidity and mortality in children. Its organization and uninterrupted implementation allowed that six diseases, two serious clinical forms and two serious complications were eliminated, and the remaining ones have incidence and mortality rates that do not represent a health problem. In Cuba, an average of 4.8 million doses of simple or combined vaccines are administered annually protecting against 13 diseases, including a pentavalent vaccine whose five components are produced in the country. Oral polio vaccination in the 1962 campaign was the first experience in the Region of the Americas with community and intersectoral participation, and Cuba was the first country to eliminate the disease. Recent results of Cuban research have influenced the World Eradication Program. The universal vaccination against hepatitis B at 24 hours after birth was achieved 19 years before the goal set by the World Health Organization using a national vaccine. In Cuba, vaccination is free and it is integrated into primary health care, with universal access. The commitment and political will to the health of the population is conveyed through a comprehensive health system. Information and epidemiological surveillance are systematic, reliable and sensitive. Vaccination coverage is above 98% for all vaccines and the population has a high immune level.

[RESUMO]. O Programa de Imunização de Cuba foi criado em 1962 como resultado das transformações políticas, econômicas e sociais iniciadas em 1959, quando as doenças transmissíveis —entre eles as que são evitáveis pelas vacinas— foram a principal causa de morbidade e mortalidade em crianças. Sua organização e execução ininterrupta permitiram que seis doenças, duas formas clínicas graves e duas complicações graves sejam eliminadas, e as demais mantêm incidência e taxas de mortalidade que não constituem um problema de saúde. Anualmente, em Cuba, uma média de 4,8 milhões de doses de vacinas simples ou combinadas são administradas que protegem contra 13 doenças, mesmo uma vacina pentavalente cujos cinco componentes são produzidos no país. A vacinação oral contra a poliomielite na campanha de 1962 foi a primeira experiência na Região das Américas com participação comunitária e intersetorial, e Cuba foi o primeiro país a eliminar a doença. Resultados recentes da pesquisa cubana influenciaram o Programa Mundial de Erradicação. A vacinação universal contra a hepatite B às 24 horas após o nascimento foi completada 19 anos antes do objetivo estabelecido pela Organização Mundial da Saúde usando uma vacina nacional. Em Cuba, a vacinação é gratuita e o acesso universal, e a vacinação é integrada na atenção primária de saúde. O compromisso e a vontade política para a saúde da população são transmitidos através de um sistema de saúde abrangente. A informação e a vigilância epidemiológica são sistemáticas, confiáveis e sensíveis. A cobertura de vacinação é superior a 98% em todas as vacinas e a população possui alto nível imune.

Evaluación del sistema de vigilancia de eventos adversos consecutivos a la vacunación en Isla de la Juventud, 2014 / Evaluation of the surveillance system of adverse events after vaccination in Isla de la Juventud, 2014

Introducción: la evaluación en la vigilancia en salud es un instrumento útil para analizar resultados en relación con los objetivos, comparar beneficios con costos y orientar los objetivos iniciales de los sistemas. Sirve a su vez para mejorar el desarrollo, uso de los recursos, la planificación general y facilita el uso de los servicios de vigilancia.Objetivo: evaluar el sistema de vigilancia de eventos adversos consecutivos a la vacunación en el municipio especial Isla de la Juventud, enero-diciembre de 2014.Métodos: se llevó a cabo un estudio mixto de evaluación, en el que se combinaron técnicas cualitativas y cuantitativas. El alcance del estudio incluyó los 68 médicos y 76 enfermeras que laboran en Atención Primaria de Salud (APS) de las tres áreas existentes en el territorio, los tres vicedirectores de higiene y epidemiología, el gerente del Programa de Inminización y las enfermeras que laboran en los vacunatorios. Se evaluaron los tres componentes del sistema: Estructura, Proceso y Resultados mediante una metodología integral.Resultados: la Estructura del sistema se evaluó como definida. El proceso de buen funcionamiento, sin embargo, se consideró poco oportuno y poco flexible. Los resultados fueron evaluados de aceptables, proporcionado por incumplir con las normas técnicas de aplicación de vacunas. De forma general el sistema fue evaluado de insatisfactorio. Conclusiones: la evaluación del sistema permitió identificar brechas en su funcionamiento tales como deficiente capacitación de los usuarios. Se pudo constatar que el buen funcionamiento de los procesos ha garantizado las actividades del sistema. Es imprescindible monitorear sus atributos, para resolver oportunamente las deficiencias detectadas(AU)

Introduction: the health surveillance evaluation is useful for analyzing results according to objectives, to compare costs and benefits, and to direct the initial objectives of the systems. It also serves to improve the development, the use of resources and the overall planning, and to facilitate the use of monitoring services.Objective: to evaluate the surveillance of adverse events following immunization in the special municipality Isla de la Juventud, from January to December 2014.Methods: a mixed assessment study was carried out where qualitative and quantitative techniques were combined. The scope of the study included 68 physicians and 76 nurses working at the primary health care level (PHC) of the three areas existing in the territory; the three vice-directors for hygiene and epidemiology, the vaccination program manager and the nurses working in vaccination centers. The three components of the system were evaluated: Structure, Process and Results through a comprehensive methodology.Results: the Structure of the system was evaluated as "definite". However, the process of "good performance" was considered little timely and flexible. The results were assessed as "acceptable" due to non-compliance with the technical standards immunizations. Generally, the system was rated as unsatisfactory.Conclusions: the evaluation of the system identified gaps in performance such as poor user training. It was found that the proper functioning of the processes has assured system activities. It is essential to monitor their attributes in order to timely solve the identified deficiencies(AU)

Episodio de Hipotonía e Hiporreactividad posterior a la aplicación de vacunas en Cuba durante el período 2012-2013 / Hypotonic-hyporesponsive episodes after the application of vaccines in Cuba during the period 2012-2013

Introducción: la vacuna contra la difteria, la tos ferina (células enteras) y el tétanos que protege contra estas enfermedades, inició su uso en la década de 1940, logró una disminución considerable de estas enfermedades. Pero también, surgieron numerosos eventos asociados a esta vacuna. Uno de ellos es el Episodio de Hipotonía e Hiporreactividad, reportado con menor frecuencia, a las vacunas contra Haemophilus influenzae tipo b y la hepatitis B. Es un evento poco conocido y raro. Objetivo: mejorar el conocimiento sobre esta entidad. Métodos: se realizó un estudio observacional retrospectivo de los Episodio de Hipotonía e Hiporreactividad el (según niveles de certeza diagnóstica), reportados durante 2012 y 2013 por el médico de familia al sistema de vigilancia de eventos adversos, procedentes de todas las provincias. Resultados: fueron reportados 27 Episodio de Hipotonía e Hiporreactividad. El 92,6 por ciento correspondió a la vacuna pentavalente, para una tasa de 3,2 x 105 Dosis Aplicadas. El 74 por ciento se notificaron en las primeras 12 horas. Se observó con mayor frecuencia después de la primera dosis, para un 48 por ciento y el 85,4 por ciento ocurrió en los menores de 6 meses. La fiebre, el llanto persistente, los vómitos, el decaimiento y la somnolencia fueron los síntomas asociados con esta entidad.Conclusiones: la vigilancia de este episodio ha permitido conocer el tiempo de aparición después de aplicar la vacuna, dosis, edad y si está asociado con otros síntomas. Constituye un primer acercamiento a este evento, para mejorar su conocimiento, lo cual permitirá continuar con la seguridad y confiabilidad del Programa Nacional de Inmunización en Cuba(AU)

Introduction: the use of the diphtheria, pertussis (whole cells) and tetanus vaccine started in the forties of the twentieth century considerably reduced theses diseases. Many events associated with this vaccine took place also, however. For example, the hypotonic-hyporesponsive episode, reported less frequently, to the Haemophilus influenzae Type B and hepatitis B vaccines. This is a rare and little known event. Objective: to improve knowledge about this entity. Methods: a retrospective observational study was performed of the hypotonic-hyporesponsive episodes (by level of diagnostic certainty) reported during 2012 and 2013 by the family doctor for the surveillance system of adverse events, coming from all provinces.Results: 27 hypotonic-hyporesponsive episodes were reported. 92.6 por ciento corresponded to the pentavalent vaccine, to a rate of 3.2x105 applied doses. 74 por ciento were reported in the first twelve hours. It was observed more frequently after the first dose, for 48 por ciento and 85.4 por ciento happened in children less than six months. Fever, persistent crying, vomiting, malaise and drowsiness were the symptoms associated with to condition.Conclusions: the surveillance of this episode has revealed the appearance time after the vaccine, dose, age and whether it is associated with other symptoms. It is a first approach to this event, to improve their knowledge, which will continue with the safety and reliability of the National Immunization Program in Cuba(AU)

Episodio de Hipotonía e Hiporreactividad posterior a la aplicación de vacunas en Cuba durante el período 2012-2013 / Hypotonic-hyporesponsive episodes after the application of vaccines in Cuba during the period 2012-2013

Introducción: la vacuna contra la difteria, la tos ferina (células enteras) y el tétanos que protege contra estas enfermedades, inició su uso en la década de 1940, logró una disminución considerable de estas enfermedades. Pero también, surgieron numerosos eventos asociados a esta vacuna. Uno de ellos es el Episodio de Hipotonía e Hiporreactividad, reportado con menor frecuencia, a las vacunas contra Haemophilus influenzae tipo b y la hepatitis B. Es un evento poco conocido y raro. Objetivo: mejorar el conocimiento sobre esta entidad. Métodos: se realizó un estudio observacional retrospectivo de los Episodio de Hipotonía e Hiporreactividad (según niveles de certeza diagnóstica), reportados durante 2012 y 2013 por el médico de familia al sistema de vigilancia de eventos adversos, procedentes de todas las provincias. Resultados: fueron reportados 27 Episodio de Hipotonía e Hiporreactividad. El 92,6 por ciento correspondió a la vacuna pentavalente, para una tasa de 3,2 x 105 Dosis Aplicadas. El 74 por ciento se notificaron en las primeras 12 horas. Se observó con mayor frecuencia después de la primera dosis, para un 48 por ciento y el 85,4 por ciento ocurrió en los menores de 6 meses. La fiebre, el llanto persistente, los vómitos, el decaimiento y la somnolencia fueron los síntomas asociados con esta entidad. Conclusiones: la vigilancia de este episodio ha permitido conocer el tiempo de aparición después de aplicar la vacuna, dosis, edad y si está asociado con otros síntomas. Constituye un primer acercamiento a este evento, para mejorar su conocimiento, lo cual permitirá continuar con la seguridad y confiabilidad del Programa Nacional de Inmunización en Cuba(AU)

Vigilancia activa de eventos adversos a la vacuna Pandemrix para prevenir la influenza AH1N1 en Cuba / Active surveillance of adverse effects of Pandemrix vaccine to prevent influenza A(H1N1) in Cuba

Introducción: en abril de 2009, en México y Norteamérica, un nuevo virus fue identificado como causa de enfermedad respiratoria, el cual se expandió rápidamente a otros países. El 11 de junio de 2009 la Organización Mundial de la Salud notificó casos en 74 países y territorios, en 2 de sus regiones. Esta transmisión elevada y sostenida de este virus en el mundo, propició que se estableciera la fase 6 o de pandemia, lo cual indicó que la situación implicaba diseminación y no mayor gravedad. Objetivos: reportar los eventos conocidos o nuevos tras la aplicación de la vacuna A (H1N1) Pandemrix...

Introduction: in April 2009, a new virus was identified in Mexico and North America as the cause of a respiratory disease. The virus quickly spread over other countries. On June 11, 2009 the World Health Organization (WHO) reported cases in 74 countries and territories located in 2 of its regions. The high sustained transmission of this virus worldwide led to establish the phase 6 or the pandemic phase, indicating that the situation had to do with spreading rather than increased severity. Objectives: to report on already known or new events after the administration of vaccine A(H1N1) called Pandemrix...

Vigilancia activa de eventos adversos a la vacuna Pandemrix para prevenir la influenza AH1N1 en Cuba / Active surveillance of adverse effects of Pandemrix vaccine to prevent influenza A(H1N1) in Cuba

Introducción: en abril de 2009, en México y Norteamérica, un nuevo virus fue identificado como causa de enfermedad respiratoria, el cual se expandió rápidamente a otros países. El 11 de junio de 2009 la Organización Mundial de la Salud notificó casos en 74 países y territorios, en 2 de sus regiones. Esta transmisión elevada y sostenida de este virus en el mundo, propició que se estableciera la fase 6 o de pandemia, lo cual indicó que la situación implicaba diseminación y no mayor gravedad. Objetivos: reportar los eventos conocidos o nuevos tras la aplicación de la vacuna A (H1N1) Pandemrix, identificar los eventos más frecuentes en las embarazadas e investigar de inmediato los eventos severos asociados. Métodos: se diseñó un estudio descriptivo prospectivo para caracterizar los eventos adversos a la vacuna Pandemrix, reportados en todo el país desde el Primero de abril hasta el 30 de junio de 2010. Se vacunaron 1 123 526 personas y se cubrió 100 por ciento de las embarazadas. Resultados: de la vigilancia activa desarrollada en el país se reportaron 5 763 síntomas y signos en 3 401 personas (615 reportes en embarazadas). La tasa general de reportes fue de 302,7 x 100 000 dosis aplicadas. Los eventos adversos: fiebre, cefalea, dolor, inflamación y enrojecimiento en el sitio de inyección, decaimiento, artralgia, manifestaciones alérgicas, vómitos y náuseas como síntomas más frecuentes. Estos 10 síntomas y signos representan 79,1 por ciento del total de eventos reportados. Se vacunó un total de 80 317 embarazadas, de las cuales 615 reportaron eventos adversos, lo que representa 0,8 por ciento del total de gestantes vacunadas. En los niños la fiebre fue el síntoma que más notificaciones produjo (193), seguido de reacciones locales en el sitio de inyección (23), vómitos (20) artralgias (17), cefalea (11), decaimiento (10) y convulsiones relacionadas con fiebre (6). Se investigaron 8 eventos como severos. Conclusiones: con la aplicación de la vacuna estaban relacionados 3 eventos, otros 3 no relacionados con la aplicación de la vacuna y en 2 se decidió que eran no concluyentes (2 abortos espontáneos). No se reportaron fallecidos. Se demostró la capacidad del sistema de salud cubano para la aplicación de la vacuna con una vigilancia activa en un corto período de tiempo. En los datos derivados de la vigilancia de eventos supuestamente atribuidos a la vacunación o inmunización, no se reportó ningún evento inusual, por lo que no se sugieren problemas de seguridad relacionados con la vacuna Pandemrix.

Introduction: in April 2009, a new virus was identified in Mexico and North America as the cause of a respiratory disease. The virus quickly spread over other countries. On June 11, 2009 the World Health Organization (WHO) reported cases in 74 countries and territories located in 2 of its regions. The high sustained transmission of this virus worldwide led to establish the phase 6 or the pandemic phase, indicating that the situation had to do with spreading rather than increased severity. Objectives: to report on already known or new events after the administration of vaccine A(H1N1) called Pandemrix, to identify the most frequent events occurred in pregnant women and to research into the associated severe events. Methods: a prospective descriptive study was designed to characterize the adverse effects of Pandemrix reported across the country from April 1st to June 30th, 2010. A total of 1,123,526 people were vaccinated in which 100 percent of pregnant women were included. Results: active surveillance nationwide reported 5 763 signs and symptoms detected in 3 401 people (615 reports from pregnant women). The overall rate of reports was 302.7 x 100 000 doses administered. Adverse events such as fever, headache, pain, swelling and redness at the injection site, malaise, arthralgia, allergic reactions, nausea and vomiting were reported as common symptoms. These 10 symptoms and signs accounted for 79.1 percent of all the reported events. A total number of 80 317 pregnant women were vaccinated of whom 615 reported adverse effects, accounting for 0.8 percent of the vaccinated pregnant women. Fever was the most notified symptom in children (193) followed by local reactions at the injection site (23), vomiting (20), arthralgia (17), headache (11), malaise (10) and high fever-related seizures (6). Eight events were analyzed as severe. Conclusions: the administration of the vaccine was related to 3 events, unrelated to other 3 events and 2 were classified as inconclusive (3 miscarriages). No deaths were reported. The capacity of the Cuban Health System for the administration of this vaccine with active surveillance in a short period of time was proved. Data from monitoring of events that were supposedly attributable to vaccination or immunization did not notify any unusual event. Therefore, no safety problem is associated to the Pandemrix vaccine.

Seguridad de las vacunas y su repercusión en la población / Vaccine safety and its impact on the population

La vacunación ha constituido uno de los logros más importantes en la historia de la salud pública y ha contribuido a la disminución de la morbilidad y mortalidad. A diferencia de los medicamentos, las vacunas se aplican generalmente a personas sanas para que continúen sanas, por tanto no deben ocasionar más daños que lo que podría producir la misma enfermedad. Es necesario que la población y la familia conozcan los beneficios y posibles riesgos que pudieran presentarse en el acto de vacunación, lo que proporcionaría mayor conocimiento sobre la importancia de las vacunas. Es tarea del médico enfatizar en este problema para garantizar mayor confiabilidad del programa de vacunación y seguridad en la población vacunada; debe, además, estar preparado para atender cualquier preocupación que surja en su área de salud o evento adverso que se produzca. El médico de familia, principal ejecutor de esta actividad, debe cumplir tres funciones básicas fundamentales: la educativa, la preventiva y la de vigilancia. En el futuro inmediato, las vacunas continuaran teniendo un gran impacto social en la prevención de las enfermedades infecciosas(AU)

Vaccination is one of the most important achievements in the history of the public health and has contributed to the decrease of morbidity and mortality. Unlike the drugs, the vaccines are generally used in healthy persons for them to continue being healthy; therefore, they should not cause more damage than the disease as such. It is necessary that the population and the family know the benefits and possible risks of vaccination, which will expand their knowledge on the importance of vaccines. It is the duty of the physician to make emphasis on this problem in order to assure greater reliability of the vaccination program and its safety in the vaccinated population. He/she must be prepared to pay attention to any concern that may arise in the health area or to any adverse event that might occur. The family doctor as the main performer of this activity should fulfil three basic functions: educational, preventive and surveillance functions. In the near future, the vaccines will continue having great social impact on the prevention of the infectious diseases(AU)

Seguridad de las vacunas y su repercusión en la población / Vaccine safety and its impact on the population

La vacunación ha constituido uno de los logros más importantes en la historia de la salud pública y ha contribuido a la disminución de la morbilidad y mortalidad. A diferencia de los medicamentos, las vacunas se aplican generalmente a personas sanas para que continúen sanas, por tanto no deben ocasionar más daños que lo que podría producir la misma enfermedad. Es necesario que la población y la familia conozcan los beneficios y posibles riesgos que pudieran presentarse en el acto de vacunación, lo que proporcionaría mayor conocimiento sobre la importancia de las vacunas. Es tarea del médico enfatizar en este problema para garantizar mayor confiabilidad del programa de vacunación y seguridad en la población vacunada; debe, además, estar preparado para atender cualquier preocupación que surja en su área de salud o evento adverso que se produzca. El médico de familia, principal ejecutor de esta actividad, debe cumplir tres funciones básicas fundamentales: la educativa, la preventiva y la de vigilancia. En el futuro inmediato, las vacunas continuaran teniendo un gran impacto social en la prevención de las enfermedades infecciosas

Vaccination is one of the most important achievements in the history of the public health and has contributed to the decrease of morbidity and mortality. Unlike the drugs, the vaccines are generally used in healthy persons for them to continue being healthy; therefore, they should not cause more damage than the disease as such. It is necessary that the population and the family know the benefits and possible risks of vaccination, which will expand their knowledge on the importance of vaccines. It is the duty of the physician to make emphasis on this problem in order to assure greater reliability of the vaccination program and its safety in the vaccinated population. He/she must be prepared to pay attention to any concern that may arise in the health area or to any adverse event that might occur. The family doctor as the main performer of this activity should fulfil three basic functions: educational, preventive and surveillance functions. In the near future, the vaccines will continue having great social impact on the prevention of the infectious diseases

[Active surveillance of adverse effects of Pandemrix vaccine to prevent influenza A(H1N1) in Cuba]. / Vigilancia activa de eventos adversos a la vacuna Pandemrix para prevenir la influenza AH1N1 en Cuba.

INTRODUCTION: in April 2009, a new virus was identified in Mexico and North America as the cause of a respiratory disease. The virus quickly spread over other countries. On June 11, 2009 the World Health Organization (WHO) reported cases in 74 countries and territories located in 2 of its regions. The high sustained transmission of this virus worldwide led to establish the phase 6 or the pandemic phase, indicating that the situation had to do with spreading rather than increased severity. OBJECTIVES: to report on already known or new events after the administration of vaccine A(H1N1) called Pandemrix, to identify the most frequent events occurred in pregnant women and to research into the associated severe events. METHODS: a prospective descriptive study was designed to characterize the adverse effects of Pandemrix reported across the country from April 1st to June 30th, 2010. A total of 1,123,526 people were vaccinated in which 100% of pregnant women were included. RESULTS: active surveillance nationwide reported 5 763 signs and symptoms detected in 3 401 people (615 reports from pregnant women). The overall rate of reports was 302.7 x 100 000 doses administered. Adverse events such as fever, headache, pain, swelling and redness at the injection site, malaise, arthralgia, allergic reactions, nausea and vomiting were reported as common symptoms. These 10 symptoms and signs accounted for 79.1% of all the reported events. A total number of 80 317 pregnant women were vaccinated of whom 615 reported adverse effects, accounting for 0.8 % of the vaccinated pregnant women. Fever was the most notified symptom in children (193) followed by local reactions at the injection site (23), vomiting (20), arthralgia (17), headache (11), malaise (10) and high fever-related seizures (6). Eight events were analyzed as severe. CONCLUSIONS: the administration of the vaccine was related to 3 events, unrelated to other 3 events and 2 were classified as inconclusive (3 miscarriages). No deaths were reported. The capacity of the Cuban Health System for the administration of this vaccine with active surveillance in a short period of time was proved. Data from monitoring of events that were supposedly attributable to vaccination or immunization did not notify any unusual event. Therefore, no safety problem is associated to the Pandemrix vaccine.