How has research on the effectiveness and safety of COVID-19 vaccination been evaluated: a scope review with emphasis on CoronaVac.

Introduction: The control of the COVID-19 epidemic has been focused on the development of vaccines against SARS-CoV-2. All developed vaccines have reported safety and efficacy results in preventing infection and its consequences, although the quality of evidence varies depending on the vaccine considered. Different methodological designs have been used for their evaluation, which can influence our understanding of the effects of these interventions. CoronaVac is an inactivated vaccine, and it has been assessed in various studies, including clinical trials and observational studies. Given these differences, our objective was to explore the published information to answer the question: how has the efficacy/effectiveness and safety of CoronaVac been evaluated in different studies? This is to identify potential gaps and challenges to be addressed in understanding its effect. Methods: A scoping review was carried out following the methodology proposed by the Joanna Briggs Institute, which included studies carried out in humans as of 2020, corresponding to systematic reviews, clinical trials, analytical or descriptive observational studies, in which the effectiveness and/or safety of vaccines for COVID19 were evaluated or described. There were no age restrictions for the study participants. Results: The efficacy/effectiveness and safety of this vaccine was assessed through 113 studies. Nineteen corresponded to experimental studies, 7 of Phase II, 5 of Phase IV, and 4 were clinical trials with random assignment. Although some clinical trials with random assignment have been carried out, these have limitations in terms of feasibility, follow-up times, and with this, the possibility of evaluating safety outcomes that occur with low frequencies. Not all studies have used homogeneous methods of analysis. Both the prevention of infection, and the prevention of outcomes such as hospitalization or death, have been valued through similar outcomes, but some through multivariate analysis of dependencies, and others through analysis that try to infer causally through different control methods of confounding. Conclusion: Published information on the evaluation of the efficacy/effectiveness and safety of the CoronaVac is abundant. However, there are differences in terms of vaccine application schedules, population definition, outcomes evaluated, follow-up times, and safety assessment, as well as non-standardization in the reporting of results, which may hinder the generalizability of the findings. It is important to generate meetings and consensus strategies for the methods and reporting of this type of studies, which will allow to reduce the heterogeneity in their presentation and a better understanding of the effect of these vaccines.

Barreras y facilitadores en la implementación de la estrategia de atención primaria en salud en Palmira, Colombia / Barriers and facilitators in the implementation of the primary health care strategy in Palmira, Colombia

RESUMEN Objetivo Conocer las barreras y facilitadores para la continuidad en la implementación de la estrategia de Atención Primaria en Salud en Palmira. Métodos Se tomó la experiencia de Atención Primaria en Salud (APS) del ente territorial de salud del Municipio de Palmira, Colombia, un territorio de aproximadamente 283 431 habitantes. Se usó el enfoque metodológico cualitativo mediante el análisis de contenido temático. La población objeto fueron los informantes clave, individuos con un papel potencialmente significativo en la formulación y desarrollo de la estrategia de APS, elegidos con un enfoque no probabilístico por conveniencia. La información se obtuvo de fuentes primarias y secundarias y se utilizó el software informático de análisis cualitativo Atlas Ti V7, como herramienta de apoyo para el manejo de datos. Resultados El análisis de barreras y facilitadores para la continuidad de la estrategia de APS identificó las principales características de la estrategia y una serie de temas recurrentes al momento de analizar las posibles barreras y facilitadores en los componentes de proceso, actores, contenido y contexto. Cada uno de estos temas presentó comportamientos diversos según la percepción de los participantes. Algunos temas fueron percibidos como facilitadores, barreras o como ambos. Conclusión Al comparar las barreras y facilitadores, se encontró que, a nivel global, son mayores las barreras que los facilitadores, comportamiento reflejado en la teoría, que indica que la población con algún tipo de vulnerabilidad presenta mayor cantidad de barreras frente a los servicios de salud y que la estrategia de APS hace especial énfasis en este tipo de población.

ABSTRACT Objective To know the barriers and facilitators for the continuity in the implementation of the Primary Health Care strategy in Palmira. Methods The Primary Health Care (PHC) experience was taken from the territorial health entity of the Municipality of Palmira, Colombia, which is a territory approximately with 283,431 habitants. The qualitative methodological approach was used through thematic content analysis. The target population was the key informants, individuals with a potentially significant role in the formulation and development of the PHC strategy, chosen with a non-probabilistic approach for convenience. The information was obtained from primary and secondary sources and the qualitative analysis computer software Atlas Ti V7 was used as a support tool for data management. Results The analysis of barriers and facilitators for the continuity of the PHC strategy, identified the main characteristics of the strategy and a series of recurring themes when analyzing the possible barriers and facilitators in the process components, actors, content, and context. Each of these themes presented different behaviors according to the perception of the participants, where some themes were perceived as facilitators, barriers, or both. Conclusión When comparing barriers and facilitators, it was found that globally the barriers are greater than facilitators, a behavior reflected in the theory since it indicates that the vulnerable population presents a greater number of barriers compared to health services and the strategy of APS places special emphasis on this type of population.