Evaluación de reportes de eventos supuestamente atribuibles a vacunación e inmunización asociados a desinformación y grupos potencialmente reticentes a la vacunación en Chile : Sección de Farmacovigilancia de Vacunas, Subdepartamento Farmacovigilancia, Agencia Nacional de Medicamentos, Instituto de Salud Pública
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Date
2023
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es
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Universidad Andrés Bello
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Abstract
Los casos de neumonía en Wuhan, en el año 2019, ocasionados por el nuevo
Coronavirus tipo 2, causante del Síndrome Respiratorio Agudo Severo (SARS-CoV2), su acelerada propagación y las numerosas defunciones que generó, permitieron
catalogar la catástrofe como una pandemia, de modo que, para mitigar y detener la
transmisión del virus, se desarrollaron las vacunas COVID-19.
Lo anterior, significó el resurgimiento de un fenómeno que, con los años, había sido
omitido por gran parte de la población: la oposición vacunal. Dicha filosofía logró
instaurarse con mayor fortaleza a partir de este periodo, a través del sentimiento de
desconfianza preexistente en la comunidad y el uso indiscriminado de redes
sociales.
Para exponer la importancia de la toma de conocimiento de las acciones del
personal potencialmente reticente a la vacunación por parte de las Autoridades
Reguladoras Nacionales, el objetivo del proyecto consistió en evaluar los reportes
de ESAVI recibidos en el Centro Nacional de Farmacovigilancia de los cuales su
sospecha se vinculó a grupos potencialmente reticentes a la vacunación y a
desinformación, en Chile.
Se revisaron 742 formularios de sospecha de ESAVI contenidos en la Base de Datos
del CNFV, donde 705 fueron analizados en profundidad. Se registraron 4.485
manifestaciones en total, sin embargo, también se detectaron algunos eventos
adversos no descritos en los folletos de información, mas una parte de ellos carece
de fundamentos empírico-científicos y parecieran ser producto de información
obtenida en redes sociales. El indicador reveló que el 90% de las notificaciones (637
reportes) son deficientes, vale decir, la información que entregan se encuentra por
debajo del 55,5% de completitud.
Se espera que este proyecto sirva de pauta para caracterizar preliminarmente
individuos/grupos potencialmente reticentes a la vacunación y sus procederes (a
través de plataformas digitales), así como también, para el fortalecimiento del
sistema de farmacovigilancia de vacunas con enfoque en población general.
The cases of pneumonia in Wuhan, in 2019, caused by the new type 2 Coronavirus, which causes Severe Acute Respiratory Syndrome (SARS-CoV-2), its accelerated spread and the numerous deaths it caused, allowed the catastrophe to be classified as a pandemic, so to mitigate and stop the transmission of the virus, COVID-19 vaccines were developed. This meant the resurgence of a phenomenon that, over the years, had been omitted by a large part of the population: vaccination opposition. This philosophy managed to establish itself with greater strength from this period, through the pre-existing feeling of mistrust in the community and the indiscriminate use of social networks. In order to expose the importance of the National Regulatory Authorities' awareness of the actions of potentially reticent personnel to vaccination, the objective of the project consisted of evaluating the ESAVI reports received at the National Pharmacovigilance Center of which their suspicion was linked groups potentially reticent to vaccination and misinformation, in Chile. 742 suspected ESAVI forms contained in the CNFV Database were reviewed, where 705 were analyzed in depth. A total of 4.485 manifestations were registered, however, some adverse events not described in the information brochures were also detected, but a part of them lacks empirical-scientific foundations and seems to be the product of information obtained in social networks. The indicator revealed that 90% of the notifications (637 reports) are deficient, that is, information they provide is below 55,5% completeness. This project is expected to serve as a guideline to preliminarily characterize individuals/groups potentially reticent to vaccination and their procedures (through digital platforms), as well as strengthen the vaccine pharmacovigilance system with a focus on the general population.
The cases of pneumonia in Wuhan, in 2019, caused by the new type 2 Coronavirus, which causes Severe Acute Respiratory Syndrome (SARS-CoV-2), its accelerated spread and the numerous deaths it caused, allowed the catastrophe to be classified as a pandemic, so to mitigate and stop the transmission of the virus, COVID-19 vaccines were developed. This meant the resurgence of a phenomenon that, over the years, had been omitted by a large part of the population: vaccination opposition. This philosophy managed to establish itself with greater strength from this period, through the pre-existing feeling of mistrust in the community and the indiscriminate use of social networks. In order to expose the importance of the National Regulatory Authorities' awareness of the actions of potentially reticent personnel to vaccination, the objective of the project consisted of evaluating the ESAVI reports received at the National Pharmacovigilance Center of which their suspicion was linked groups potentially reticent to vaccination and misinformation, in Chile. 742 suspected ESAVI forms contained in the CNFV Database were reviewed, where 705 were analyzed in depth. A total of 4.485 manifestations were registered, however, some adverse events not described in the information brochures were also detected, but a part of them lacks empirical-scientific foundations and seems to be the product of information obtained in social networks. The indicator revealed that 90% of the notifications (637 reports) are deficient, that is, information they provide is below 55,5% completeness. This project is expected to serve as a guideline to preliminarily characterize individuals/groups potentially reticent to vaccination and their procedures (through digital platforms), as well as strengthen the vaccine pharmacovigilance system with a focus on the general population.
item.page.dc.description
Seminario (Química Farmacéutica)
Keywords
Vacunas, Efectos Adversos, Evaluación, Vacilación ante las Vacunas, Chile