Importancia de la vigilancia poscomercialización en las vacunas contra SARS-CoV-2

Autores/as

Palabras clave:

vacuna, SARS-CoV-2, COVID-19, eventos adversos, virus.

Resumen

Introducción: La vacunación ha sido una de las intervenciones sanitarias más costo-efectivas, por su impacto en el control de las enfermedades inmunoprevenibles. La pandemia ocasionada por SARS-CoV-2 condujo al desarrollo mundial de más de doscientas vacunas en diferentes fases de investigación con diversas plataformas.

Objetivo: Caracterizar la evaluación del control de calidad de las vacunas contra SARS-CoV-2 y los eventos adversos de las aprobadas contra otros agentes patógenos en las diferentes etapas del ensayo preclínico y clínico.

Métodos: Se realizó una búsqueda en Google Académico y PubMed/Medline de artículos publicados entre 1969 y marzo de 2021. Se seleccionaron los de mayor relevancia.

Desarrollo: Las vacunas se desarrollaron en un corto tiempo ante la pandemia de COVID-19, sin comprometer el adecuado control de los ensayos clínicos. Aunque resultan seguras, no están exentas de eventos adversos; por ello se debe vigilar su seguridad durante el proceso de poscomercialización. Muchas de ellas han comprometido su seguridad.

Conclusiones: Las vacunas deben poseer inmunogenicidad, eficacia y seguridad comprobadas. Los eventos adversos pueden surgir en cualquier etapa de la investigación; por tanto, resulta fundamental la vigilancia en la fase de poscomercialización.


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Biografía del autor/a

Alex Omar Franco Lacato, Hospital Universitario San Juan de Dios

Especialista de inmunología de sala de medicina interna

Nataniel Aldo Chaparro Mérida, Hospital Viedma

Especialista de inmunología del Hospital Viedma

Oliver Pérez Mártin, Instituto de Ciencias Básicas y Preclínicas Victoria de Girón. Universidad de Ciencias Médicas de La Habana, Cuba.

DrC. especialista en inmunología

Profesor Titular de la Universidad de Ciencias Médicas de La Habana, Cuba.

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Publicado

2024-03-21

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1.
Franco Lacato AO, Chaparro Mérida NA, Mártin OP. Importancia de la vigilancia poscomercialización en las vacunas contra SARS-CoV-2. Rev Cubana Inv Bioméd [Internet]. 21 de marzo de 2024 [citado 15 de julio de 2025];43. Disponible en: https://revibiomedica.sld.cu/index.php/ibi/article/view/1871

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