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@#Objective To analyze the surveillance quality and characteristics of adverse events following immunization(AEFIs)in Shaanxi Province,from 2010 to 2021.Methods The vaccine doses administered data and AEFI data reported from 2010 to 2021 in Shaanxi Province were collected through the National Immunization Program Information Management System and AEFI information management system,and descriptive epidemiological methods were used for analysis.Results A total of 24 057 AEFIs were reported from 2010 to 2021 in Shaanxi Province.The average annual reported incidence of AEFI in 2014-2021 was 18.998 per 100 000 doses,with 17.998,0.702,and 0.112 per 100 000 doses for common vaccine reactions,rare vaccine reactions,and serious rare vaccine reactions,respectively.The incidence of AEFI was high from May to August,with an average of 26.304 per 100 000 doses.There were 69.83% of the cases reported by the children younger than 1 year old.In Expanded Program on Immunization vaccines,the incidence of AEFI in DTaP(diphtheria,tetanus and acellular pertussis combined vaccine)was the highest(57.948 per 100 000 doses),and the incidence of rare vaccine reactions in MR,MMR and MM(measles and rubella vaccine,measles mumps and rubella vaccine,measles and mumps combined vaccine)was the highest(1.875 per 100 000 doses).In non-Expanded Program on Immunization vaccines,the incidence of AEFI in DTaP-Hib(diphtheria,tetanus and acellular pertussis,inactivated poliomyelitis and haemophilus influenzae type b conjugate combined vaccine)was the highest(37.073 per 100 000 doses),and the incidence of rare vaccine reactions in MPV-ACYW135(group A,C,Y and W123 meningococcal polysaccharide vaccine)was the highest(2.392 per 100 000 doses).In common vaccine reactions,the fever/local redness and swelling/local induration were the main clinical diagnosis(22.481 per 100 000 doses).In rare vaccine reactions,allergic rash was the main clinical diagnosis(0.473 per 100 000 doses).Conclusion The sensitivity of AEFI surveillance system in Shaanxi Province is increasing year by year,and the vaccines have good safety,with common vaccine reactions as the main ones and serious rare vaccine reactions as the rare ones.There were differences in AEFI surveillance levels in different prefecture-level cities,so it is still necessary to strengthen the training.
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@#Objective To analyze the safety of children of different ages vaccinated with measles,mumps and rubella combined attenuated live vaccine(MMR in brief)/measles and rubella combined attenuated live vaccine(MR in brief)in Jilin Province from 2015 to 2022.Methods The actual vaccination data of MMR and MR from January 1,2015 to December 31,2022 were collected through the Jilin information management system for immunization programming,and all AEFI case information reported after vaccination with MMR and MR in this period was collected through the national adverse event following immunization(AEFI) monitoring and reporting system.The incidence rates of AEFI reports were compared among8-month-old children vaccinated with the first dose of MMR(MMR 8 group) and MR(MR8 group),18-month-old children vaccinated with the first dose of MMR(vaccinated with MR at 8 months old,MMR18-1 group) and the second dose of MMR(vaccinated with the first dose of MMR at 8 months old,MMR18-2 group) to preliminarily evaluate the safety of children vaccinated with MMR and MR at different ages.Results The reported incidence of AEFI in MMR8,MR8,MMR18-1 and MMR18-2 groups were 374.41/100 000,350.81/100 000,101.70/100 000 and 104.91/100 000,respectively,with significant difference among the four groups(χ~2=1 145.47,P=0.00);There was no significant difference between MMR8 and MR8,as well as MMR18-1 and MMR18-2 groups(χ~2=3.780 and 0.194,respectively,each P> 0.05);There were significant differences between MMR8 and MMR18-1,MMR8 and MMR18-2,as well as MR8 and MMR18-1groups(χ~2=920.440,412.110 and 1 021.120,respectively,each P=0.00).Most of the adverse reactions were general reactions,mainly fever,local redness and induration;A few were abnormal reactions,which were mainly allergic reactions(rash,papules,urticaria,etc.).Only one case of coincidence was reported in MMR8 group,and no psychogenic reaction,vaccine quality accident and vaccination accident occurred.All AEFI turned out to be improved or cured.Conclusion The differences of AEFI reported incidence of 8-month-old children vaccinated with MMR and MR were all small,and the difference of AEFI reported incidence of 18-month-old children vaccinated with the second dose of MMR was small regardless of the initial vaccination with MMR or MR.It is safe to use MMR instead of MR for the first vaccination in8-month-old children.
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La inmunización se encuentra entre las intervenciones en salud pública más exitosas y costo efectivas de todas las épocas, siendo su beneficio tan importante como su seguridad. Las vacunas, como cualquier otro medicamento, pueden generar eventos adversos, los que deben ser monitorizados permanentemente por sistemas de vigilancia. Esta disciplina recibe el nombre de Farmacovigilancia de Vacunas (FVV), encargada de estudiar los Eventos Supuestamente Atribuidos a la Vacunación ó Inmunización (ESAVI). El objetivo de este trabajo es revisar la evolución del sistema de farmacovigilancia de vacunas en Chile. El sistema de FVV chileno se basa en la vigilancia pasiva, y contempla la notificación obligatoria al Instituto de Salud Pública (ISP) de todos los ESAVI detectados, por parte de profesionales de la salud, directores de establecimientos y titulares de registro sanitario, priorizando las notificaciones de ESAVI serios e incluyendo la monitorización de todas las vacunas usadas en el país, tanto las que se encuentran incorporadas al Programa Nacional de Inmunización (PNI), como las que se encuentran fuera de este. El sistema de FVV chileno se caracteriza por un trabajo colaborativo permanente entre el ISP y el PNI, y parte de sus desafíos incluyen generar capacidades y alianzas estratégicas con la academia para la realización de estudios post comercialización sobre seguridad de vacunas. Finalmente, es importante destacar que tanto el marco normativo promulgado el año 2010, como la elaboración de procedimientos, el trabajo permanente con el PNI, y la conformación de un comité de expertos de ESAVI, y las diferentes estrategias de retroalimentación, son medidas implementadas que han contribuido a mejorar la tasa de reporte nacional y el análisis de los casos.
Immunization is among the most successful and cost-effective public health interventions of all times, its benefits being as important as its safety. Vaccines, like any other medicine, can generate adverse events, which must be permanently monitored by surveillance systems. Vaccine Pharmacovigilance (VPV) is the discipline responsible for studying Adverse Events Following Immunization (AEFI). The objective of this article is to review the evolution of the pharmacovigilance system of vaccines in Chile. The Chilean VPV system is based on passive surveillance, and establishes the mandatory reporting of all AEFI detected by healthcare workers, directors of healthcare facilities, and Marketing Authorization holders, to the Public Health Institute of Chile (PHI), prioritizing the reporting of serious ESAVI and including the monitoring of all vaccines used in the country, both those that are incorporated into the National Immunization Program (NIP), and those that are outside of it. The Chilean VPV system is characterized by a permanent collaborative work between the PHI and the NIP, and its challenges include generating capacities and strategic alliances with the academy to carry out post-marketing studies on vaccine safety. Finally, it's important to point out that the regulatory framework promulgated in 2010, as well as the elaboration of procedures, the permanent work with the NIP, the formation of an AEFI expert committee, and the different feedback strategies implemented, have contributed in improving case analysis and the national reporting rate.