Deaths reported to national surveillance for adverse events following immunization in China, 2010–2015

Abstract

Background:The national Adverse Events Following Immunization (AEFI) surveillance system in China (CNAEFIS) has collected AEFI reports -including deaths -following all vaccines used in China since 2008. Aims:To review reports of AEFI-associated death cases from 2010 to 2015 to assess potential vaccine safety issues.Methods: Descriptive analysis of epidemiologic characteristic of AEFI-associated death cases and standard causality assessment for reported causes of deaths. To estimate the risk of death after vaccination, we used population data, administered doses and live births to calculate denominators. Results:During 2010-2015, 753 deaths were reported to CNAEFIS from mainland China. Highest numbers were reported in 2013 and 2014 when reporting peak of AEFI-associated deaths occurred after media reports concerning "death following Hepatitis B vaccination" in China. About 95% of deaths were in children <5 years of age and males accounted for 60%. Most common vaccines associated with reports of fatal AEFIs were vaccines in national immunization schedule. In causality assessment, 120 (16.0%) deaths were classified as vaccine-associated reactions such as anaphylactic reactions and disseminated BCG infections; 594 (78.9%) deaths were identified as coincidental events. The main causes of death were asphyxia, and Sudden Infant Death Syndrome. The overall estimated AEFI-associated death rates were: 0.26 per million vaccination doses administered and 0.09 per million population. The neonatal AEFI death rate was 0.77 per million live births. Conclusions:These data provide reassuring information about the small risk of death following immunization. They also illustrate sensitivity of passive reporting to public information and that peaks in serious AEFI reports should be interpreted with caution. Continuous monitoring and scientific causality assessment for serious AEFIs, including AEFI-associated deaths is imperative to ensure public confidence in the immunization program.

A fuzzy decision framework of lean-agile-green (LAG) practices for sustainable vaccine supply chain

“…There are several cases of deaths reported of AEFI in developing countries like India and China due to the damaged quality of vaccines (Joshi et al. , 2018; Wu et al. , 2019).…”

“…This is because the quality of vaccines is directly related to their effectiveness, potency (Lin et al, 2020) and the adverse after-effects following immunization (AEFI) program (Patil, 2014). There are several cases of deaths reported of AEFI in developing countries like India and China due to the damaged quality of vaccines (Joshi et al, 2018;Wu et al, 2019). The damaged quality also contributes to vaccine wastage, leading to the inefficiency of the SC.…”

Real-world safety profile of the 9-valent human papillomavirus vaccine: A study in Zhejiang, China from 2019 to 2021

“…The 9vHPV reporting rates for serious vaccination-related reactions and total AEFI varied across cities in this study, possibly due to the different surveillance sensitivities across cities. 23 , 24 For instance, some cities had a high overall reporting AEFI rate but had no severe vaccination-related reaction reports (e.g., Quzhou and Lishui). This could be attributed to differences in cognitive abilities between investigation and notification procedures.…”

Safety evaluation on concomitant immunization with inactivated poliomyelitis vaccine produced from Sabin strains and other vaccines (from 2015 to 2020)

“…AEFI cases that occurred at different times were reported and uploaded into the system by a responsible reporting unit according to the National AEFI guidelines. 22 , 23 The data evaluated in this article covered nationwide AEFI cases after administrating sIPV alone and simultaneous with other vaccines that were reported from January 2015 to December 2020.…”