Surveillance of adverse events following immunization in China: Past, present, and future

Liu, Dawei; Wu, Wendi; Li, Keli; Xu, De‐Hai; Ye, Jiakai; Li, Li; Wang, Huaqing

doi:10.1016/j.vaccine.2015.04.060

Cited by 42 publications

(37 citation statements)

References 21 publications

(14 reference statements)

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“…In [11,22,23], researchers have argued that pharmaceutical enterprises are responsible for the vaccine-related scandals in China and that the government should reform the supervisory model to strengthen regulation of the vaccine chain from production to market and to alleviate public anxiety. Similarly, in [24], the authors argued that the surveillance system of Adverse Events Following Immunization played a major role in stimulating distrust because the system was unable to collect sufficient data about the side effects of vaccination and underreported the social impact of such side effects. According to [24], the government should strengthen its surveillance capacity and develop a new, active surveillance system.…”

Section: Introductionmentioning

confidence: 99%

“…Similarly, in [24], the authors argued that the surveillance system of Adverse Events Following Immunization played a major role in stimulating distrust because the system was unable to collect sufficient data about the side effects of vaccination and underreported the social impact of such side effects. According to [24], the government should strengthen its surveillance capacity and develop a new, active surveillance system.…”

Section: Introductionmentioning

confidence: 99%

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Addressing Vaccine Hesitancy in China: A Scoping Review of Chinese Scholarship

2019

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Despite the well-developed Chinese National Immunization Program, vaccine hesitancy in China is rising. As part of the response, Chinese scholars have studied determinants and proposed solutions to vaccination hesitancy. We performed a scoping review of Chinese literature (2007–2019), drawn from four Chinese databases. We mapped relevant information and presented a systemic account of the proposed determinants and responses to vaccine hesitancy in China. We identified 77 relevant studies that reveal four approaches to vaccine hesitancy. Most Chinese studies define vaccine hesitancy as a problem of vaccine safety and vaccine incident response and place accountability on the level of governance, such as regulation deficits and inappropriate crisis management. A first minority of studies tied vaccination hesitancy to unprofessional medical conduct and called for additional resources and enhanced physician qualifications. A second minority of studies positioned vaccination hesitancy as a problem of parental belief and pointed to the role of media, proposing enhanced communication and education. Chinese literature ties vaccine hesitancy primarily to vaccine safety and medical conduct. Compared to international research, parental concerns are underrepresented. The Chinese context of vaccination scandals notably frames the discussion of vaccination hesitancy and potential solutions, which stresses the importance of considering vaccination hesitancy in specific social and political contexts.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Addressing Vaccine Hesitancy in China: A Scoping Review of Chinese Scholarship

2019

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“…The CNAEFIS is a nationwide passive surveillance system for AEFI [2,5]. In 2008, after 3 years of various pilot studies [6][7], the CNAEFIS became an online system covering all provinces.…”

Section: Data Sourcesmentioning

confidence: 99%

“…In cases of deaths, prefectural or provincial CDCs establish the AEFI Investigation and Diagnosis Expert Committee, which includes experts and committee members related to the case. This Committee then conducts the causality assessment [5,10].…”

Section: Causality Assessmentmentioning

confidence: 99%

“…All vaccines administered in mainland China are monitored and considered to be safe and effective by the National Regulatory Authority [3]. Since 2008, Chinese Center for Disease Control and Prevention (CCDC) has monitored AEFI reports, which are recorded using a passive AEFI nationwide surveillance program (Chinese AEFI Information System [CNAEFIS]) [5]. Since its implementation, the CNAEFIS has collected information on a large number of AEFI cases associated with vaccines used in China.…”

Section: Introductionmentioning

confidence: 99%

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

Liu

Nuorti

et al. 2019

Vaccine

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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.

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