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KMID : 1143420210140050215
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Public Health Weekly Report
2021 Volume.14 No. 5 p.215 ~ p.228
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Analysis of adverse events following immunization with influenza vaccines in the 2020-2021 season
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Kim Sung-Nam
Kim Hee-Kyoung
Lee Yeon-Kyeong
Yang Yun-Jeong
Lee Jae-Young
Hong Jeong-Ik
Park Young-Joon
Kwon Yun-Hyung
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Abstract
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The Korea Disease Control and Prevention Agency (KDCA) monitors the safety of all vaccines administered in the Republic of Korea (ROK), including seasonal influenza vaccines. The aim of this article was to analyze adverse events following immunization (AEFI) with influenza vaccines. To that end, this article analyzed AEFIs reported to the KDCA’s integrated disease and health management system (https://is.cdc.go.kr) from September to December 2020. In addition, this article examined the KDCA’s Vaccination Injury Investigation Group’s data to find a causal association between death and vaccination and to examine the mortality rates of influenza vaccinated and non-vaccinated groups by influenza season. As of December 31, 2020, the number of reported AEFI with influenza vaccines totaled 2,059; 345 reports of fever (16.8%), 401 allergic reactions (19.5%), and 242 reports of local adverse reactions (11.8%) such as pain at the injection site. With regards to the most common neurological reactions, 72 cases of Guillain-Barre syndrome and convulsions were reported (3.5%) and 71 cases of nausea and vomiting (3.4%) were reported. The results of basic and epidemiological investigations, autopsy results, medical records, and examination records were reviewed for 110 cases reported as deaths after influenza vaccination. The key findings indicated that seasonal influenza vaccine-related mortality was not significant. First, in all cases of mortality, there was no indication that AEFI was a factor at the time of death. Second, death was most likely due to the worsening of an underlying disease such as cardiovascular disease, cerebrovascular disease, diabetes, chronic liver disease, chronic kidney failure, arrhythmia, chronic lung disease, a malignant tumor and so on than to an influenza vaccine. Third, according to autopsy results, the causes of death, such as aortic dissection, acute myocardial infarction, cerebral hemorrhage, and pulmonary artery thromboembolism were clearly indicated. Lastly, cerebral hemorrhage, myocardial infarction, asphyxia, septic shock, pneumonia, and kidney failure were found to be causes of death. All cases reviewed had inconsistent causal association with influenza immunization. In addition, this article compared the mortality rates of influenza vaccinated and unvaccinated groups from the 2015-2016 and 2019-2020 influenza seasons. Mortality rates of the unvaccinated group were 6.2-8.5 times higher than those of the vaccinated group. An average of 594 people a day in the 65-year-old and up age group died during the national influenza immunization program. To sustain vaccination as the most cost-effective means of preventing infectious disease, the most important thing is ublic confidence in safety. In the event of serious adverse reactions such as death, initial risk communication is very mportant. In addition, it is necessary to provide accurate information based on scientific evidence, transparent ommunication, and various public relations measures.
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KEYWORD
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Influenza, Vaccination, Immunization, Adverse events
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Listed journal information
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