Osong Public Health and Research Perspectives

Original Articles

The incidence and clinical characteristics of myocarditis and pericarditis following mRNA-based COVID-19 vaccination in Republic of Korea adolescents from July 2021 to September 2022: Ju-Young Sim, Seung-Yun Kim, Eun-Kyoung Kim; Osong Public Health Res Perspect. 2023;14(2):76-88. Published online April 18, 2023; DOI: https://doi.org/10.24171/j.phrp.2023.0032

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Objectives
Age-specific information regarding myocarditis/pericarditis in adolescents following mRNA-based coronavirus disease 2019 (COVID-19) vaccination in Asia remains insufficient. This study investigated the incidence and clinical characteristics of myocarditis/pericarditis in Republic of Korea adolescents after mRNA-based COVID-19 vaccination.
Methods
This retrospective descriptive study utilized patient data from the Korea Immunization Management System. Incidence rates were calculated according to age and sex. Clinical characteristics (symptoms/signs, laboratory values, and imaging results) were compared between mild and severe cases.
Results
Between July 19, 2021 and September 30, 2022, 3,728,224 individuals aged 12 to 19 years received 6,484,165 mRNA-based COVID-19 vaccines, and 173 cases met the case definition for myocarditis/pericarditis: 151 mild (87.3%) and 22 severe (12.7%). The incidence was 3.8-fold higher in males than in females. Troponin I/ troponin T was elevated in 96% of myocarditis cases, demonstrating higher sensitivity than creatine kinase-myocardial band (67.6%) or C-reactive protein (75.2%). ST-segment or Twave on electrography abnormalities were found in 60.3% (85/141). Paroxysmal/sustained atrial/ventricular arrhythmias were more common in severe than in mild cases (45.5% vs. 16.8%, p=0.008). Edema on T2-weighted magnetic imaging occurred in 21.6% (8/37) and 62.5% (5/8) of mild and severe cases, respectively (p=0.03). Abnormal pericardial fluid collection or pericardial inflammation was found in 75.4% of pericarditis cases (49/65).
Conclusion
Myocarditis/pericarditis occurred in rare cases following mRNA-based COVID-19 vaccination. Most cases were mild, but the incidence was higher in adolescent males and after the second dose. As bivalent severe acute respiratory syndrome coronavirus 2 mRNA vaccination started in Republic of Korea in October 2022, the post-vaccination incidence of myocarditis/pericarditis should be closely monitored, considering clinical characteristics.

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To become a more stronger and safer country
Jong-Koo Lee
Osong Public Health and Research Perspectives.2023; 14(2): 67. CrossRef

Risk factors for deaths associated with COVID-19 according to the cause of death classification in Republic of Korea: Na-Young Kim, Seong-Sun Kim, Hyun Ju Lee, Dong Hwi Kim, Boyeong Ryu, Eunjeong Shin, Donghyok Kwon; Osong Public Health Res Perspect. 2023;14(2):89-99. Published online April 18, 2023; DOI: https://doi.org/10.24171/j.phrp.2022.0312

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Graphical Abstract Abstract PDF: Objectives
This study aimed to classify coronavirus disease 2019 (COVID-19)-related deaths according to whether COVID-19 was listed as the cause of death, and to investigate the differences in demographic characteristics and risk factors for COVID-19 death classifications.
Methods
A total of 5,625 deaths in South Korea among patients with confirmed COVID-19 from January 20, 2020 to December 31, 2021 were selected. Excluding false reports and unnatural deaths, 5,597 deaths were analyzed. Based on death report data, deaths were classified according to whether the cause of death was listed as COVID-19 (CD) or not (NCD). The epidemiological characteristics and causes of deaths were investigated using descriptive, univariate, and multivariate statistical analyses. Odds ratios (ORs) and 95% confidence intervals (CIs) were calculated to analyze the risk factors.
Results
The case fatality ratio was 0.89% and increased with age. Additionally, 96.4% of the subjects had an underlying disease, and 53.4% died in winter. The proportion of NCDs was 9.3%, of whom 19.1% died at home and 39.0% were confirmed to have COVID-19 after death. Malignant neoplasms (102/416 vs. 637/4,442; OR, 1.71; 95% CI, 1.36−2.16; p<0.001) were significantly associated with NCD.
Conclusion
This is the first study to analyze risk factors by cause of death using COVID-19 death report data in South Korea. These results are expected to be used as evidence for establishing a death monitoring system that can collect timely information in a new infectious disease pandemic.

Analysis of pregnant women with critically severe COVID-19 in Republic of Korea from February 2020 and December 2021: Ji Joo Lee, Sang-Eun Lee, Yeonjung Kim, Young-Joon Park; Osong Public Health Res Perspect. 2023;14(2):129-137. Published online April 5, 2023; DOI: https://doi.org/10.24171/j.phrp.2023.0025

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Graphical Abstract Abstract PDF: Objectives
This study aimed to describe the characteristics and risk factors for severe disease in pregnant women infected with coronavirus disease 2019 (COVID-19) from the early days of the COVID-19 epidemic in Korea to the predominant period of the Delta variant.
Methods
A retrospective cohort study was conducted among pregnant women diagnosed with COVID-19 between February 2020 and December 2021. Logistic regression analysis was performed to compare severe and mild cases after adjusting for pregnant women’s age, nationality, infection route, outbreak area, infection period, symptoms, underlying disease, smoking status, trimester, and COVID-19 vaccination status.
Results
In total, 2,233 pregnant women were diagnosed with COVID-19 by December 2021. Among these, 96.7% had mild symptoms, 3.3% had severe symptoms, and 0.04% died. The risk factors for severe disease in pregnant women with confirmed COVID-19 were being in the age group of 35 to 45 years, having hyperlipidemia, being in the second or third trimester of pregnancy at the time of COVID-19 diagnosis, being infected during the Delta-predominant period, and having a fever (≥38 °C) at diagnosis. Furthermore, 47.1% of patients in the mild group and 84.9% of patients in the severe group had 3 or more risk factors.
Conclusion
Pregnant women with COVID-19 mainly experienced mild symptoms, but those with risk factors were at a higher risk of developing severe symptoms. Therefore, treatment and follow-up management should be thoroughly implemented.

COVID-19 outbreak in a religious village community in Republic of Korea and risk factors for transmission: Jiae Shim, Eunju Lee, Eunyoung Kim, Yeonhwa Choi, Giseok Kang, Bryan Inho Kim; Osong Public Health Res Perspect. 2023;14(2):110-118. Published online April 5, 2023; DOI: https://doi.org/10.24171/j.phrp.2023.0002

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Graphical Abstract Abstract PDF: Objectives
This study aimed to assess the scale and transmission patterns of coronavirus disease 2019 (COVID-19) in a religious village community in South Korea, to determine the risk factors of transmission, and to evaluate vaccine effectiveness.
Methods
An epidemiological survey was conducted, and data were collected and analyzed from 602 villagers in the religious village community. Multivariate logistic regression analysis was used to identify the risk factors for COVID-19 transmission and to evaluate vaccine effectiveness.
Results
The outbreak attack rate was 72.1% (434/602). The attack rate was high among women in their 60s, the unemployed, residents living near religious facility (<500 m), and the unvaccinated. Age, the distance between religious facility and residences, and the absence of vaccination were identified as risk factors for transmission. Vaccine effectiveness was 49.0%, and the highest effectiveness was seen in the age group of 59 years or younger (65.8%).
Conclusion
This village community was isolated, with little communication with the outside world. However, the frequency of close contact between residents was relatively high, contributing to the spread of COVID-19 in the village even with relatively short exposure. Vaccination rates in the village community were also lower than those in the general public. Public health authorities should consider the potential impact of cultural factors, including religion, that could lead to the exponential spread of COVID-19 in closed village communities.

Vaccine hesitancy in patients with COVID-19 who have back pain: Askeri Türken, Haşim Çapar; Osong Public Health Res Perspect. 2023;14(2):100-109. Published online March 24, 2023; DOI: https://doi.org/10.24171/j.phrp.2023.0003

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Graphical Abstract Abstract PDF: Objectives
Musculoskeletal pain is among the most common symptoms in patients diagnosed with coronavirus disease 2019 (COVID-19), and it has placed a significant burden on health worldwide during the pandemic. This study explored vaccine hesitancy and associated factors in patients with positive COVID-19 polymerase chain reaction test results who were hospitalized and had back pain.
Methods
A cross-sectional study was conducted among 170 hospitalized COVID-19 patients over 18 years of age. Data were analyzed using descriptive statistics with IBM SPSS ver. 25.0.
Results
COVID-19 patients who were married considered COVID-19 vaccinations riskier than unmarried COVID-19 patients. Patients who had not been vaccinated expressed higher levels of distrust towards COVID-19 vaccines than patients who had been vaccinated. Participants had relatively little hesitation toward the Sinovac vaccine. High vaccine confidence was found in all participants regardless of vaccination status. Those who had not received the COVID-19 vaccine reported higher risk perceptions than those who had received at least 1 dose of any COVID-19 vaccine.
Conclusion
Measurements of the hesitancy of vaccinated and non-vaccinated patients or members of society towards vaccines can be an important parameter for health authorities to find solutions.

Special Article

A framework for nationwide COVID-19 vaccine safety research in the Republic of Korea: the COVID-19 Vaccine Safety Research Committee: Na-Young Jeong, Hyesook Park, Sanghoon Oh, Seung Eun Jung, Dong-Hyun Kim, Hyoung-Shik Shin, Hee Chul Han, Jong-Koo Lee, Jun Hee Woo, Byung-Joo Park, Nam-Kyong Choi; Osong Public Health Res Perspect. 2023;14(1):5-14. Published online February 28, 2023; DOI: https://doi.org/10.24171/j.phrp.2023.0026

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Graphical Abstract Abstract PDF

With the introduction of coronavirus disease 2019 (COVID-19) vaccines, the Korea Disease Control and Prevention Agency (KDCA) commissioned the National Academy of Medicine of Korea to gather experts to independently assess post-vaccination adverse events. Accordingly, the COVID-19 Vaccine Safety Research Committee (CoVaSC) was launched in November 2021 to perform safety studies and establish evidence for policy guidance. The CoVaSC established 3 committees for epidemiology, clinical research, and communication. The CoVaSC mainly utilizes pseudonymized data linking KDCA’s COVID-19 vaccination data and the National Health Insurance Service’s claims data. The CoVaSC’s 5-step research process involves defining the target diseases and organizing ad-hoc committees, developing research protocols, performing analyses, assessing causal relationships, and announcing research findings and utilizing them to guide compensation policies. As of 2022, the CoVaSC completed this research process for 15 adverse events. The CoVaSC launched the COVID-19 Vaccine Safety Research Center in September 2022 and has been reorganized into 4 divisions to promote research including international collaborative studies, long-/short-term follow-up studies, and education programs. Through these enhancements, the CoVaSC will continue to swiftly provide scientific evidence for COVID-19 vaccine research and compensation and may serve as a model for preparing for future epidemics of new diseases.

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To become a more stronger and safer country
Jong-Koo Lee
Osong Public Health and Research Perspectives.2023; 14(2): 67. CrossRef

Brief Report

Early countermeasures to COVID-19 at long-term care facilities in Gwangju Metropolitan City, Republic of Korea: Hye-Jin Kim, Jieun Kim, Yoon Suk Jang, Hanul Park, Jong Mu Kim, Young Joon Park, So-Yeon Ryu, Jun Hwi Cho, So Yeong Park, Sang-Eun Lee; Osong Public Health Res Perspect. 2023;14(1):59-65. Published online February 1, 2023; DOI: https://doi.org/10.24171/j.phrp.2022.0293

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Graphical Abstract Abstract PDF: Objectives
The coronavirus disease 2019 (COVID-19) pandemic has continued since its first detection in the Republic of Korea on January 20, 2020. This study describes the early countermeasures used to minimize the risk of COVID-19 outbreaks during cohort quarantine and compares the epidemiological characteristics of 2 outbreaks in long-term care facilities (LTCFs) in Gwangju Metropolitan City in summer 2020. Methods: An epidemiological investigation was conducted via direct visits. We investigated epidemiological characteristics, including incidence, morbidity, and mortality rates, for all residents and staff members. Demographic characteristics were analyzed using a statistical program. Additionally, the method of managing infection in LTCFs is described. Results: Residents and caregivers had high incidence rates in LTCF-A and LTCF-B, respectively. LTCF-B had a longer quarantine period than LTCF-A. The attack rate was 20.02% in LTCF-A and 27.9% in LTCF-B. The mortality rate was 2.3% (1/43) in LTCF-B, the only facility in which a COVID-19 death occurred. Conclusion: Extensive management requires contact minimization, which involves testing all contacts to mitigate further transmission in the early stages of LTCF outbreaks. The findings of this study can help inform and prepare public health authorities for COVID-19 outbreaks, particularly for early control in vulnerable facilities.

Original Articles

Association between face covering policies and the incidence of coronavirus disease 2019 in European countries: Sookhyun Kim, Jiyoung Oh, Sangwoo Tak; Osong Public Health Res Perspect. 2023;14(1):31-39. Published online February 1, 2023; DOI: https://doi.org/10.24171/j.phrp.2022.0287

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Graphical Abstract Abstract PDF: Objectives
This study was conducted to determine the impact of the strengthening or relaxation of face covering mandates on the subsequent national case incidence of coronavirus disease 2019 (COVID-19) in Europe as the full vaccination rate was increasing.
Methods
European countries in which case incidence increased for 3 consecutive weeks were monitored and analyzed using COVID-19 incidence data shared by the World Health Organization (WHO). The epidemic trend of COVID-19 in Europe was compared with that of countries elsewhere in the world based on WHO weekly epidemiological reports from June 20 to October 30, 2021. In addition, this study provided insight into the impact of government mask mandates on COVID-19 incidence in Europe by measuring the index scores of those facial covering policies before and after mandate relaxation or strengthening. The effects of the vaccination rate and the speed of vaccination on COVID-19 incidence were also analyzed.
Results
The incidence of COVID-19 after the relaxation of face covering mandates was significantly higher than before relaxation. However, no significant difference was observed in vaccination rate between countries with increased and decreased incidence. Instead, rapid vaccination delayed the resurgence in incidence.
Conclusion
The findings suggest that face covering policies in conjunction with rapid vaccination efforts are essential to help mitigate the spread of COVID-19.

Evaluation and follow-up of pain, fatigue, and quality of life in COVID-19 patients: Sevda Adar, Petek Şarlak Konya, Ali İzzet Akçin, Ümit Dündar, Neşe Demirtürk; Osong Public Health Res Perspect. 2023;14(1):40-50. Published online February 1, 2023; DOI: https://doi.org/10.24171/j.phrp.2022.0275

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Graphical Abstract Abstract PDF: Objectives
We evaluated pain, fatigue, anxiety, depression, and quality of life in patients hospitalized for coronavirus disease 2019 (COVID-19) and observed them over a period of 3 months. We also investigated the relationship of these symptoms to age, sex, disease severity, and levels of anxiety and depression. Methods: The study included 100 confirmed COVID-19 patients (i.e., positive on a polymerase chain reaction test) between the ages of 18 and 75 years. Pain (visual analog scale [VAS]), fatigue (fatigue severity scale), anxiety, and depression (hospital anxiety and depression scales) were evaluated on the first day of hospitalization and at 1-month and 3-month follow-ups. The short form-12 questionnaire was used to measure quality of life at the 1-month and 3-month followups. Results: No differences were found in pain, fatigue, anxiety levels, depression levels, and quality of life according to disease severity. High VAS scores at hospital admission were related to continued pain at the 3-month follow-up (odds ratio [OR], 1.067; p<0.001). High VAS (OR, 1.072; p=0.003) and anxiety levels (OR, 1.360; p=0.007) were related to severe fatigue at the 3-month evaluation. Conclusion: Pain, fatigue, anxiety, and depression appear to be long-term sequelae of COVID-19 and can affect quality of life. High VAS and anxiety levels were found to be associated with long-term fatigue.

Brief Report

The effectiveness of Paxlovid treatment in long-term care facilities in South Korea during the outbreak of the Omicron variant of SARS-CoV-2: Hanul Park, Young Joon Park, Hye Young Lee, Mi Yu, Yeong-Jun Song, Sang Eun Lee, Ji-Joo Lee, Eun-Sol Lee, Yeonjung Kim; Osong Public Health Res Perspect. 2022;13(6):443-447. Published online December 23, 2022; DOI: https://doi.org/10.24171/j.phrp.2022.0262

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Graphical Abstract Abstract PDF

Objectives
On November 5, 2021, Pfizer Inc. announced Paxlovid (nirmatrelvir +ritonavir) asa treatment method that could reduce the risk of hospitalization or death for patients withconfirmed coronavirus disease 2019 (COVID-19).Methods: From February 6, 2022 to April 2, 2022, the incidence of COVID-19 and the effectsof treatment with Paxlovid were analyzed in 2,241 patients and workers at 5 long-term carefacilities during the outbreak of the Omicron variant of severe acute respiratory syndromecoronavirus 2 in South Korea.Results: The rate of severe illness or death in the group given Paxlovid was 51% lower thanthat of the non-Paxlovid group (adjusted risk ratio [aRR], 0.49; 95% confidence interval [CI],0.24−0.98). Compared to unvaccinated patients, patients who had completed 3 doses of thevaccine had a 71% reduced rate of severe illness or death (aRR, 0.29; 95% CI, 0.13−0.64) and a65% reduced death rate (aRR, 0.35; 95% CI, 0.15−0.79).Conclusion: Patients given Paxlovid showed a lower rate of severe illness or death and alower fatality rate than those who did not receive Paxlovid. Patients who received 3 dosesof the vaccine had a lower rate of severe illness or death and a lower fatality rate than theunvaccinated group.

Citations

Citations to this article as recorded by

COVID ‐19 infection in patients with haematological malignancies: A single‐centre survey in the latest Omicron wave in China
Xiaolu Zhu, Qian Jiang, Jin Lu, Yuqian Sun, Xiaosu Zhao, Shenmiao Yang, Feifei Tang, Wenjing Yu, Ting Zhao, Xiaohong Liu, Jinsong Jia, Wenbing Duan, Lijuan Hu, Jing Wang, Yang Liu, Nan Peng, Xuelin Dou, Rui Ma, Qiang Fu, Huifang Wang, Kaiyan Liu, Xiaojun
British Journal of Haematology.2023;[Epub] CrossRef
The association mental health of adolescents with economic impact during the COVID-19 pandemic: a 2020 Korean nationally representative survey
Hanul Park, Kang-Sook Lee
BMC Public Health.2023;[Epub] CrossRef

Original Articles

mRNA vaccine effectiveness against SARS-CoV-2 B.1.617.2 (Delta) and B.1.1.529 (Omicron) variant transmission from home care cases to household contacts in South Korea: Hanul Park, Young Joon Park, Sang Eun Lee, Min Jei Lee, Hyungtae Ahn; Osong Public Health Res Perspect. 2022;13(6):435-442. Published online November 28, 2022; DOI: https://doi.org/10.24171/j.phrp.2022.0243

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Graphical Abstract Abstract PDF: Objectives
Household contacts of confirmed cases of coronavirus disease 2019 (COVID-19) areexposed to a high risk of viral transmission, and secondary incidence is an important indicatorof community transmission. This study analyzed the secondary attack rate and mRNA vaccineeffectiveness against transmission (VET) for index cases (patients treated at home) confirmedto be infected with the Delta and Omicron variants.Methods: The subjects of the study were 4,450 index cases and 10,382 household contacts.Logistic regression analysis was performed to compare the secondary attack rate byvaccination status, and adjusted relative risk and 95% confidence intervals were identified.Results: The secondary attack rate of the Delta variant was 27.3%, while the secondary attackrate of the Omicron variant was 29.8%. For the Delta variant, groups with less than 90 daysand more than 90 days after 2 doses of mRNA vaccination both showed a VET of 37%. For theOmicron variant, a 64% VET was found among those with less than 90 days after 2 doses ofmRNA vaccination.Conclusion: This study provides useful data on the secondary attack rate and VET of mRNAvaccines for household contacts of COVID-19 cases in South Korea.

Time-series comparison of COVID-19 case fatality rates across 21 countries with adjustment for multiple covariates: Yongmoon Kim, Bryan Inho Kim, Sangwoo Tak; Osong Public Health Res Perspect. 2022;13(6):424-434. Published online November 28, 2022; DOI: https://doi.org/10.24171/j.phrp.2022.0212

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Objectives
Although it is widely used as a measure for mortality, the case fatality rate (CFR) ofcoronavirus disease 2019 (COVID-19) can vary over time and fluctuate for many reasons otherthan viral characteristics. To compare the CFRs of different countries in equal measure, weestimated comparable CFRs after adjusting for multiple covariates and examined the mainfactors that contributed to variability in the CFRs among 21 countries.Methods: For statistical analysis, time-series cross-sectional data were collected from OurWorld in Data, CoVariants.org, and GISAID. Biweekly CFRs of COVID-19 were estimated bypooled generalized linear squares regression models for the panel data. Covariates includedthe predominant virus variant, reproduction rate, vaccination, national economic status,hospital beds, diabetes prevalence, and population share of individuals older than age 65. Intotal, 21 countries were eligible for analysis.Results: Adjustment for covariates reduced variation in the CFRs of COVID-19 across countriesand over time. Regression results showed that the dominant spread of the Omicron variant,reproduction rate, and vaccination were associated with lower country-level CFRs, whereasage, the extreme poverty rate, and diabetes prevalence were associated with higher countrylevel CFRs.Conclusion: A direct comparison of crude CFRs among countries may be fallacious, especiallyin a cross-sectional analysis. Our study presents an adjusted comparison of CFRs over timefor a more proper comparison. In addition, our findings suggest that comparing CFRs amongdifferent countries without considering their context, such as the epidemic phase, medicalcapacity, surveillance strategy, and socio-demographic traits, should be avoided.

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Comments on the article "Time-series comparison of COVID-19 case fatality rates across 21 countries with adjustment for multiple covariates"
Gaetano Perone
Osong Public Health and Research Perspectives.2023; 14(2): 146. CrossRef

Review Article

SARS-CoV-2 in brief: from virus to prevention: Hassan Karami, Zeinab Karimi, Negin Karami; Osong Public Health Res Perspect. 2022;13(6):394-406. Published online November 28, 2022; DOI: https://doi.org/10.24171/j.phrp.2022.0155

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Abstract PDF

The recent outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), ahighly transmissible virus with a likely animal origin, has posed major and unprecedentedchallenges to millions of lives across the affected nations of the world. This outbreak firstoccurred in China, and despite massive regional and global attempts shortly thereafter, itspread to other countries and caused millions of deaths worldwide. This review presents keyinformation about the characteristics of SARS-CoV-2 and its associated disease (namely,coronavirus disease 2019) and briefly discusses the origin of the virus. Herein, we also brieflysummarize the strategies used against viral spread and transmission.

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Surveillance of endemic coronaviruses during the COVID‐19 pandemic in Iran, 2021–2022
Hassan Karami, Kaveh Sadeghi, Sevrin Zadheidar, Fatemeh Saadatmand, Negar Mirsalehi, Nima Hoveidi Ardestani, Shirin Kalantari, Mohammad Farahmand, Jila Yavarian, Talat Mokhtari‐Azad
Influenza and Other Respiratory Viruses.2023;[Epub] CrossRef

Original Article

Clinical outcomes of remdesivir-treated COVID-19 patients in South Korea: Mi Yu, Bryan Inho Kim, Jungyeon Kim, Jin Gwack; Osong Public Health Res Perspect. 2022;13(5):370-376. Published online October 18, 2022; DOI: https://doi.org/10.24171/j.phrp.2022.0138

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Abstract PDF: Objectives
This study analyzed the clinical outcomes of remdesivir treatment in coronavirus disease 2019 (COVID-19) patients in South Korea.
Methods
This retrospective cohort study involved the secondary analysis of epidemiological data. Among patients diagnosed with COVID-19 from July 2, 2020 to March 23, 2021 (12 AM), 4,868 who received oxygen therapy and were released from isolation after receiving remdesivir treatment were assigned to the treatment group, and 6,068 patients who received oxygen therapy but not remdesivir were assigned to the untreated group. The study subjects included children under the age of 19. The general characteristics and severity were compared between the groups. Differences in the time to death and mortality were also compared.
Results
In the untreated group, the hazard ratio [HR] for mortality was 1.59 among patients aged ≥70 years and 2.32 in patients with severe disease in comparison to the treatment group. In a comparison of survival time among patients with severe disease aged ≥70 years, the HR for mortality before 50 days was 2.09 in the untreated group compared to the treatment group.
Conclusion
Patients with remdesivir treatment showed better clinical outcomes in this study, but these results should be interpreted with caution since this study was not a fully controlled clinical trial.

Brief Report

Adverse events of the Pfizer-BioNTech COVID-19 vaccine in Korean children and adolescents aged 5 to 17 years: Seontae Kim, Yeseul Heo, Soon-Young Seo, Do Sang Lim, Enhi Cho, Yeon-Kyeng Lee; Osong Public Health Res Perspect. 2022;13(5):382-390. Published online October 14, 2022; DOI: https://doi.org/10.24171/j.phrp.2022.0233

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Abstract PDF: Objectives
This study aimed to identify potential safety signals and adverse events following the primary Pfizer-BioNTech coronavirus disease 2019 (COVID-19) vaccination series among children and adolescents aged 5 to 17 years in the Republic of Korea. Methods: Adverse events reported through the COVID-19 vaccination management system (CVMS, a web-based passive vaccine safety surveillance system) and adverse events and health conditions collected from a text message-based survey were analyzed. Results: A total of 14,786 adverse events among 5 to 17-year-old children and adolescents were reported in the CVMS; 14,334 (96.9%) were non-serious and 452 (3.1%) were serious, including 125 suspected cases of acute cardiovascular injury and 101 suspected cases of anaphylaxis. The overall reporting rate was lower in 5 to 11-year-old children (64.5 per 100,000 doses) than in 12 to 17-year-old adolescents (300.5 per 100,000 doses). The text message survey identified that local and systemic adverse events after either dose were reported less frequently in 5 to 11-year-old children than in 12 to 17-year-old adolescents (p<0.001). The most commonly reported adverse events were pain at the injection site, myalgia, headache, and fatigue/tiredness. Conclusion: The overall results are consistent with the results of controlled trials; serious adverse events were extremely rare among 5 to 17-year-old children and adolescents following Pfizer-BioNTech COVID-19 vaccination. Adverse events were less frequent in children aged 5 to 11 years than in adolescents aged 12 to 17 years.

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