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Brief Reports
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
  • 829 View
  • 67 Download
AbstractAbstract 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.
Safety monitoring of COVID-19 vaccination among adolescents aged 12 to 17 years old in the Republic of Korea
Seontae Kim, Insob Hwang, Mijeong Ko, Yunhyung Kwon, Yeon-Kyeng Lee
Osong Public Health Res Perspect. 2022;13(3):230-237.   Published online June 10, 2022
DOI: https://doi.org/10.24171/j.phrp.2022.0122
  • 1,992 View
  • 104 Download
  • 1 Citations
Graphical AbstractGraphical Abstract AbstractAbstract PDF
Objectives
This study aimed to disseminate information on coronavirus disease 2019 (COVID-19) vaccine safety among adolescents aged 12 to 17 years in the Republic of Korea. Methods: Two databases were used to assess COVID-19 vaccine safety in adolescents aged 12 to 17 years who completed the primary Pfizer-BioNTech vaccination series. Adverse events reported to the web-based COVID-19 vaccination management system (CVMS) and collected in the text message-based system were analyzed. Results: From March 5, 2021 to February 13, 2022, 12,216 adverse events among 12- to 17-yearolds were reported to the CVMS, of which 97.1% were non-serious adverse events and 2.9% were serious adverse events, including 85 suspected cases of anaphylaxis, 74 suspected cases of myocarditis and/or pericarditis, and 2 deaths. From December 13, 2021 to January 26, 2022, 10,389 adolescents responded to a text message survey, and local/systemic adverse events were more common after dose 2 than after dose 1. The most commonly reported events following either vaccine dose were pain at the injection site, headache, fatigue/tiredness, and myalgia. Conclusion: The overall results are consistent with previous findings; the great majority of adverse events were non-serious, and serious adverse events were rare among adolescents aged 12 to 17 years following Pfizer-BioNTech COVID-19 vaccination.

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  • COVID-19 Vaccination in Korea: Past, Present, and the Way Forward
    Eliel Nham, Joon Young Song, Ji Yun Noh, Hee Jin Cheong, Woo Joo Kim
    Journal of Korean Medical Science.2022;[Epub]     CrossRef
COVID-19 vaccine safety monitoring in Republic of Korea from February 26, 2021 to October 31, 2021
Insob Hwang, Kyeongeun Park, Tae Eun Kim, Yunhyung Kwon, Yeon-Kyeng Lee
Osong Public Health Res Perspect. 2021;12(6):396-402.   Published online December 21, 2021
DOI: https://doi.org/10.24171/j.phrp.2021.0310
  • 4,480 View
  • 159 Download
  • 7 Citations
Graphical AbstractGraphical Abstract AbstractAbstract PDFSupplementary Material
Objectives
This study aimed to present data on reported adverse events following coronavirus disease 2019 (COVID-19) vaccination in Republic of Korea from February 26 to October 31, 2021, and to determine whether any significant patterns emerged from an analysis of the characteristics of suspected adverse event cases for each type of vaccine.
Methods
Adverse events following COVID-19 vaccination reported by medical doctors and forensic pathologists were analyzed. Cases of suspected anaphylaxis were classified using the Brighton Collaboration definition.
Results
By October 31, 2021, a total of 353,535 (0.45%) adverse events were reported after 78,416,802 COVID-19 vaccine doses. Of the adverse events, 96.4% were non-serious and 3.6% were serious. The most frequently reported adverse events were headache, myalgia, and dizziness. Of the 835 reported deaths after COVID-19 vaccination, 2 vaccine-related deaths were confirmed. Suspected anaphylaxis was confirmed in 454 cases using the Brighton Collaboration definition.
Conclusion
The commonly reported symptoms were similar to those described in clinical trials. Most reported adverse events were non-serious, and the reporting rate of adverse events following COVID-19 vaccination was higher in women than in men (581 vs. 315 per 100,000 vaccinations). Confirmed anaphylaxis was reported in 5.8 cases per 1,000,000 vaccinations.

Citations

Citations to this article as recorded by  
  • Allergic Reactions to COVID-19 Vaccines: Risk Factors, Frequency, Mechanisms and Management
    Nicoletta Luxi, Alexia Giovanazzi, Alessandra Arcolaci, Patrizia Bonadonna, Maria Angiola Crivellaro, Paola Maria Cutroneo, Carmen Ferrajolo, Fabiana Furci, Lucia Guidolin, Ugo Moretti, Elisa Olivieri, Giuliana Petrelli, Giovanna Zanoni, Gianenrico Senna,
    BioDrugs.2022; 36(4): 443.     CrossRef
  • Safety monitoring of COVID-19 vaccination among adolescents aged 12 to 17 years old in the Republic of Korea
    Seontae Kim, Insob Hwang, Mijeong Ko, Yunhyung Kwon, Yeon-Kyeng Lee
    Osong Public Health and Research Perspectives.2022; 13(3): 230.     CrossRef
  • Incidence and Characteristics of Adverse Events after COVID-19 Vaccination in a Population-Based Programme
    Laura Bonzano, Olivera Djuric, Pamela Mancuso, Lidia Fares, Raffaele Brancaccio, Marta Ottone, Eufemia Bisaccia, Massimo Vicentini, Alessia Cocconcelli, Alfonso Motolese, Rostyslav Boyko, Paolo Giorgi Rossi, Alberico Motolese
    Vaccines.2022; 10(7): 1111.     CrossRef
  • Global Predictors of COVID-19 Vaccine Hesitancy: A Systematic Review
    Carla Pires
    Vaccines.2022; 10(8): 1349.     CrossRef
  • Anaphylaxis and Related Events Following COVID‐19 Vaccination: A Systematic Review
    Pradipta Paul, Emmad Janjua, Mai AlSubaie, Vinutha Ramadorai, Beshr Mushannen, Ahamed Lazim Vattoth, Wafa Khan, Khalifa Bshesh, Areej Nauman, Ibrahim Mohammed, Imane Bouhali, Mohammed Khalid, Dalia Zakaria
    The Journal of Clinical Pharmacology.2022; 62(11): 1335.     CrossRef
  • 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 and Research Perspectives.2022; 13(5): 382.     CrossRef
  • COVID-19 Vaccination in Korea: Past, Present, and the Way Forward
    Eliel Nham, Joon Young Song, Ji Yun Noh, Hee Jin Cheong, Woo Joo Kim
    Journal of Korean Medical Science.2022;[Epub]     CrossRef
COVID-19 vaccine safety monitoring in the Republic of Korea: February 26, 2021 to April 30, 2021
Hyun-kyung Oh, Eun Kyeong Kim, Insob Hwang, Tae Eun Kim, Yeon-kyeong Lee, Eunju Lee, Yeon-Kyeng Lee
Osong Public Health Res Perspect. 2021;12(4):264-268.   Published online August 13, 2021
DOI: https://doi.org/10.24171/j.phrp.2021.0157
  • 3,841 View
  • 123 Download
  • 4 Citations
AbstractAbstract PDF
Objectives
On February 26, 2021, coronavirus disease 2019 (COVID-19) vaccination was started for high-priority groups based on the recommendation of the Advisory Committee on Immunization Practices with 2 available COVID-19 vaccines (AstraZeneca and Pfizer-BioNTech) in Korea. This report provides a summary of adverse events following COVID-19 vaccination as of April 30, 2021.
Methods
Adverse events following immunization are notifiable by medical doctors to the Korea Immunization Management System (KIMS) under the national surveillance system. We analyzed all adverse events reports following COVID-19 vaccination to the KIMS from February 26 to April 30, 2021.
Results
In total, 16,196 adverse events following 3,586,814 administered doses of COVID-19 vaccines were reported in approximately 2 months (February 26 to April 30, 2021). Of these, 15,658 (96.7%) were non-serious adverse events, and 538 (3.3%) were serious adverse events, including 73 (0.5%) deaths. The majority of adverse events (n=13,063, 80.7%) were observed in women, and the most frequently reported adverse events were myalgia (52.2%), fever (44.9%), and headache (34.9%). Of the 73 deaths following the COVID-19 vaccination, none were related to the vaccines.
Conclusion
By April 30, 3.6 million doses of the COVID 19 vaccine had been given in Korea, and the overwhelming majority of reports were for non-serious events. The Korea Disease Control and Prevention Agency continues to monitor the safety of COVID-19 vaccination.

Citations

Citations to this article as recorded by  
  • Safety and effectiveness of BNT162b2 mRNA Covid-19 vaccine in adolescents
    Young June Choe, Seonju Yi, Insob Hwang, Jia Kim, Young-Joon Park, Eunhee Cho, Myoungyoun Jo, Hyunju Lee, Eun Hwa Choi
    Vaccine.2022; 40(5): 691.     CrossRef
  • Direct and Indirect Associations of Media Use With COVID-19 Vaccine Hesitancy in South Korea: Cross-sectional Web-Based Survey
    Minjung Lee, Myoungsoon You
    Journal of Medical Internet Research.2022; 24(1): e32329.     CrossRef
  • Self-Reported COVID-19 Vaccines’ Side Effects among Patients Treated with Biological Therapies in Saudi Arabia: A Multicenter Cross-Sectional Study
    Lama T AlMutairi, Wesal Y Alalayet, Sondus I Ata, Khalidah A Alenzi, Yazed AlRuthia
    Vaccines.2022; 10(6): 977.     CrossRef
  • COVID-19 vaccine safety monitoring in Republic of Korea from February 26, 2021 to October 31, 2021
    Insob Hwang, Kyeongeun Park, Tae Eun Kim, Yunhyung Kwon, Yeon-Kyeng Lee
    Osong Public Health and Research Perspectives.2021; 12(6): 396.     CrossRef
Original Articles
Perception and Practice of Road Safety among Medical Students, Mansoura, Egypt
Randah Helal, Ghada El-Khawaga, Abdel-Hady El-Gilany
Osong Public Health Res Perspect. 2018;9(1):25-31.   Published online December 31, 2017
DOI: https://doi.org/10.24171/j.phrp.2018.9.1.05
  • 3,980 View
  • 49 Download
  • 6 Citations
AbstractAbstract PDF
Objectives

To assess the knowledge and attitude of medical students towards road safety and to determine their driving behavior and its relation to different related factors.

Methods

This cross-sectional study involved 480 medical students at Mansoura University, Egypt. A self-administered questionnaire was used to collect student personal data, knowledge about road safety, attitude towards road safety, and driving practices.

Results

More than 40% of students experienced an injury in the previous year, mainly as a pedestrian (56%), and 15.2% practiced driving, although only 9.6% had a driving licence. Most of the students had correct road safety knowledge except for awareness that the safe time to read maps is when your vehicle is parked (44%), one should drive in the left lane (29.6%), and one should overtake from the right-hand lane only (25.8%). The majority of the students reported that road traffic injuries can be prevented (89.2%). The mean score of the driving practices of the students ranged from 0.66±1.04 to 2.44±6.28 and rural residents showed significantly higher score regarding errors and lapses.

Conclusion

Good road safety knowledge and a favorable, low risk attitude, did not translate into improved road traffic behavior and this highlights the importance of stricter implementation of the existing rules and including road safety in medical education programs.

Citations

Citations to this article as recorded by  
  • Risk Factors Related to Road Traffic Accidents in Phuket Province, Southern Thailand: a Confirmatory Factor Analysis
    Jinda Kongcharoen, Nutthajit Onmek, Seppo Karrila, Jariya Seksan
    Transactions on Transport Sciences.2022; 13(1): 17.     CrossRef
  • Effect of Educational Intervention on Road Safety Awareness and Practice among Medical Students in Chennai-A Cross-Sectional Study
    Swetha NB, Sujitha P, Ashni Bhandari
    National Journal of Community Medicine.2022; 12(10): 325.     CrossRef
  • Factors associated and knowledge on road traffic accidents, rules among private university students in Chengalpattu district, Tamil Nadu, India – A cross-sectional study
    G Vijayakrishnan, P Priyadharshini, Balaji Ramraj, VV Anantharaman
    Journal of Education and Health Promotion.2022; 11(1): 148.     CrossRef
  • A STUDY ON BASIC KNOWLEDGE AND PRACTICES FOR ROAD TRAFFIC SAFETY MEASURES AMONG UNDERGRADUATE MEDICAL STUDENTS OF UTTAR PRADESH
    SOM NATH, SANDEEP KUMAR, KAMRAN JAVED NAQUVI, MANJUSHA NATH
    Asian Journal of Pharmaceutical and Clinical Resea.2022; : 110.     CrossRef
  • A cross-sectional study to assess the knowledge, attitude, and practices towards road traffic safety regulations among college going students of himalayan region, Uttarakhand, India
    Swati Sharma, Neha Sharma, Shaili Vyas, Jayanti Semwal
    Journal of Public Health and Primary Care.2020; 1(1): 30.     CrossRef
  • A study on awareness of road traffic accidents and their basic management among medical students of government medical college, Maharashtra, India
    Abhay Srivastava, Shruti Gaikwad, Pallavi Pagdal, Sudip Bhattacharya
    CHRISMED Journal of Health and Research.2019; 6(4): 216.     CrossRef
Development of a Food Safety and Nutrition Education Program for Adolescents by Applying Social Cognitive Theory
Jounghee Lee, Soyeon Jeong, Gyeongah Ko, Hyunshin Park, Youngsook Ko
Osong Public Health Res Perspect. 2016;7(4):248-260.   Published online August 31, 2016
DOI: https://doi.org/10.1016/j.phrp.2016.05.005
  • 2,248 View
  • 18 Download
  • 7 Citations
AbstractAbstract PDF
Objectives
The purpose of this study was to develop an educational model regarding food safety and nutrition. In particular, we aimed to develop educational materials, such as middle- and high-school textbooks, a teacher’s guidebook, and school posters, by applying social cognitive theory.
Methods
To develop a food safety and nutrition education program, we took into account diverse factors influencing an individual’s behavior, such as personal, behavioral, and environmental factors, based on social cognitive theory. We also conducted a pilot study of the educational materials targeting middle-school students (n = 26), high-school students (n = 24), and dietitians (n = 13) regarding comprehension level, content, design, and quality by employing the 5-point Likert scale in May 2016.
Results
The food safety and nutrition education program covered six themes: (1) caffeine; (2) food additives; (3) foodborne illness; (4) nutrition and meal planning; (5) obesity and eating disorders; and (6) nutrition labeling. Each class activity was created to improve self-efficacy by setting one’s own goal and to increase self-control by monitoring one’s dietary intake. We also considered environmental factors by creating school posters and leaflets to educate teachers and parents. The overall evaluation score for the textbook was 4.0 points among middle- and high-school students, and 4.5 points among dietitians.
Conclusion
This study provides a useful program model that could serve as a guide to develop educational materials for nutrition-related subjects in the curriculum. This program model was created to increase awareness of nutrition problems and self-efficacy. This program also helped to improve nutrition management skills and to promote a healthy eating environment in middle- and high-school students.

Citations

Citations to this article as recorded by  
  • Evaluating the Consistency Between Conceptual Frameworks and Factors Influencing the Safe Behavior of Iranian Workers in the Petrochemical Industry: Mixed Methods Study
    Azita Zahiri Harsini, Philip Bohle, Lynda R Matthews, Fazlollah Ghofranipour, Hormoz Sanaeinasab, Farkhondeh Amin Shokravi, Krishan Prasad
    JMIR Public Health and Surveillance.2021; 7(5): e22851.     CrossRef
  • Critical Consciousness of Food Systems as a Potential Lifestyle Intervention on Health Issues
    Sothy Eng, Carli Donoghue, Tricia Khun, Whitney Szmodis
    American Journal of Lifestyle Medicine.2020; 14(3): 258.     CrossRef
  • Development, Implementation, and Process Evaluation of a Theory-Based Nutrition Education Programme for Adults Living With HIV in Abeokuta, Nigeria
    Temitope K. Bello, Gerda J. Gericke, Una E. MacIntyre
    Frontiers in Public Health.2019;[Epub]     CrossRef
  • What matters for higher education success of private educational institutions? Senior students’ perceptions in Malaysia
    Jayaraman Krishnaswamy, Zarif Hossain, Mohan Kumar Kavigtha, Annamalai Nagaletchimee
    Journal of Applied Research in Higher Education.2019; 11(3): 616.     CrossRef
  • Augmented reality of traditional food for nutrition education
    Cica Yulia, H Hasbullah, E.E. Nikmawati, S.R. Mubaroq, Cep Ubad Abdullah, Isma Widiaty, Ade Gafar Abdullah, Asep Bayu Dani Nandiyanto
    MATEC Web of Conferences.2018; 197: 16001.     CrossRef
  • Decreasing the use of edible oils in China using WeChat and theories of behavior change: study protocol for a randomized controlled trial
    Rui Zhu, Xianglong Xu, Yong Zhao, Manoj Sharma, Zumin Shi
    Trials.2018;[Epub]     CrossRef
  • Chemicals as additives in food processing -a review
    KUMARESAN D, NITHYA SERMUGAPANDIAN, HEMASHREE S, RUBINI K R
    International Journal of Pharma and Bio Science.2017;[Epub]     CrossRef
Impact of Community-Based Approach as Policy Tool: World Health Organization-Designated Safe Communities of Korea and Health Action Zones of the United Kingdom
Changhyun Kang, Jihyung Shin, Bob Matthews
Osong Public Health Res Perspect. 2016;7(1):36-42.   Published online February 28, 2016
DOI: https://doi.org/10.1016/j.phrp.2015.10.005
  • 2,065 View
  • 17 Download
  • 2 Citations
AbstractAbstract PDF
Objectives
The aim of this study is to ascertain and identify the effectiveness of area-based initiatives as a policy tool mediated by societal and individual factors in the five World Health Organization (WHO)-designated Safe Communities of Korea and the Health Action Zones of the United Kingdom (UK).
Methods
The Korean National Hospital discharge in-depth injury survey from the Korea Centers for Disease Control and Prevention and causes of death statistics by the Statistics Korea were used for all analyses. The trend and changes in injury rate and mortality by external causes were compared among the five WHO-designated Safe Communities in Korea.
Results
The injury incident rates decreased at a greater level in the Safe Communities compared with the national average. Similar results were shown for the changes in unintentional injury incident rates. In comparison of changes in mortality rate by external causes between 2005 and 2011, the rate increase in Safe Communities was higher than the national average except for Jeju, where the mortality rate by external causes decreased.
Conclusion
When the Healthy Action Zones of the UK and the WHO Safe Communities of Korea were examined, the outcomes were interpreted differently among the compared index, regions, and time periods. Therefore, qualitative outcomes, such as bringing the residents' attention to the safety of the communities and promoting participation and coordination of stakeholders, should also be considered as important impacts of the community-based initiatives.

Citations

Citations to this article as recorded by  
  • Working in partnership with communities to improve health and research outcomes. Comparisons and commonalities between the UK and South Africa
    Patricia Wilson, Azwihangwisi Helen Mavhandu-Mudzusi
    Primary Health Care Research & Development.2019;[Epub]     CrossRef
  • THE SAFE COMMUNITY CONCEPT – A SUCCESSFUL TOOL FOR INJURY PREVENTION AND SAFETY PROMOTION
    Birutė Strukčinskienė, Sabine Distl, Sigitas Griškonis
    Visuomenės sveikata.2019; 28(7): 41.     CrossRef

PHRP : Osong Public Health and Research Perspectives