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COVID-19: Original Article
Barriers to COVID-19 vaccine surveillance: the issue of under-reporting adverse events
Yunha Noh, Hwa Yeon Ko, Ju Hwan Kim, Dongwon Yoon, Young June Choe, Seung-Ah Choe, Jaehun Jung, Ju-Young Shin
Epidemiol Health. 2023;45:e2023054.   Published online June 7, 2023
DOI: https://doi.org/10.4178/epih.e2023054
  • 6,318 View
  • 147 Download
  • 1 Web of Science
  • 1 Crossref
AbstractAbstract AbstractSummary PDFSupplementary Material
Abstract
OBJECTIVES
This study investigated the reporting rates of adverse events following immunization (AEFIs) to the spontaneous reporting system (SRS) and its predictors among individuals with AEFIs after coronavirus disease 2019 (COVID-19) vaccination.
METHODS
A cross-sectional, web-based survey was conducted from December 2, 2021 to December 20, 2021, recruiting participants >14 days after completion of a primary COVID-19 vaccination series. Reporting rates were calculated by dividing the number of participants who reported AEFIs to the SRS by the total number of participants who experienced AEFIs. We estimated adjusted odds ratios (aORs) using multivariate logistic regression to determine factors associated with spontaneous AEFIs reporting.
RESULTS
Among 2,993 participants, 90.9% and 88.7% experienced AEFIs after the first and second vaccine doses, respectively (reporting rates, 11.6 and 12.7%). Furthermore, 3.3% and 4.2% suffered moderate to severe AEFIs, respectively (reporting rates, 50.5 and 50.0%). Spontaneous reporting was more prevalent in female (aOR, 1.54; 95% confidence interval [CI], 1.31 to 1.81); those with moderate to severe AEFIs (aOR, 5.47; 95% CI, 4.45 to 6.73), comorbidities (aOR, 1.31; 95% CI, 1.09 to 1.57), a history of severe allergic reactions (aOR, 2.02; 95% CI, 1.47 to 2.77); and those who had received mRNA-1273 (aOR, 1.25; 95% CI, 1.05 to 1.49) or ChAdOx1 (aOR, 1.62; 95% CI, 1.15 to 2.30) vaccines versus BNT162b2. Reporting was less likely in older individuals (aOR, 0.98; 95% CI, 0.98 to 0.99 per 1-year age increment).
CONCLUSIONS
Spontaneous reporting of AEFIs after COVID-19 vaccination was associated with younger age, female sex, moderate to severe AEFIs, comorbidities, history of allergic reactions, and vaccine type. AEFIs under-reporting should be considered when delivering information to the community and in public health decision-making.
Summary
Korean summary
본 연구는 국내 19-49세 성인을 대상으로, 코로나19 예방 백신 접종 후 이상반응 경험에 대한 자발적 보고율을 조사하고, 자발적 보고와 관련된 요인을 파악하고자 하였다. 2021년 12월 2일부터 20일까지 온라인 설문조사를 통하여 자료를 수집하였으며, 연구대상자는 코로나19 예방 백신의 기초접종을 완료한 후 2주 경과한 19-49세 성인으로, 전국 대표성을 확보하기 위해 성별, 연령, 지역별로 층화하여 모집하였다. 이상반응 자발적 보고율은 1차 접종과 2차 접종 후 각각 약 11.6%, 12.7%로 나타났으며, 중등도에서 중증의 이상반응에 대한 자발적 보고율은 약 50.5%, 50.0%로 나타났다. 이상반응 자발적 보고율 관련 영향요인으로는 젊은 연령층, 여성, 이상반응의 중증도, 동반질환, 알러지 반응 이력, 기초접종 백신 종류가 포함되었다.
Key Message
Spontaneous reporting rates of adverse events following immunization (AEFIs) against coronavirus disease 2019 (COVID-19) were low, at around 12 % of any AEFIs and 50 % of moderate-to-severe AEFIs. Younger age, female sex, severe AEFIs, comorbidities, history of allergic reactions, and the type of COVID-19 vaccine were associated with the AEFIs reporting.

Citations

Citations to this article as recorded by  
  • The effect of covid vaccination on menstruation and attitude to the vaccine among Indian women – Results of a prospective survey
    Anbukkani Subbian, Jeevithan Shanmugam, Uma Ram
    Indian Journal of Obstetrics and Gynecology Research.2024; 11(1): 70.     CrossRef
COVID-19: Original Article
Predictors of COVID-19 booster vaccine hesitancy among fully vaccinated adults in Korea: a nationwide cross-sectional survey
Yunha Noh, Ju Hwan Kim, Dongwon Yoon, Young June Choe, Seung-Ah Choe, Jaehun Jung, Sang-Won Lee, Ju-Young Shin
Epidemiol Health. 2022;44:e2022061.   Published online July 22, 2022
DOI: https://doi.org/10.4178/epih.e2022061
  • 11,043 View
  • 375 Download
  • 14 Web of Science
  • 14 Crossref
AbstractAbstract AbstractSummary PDFSupplementary Material
Abstract
OBJECTIVES
This study explored predictors of coronavirus disease 2019 (COVID-19) booster hesitancy among fully vaccinated young adults and parental COVID-19 vaccine hesitancy for their children.
METHODS
This cross-sectional study administered an online survey from December 2 to December 20, 2021. We enrolled participants aged 18-49 years, for whom ≥2 weeks had passed after their initial COVID-19 vaccination. We estimated odds ratios (ORs) with 95% confidence intervals (CIs) using multivariate logistic regression to evaluate factors associated with booster/vaccine hesitancy.
RESULTS
Among the 2,993 participants, 48.8% showed hesitancy (wait and see: 40.2%; definitely not: 8.7%). Booster hesitancy was more common among women (OR, 1.25; 95% CI, 1.05 to 1.50), younger people (OR, 1.44; 95% CI, 1.17 to 1.77), those with a lower education level (OR, 2.05; 95% CI, 1.10 to 3.82), those who received the mRNA-1273 vaccine type (OR, 2.01; 95% CI, 1.65 to 2.45), and those who experienced serious adverse events following previous COVID-19 vaccination (OR, 2.03; 95% CI, 1.47 to 2.80). The main reasons for booster hesitancy were concerns about safety (54.1%) and doubts about efficacy (29.8%). Among the 1,020 respondents with children aged <18 years, 65.8% were hesitant to vaccinate their children against COVID-19; hesitancy was associated with younger parental age, education level, the type of vaccine the parent received, and a history of COVID-19 infection.
CONCLUSIONS
Concerns about the efficacy and safety of COVID-19 vaccines were the major barrier to booster acceptance. The initial COVID-19 vaccine type (mRNA-1273), young age, gender (women), a low education level, and adverse events after the first COVID-19 vaccine were key predictors of booster hesitancy.
Summary
Korean summary
본 연구는 국내 19-49세 성인을 대상으로, 코로나19 3차접종 의향과 그들의 18세 미만 자녀에 대한 코로나19 기초접종 의향을 조사하고, 코로나19 백신접종 기피와 관련된 요인을 파악하고자 하였다. 2021년 12월 2일부터 20일까지 온라인 설문조사를 통하여 자료를 수집하였으며, 연구대상자는 코로나19 기초접종을 완료한 후 2주 경과한 19-49세 성인으로, 전국 대표성을 확보하기 위해 성별, 연령, 지역별로 층화하여 모집하였다. 코로나19 3차접종 기피율은 약 48.8%로 나타났으며, 접종 기피 관련 영향요인으로는 젊은 연령층, 여성, 낮은 교육수준, 기초접종 백신 종류, 기초접종 후 중증 이상반응 경험이 포함되었으며, 18세 미만 자녀에 대한 코로나19 기초접종 기피율은 65.8%로, 관련 영향요인으로는 젊은 부모 연령, 교육수준, 부모의 기초접종 백신 종류, 코로나19 감염 과거력이 포함되었다.
Key Message
Concerns about the safety and efficacy of COVID-19 vaccines were the major barrier to booster acceptance; the initial COVID-19 vaccine type (mRNA-1273), younger age, gender (women), a low education level, and adverse events after the first COVID-19 vaccine were key predictors of booster hesitancy.

Citations

Citations to this article as recorded by  
  • Factors influencing Thai university students’ decisions to take COVID-19 vaccine booster doses: a cross-sectional survey
    Weerakorn Thichumpa, Naphat Yimthin, Anawat Ratchatorn, Satoko Izumi, Wirichada Pan-ngum
    Tropical Medicine and Health.2024;[Epub]     CrossRef
  • Short-term side effects of BNT162b2 vaccine in primary care settings in Qatar: a retrospective study
    Sami Abdeen, Muna Abed Alah, Manal Al-Zaidan, Mohamed Izham Mohamed Ibrahim, Jazeel Abdulmajeed, Asma Ali Al-Nuaimi, Mohamed Ghaith Al-Kuwari
    Frontiers in Public Health.2024;[Epub]     CrossRef
  • Factors associated with intention to be vaccinated with the COVID-19 booster dose: a cross-sectional study in Peru
    Rodrigo Camacho-Neciosup, Ericka N. Balcazar-Huaman, Margarita L. Alvarez-Vilchez, Janith P. De la Cruz-Galán, Yubely Gálvez-Guadalupe, Edwin D. Garcia-Muñoz, Greysi Cerron-Daga, Virgilio E. Failoc-Rojas, Mario J. Valladares-Garrido
    PeerJ.2024; 12: e16727.     CrossRef
  • Impact of prior SARS-CoV-2 infection on college students’ hesitancy to receive additional COVID-19 vaccine booster doses: A study from Taizhou, China
    Jing-Shan Deng, Chun-Lian Huang, Qiong-Ying Hu, Lei Shi, Xiao-Ying Chen, Xu Luo, Tao-Hsin Tung, Jian-Sheng Zhu
    Preventive Medicine Reports.2024; 41: 102709.     CrossRef
  • Adverse events of COVID-19 vaccination during 2021–2022 suppressed by breakfast consumption and favorable sleeping habit among Japanese university students
    Nobuyuki Tetsuka, Keiko Suzuki, Kodai Suzuki, Takuma Ishihara, Takao Miwa, Satoko Tajirika, Miho Adachi, Ryo Horita, Taku Fukao, Mayumi Yamamoto
    Vaccine: X.2024; 19: 100516.     CrossRef
  • Understanding the factors associated with COVID-19 vaccine hesitancy in Venezuela
    Fabián R. Chacón-Labrador, María G. Passantino, Augusto Moncada-Ortega, Atahualpa A. Ávila, Andrea A. Moreno, Nicolle A. Kuffaty-Akkou, Luisana M. Pedroza, Natasha A. Camejo-Ávila, Daniela L. Mendoza-Millán, Carlis M. Rodriguez-Saavedra, María V. Marcano-
    BMC Public Health.2024;[Epub]     CrossRef
  • Why Some People Are Hesitant to Receive COVID-19 Boosters: A Systematic Review
    Yam B. Limbu, Bruce A. Huhmann
    Tropical Medicine and Infectious Disease.2023; 8(3): 159.     CrossRef
  • COVID-19 Vaccine Booster Hesitancy in Malaysia: A Web-Based Cross-Sectional Study
    Kai Wei Lee, Sook Fan Yap, Hooi Tin Ong, Myo Oo, Kye Mon Min Swe
    Vaccines.2023; 11(3): 638.     CrossRef
  • Factors associated with parental intention to vaccinate their preschool children against COVID-19: a cross-sectional survey in urban area of Jakarta, Indonesia
    Theresia Santi, Badriul Hegar, Zakiudin Munasir, Ari Prayitno, Retno Asti Werdhani, Ivo Novita Sah Bandar, Juandy Jo, Ruswati Uswa, Ratna Widia, Yvan Vandenplas
    Clinical and Experimental Vaccine Research.2023; 12(3): 240.     CrossRef
  • Factors associated with COVID-19 booster vaccine hesitancy: a nationwide, cross-sectional survey in Japan
    A. Takamatsu, H. Honda, T. Miwa, T. Tabuchi, K. Taniguchi, K. Shibuya, Y. Tokuda
    Public Health.2023; 223: 72.     CrossRef
  • Predictors of COVID-19 Vaccine Hesitancy Among Parents of Children Aged 5–11 Years in Korea
    Ju Hwan Kim, Dongwon Yoon, Yunha Noh, Jaehun Jung, Young June Choe, Ju-Young Shin
    Journal of Korean Medical Science.2023;[Epub]     CrossRef
  • Effective Vaccination and Education Strategies for Emerging Infectious Diseases Such as COVID-19
    Seong-Heon Wie, Jaehun Jung, Woo Joo Kim
    Journal of Korean Medical Science.2023;[Epub]     CrossRef
  • COVID-19 vaccination acceptance, safety and side-effects in European patients with severe asthma
    Apostolos Bossios, Alison M. Bacon, Katrien Eger, Dóra Paróczai, Florence Schleich, Shane Hanon, Svetlana Sergejeva, Eleftherios Zervas, Konstantinos Katsoulis, Christina Aggelopoulou, Konstantinos Kostikas, Eleni Gaki, Nikoletta Rovina, Zsuzsanna Csoma,
    ERJ Open Research.2023; 9(6): 00590-2023.     CrossRef
  • Parental concerns about COVID-19 vaccine safety and hesitancy in Korea: implications for vaccine communication
    Hye-Kyung Cho, Hyunju Lee, Young June Choe, Shinkyeong Kim, Sujin Seo, Jiwon Moon, Eun Hwa Choi, Geun-Yong Kwon, Jee Yeon Shin, Sang-Yoon Choi, Mi Jin Jeong, Myoungsoon You
    Epidemiology and Health.2022; 45: e2023004.     CrossRef
COVID-19: Original Article
Clinical outcomes of COVID-19 following the use of angiotensin-converting enzyme inhibitors or angiotensin-receptor blockers among patients with hypertension in Korea: a nationwide study
Ju Hwan Kim, Yeon-Hee Baek, Hyesung Lee, Young June Choe, Hyun Joon Shin, Ju-Young Shin
Epidemiol Health. 2021;43:e2021004.   Published online December 29, 2020
DOI: https://doi.org/10.4178/epih.e2021004
  • 30,915 View
  • 456 Download
  • 9 Web of Science
  • 8 Crossref
AbstractAbstract AbstractSummary PDF
Abstract
OBJECTIVES
Recent evidence has shown no harm associated with the use of angiotensin-converting enzyme inhibitors (ACEIs) or angiotensin-receptor blockers (ARBs) in patients with coronavirus disease 2019 (COVID-19). We sought to further clarify the possible association between ACEI/ARB use and the risk of poor clinical outcomes of COVID-19.
METHODS
From the completely enumerated COVID-19 cohort in Korea, we identified 1,290 patients with hypertension, of whom 682 had and 603 did not have records of ACEI/ARB use during the 30-day period before their COVID-19 diagnosis. Our primary endpoint comprised clinical outcomes, including all-cause mortality, use of mechanical ventilation, intensive care unit admission, and sepsis. We used inverse probability of treatment weighting (IPTW) to mitigate selection bias, and a Poisson regression model to estimate the relative risks (RRs) and 95% confidence intervals (CIs) for comparing outcomes between ACEI/ARB users and non-users.
RESULTS
Compared to non-use, ACEI/ARB use was associated with lower clinical outcomes (IPTW-adjusted RR, 0.60; 95% CI, 0.42 to 0.85; p=0.005). For individual outcomes, ACEI/ARB use was not associated with all-cause mortality (IPTW-adjusted RR, 0.62; 95% CI, 0.35 to 1.09; p=0.097) or respiratory events (IPTW-adjusted RR, 0.99; 95% CI, 0.84 to 1.17; p=0.904). Subgroup analysis showed a trend toward a protective role of ACEIs and ARBs against overall outcomes in men (IPTW-adjusted RR, 0.84; 95% CI, 0.69 to 1.03; p<sub>interaction</sub>=0.008) and patients with pre-existing respiratory disease (IPTW-adjusted RR, 0.74; 95% CI, 0.60 to 0.92; p<sub>interaction</sub>=0.002).
CONCLUSIONS
We present clinical evidence to support continuing ACE/ARB use in COVID-19 patients with hypertension based on the completely enumerated Korean cohort.
Summary
Korean summary
– 코로나-19 검사를 받은 69,793명 중에 코로나-19 양성이며 고혈압이 있는 1,290명을 연구대상자로 선정했으며, 이중 코로나-19 진단일로부터 30일이내에 ACEI 또는 ARB를 사용한 환자는 682명이었음. – ACEI 또는 ARB 사용은 비사용 대비 사망 또는 폐 관련 질환의 위험과의 관련성이 없었음. – 하위그룹 분석에서 남성 또는 기저 폐질환 보유 환자에서 ACEI 또는 ARB 사용이 코로나-19 예후 악화를 예방하는 트렌드를 보였음.
Key Message
– Among 69,793 individuals screened for COVID-19, we identified 1,290 patients with hypertension who tested positive, of whom 682 had records of using ACEIs or ARBs in the 30 days before their COVID-19 diagnosis. – ACEI/ARB use (compared with non-use) was not associated with all-cause mortality or respiratory events. – A subgroup analysis showed a trend toward a protective role of ACEIs and ARBs against the overall composite endpoint of poor outcomes in men and those with pre-existing respiratory disease.

Citations

Citations to this article as recorded by  
  • Systematic review and meta-analysis of the clinical outcomes of ACEI/ARB in East-Asian patients with COVID-19
    Nancy Xurui Huang, Qi Yuan, Fang Fang, Bryan P. Yan, John E. Sanderson, Masaki Mogi
    PLOS ONE.2023; 18(1): e0280280.     CrossRef
  • Mortality and Severity in COVID-19 Patients on ACEIs and ARBs—A Systematic Review, Meta-Analysis, and Meta-Regression Analysis
    Romil Singh, Sawai Singh Rathore, Hira Khan, Abhishek Bhurwal, Mack Sheraton, Prithwish Ghosh, Sohini Anand, Janaki Makadia, Fnu Ayesha, Kiran S. Mahapure, Ishita Mehra, Aysun Tekin, Rahul Kashyap, Vikas Bansal
    Frontiers in Medicine.2022;[Epub]     CrossRef
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    Jordan Loader, Frances C. Taylor, Erik Lampa, Johan Sundström
    Journal of the American Heart Association.2022;[Epub]     CrossRef
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    Ruchika Sharma, Anoop Kumar, Jaseela Majeed, Ajit K. Thakur, Geeta Aggarwal
    The Egyptian Heart Journal.2022;[Epub]     CrossRef
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    Ahmed Maseh Haidary, Sarah Noor, Esmatullah Hamed, Tawab Baryali, Soma Rahmani, Maryam Ahmad, Farahnaz Erfani, Hashmatullah Azimi, Habib Ul Rahman Habib, Gul Ahmad Tahiri, Ramin Saadaat, Abdul Sami Ibrahimkhil, Esmatullah Esmat, Haider Ali Malakzai
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    Journal of the American Heart Association.2021;[Epub]     CrossRef
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