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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
  • 3,736 View
  • 134 Download
  • 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
  • 8,058 View
  • 366 Download
  • 11 Web of Science
  • 8 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  
  • 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
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