Osong Public Health and Research Perspectives

Review Article

Psychiatric adverse events associated with the COVID-19 vaccines approved in the Republic of Korea: a systematic review: Seungeun Ryoo, Miyoung Choi, Nam-Kyong Choi, Hyoung-Shik Shin, Jun Hee Woo, Byung-Joo Park, Sanghoon Oh; Osong Public Health Res Perspect. 2024;15(2):107-114. Published online March 28, 2024; DOI: https://doi.org/10.24171/j.phrp.2023.0325

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This systematic review evaluated psychiatric adverse events (AEs) following vaccination against coronavirus disease 2019 (COVID-19). We included studies that reported or investigated psychiatric AEs in individuals who had received an approved COVID-19 vaccine in the Republic of Korea. Systematic electronic searches of Ovid-Medline, Embase, CENTRAL, and KoreaMed databases were conducted on March 22, 2023. Risk of bias was assessed using the Risk of Bias Assessment Tool for Non-randomized Studies 2.0. The study protocol was registered in the International Prospective Register of Systematic Reviews (CRD42023449422). Of the 301 articles initially selected, 7 were included in the final analysis. All studies reported on sleep disturbances, and 2 highlighted anxiety-related AEs. Sleep disorders like insomnia and narcolepsy were the most prevalent AEs, while depression was not reported. Our review suggests that these AEs may have been influenced by biological mechanisms as well as the broader psychosocial context of the COVID-19 pandemic. Although this study had limitations, such as a primary focus on the BNT162b2 vaccine and an observational study design, it offered a systematic, multi-vaccine analysis that fills a critical gap in the existing literature. This review underscores the need for continued surveillance of psychiatric AEs and guides future research to investigate underlying mechanisms, identify risk factors, and inform clinical management.

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A review of the scientific literature on experimental toxicity studies of COVID-19 vaccines, with special attention to publications in toxicology journals
Jose L. Domingo
Archives of Toxicology.2024; 98(11): 3603. CrossRef

Original Articles

COVID-19 infection among people with disabilities in 2021 prior to the Omicron-dominant period in the Republic of Korea: a cross-sectional study: Seul-Ki Kang, Bryan Inho Kim; Osong Public Health Res Perspect. 2024;15(2):150-158. Published online March 28, 2024; DOI: https://doi.org/10.24171/j.phrp.2023.0194

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Graphical Abstract Abstract PDF: Objectives
This study investigated the characteristics of coronavirus disease 2019 (COVID-19) among individuals with disabilities on a nationwide scale in the Republic of Korea, as limited research has examined this population. Methods: Between January 1 and November 30, 2021, a total of 5,687 confirmed COVID-19 cases among individuals with disabilities were reported through the Korea Disease Control and Prevention Agency’s COVID-19 web reporting system. Follow-up continued until December 24, and demographic, epidemiological, and clinical characteristics were analyzed. Results: Individuals with disabilities represented approximately 1.5% of confirmed cases, with a mean age of 58.1 years. Most resided in or near metropolitan areas (86.6%) and were male (60.6%). Frequent sources of infection included home (33.4%) and contact with confirmed cases (40.7%). Many individuals (75.9%) had underlying conditions, and 7.7% of cases were severe. People with disabilities showed significantly elevated risk of severe infection (adjusted odds ratio [aOR], 1.63; 95% confidence interval [CI], 1.47–1.81) and mortality (aOR, 1.65; 95% CI, 1.43–1.91). Vaccination against COVID-19 was associated with significantly lower risk of severe infection (aORs for the first, second, and third doses: 0.60 [95% CI, 0.42–0.85], 0.28 [95% CI, 0.22–0.35], and 0.16 [95% CI, 0.05–0.51], respectively) and death (adjusted hazard ratios for the first and second doses: 0.57 [95% CI, 0.35–0.93] and 0.30 [95% CI, 0.23–0.40], respectively). Conclusion: Individuals with disabilities showed higher risk of severe infection and mortality from COVID-19. Consequently, it is critical to strengthen COVID-19 vaccination initiatives and provide socioeconomic assistance for this vulnerable population.

Evaluation of COVID-19 vaccine effectiveness in different high-risk facility types during a period of Delta variant dominance in the Republic of Korea: a cross-sectional study: Min Jei Lee, Myung-Jae Hwang, Dong Seob Kim, Seon Kyeong Park, Jihyun Choi, Ji Joo Lee, Jong Mu Kim, Young-Man Kim, Young-Joon Park, Jin Gwack, Sang-Eun Lee; Osong Public Health Res Perspect. 2023;14(5):418-426. Published online October 19, 2023; DOI: https://doi.org/10.24171/j.phrp.2023.0188

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Graphical Abstract Abstract PDF: Objectives
We evaluated the effectiveness of coronavirus disease 2019 vaccination in high-risk facilities in the Republic of Korea during the period when the highly transmissible Delta variant was prevalent. Additionally, we aimed to explore any disparities in vaccine effectiveness (VE) across various types of institutions, specifically distinguishing between non-medical and medical establishments. Methods: We examined 8 outbreak clusters covering 243 cases and 895 contacts from 8 high-risk facilities divided into 2 groups: group A (4 non-medical institutions) and group B (4 medical institutions). These clusters were observed from July 27, 2021 to October 16, 2021 for the attack rate (AR) and VE with respect to disease severity. A generalized linear model with a binomial distribution was used to determine the odds ratio (OR) for disease severity and death. Results: AR was notably lower in group B (medical institutions). Furthermore, VE analysis revealed that group A exhibited higher effectivity for disease severity and death than group B. The OR for disease severity was 0.24 (95% confidence interval [CI], 0.03–2.16) for group A and 0.27 (95% CI, 0.12–0.64) for group B, with the OR for death at 0.12 (95% CI, 0.01–1.32) in group A and 0.34 (95% CI, 0.14–0.87) in group B. Conclusion: Although VE may vary across institutions, our findings underscore the importance of implementing vaccinations in high-risk facilities. Customized vaccination programs, tailored response plans, and competent management personnel are essential for effectively addressing and mitigating public health challenges.

Brief Report

Temporal association between the age-specific incidence of Guillain-Barré syndrome and SARS-CoV-2 vaccination in Republic of Korea: a nationwide time-series correlation study: Hyunju Lee, Donghyok Kwon, Seoncheol Park, Seung Ri Park, Darda Chung, Jongmok Ha; Osong Public Health Res Perspect. 2023;14(3):224-231. Published online June 22, 2023; DOI: https://doi.org/10.24171/j.phrp.2023.0050

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Graphical Abstract Abstract PDF

Objectives
The incidence of Guillain-Barré syndrome (GBS) changed significantly during the coronavirus disease 2019 (COVID-19) pandemic. Emerging reports suggest that viral vector-based vaccines may be associated with an elevated risk of GBS.
Methods
In this nationwide time-series correlation study, we examined the age-specific incidence of GBS from January 2011 to August 2022, as well as data on severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccinations and infections from February 2021 to August 2022. We compared the forecasted estimates of age-specific GBS incidence, using the pre-SARS-CoV-2 period as a benchmark, with the actual incidence observed during the post-vaccination period of the pandemic. Furthermore, we assessed the temporal association between GBS, SARS-CoV-2 vaccinations, and COVID-19 for different age groups.
Results
In the age group of 60 and older, the rate ratio was significantly elevated during June-August and November 2021. A significant, strong positive association was observed between viral vector-based vaccines and GBS incidence trends in this age group (r=0.52, p=0.022). For the 30 to 59 years age group, the rate ratio was notably high in September 2021. A statistically significant, strong positive association was found between mRNA-based vaccines and GBS incidence in this age group (r=0.61, p=0.006).
Conclusion
Viral vector-based SARS-CoV-2 vaccines were found to be temporally associated with an increased risk of GBS, particularly in older adults. To minimize age-specific and biological mechanism-specific adverse events, future vaccination campaigns should adopt a more personalized approach, such as recommending homologous mRNA-based SARS-CoV-2 vaccines for older adults to reduce the heightened risk of GBS.

Citations

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mRNA-LNP COVID-19 Vaccine Lipids Induce Complement Activation and Production of Proinflammatory Cytokines: Mechanisms, Effects of Complement Inhibitors, and Relevance to Adverse Reactions
Tamás Bakos, Tamás Mészáros, Gergely Tibor Kozma, Petra Berényi, Réka Facskó, Henriette Farkas, László Dézsi, Carlo Heirman, Stefaan de Koker, Raymond Schiffelers, Kathryn Anne Glatter, Tamás Radovits, Gábor Szénási, János Szebeni
International Journal of Molecular Sciences.2024; 25(7): 3595. CrossRef
Guillain-barre syndrome following COVID-19 vaccination: A study of 70 case reports
Biki Kumar Sah, Zahra Fatima, Rajan Kumar Sah, Bushra Syed, Tulika Garg, Selia Chowdhury, Bikona Ghosh, Binita Kunwar, Anagha Shree, Vivek Kumar Sah, Anisha Raut
Annals of Medicine & Surgery.2024;[Epub] CrossRef
Deciphering changes in the incidence of hemorrhagic stroke and cerebral venous sinus thrombosis during the coronavirus disease 2019 pandemic: A nationwide time-series correlation study
Soo Hyeon Cho, Dong Kyu Kim, Min Cheol Song, Euiho Lee, Seoncheol Park, Darda Chung, Jongmok Ha, Sonu Bhaskar
PLOS ONE.2024; 19(10): e0301313. CrossRef
Before Diagnosing SARS-CoV-2 Vaccination-Related Funicular Myelosis, GBS and Other Differentials Must be Ruled Out
Josef Finsterer
Neurology India.2024; 72(5): 1100. CrossRef

Original Article

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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Graphical Abstract Abstract PDF

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.

Citations

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Responses to Common Misconceptions Relating to COVID-19 Variant-Adapted mRNA Vaccines
George Kassianos, Pauline MacDonald, Ivan Aloysius, Shanti Pather
Vaccines.2024; 12(1): 57. CrossRef
Comparative safety of monovalent and bivalent mRNA COVID-19 booster vaccines in adolescents aged 12 to 17 years in the Republic of Korea
Mijeong Ko, Seontae Kim, Seok-Kyoung Choi, Seung Hwan Shin, Yeon-Kyeng Lee, Yunhyung Kwon
Osong Public Health and Research Perspectives.2024; 15(4): 364. CrossRef
Epidemiological Characteristics and Outcome of Myocarditis and Pericarditis Temporally Associated With BNT162b2 COVID-19 Vaccine in Adolescents: Korean National Surveillance
Bin Ahn, Seung Hwan Shin, Myung-Jae Hwang, HyoSug Choi, Sara Na, Sangshin Park, Jue Seong Lee, Young June Choe, Yoonsun Yoon, Kyoungsan Seo, Jong Hee Kim, Hyun Mi Kang
Journal of Korean Medical Science.2024;[Epub] CrossRef
To become a more stronger and safer country
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Osong Public Health and Research Perspectives.2023; 14(2): 67. CrossRef

Review Articles

India’s efforts to achieve 1.5 billion COVID-19 vaccinations: a narrative review: Kapil Singh, Ashwani Verma, Monisha Lakshminarayan; Osong Public Health Res Perspect. 2022;13(5):316-327. Published online October 14, 2022; DOI: https://doi.org/10.24171/j.phrp.2022.0104

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Graphical Abstract Abstract PDF

The initial case of coronavirus disease 2019 (COVID-19) in India was reported on January 30, 2020, and subsequently, the number of COVID-19-infected patients surged during the first wave of April 2020 and the second wave in the same month of 2021. The government of India imposed a strict nationwide lockdown in April 2020 and extended it until May 2020. The second wave of COVID-19 in India overwhelmed the country’s health facilities and exhausted its medical and paramedical workforce. This narrative review was conducted with the aim of summarizing the evidence drawn from policy documents of governmental and non-governmental organizations, as well as capturing India's COVID-19 vaccination efforts. The findings from this review cover the Indian government's vaccination initiatives, which ranged from steps taken to combat vaccine hesitancy to vaccination roadmaps, deployment plans, the use of digital health technology, vaccination monitoring, adverse effects, and innovative strategies such as Har Ghar Dastak and Jan Bhagidari Andolan (people’s participation). These efforts collectively culminated in the successful administration of more than 1.8 billion doses of COVID-19 vaccines in India. This review also provides insights into other countries’ responses to COVID-19 and guidance for future pandemics.

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Developments and Trends of Immunization in India: A Narrative Review
Pratik P Tawde, Zahiruddin Quazi, Abhay Gaidhane, Sonali G Choudhari
Cureus.2024;[Epub] CrossRef
Digital health technology used in emergency large-scale vaccination campaigns in low- and middle-income countries: a narrative review for improved pandemic preparedness
Paula Mc Kenna, Lindsay A. Broadfield, Annik Willems, Serge Masyn, Theresa Pattery, Ruxandra Draghia-Akli
Expert Review of Vaccines.2023; 22(1): 243. CrossRef
Media Reporting Relating to COVID-19 Vaccination as a Driver of Vaccine Hesitancy Prior to the Second Wave of the COVID-19 Pandemic in India: A Content Analysis of Newspaper and Digital Media Reports
Saurav Basu, Himanshi Sharma
Cureus.2023;[Epub] CrossRef
An assessment of the strategy and status of COVID-19 vaccination in India
Sneh Lata Gupta, Surbhi Goswami, Ananya Anand, Namrata Naman, Priya Kumari, Priyanka Sharma, Rishi K. Jaiswal
Immunologic Research.2023; 71(4): 565. CrossRef
Development of a Choice-framework for Covid vaccines in India using a multi-criteria decision analysis approach
Tarun K. George, Nayana P. Nair, Awnish Kumar Singh, A. Dilesh Kumar, Arup Deb Roy, Varshini Neethi Mohan, Gagandeep Kang
Vaccine.2023; 41(25): 3755. CrossRef
COVID-19 Booster Dose Coverage and Hesitancy among Older Adults in an Urban Slum and Resettlement Colony in Delhi, India
Nandini Sharma, Saurav Basu, Heena Lalwani, Shivani Rao, Mansi Malik, Sandeep Garg, Rahul Shrivastava, Mongjam Meghachandra Singh
Vaccines.2023; 11(7): 1177. CrossRef
Review of the unmet medical need for vaccination in adults with immunocompromising conditions: An Indian perspective
Ashok Vaid, Neha Rastogi, T. Mark Doherty, Peter San Martin, Yashpal Chugh
Human Vaccines & Immunotherapeutics.2023;[Epub] CrossRef
Translating the COVID-19 experience in widening the HPV vaccination campaign for cervical cancer in India
Aruni Ghose, Anisha Agarwal, Bhawna Sirohi, Shona Nag, Linus Chuang, Swarupa Mitra
Gynecologic Oncology Reports.2023; 48: 101247. CrossRef
Symptomatic prevalence of covid-19 in vaccinated and non-vaccinated population
Jay Bhupesh Pandya, Nirali Milind Shethia, Divya Bangera, Shailaja Gada Saxena
IP International Journal of Medical Microbiology a.2023; 9(2): 110. CrossRef
Active surveillance of adverse events following COVID-19 vaccines in a tertiary care hospital
Naveena Mary Cherian, Dravya Anna Durai, Muhammed Jaisel, Divyansh Sharma, Juny Sebastian, Chetak Kadabasal Basavaraja, Merrin Mathew
Therapeutic Advances in Vaccines and Immunotherapy.2023;[Epub] CrossRef
Effectiveness of ayurvedic formulation, NAOQ19 along with standard care in the treatment of mild-moderate COVID-19 patients: A double blind, randomized, placebo-controlled, multicentric trial
Pankaj Bhardwaj, Kalaiselvan Ganapathy, Monika Pathania, K.H. Naveen, Jaykaran Charan, Siddhartha Dutta, Ravisekhar Gadepalli, Srikanth Srinivasan, Manoj Kumar Gupta, Akhil D. Goel, Naresh Midha, Bharat Kumar, Meenakshi Sharma, Praveen Sharma, Mithu Baner
Journal of Ayurveda and Integrative Medicine.2023; 14(6): 100778. CrossRef
Balancing Routine and Pandemic: The Synergy of India’s Universal Immunization Program and COVID-19 Vaccination Program
Pawan Kumar, Ashish Birendra Chakraborty, Suhas Dhandore, Pritu Dhalaria, Ajeet Kumar Singh, Disha Agarwal, Kapil Singh, Pretty Priyadarshini, Paras Jain, Vidushi Bahl, Gunjan Taneja
Vaccines.2023; 11(12): 1776. CrossRef
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Megha Hegde, Saurav Raj, Dhananjay Tikadar, Sanatkumar B Nyamagoud
Monaldi Archives for Chest Disease.2023;[Epub] CrossRef

Points to consider for COVID-19 vaccine quality control and national lot release in Republic of Korea: focus on a viral vector platform: Jung Hun Ju, Naery Lee, Sun-hee Kim, Seokkee Chang, Misook Yang, Jihyun Shin, Eunjo Lee, Sunhwa Sung, Jung-Hwan Kim, Jin Tae Hong, Ho Jung Oh; Osong Public Health Res Perspect. 2022;13(1):4-14. Published online February 8, 2022; DOI: https://doi.org/10.24171/j.phrp.2021.0311

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Graphical Abstract Abstract PDF: Due to the global public health crisis caused by the coronavirus disease 2019 (COVID-19) pandemic, the importance of vaccine development has increased. In particular, a rapid supply of vaccines and prompt deployment of vaccination programs are essential to prevent and overcome the spread of COVID-19. As a part of the vaccine regulations, national lot release is regulated by the responsible authorities, and this process involves the assessment of the lot before a vaccine is marketed. A lot can be released for use when both summary protocol (SP) review and quality control testing are complete. Accelerated lot release is required to distribute COVID-19 vaccines in a timely manner. In order to expedite the process by simultaneously undertaking the verification of quality assessment and application for approval, it is necessary to prepare the test methods before marketing authorization. With the prolonged pandemic and controversies regarding the effectiveness of the COVID-19 vaccine against new variants, public interest for the development of a new vaccine are increasing. Domestic developers have raised the need to establish standard guidance on the requirements for developing COVID-19 vaccine. This paper presents considerations for quality control in the manufacturing process, test items, and SP content of viral vector vaccines.

Original Article

Factors influencing acceptance of the COVID-19 vaccine in Malaysia: a web-based survey: June Fei Wen Lau, Yuan Liang Woon, Chin Tho Leong, Hoon Shien Teh; Osong Public Health Res Perspect. 2021;12(6):361-373. Published online November 25, 2021; DOI: https://doi.org/10.24171/j.phrp.2021.0085

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Abstract PDF Supplementary Material

Objectives
The coronavirus disease 2019 (COVID-19) pandemic has set a precedent for the fastest-produced vaccine as a result of global collaboration and outreach. This study explored Malaysians’ acceptance of the COVID-19 vaccine and its associated factors.
Methods
A cross-sectional anonymous web-based survey was disseminated to Malaysian adults aged ≥18 years old via social media platforms between July 10, 2020 and August 31, 2020.
Results
In the analysis of 4,164 complete responses, 93.2% of participants indicated that they would accept the COVID-19 vaccine if it was offered for free by the Malaysian government. The median out-of-pocket cost that participants were willing to pay for a COVID-19 vaccine was Malaysian ringgit (MYR) 100 (interquartile range [IQR], 100) if it was readily available and MYR 150 (IQR, 200) if the supply was limited. Respondents with a low likelihood of vaccine hesitancy had 13 times higher odds of accepting the COVID-19 vaccine (95% confidence interval [CI], 8.69 to 19.13). High perceived risk and severity were also associated with willingness to be vaccinated, with adjusted odds ratios of 2.22 (95% CI, 1.44 to 3.41) and 2.76 (95% CI, 1.87 to 4.09), respectively. Age and ethnicity were the only independent demographic characteristics that predicted vaccine uptake.
Conclusion
Public health strategies targeting perceived risk, perceived susceptibility and vaccine hesitancy could be effective in enhancing vaccine uptake.

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Nicholas Yee Liang Hing, Yuan Liang Woon, Yew Kong Lee, Hyung Joon Kim, Nurhyikmah M Lothfi, Elizabeth Wong, Komathi Perialathan, Nor Haryati Ahmad Sanusi, Affendi Isa, Chin Tho Leong, Joan Costa-Font
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