The COVID-19 Vaccine Safety Research Committee (CoVaSC) was established in November 2021 to address the growing need for independent, in-depth scientific evidence on adverse events (AEs) following coronavirus disease 2019 (COVID-19) vaccination. This initiative was requested by the Korea Disease Control and Prevention Agency and led by the National Academy of Medicine of Korea. In September 2022, the COVID-19 Vaccine Safety Research Center was established, strengthening CoVaSC’s initiatives. The center has conducted various studies on the safety of COVID-19 vaccines. During CoVaSC’s second research year, from September 29, 2022 to July 19, 2023, the center was restructured into 4 departments: Epidemiological Research, Clinical Research, Communication & Education, and International Cooperation & Policy Research. Its main activities include (1) managing CoVaSC and the COVID-19 Vaccine Safety Research Center, (2) surveying domestic and international trends in AE causality investigation, (3) assessing AEs following COVID-19 vaccination, (4) fostering international collaboration and policy research, and (5) organizing regular fora and training sessions for the public and clinicians. Causality assessments have been conducted for 27 diseases, and independent research has been conducted after organizing ad hoc committees comprising both epidemiologists and clinical experts on each AE of interest. The research process included protocol development, data analysis, interpretation of results, and causality assessment. These research outcomes have been shared transparently with the public and healthcare experts through various fora. The COVID-19 Vaccine Safety Research Center plans to continue strengthening and expanding its research activities to provide reliable, high-quality safety information to the public.
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.
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: 0.6 [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 0.3 [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 strenghthenCOVID-19 vaccination initiatives and provide socioeconomic assistance for this vulnerable population.
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
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.
Objectives With the recent global mpox outbreak, the JYNNEOS vaccine (Modified Vaccinia Ankara-Bavarian Nordic) was developed as a third-generation smallpox vaccine and initially favored for mpox immunization. Vaccine-associated side effects contribute to vaccine hesitancy. Consequently, tracking adverse events post-immunization is crucial for safety management. This study used data from the national active vaccine safety surveillance conducted in Korea from August 25 to November 24, 2022 to detect potential safety signals and adverse events. Methods: Data on health conditions following vaccination were gathered from web-based surveys and reported via active surveillance through the Immunization Registry Information System. This follow-up system functioned via a text message link, surveying adverse events and health conditions beginning on the second day post-vaccination. Information about specific adverse events, including both local and systemic reactions, was collected. Results: The study included 86 healthcare workers who had received at least 1 dose of the JYNNEOS vaccine. Among the respondents, 79.1% reported experiencing at least 1 adverse event, with the majority being local reactions at the injection site. The incidence of adverse events was higher following the first dose (67.9%) than after the second dose (34.4%). The most frequently reported adverse event for both doses was mild pain at the injection site. Conclusion: The study provides crucial information on the safety of the JYNNEOS vaccine, demonstrating that most adverse events were manageable and predominantly localized to the injection site. Nonetheless, additional research is needed on the safety of various vaccine administration techniques and the vaccine’s effects on broader demographics.
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Objectives This study aimed to examine the prevalence and pattern of adverse events following childhood immunization and the responses of mothers in Ile-Ife, South West Nigeria.
Methods This descriptive cross-sectional study was conducted among 422 mothers of children aged 0 to 24 months attending any of the 3 leading immunization clinics in Ile-Ife, Nigeria. The respondents were selected using the multi-stage sampling technique. Data were collected using a pretested structured interviewer-administered questionnaire and analyzed using IBM SPSS ver. 26.0. The chi-square test was used to test associations, while binary logistic regression was used to determine the predictors of mothers’ responses to adverse events following immunization (AEFIs). A p-value of <0.05 was considered statistically significant.
Results The mean age of the respondents was 29.99±5.74 years. About 38% of the children had experienced an AEFI. Most mothers believed that the pentavalent vaccine was the most common cause of AEFIs (67.5%). Fever (88.0%) and pain and swelling (76.0%) were the most common AEFIs. More than half of the mothers (53.7%) administered home treatment following an AEFI. Younger mothers (odds ratio [OR], 2.43; 95% confidence interval [CI], 1.20–5.01), mothers who delivered their children at a healthcare facility (OR, 3.24; 95% CI, 1.08–9.69), and mothers who were knowledgeable about reporting AEFIs (OR, 2.53; 95% CI, 1.04–7.70) were most likely to respond appropriately to AEFIs.
Conclusion The proportion of mothers who responded poorly to AEFIs experienced by their children was significant. Therefore, strategies should be implemented to improve mothers’ knowledge about AEFIs to improve their responses.
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.
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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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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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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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Objectives We estimated the overall and age-specific percentages of the Korean population
with presumed immunity against severe acute respiratory syndrome coronavirus 2 (SARSCoV-2) as of April 2022 using the national registry.
Methods We used the national coronavirus disease 2019 (COVID-19) infection and vaccination
registry from South Korea, as described to define individuals with a previous history of
COVID-19 infection, vaccination, or both, as persons with presumed immunity.
Results Of a total of 53,304,627 observed persons, 24.4% had vaccination and infection, 58.1%
had vaccination and no infection, 7.6% had infection and no vaccination, and 9.9% had no
immunity. The SARS-CoV-2 Omicron variant emerged at a time when the presumed population
immunity ranged from 80% to 85%; however, nearly half of the children were presumed to
have no immunity.
Conclusion We report a gap in population immunity, with lower presumed protection in
children than in adults. The approach presented in this work can provide valuable informed
tools to assist vaccine policy-making at a national level.
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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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The coronavirus disease 2019 (COVID-19) pandemic rapidly spread globally. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which causes COVID-19, is a positive-sense single-stranded RNA virus with a reported fatality rate ranging from 1% to 7%, and people with immune-compromised conditions, children, and older adults are particularly vulnerable. Respiratory failure and cytokine storm-induced multiple organ failure are the major causes of death. This article highlights the innate and adaptive immune mechanisms of host cells activated in response to SARS-CoV-2 infection and possible therapeutic approaches against COVID-19. Some potential drugs proven to be effective for other viral diseases are under clinical trials now for use against COVID-19. Examples include inhibitors of RNA-dependent RNA polymerase (remdesivir, favipiravir, ribavirin), viral protein synthesis (ivermectin, lopinavir/ ritonavir), and fusion of the viral membrane with host cells (chloroquine, hydroxychloroquine, nitazoxanide, and umifenovir). This article also presents the intellectual groundwork for the ongoing development of vaccines in preclinical and clinical trials, explaining potential candidates (live attenuated-whole virus vaccines, inactivated vaccines, subunit vaccines, DNAbased vaccines, protein-based vaccines, nanoparticle-based vaccines, virus-like particles and mRNA-based vaccines). Designing and developing an effective vaccine (both prophylactic and therapeutic) would be a long-term solution and the most effective way to eliminate the COVID-19 pandemic.
Objectives We descriptively reviewed a coronavirus disease 2019 (COVID-19) outbreak at a nursing hospital in Gyeonggi Province (South Korea) and assessed the effectiveness of the first dose of the Oxford-AstraZeneca vaccine in a real-world population. Methods: The general process of the epidemiological investigation included a public health intervention. The relative risk (RR) of vaccinated and unvaccinated groups was calculated and compared to confirm the risk of severe acute respiratory syndrome coronavirus-2 (SARSCoV-2) infection, and vaccine effectiveness was evaluated based on the calculated RR. Results: The population at risk was confined to ward E among 8 wards of Hospital X, where the outbreak occurred. This population comprised 55 people, including 39 patients, 12 nurses, and 4 caregivers, and 19 cases were identified. The RR between the vaccinated and unvaccinated groups was 0.04, resulting in a vaccine effectiveness of 95.3%. The vaccination rate of the nonpatients in ward E was the lowest in the entire hospital, whereas the overall vaccination rate of the combined patient and non-patient groups in ward E was the third lowest. Conclusion: The first dose of the Oxford-AstraZeneca vaccine (ChAdOx1-S) was effective in preventing SARS-CoV-2 infection. To prevent COVID-19 outbreaks in medical facilities, it is important to prioritize the vaccination of healthcare providers.
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