A Nationwide Survey of mRNA COVID-19 Vaccinee's Experiences on Adverse Events and Its Associated Factors.

BACKGROUND: Although coronavirus disease 2019 (COVID-19) vaccines have been distributed worldwide under emergency use authorization, the real-world safety profiles of mRNA vaccines still need to be clearly defined. We aimed to identify the overall incidence and factors associated with adverse events (AEs) following mRNA COVID-19 vaccination. METHODS: We conducted web-based survey from December 2 to 10 in 2021 with a 2,849 nationwide sampled panel. Study participants were individuals who had elapsed at least two-weeks after completing two dosing schedules of COVID-19 vaccination aged between 18-49 years. We weighted the participants to represent the Korean population. The outcome was the overall incidence of AEs following mRNA COVID-19 vaccination and associated factors. We estimated the weighted odds ratios (ORs) using multivariable logistic regression models to identify the factors associated with AEs. RESULTS: Of the 2,849 participants (median [interquartile range] age, 35 [27-42] years; 51.6% male), 90.8% (n = 2,582) for the first dose and 88.7% (n = 2,849) for the second dose reported AEs, and 3.3% and 4.3% reported severe AEs, respectively. Occurrence of AEs was more prevalent in mRNA-1273 (OR, 2.06; 95% confidence interval [CI], 1.59-2.67 vs. BNT162b2), female sex (1.88; 1.52-2.32), and those with dermatologic diseases (2.51; 1.32-4.77). History of serious allergic reactions (1.96; 1.06-3.64) and anticoagulant medication use (4.72; 1.92-11.6) were associated with severe AEs. CONCLUSION: Approximately 90% of participants reported AEs following mRNA COVID-19 vaccination. Substantial factors, including vaccine type (mRNA-1273), female sex, and dermatologic diseases were associated with AEs. Our findings could aid policymakers in establishing vaccination strategies tailored to those potentially susceptible to AEs.

Barriers to COVID-19 vaccine surveillance: the issue of under-reporting adverse events.

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 to 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 AEFI 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 women (AOR=1.54; 95% CI, 1.31-1.81); those with moderate to severe AEFIs (AOR=5.47; 95% CI, 4.45-6.73), comorbidities (AOR=1.31; 95% CI, 1.09-1.57), a history of severe allergic reactions (AOR=2.02; 95% CI, 1.47-2.77); and those who had received mRNA-1273 (AOR=1.25; 95% CI, 1.05-1.49) or ChAdOx1 (AOR=1.62; 95% CI, 1.15-2.30) vaccines versus BNT162b2. Reporting was less likely in older individuals (AOR=0.98; 95% CI, 0.98-0.99 per 1-year age increment). Conclusion: 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. AEFI under-reporting should be considered when delivering information to the community and in public health decision-making.

Age-specific Risk of SARS-CoV-2 Reinfection During Omicron Outbreaks, South Korea.

We assessed the risk of reinfection among all residents in South Korea who tested positive for coronavirus disease 2019 from January to August 2022. Children 5-11 years [adjusted hazard ratio (aHR) = 2.20], and 12-17 years old (aHR = 2.00), were at higher risk; whereas 3-dose vaccination (aHR = 0.20) lowered the risk of reinfection.

Effectiveness of Heterologous COVID-19 Vaccine Booster in Korean Elderly Population, 2022.

We conducted a cohort study to assess vaccine effectiveness (VE) of coronavirus disease 2019 vaccine combinations on severe acute respiratory syndrome coronavirus 2 critical infection and death among elderly population in Korea. From January to August 2022, VE against death for 4 doses mRNA recipients was 96.1%, whereas 1-dose viral vector + 3-dose mRNA recipients had VE of 90.8%.

Predicting COVID-19 transmission in a student population in Seoul, South Korea, 2020-2021.

BACKGROUND: As coronavirus disease 2019 (COVID-19) transmission depends on factors such as demography, comorbidity, and patterns of daily activity, a better understanding of the societal factors of the infection among students would be useful in planning prevention strategies. However, no studies to date have focused on societal factors associated with COVID-19 transmission among students. PURPOSE: This study aimed to characterize the factors of a student population associated with COVID-19 transmission in the metropolitan city of Seoul, South Korea. METHODS: We analyzed the epidemiological data for laboratory-confirmed (reverse transcription polymerase chain reaction) COVID-19 cases collected by the Korea Disease Control and Prevention Agency and Ministry of Education from January 2020 to October 2021. We calculated the global Moran's index, local Moran's index, and Getis-Ord's index. A spatial regression analysis was performed to identify sociodemographic predictors of COVID-19 at the district level. RESULTS: The global spatial correlation estimated by Moran's index was 0.082 for the community population and 0.064 for the student population. The attack rate of adults aged 30- 59 years (P=0.049) was associated with an increased risk of COVID-19 attack rates in students, whereas the number of students per primary- (P=0.003) and middle- (P=0.030) school class was inversely associated with risk of COVID-19 attack among students. CONCLUSION: We found that COVID-19 transmission was more attributable to the community-level burden in students than adults. We recommend that public health initiatives target initiatives that protect students from COVID-19 when the community carries a high burden of infection.

Vaccine Effectiveness Against Severe Disease and Death for Patients With COVID-19 During the Delta-Dominant and Omicron-Emerging Periods: A K-COVE Study.

National cohort data collected during the coronavirus disease 2019 (COVID-19) delta and omicron periods in Korea revealed a lower risk of severe infection in recipients of three doses of the COVID-19 vaccine (adjusted odds ratio [aOR], 0.05-0.08). The risk of death was reduced during the omicron period compared to the delta period (aOR, 0.75; 95% confidence interval, 0.67-0.84).

Effectiveness of A Fourth Dose of COVID-19 mRNA Vaccine in the Elderly Population During the Omicron BA.2 and BA.5 Circulation: A Nationwide Cohort Study in Korea (K-COVE).

We estimate the effectiveness of a fourth dose booster of coronavirus disease 2019 mRNA vaccine in individuals aged ≥60 years during Omicron BA.2 and BA.5 circulation in Korea. The effectiveness against critical infection was 67.7% (95% confidence interval, 50.7%-78.8%) at 31-60 days and 62.1% (95% confidence interval, 45.5%-73.7%) at 61-90 days.

Building of Pediatric COVID-19 Module Clinic: A Novel Operation Model in Response to COVID-19 Pandemic.

In mid-2022, as the wave of pediatric coronavirus disease 2019 (COVID-19) cases escalated in South Korea, a public-private partnership was made to establish a Pediatric COVID-19 Module Clinic (PMC). We describe the utilization of the first prototype children's modular clinic in Korea University Anam Hospital functioning as the COVID-19 PMC. Between August 1 and September 30, 2022, a total of 766 children visited COVID-19 PMC. Daily number of patient visits to the COVID-19 PMC ranged between 10 and 47 in August; and less than 13 patients per day in September 2022. Not only the model provided timely care for the COVID-19 pediatric patients, but it also enabled safe and efficacious care for the non-COVID-19 patients in the main hospital building while minimizing exposure risk to severe acute respiratory syndrome coronavirus 2 transmission. Current description highlights the importance of spatial measures for mitigating in-hospital transmission of COVID-19, in specifically on pediatric care.

Predictors of COVID-19 booster vaccine hesitancy among fully vaccinated adults in South Korea: a nationwide cross-sectional survey.

Objectives: To explore predictors of COVID-19 booster hesitancy among fully vaccinated young adults and parental factors on COVID-19 vaccine hesitancy for their children. Methods: A cross-sectional study was conducted via an online survey from December 2 to 20, 2021. We enrolled participants aged 18-49 years and elapsed ≥2 weeks after completing a primary series of COVID-19 vaccination. We estimated odds ratios (ORs) with 95% confidence intervals (CIs) using multivariate logistic regressions to evaluate factors associated with booster/vaccine hesitancy. Results: Among 2,993 participants, 48.8% indicated hesitancy (wait and see: 40.2%; definitely not: 8.7%). The booster hesitancy was more in females (OR 1.25, 95% CI 1.05-1.50), younger age group (1.44 [1.17-1.77] at 18-29 years vs. 40-49 years), lower education level (2.05 [1.10-3.82] in no high school vs. graduate degree), mRNA-1273 (2.01, 1.65-2.45 vs. BNT162b2), and those with serious adverse events following previous COVID-19 vaccination (2.03, 1.47-2.80). The main reasons for booster hesitancy were concerns about its safety (54.1%), followed by doubt about the efficacy (29.8%). Among 1,020 respondents who had children aged <18 years, 65.8% indicated COVID-19 vaccine hesitancy for their children; the hesitancy for children was higher at the younger age, and lower at lower education level, ChAdOx1 (vs. BNT162b2), and those with history of COVID-19 infection. Conclusion: Concerns on the efficacy and safety of COVID-19 vaccines were the major barrier to booster hesitancy. The initial COVID-19 vaccine type, younger age, women, lower education level, and adverse events following COVID-19 vaccine were the key predictors of booster hesitancy.

Estimated Effectiveness of Prior SARS-CoV-2 BA.1 or BA.2 Infection and Booster Vaccination Against Omicron BA.5 Subvariant Infection.

This case-control study estimates the effectiveness of prior SARS-CoV-2 BA.1 or BA.2 infection and booster vaccination against Omicron BA.5 subvariant infection.

Positive Predictive Value of Rapid Antigen Tests in School During SARS-CoV-2 Omicron Variant Surge.

In Korea, we conducted a national observational study to calculate the positive predictive value of SARS-CoV-2 rapid antigen tests in K-12 schools during the Omicron variant surge in March 2022. The weekly positive predictive value ranged from 86.4% to 93.2%. The positive predictive value was the highest among elementary school students with symptoms (95.7%) and lowest among teachers/staff without symptoms (70.9%).

BNT162b2 Vaccine Effectiveness Against the SARS-CoV-2 Omicron Variant in Children Aged 5 to 11 Years.

This cohort study examines data for all children aged 5 to 11 years in South Korea to gauge the effectiveness of the BNT162b2 vaccine when the Omicron variant was the dominant SARS-CoV-2 infection in the country.

Parental concerns about COVID-19 vaccine safety and hesitancy in Korea: implications for vaccine communication.

OBJECTIVES: Vaccination is one of the most important strategies to contain the spread of coronavirus disease 2019 (COVID-19). Vaccination in children is dependent on their parents, making it important to understand parents' awareness and attitudes toward vaccines in order to devise strategies to raise vaccination rates in children. METHODS: A web-based nationwide survey was conducted among Korean parents of 7-year-old to 18-year-old children in August 2021 to estimate parents' intention to vaccinate their children against COVID-19 and identify key factors affecting parental acceptance and hesitancy through regression analysis. RESULTS: Approximately 56.4% (575/1,019) were willing to vaccinate their children against COVID-19. Contributing factors to COVID-19 vaccine hesitancy were being a mother (adjusted odds ratio [aOR], 0.36; 95% confidence interval [CI], 0.25 to 0.52), a lower education level (aOR, 0.83; 95% CI, 0.70 to 0.97), hesitancy to other childhood vaccines (aOR, 0.78; 95% CI, 0.64 to 0.96), and refusal to vaccinate themselves (aOR, 0.08; 95% CI, 0.02 to 0.20). Having older children (aOR, 1.20; 95% CI, 1.13 to 1.28), trusting the child's doctor (aOR, 1.19; 95% CI, 1.07 to 1.32), positive perceptions of the COVID-19 vaccine's effectiveness (aOR, 2.60; 95% CI, 1.90 to 3.57) and perceiving the COVID-19 vaccine as low-risk (aOR, 1.68; 95% CI, 1.27 to 2.24) were associated with COVID-19 vaccine acceptance. Concerns about adverse reactions were the most common cause of hesitancy. CONCLUSIONS: Providing parents with accurate and reliable information on vaccine effectiveness and safety is important to increase COVID-19 vaccine uptake in children. Differential or targeted approaches to parents according to gender, age, and their children's age are necessary for effective communication about vaccination in children.

Pediatric Deaths Associated With Coronavirus Disease 2019 (COVID-19) in Korea.

As of September 3, 2022, 5,388,338 coronavirus disease 2019 (COVID-19) cases and 46 deaths (3 in 2021 and 43 in 2022) were reported in children ≤ 18 years in Korea. Cumulative confirmed cases accounted for 67.3% of the population aged ≤ 18 years and case fatality rate was 0.85/100,000. Among 46 fatal cases, 58.7% were male and median age was 7 years. Underlying diseases were present in 47.8%; neurologic diseases (63.6%) and malignancy (13.6%) most common. Only four had history of COVID-19 immunization. COVID-19 associated deaths occurred at median 2 days from diagnosis (range: -1 to 21). Among COVID-19 deaths, 41.3% occurred before admission; 2 before hospital arrival and 17 in the emergency department. Among children whose cause was documented, myocarditis, respiratory and multiorgan failure were most common. COVID-19 associated death was seen early after diagnosis in children and public health policies to provide access to medical care for children with COVID-19 are essential during the pandemic.

Parental Acceptance of COVID-19 Vaccination for Children and Its Association With Information Sufficiency and Credibility in South Korea.

Importance: Vaccination against COVID-19 is an effective method for individuals to reduce negative health outcomes. However, widespread COVID-19 vaccination among children has been challenging owing to parental hesitancy. Objective: To examine parental decision-making in favor of the COVID-19 vaccine for their children and its association with the sufficiency and credibility of the information about the vaccine. Design, Setting, and Participants: This cross-sectional survey study was conducted in South Korea from February 7 to 10, 2022, 7 weeks before initiation of the COVID-19 vaccine for children aged 5 to 11 years. Parents were included if they spoke Korean and had at least 1 child in elementary school (grades 1-6). Parents and children were included in a 1:1 ratio; a total of 113 450 parents and 113 450 children were included in the analysis. Statistical analysis was performed between March and April 2022. Main Outcomes and Measures: The main outcomes of interest were (1) parental acceptance of COVID-19 vaccination for their children and (2) its association with self-reported sufficiency and credibility of information about the vaccine. A multivariable logistic regression was used to evaluate factors associated with parental decision-making in favor of COVID-19 vaccination; path analysis was used to examine indirect effects of information sufficiency and credibility. Results: Of the 113 450 children, 58 342 (51.4%) were boys, and the mean (SD) age was 10.1 (1.5) years. Of the 113 450 parents who responded, 7379 (6.5%) were accepting vaccination for their children; 15 731 (13.9%) reported the vaccine-related information they received was sufficient, and 23 021 (20.3%) reported the information was credible. Parents who reported that the information was sufficient were 3.08 times (95% CI, 2.85-3.33; P < .001) more likely to report being willing to vaccinate their children than those who believed the information was insufficient, and those who reported that the information was credible were 7.55 times (95% CI, 6.46-8.87; P < .001) more likely to report being willing to vaccinate their children than those who believed the information was not credible. Higher levels of information sufficiency and credibility were associated with perceptions of increased vaccine safety (sufficiency: ß = 0.08; P < .001; credibility: ß = 0.59; P < .001) and effectiveness (sufficiency: ß = 0.05; P < .001; credibility: ß = 0.60; P < .001). Conclusions and Relevance: In this study, a significant association was found between self-reported sufficiency and credibility of vaccine-related information and parental decision-making regarding COVID-19 vaccination for their children, suggesting that communications and policies that provide sound information are essential to improve vaccination rates.

Spatial distribution of SARS-CoV-2 infection in schools, South Korea.

Identification of geographical areas with high burden of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) transmission in schools using spatial analyses has become an important tool to guide targeted interventions in educational setting. In this study, we aimed to explore the spatial distribution and determinants of coronavirus disease 2019 (COVID-19) among students aged 3-18 years in South Korea. We analysed the nationwide epidemiological data on laboratory-confirmed COVID-19 cases in schools and in the communities between January 2020 and October 2021 in South Korea. To explore the spatial distribution, the global Moran's I and Getis-Ord's G using incidence rates among the districts of aged 3-18 years and 30-59 years. Spatial regression analysis was performed to find sociodemographic predictors of the COVID-19 attack rate in schools and in the communities. The global spatial correlation estimated by Moran's I was 0.647 for the community population and 0.350 for the student population, suggesting that the students were spatially less correlated than the community-level outbreak of SARS-CoV-2. In schools, attack rate of adults aged 30-59 years in the community was associated with increased risk of transmission (P < 0.0001). Number of students per class (in kindergartens, primary schools, middle schools and high schools) did not show significant association with the school transmission of SARS-CoV-2. In South Korea, COVID-19 in students had spatial variations across the country. Statistically significant high hotspots of SARS-CoV-2 transmission among students were found in the capital area, with dense population level and high COVID-19 burden among adults aged 30-59 years. Our finding suggests that controlling community-level burden of COVID-19 can help in preventing SARS-CoV-2 infection in school-aged children.

The Seroprevalence of SARS-CoV-2 in Children During Early COVID-19 Pandemic in Korea: A Nationwide, Population-Based Study.

BACKGROUND: Coronavirus disease 2019 (COVID-19) is often asymptomatic and associated with mild clinical symptoms in children. Social distancing measures have led to a relatively small number of confirmed COVID-19 cases in Korea than in other countries in the earlier pandemic phase. Previous seroprevalence studies in Korean adults before the introduction of COVID-19 vaccination campaign have shown a low antibody positivity rate. However, data on COVID-19 seroprevalence in Korean children remained scarce. In this study, we assessed the seroprevalence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in children in Korea. METHODS: Between December 2020 and March 2021, stratified serum samples were collected from children aged 0-18 years in 17 different regions across the country. The SARS-CoV-2 antibody test was conducted using an electro-chemiluminescence immunoassay (ECLIA) to detect the antibodies against nucleocapsid antigens of SARS-CoV-2. Samples that tested positive using the ECLIA were reflexed to an additional plaque reduction neutralization test (PRNT) for SARS-CoV-2. RESULTS: A total of 1,887 samples were collected. Excluding 21 samples collected from regional medical centers, 1,866 samples were included in the final analysis. Two samples (0.11%) were positive for the antibodies against nucleocapsid antigens of SARS-CoV-2. Both samples were shown to have neutralizing antibodies for SARS-CoV-2 via PRNT. CONCLUSION: After 1 year since the start of COVID-19 pandemic, the seroprevalence of SARS-CoV-2 among Korean children was 0.11%, which was lower than the adults (0.52%) in another study conducted during a similar period. In the early stages of the COVID-19 pandemic, the seroprevalence of SARS-CoV-2 in Korea was lower than those of other countries, which was presumed to be the consequence of a very strong social distancing measures.

Presumed population immunity to SARS-CoV-2 in South Korea, April 2022.

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.

Effectiveness of Second mRNA COVID-19 Booster Vaccine in Immunocompromised Persons and Long-Term Care Facility Residents.

We used a nationwide population registry in South Korea to estimate the effect of a second booster dose of mRNA COVID-19 vaccine on the risk for laboratory-confirmed SARS-CoV-2 infection, critical infection, and death in immunocompromised persons and long-term care facility (LTCF) residents. During February 16-May 7, 2022, among 972,449 eligible persons, 736,439 (75.7%) received a first booster and 236,010 (24.3%) persons received a second booster. Compared with the first booster group, at 30-53 days, the second booster recipients had vaccine effectiveness (VE) against all infections of 22.28% (95% CI 19.35%-25.11%), VE against critical infection of 56.95% (95% CI 29.99%-73.53%), and VE against death of 62.96% (95% CI 34.18%-79.15%). Our findings provide real-world evidence that a second booster dose of mRNA vaccine substantially increases protection against critical infection and death in these high-risk population groups.

A global epidemiological analysis of COVID-19 vaccine types and clinical outcomes.

OBJECTIVES: To compare messenger RNA (mRNA)-based and adenovirus-vectored vaccines (ADVVs) with inactivated virus vaccines (IVVs) using real-world aggregate data. METHODS: We performed longitudinal analyses of publicly accessible epidemiological, clinical, virological, vaccine-related, and other public health data from 41 eligible countries during the first half of 2021. The relationships between vaccination coverage and clinical outcomes were analyzed using repeated measures correlation analyses and mixed-effects modeling to adjust for potential mediating and confounding factors. RESULTS: Countries that used mRNA and/or ADVV (n = 31) vs IVV, among other vaccine types (n = 10), had different distributions of age (42.4 vs 33.9 years, respectively; P-value = 0.0006), gross domestic product per capita ($ 38,606 vs $ 20,422, respectively; P <0.0001), and population sizes (8,655,541 vs 5,139,162, respectively; P-value = 0.36). After adjustment for country differences, the stringency of nonpharmaceutical interventions, and dominant SARS-CoV-2 variant types, populations that received mRNA and/or ADVV had significantly lower rates of cases and deaths over time (P <0.001 for each analysis). Populations vaccinated with IVV, among others, had significantly higher rates of cases and deaths over time (P <0.05 for each analysis). CONCLUSION: The real-world effectiveness of IVV may be inferior to mRNA and/or ADVV, and prospective comparative studies are needed to critically evaluate the role of IVV in the context of contemporary SARS-CoV-2 variants.