COVID-19 vaccine safety profile in Republic of Korea, February 26, 2021 through April 30, 2022.

Background: As of June, 2022, five coronavirus disease 2019 (COVID-19) vaccine brands were used for the national immunization program. The Korea Diseases Control and Prevention Agency has enhanced vaccine safety monitoring through a passive, web-based reporting system and active, text message-based mornitoring. Purpose: This study described the enhanced safety monitoring system of COVID-19 vaccines, and analyzed the frequencies and types of AEs among five brands of COVID-19 vaccines. Methods: AEs reports through the web-based Adverse Events Reporting System in COVID-19 Vaccination Management System and the text message-based among recipients were analyzed. AEs were classified as non-serious AEs and serious AEs (e.g., death and anaphylaxis). AEs were classified as non-serious AEs and serious AEs (e.g., death and anaphylaxis). AE reporting rates were calculated based on the number of COVID-19 vaccine dose administered. Results: A total of 125,107,883 doses were administered in Korea from February 26, 2021 to June 4, 2022. Among them, a total of 471,068 AEs reported, of which 96.1% were non-serious AEs and 3.9% were serious AEs. Among the 72,609 participants in the text message-based AE monitoring, a higher AE rate was reported in the 3rd dose compare to primary doses in both local and systemic reactions. A total of 874 cases of anaphylaxis (7.0 per 1,000,000 doses), four cases of TTS, 511 cases of myocarditis (4.1 per 1,000,000 doses) and 210 cases of pericarditis (1.7 per 1,000,000 doses) were confirmed. A total of seven fatal cases were associated with COVID-19 vaccination (1 TTS case and 5 myocarditis cases). Conclusions: Young adult and female sex were related with a higher reported rate of AEs with COVID-19 vaccines, most of the reported AEs of COVID-19 vaccines was non-serious AEs of mild intensity.

Self-reported adverse events after 2 doses of COVID-19 vaccine in Korea.

OBJECTIVES: In Korea, a national coronavirus disease 2019 (COVID-19) vaccination program was implemented, including 4 vaccines against COVID-19. A text messaging-based survey, in addition to a passive adverse event reporting system, was launched to quickly report unusual symptoms post-vaccination. This study compared the frequency of adverse events after COVID-19 vaccination based on the vaccine type and the type of 2-dose regimen (homologous or heterologous). METHODS: Self-reported adverse events were collected through a text-message survey for 7 days after each vaccination. This study included 50,950 vaccine recipients who responded to the survey at least once. Informed consent to receive surveys via text was obtained from the vaccine recipients on the date of first vaccination. RESULTS: The recipients of mRNA vaccines reported local and systemic reactions 1.6 times to 2.8 times more frequently after dose 2 than after dose 1 (p<0.001), whereas ChAdOx1-S recipients reported significantly fewer local and systemic reactions after dose 2 than after dose 1 (p<0.001). Local and systemic reactions were approximately 2 times and 4 times more frequent for heterologous vaccination than for BNT162b2/BNT162b2 and ChAdOx1-S/ChAdOx1-S regimens, respectively. Young individuals, female, and those receiving heterologous vaccine regimens including ChAdOx1-S/BNT162b2 vaccines reported more adverse events than older participants, male, and those with homologous vaccine regimens. CONCLUSIONS: Although a heterologous regimen, youth, and female sex were associated with a higher risk of adverse reactions after COVID-19 vaccination, no critical issues were noted. Active consideration of heterologous schedules based on the evidence of efficacy and safety appears desirable.

Safety monitoring of COVID-19 vaccination among adolescents aged 12 to 17 years old in the Republic of Korea.

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.

COVID-19 vaccine safety monitoring in Republic of Korea from February 26, 2021 to October 31, 2021.

OBJECTIVE: This study aimed to present data on reported adverse events following coronavirus disease 2019 (COVID-19) vaccination in Republic of Korea from February 26 to October 31, 2021, and to determine whether any significant patterns emerged from an analysis of the characteristics of suspected adverse event cases for each type of vaccine. METHODS: Adverse events following COVID-19 vaccination reported by medical doctors and forensic pathologists were analyzed. Cases of suspected anaphylaxis were classified using the Brighton Collaboration definition. RESULTS: By October 31, 2021, a total of 353,535 (0.45%) adverse events were reported after 78,416,802 COVID-19 vaccine doses. Of the adverse events, 96.4% were non-serious and 3.6% were serious. The most frequently reported adverse events were headache, myalgia, and dizziness. Of the 835 reported deaths after COVID-19 vaccination, 2 vaccine-related deaths were confirmed. Suspected anaphylaxis was confirmed in 454 cases using the Brighton Collaboration definition. CONCLUSION: The commonly reported symptoms were similar to those described in clinical trials. Most reported adverse events were non-serious, and the reporting rate of adverse events following COVID-19 vaccination was higher in women than in men (581 vs. 315 per 100,000 vaccinations). Confirmed anaphylaxis was reported in 5.8 cases per 1,000,000 vaccinations.

Delays in the diagnosis and treatment of tuberculosis during the COVID-19 outbreak in the Republic of Korea in 2020.

OBJECTIVE: We investigated the impact of the coronavirus disease 2019 (COVID-19) pandemic on tuberculosis (TB) "diagnosis and" management in the Republic of Korea (ROK). METHODS: This retrospective cross-sectional study used nationwide ROK TB notification data (98,346 cases) from 2017 to 2020. The median time from the onset of TB symptoms to treatment initiation and the compliance rates with the required timing for notification and individual case investigations were measured and compared across periods and regions affected by the COVID-19 epidemic. RESULTS: TB diagnosis during the COVID-19 pandemic was delayed. The median time to TB treatment initiation (25 days) in 2020 increased by 3 days compared to that of the previous 3 years (22 days) (p<0.0001). In the outbreak in Seoul, Incheon, and Gyeonggi province during August, the time to TB diagnosis was 4 days longer than in the previous 3 years (p=0.0303). In the outbreak in Daegu and Gyeongbuk province from February to March 2020, the compliance rate with the required timing for individual case investigations was 2.2%p lower than in other areas in 2020 (p=0.0148). For public health centers, the rate was 13%p lower than in other areas (80.3% vs. 93.3%, p=0.0003). CONCLUSION: TB diagnoses during the COVID-19 pandemic in the ROK were delayed nationwide, especially for patients notified by public-private mix TB control hospitals. TB individual case investigations were delayed in regional COVID-19 outbreak areas (Daegu and Gyeongbuk province), especially in public health centers. Developing strategies to address this issue will be helpful for sustainable TB management during future outbreaks.

Impact of COVID-19 Pandemic on the National PPM Tuberculosis Control Project in Korea: the Korean PPM Monitoring Database between July 2019 and June 2020.

BACKGROUND: The coronavirus disease 2019 (COVID-19) pandemic caused disruptions to healthcare systems and endangered the control and prevention of tuberculosis (TB). We investigated the nationwide effects of COVID-19 on the national Public-Private Mix (PPM) TB control project in Korea, using monitoring indicators from the Korean PPM monitoring database. METHODS: The Korean PPM monitoring database includes data from patients registered at PPM hospitals throughout the country. Data of six monitoring indicators for active TB cases updated between July 2019 and June 2020 were collected. The data of each cohort throughout the country and in Daegu-Gyeongbuk, Seoul Metropolitan Area, and Jeonnam-Jeonbuk were collated to provide nationwide data. The data were compared using the χ² test for trend to evaluate quarterly trends of each monitoring indicator at the national level and in the prespecified regions. RESULTS: Test coverages of sputum smear (P = 0.622) and culture (P = 0.815), drug susceptibility test (P = 0.750), and adherence rate to initial standard treatment (P = 0.901) at the national level were not significantly different during the study period. The rate of loss to follow-up among TB cases at the national level was not significantly different (P = 0.088); however, the treatment success rate among the smear-positive drug-susceptible pulmonary TB cohort at the national level significantly decreased, from 90.6% to 84.1% (P < 0.001). Treatment success rate in the Seoul metropolitan area also significantly decreased during the study period, from 89.4% to 84.5% (P = 0.006). CONCLUSION: Our study showed that initial TB management during the COVID-19 pandemic was properly administered under the PPM project in Korea. However, our study cannot confirm or conclude a decreased treatment success rate after the COVID-19 pandemic due to limited data.