OBJECTIVES: We analyzed Korea's data privacy regime in the context of protecting and utilizing health and medical big data and tried to draw policy implications from the analyses. METHODS: We conducted comparative analyses of the legal and regulatory environments governing health and medical big data with a view to drawing policy implications for Korea. The legal and regulatory regimes considered include the following: the European Union, the United Kingdom, France, the United States, and Japan. We reviewed relevant statutory materials as well as various non-statutory materials and guidelines issued by public authorities. Where available, we also examined policy measures implemented by government agencies. RESULTS: In this study, we investigated how various jurisdictions deal with legal and regulatory issues that may arise from the use of health and medical information with regard to the protection of data subjects' rights and the protection of personal information. We compared and analyzed various forms of legislation in various jurisdictions and also considered technical methods, such as de-identification. The main findings include the following: there is a need to streamline the relationship between the general data privacy regime and the regulatory regime governing health and medical big data; the regulatory and institutional structure for data governance should be more clearly delineated; and regulation should encourage the development of suitable methodologies for the de-identification of data and, in doing so, a principle-based and risk-based approach should be taken. CONCLUSIONS: Following our comparative legal analyses, implications were drawn. The main conclusion is that the relationship between the legal requirements imposed for purposes of personal information protection and the regulatory requirements governing the use of health and medical data is complicated and multi-faceted and, as such, their relationship should be more clearly streamlined and delineated.
Computer Security ; European Union ; France ; Government Agencies ; Great Britain ; Humans ; Japan ; Korea ; Privacy ; United States

Objectives: The household secondary attack rate (SAR) of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is an important indicator for community transmission. This study aimed to characterize transmission by comparing household SARs and identifying risk factors during the periods of Delta and Omicron variant predominance in Republic of Korea. Methods: We defined the period of Delta variant predominance (Delta period) as July 25, 2021 to January 15, 2022, and the period of Omicron variant predominance (Omicron period) as February 7 to September 3, 2022. The number of index cases included was 214,229 for the Delta period and 5,521,393 for the Omicron period. To identify the household SARs and risk factors for each period, logistic regression was performed to determine the adjusted odds ratio (aOR). Results: The SAR was 35.2% for the Delta period and 43.1% for the Omicron period. The aOR of infection was higher in 2 groups, those aged 0 to 18 years and ≥75 years, compared to those aged 19 to 49 years. Unvaccinated individuals (vs. vaccinated individuals) and individuals experiencing initial infection (vs. individuals experiencing a second or third infection) had an increased risk of infection with SARS-CoV-2. Conclusion: This study analyzed the household SARs and risk factors. We hope that the results can help develop age-specific immunization plans and responses to reduce the SAR in preparation for emerging infectious diseases or potential new variants of SARS-CoV-2.

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-year-olds 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.

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.

Objectives: The aim of this study was to disseminate information about the safety of bivalent coronavirus disease 2019 (COVID-19) mRNA booster vaccines administered to adults in the Republic of Korea. Methods: Two databases were used to assess the safety of COVID-19 booster doses of Pfizer BA.1, Pfizer BA.4/5, Moderna BA.1, and Moderna BA.4/5 vaccines for adults aged 18 years and older.Adverse events (AEs) were analyzed using data reported to the web-based COVID-19 vaccination management system (CVMS) and a self-reported text-message survey. Results: Between October 11, 2022 and March 30, 2023, the CVMS received reports of 2,369 (93.7%) non-serious AEs from vaccinated adults, along with 158 (6.3%) serious AEs, which included 5 cases of anaphylaxis and 33 deaths. From October 11, 2022 to January 27, 2023, 40,022 people aged 18 and older responded to a survey conducted via text message. The booster doses were associated with fewer local and systemic AEs compared to the original vaccines. After receiving the bivalent vaccine, the most commonly reported AEs were pain at the injection site, headache, fatigue, and myalgia. Conclusion Overall, bivalent vaccines exhibited fewer AEs compared to the original vaccines. The majority of AEs were non-serious, and serious AEs were rare among adults aged 18 years and older following vaccination with the Pfizer and Moderna bivalent vaccines.

Objectives: The aim of this study was to disseminate information about the safety of bivalent coronavirus disease 2019 (COVID-19) mRNA booster vaccines administered to adults in the Republic of Korea. Methods: Two databases were used to assess the safety of COVID-19 booster doses of Pfizer BA.1, Pfizer BA.4/5, Moderna BA.1, and Moderna BA.4/5 vaccines for adults aged 18 years and older.Adverse events (AEs) were analyzed using data reported to the web-based COVID-19 vaccination management system (CVMS) and a self-reported text-message survey. Results: Between October 11, 2022 and March 30, 2023, the CVMS received reports of 2,369 (93.7%) non-serious AEs from vaccinated adults, along with 158 (6.3%) serious AEs, which included 5 cases of anaphylaxis and 33 deaths. From October 11, 2022 to January 27, 2023, 40,022 people aged 18 and older responded to a survey conducted via text message. The booster doses were associated with fewer local and systemic AEs compared to the original vaccines. After receiving the bivalent vaccine, the most commonly reported AEs were pain at the injection site, headache, fatigue, and myalgia. Conclusion Overall, bivalent vaccines exhibited fewer AEs compared to the original vaccines. The majority of AEs were non-serious, and serious AEs were rare among adults aged 18 years and older following vaccination with the Pfizer and Moderna bivalent vaccines.

Objectives: The aim of this study was to disseminate information about the safety of bivalent coronavirus disease 2019 (COVID-19) mRNA booster vaccines administered to adults in the Republic of Korea. Methods: Two databases were used to assess the safety of COVID-19 booster doses of Pfizer BA.1, Pfizer BA.4/5, Moderna BA.1, and Moderna BA.4/5 vaccines for adults aged 18 years and older.Adverse events (AEs) were analyzed using data reported to the web-based COVID-19 vaccination management system (CVMS) and a self-reported text-message survey. Results: Between October 11, 2022 and March 30, 2023, the CVMS received reports of 2,369 (93.7%) non-serious AEs from vaccinated adults, along with 158 (6.3%) serious AEs, which included 5 cases of anaphylaxis and 33 deaths. From October 11, 2022 to January 27, 2023, 40,022 people aged 18 and older responded to a survey conducted via text message. The booster doses were associated with fewer local and systemic AEs compared to the original vaccines. After receiving the bivalent vaccine, the most commonly reported AEs were pain at the injection site, headache, fatigue, and myalgia. Conclusion Overall, bivalent vaccines exhibited fewer AEs compared to the original vaccines. The majority of AEs were non-serious, and serious AEs were rare among adults aged 18 years and older following vaccination with the Pfizer and Moderna bivalent vaccines.

Objectives: The aim of this study was to disseminate information about the safety of bivalent coronavirus disease 2019 (COVID-19) mRNA booster vaccines administered to adults in the Republic of Korea. Methods: Two databases were used to assess the safety of COVID-19 booster doses of Pfizer BA.1, Pfizer BA.4/5, Moderna BA.1, and Moderna BA.4/5 vaccines for adults aged 18 years and older.Adverse events (AEs) were analyzed using data reported to the web-based COVID-19 vaccination management system (CVMS) and a self-reported text-message survey. Results: Between October 11, 2022 and March 30, 2023, the CVMS received reports of 2,369 (93.7%) non-serious AEs from vaccinated adults, along with 158 (6.3%) serious AEs, which included 5 cases of anaphylaxis and 33 deaths. From October 11, 2022 to January 27, 2023, 40,022 people aged 18 and older responded to a survey conducted via text message. The booster doses were associated with fewer local and systemic AEs compared to the original vaccines. After receiving the bivalent vaccine, the most commonly reported AEs were pain at the injection site, headache, fatigue, and myalgia. Conclusion Overall, bivalent vaccines exhibited fewer AEs compared to the original vaccines. The majority of AEs were non-serious, and serious AEs were rare among adults aged 18 years and older following vaccination with the Pfizer and Moderna bivalent vaccines.

Objectives: The aim of this study was to disseminate information about the safety of bivalent coronavirus disease 2019 (COVID-19) mRNA booster vaccines administered to adults in the Republic of Korea. Methods: Two databases were used to assess the safety of COVID-19 booster doses of Pfizer BA.1, Pfizer BA.4/5, Moderna BA.1, and Moderna BA.4/5 vaccines for adults aged 18 years and older.Adverse events (AEs) were analyzed using data reported to the web-based COVID-19 vaccination management system (CVMS) and a self-reported text-message survey. Results: Between October 11, 2022 and March 30, 2023, the CVMS received reports of 2,369 (93.7%) non-serious AEs from vaccinated adults, along with 158 (6.3%) serious AEs, which included 5 cases of anaphylaxis and 33 deaths. From October 11, 2022 to January 27, 2023, 40,022 people aged 18 and older responded to a survey conducted via text message. The booster doses were associated with fewer local and systemic AEs compared to the original vaccines. After receiving the bivalent vaccine, the most commonly reported AEs were pain at the injection site, headache, fatigue, and myalgia. Conclusion Overall, bivalent vaccines exhibited fewer AEs compared to the original vaccines. The majority of AEs were non-serious, and serious AEs were rare among adults aged 18 years and older following vaccination with the Pfizer and Moderna bivalent vaccines.