THE RED FLAG OF EMERGENCY USE AUTHORIZATION (EUA)

The Emergency Use Authorization (EUA) policy, a representative biodefense policy, was legislated in the United States in 2001 based on lessons learned from Amerithrax, whereas Korea's EUA policy was based on lessons learned from the Middle East Respiratory Syndrome outbreak in 2015. Due to these divergent origins, the U.S. EUA's homeland security objectives were specialized to deal with highly pathogenic biological agents that could be exploited for bioterrorism, whereas the Korean EUA pursues disease containment purposes to strengthen mass-testing practices. During the early phase of the COVID-19 pandemic, the U.S. EUA revealed limitations in its integration with public health surveillance, laboratory partnerships, and insurance systems, which hampered the rapid expansion of testing capacities. Thereafter, once the limitations of the EUA were circumvented, the testing capacity of the United States began to catch up with that of South Korea, and later skyrocketed after solving these issues. (English) [ FROM AUTHOR] La política de autorización de uso de emergencia (EUA), una política representativa de biodefensa, se legisló en los Estados Unidos en 2001 en base a las lecciones aprendidas de Amerithrax, mientras que la política de EUA de Corea se basó en las lecciones aprendidas del brote del síndrome respiratorio de Oriente Medio (MERS) en 2015 Debido a estos orígenes divergentes, los objetivos de seguridad nacional de la EUA EUA se especializaron para tratar con agentes biológicos altamente patógenos que podrían explotarse para el bioterrorismo, mientras que la EUA coreana persigue propósitos de contención de enfermedades para fortalecer las prácticas de pruebas masivas. Durante la fase inicial de la pandemia de COVID-19, la EUA EUA reveló limitaciones en su integración con la vigilancia de la salud pública, las asociaciones de laboratorios y los sistemas de seguros, lo que obstaculizó la rápida expansión de las capacidades de prueba. A partir de entonces, una vez que se eludieron las limitaciones de la EUA, la capacidad de prueba de los Estados Unidos comenzó a alcanzar a la de Corea del Sur y luego se disparó después de resolver estos problemas. (Spanish) [ FROM AUTHOR] 美国在2001年根据炭疽攻击事件(Amerithrax)的经验教训制定了一项具有代表性的生物防卫政策，即紧急使用授权(EUA)政策，而韩国的EUA政策则基于2015年爆发的中东呼吸综合征(MERS)的经验教训。鉴于这些不同的起源，美国EUA的国土安全目标专门应对可能被用于生物恐怖主义的高致病性生物制剂，而韩国EUA则追求疾病遏制目的，以加强大规模检测实践。在2019冠状病毒病(COVID-19)大流行的早期阶段，美国EUA在与公共卫生监测、实验室合作伙伴关系和保险系统的整合方面存在局限性，这阻碍了检测能力的快速扩展。此后，当绕过EUA的限制后，美国的检测能力开始赶上韩国，并在解决这些问题后，检测能力直线上升。 (Chinese) [ FROM AUTHOR] Copyright of World Affairs is the property of Sage Publications Inc. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full . (Copyright applies to all s.)

Biodefense and emergency use authorization: different originations, purposes, and evolutionary paths of institutions in the United States and South Korea.

BACKGROUND: Emergency-use-authorization (EUA) is the representative biodefense policy that allows the use of unlicensed medical countermeasures or off-label use of approved medical countermeasures in response to public health emergencies. This article aims to determine why the EUA policies of the United States and South Korea produced drastically different outcomes during the COVID-19 pandemic, and how these outcomes were determined by the originations and evolutionary paths of the two policies. METHOD: Historical institutionalism (HI) explains institutional changes-that is, how the institution is born and how it evolves-based on the concept of path dependency. However, the HI analytical narratives remain at the meso level of analysis in the context of structure and agency. This article discusses domestic and policy-level factors related to the origination of the biodefense institutions in the United States and South Korea using policy-learning concepts with the Event-related Policy Change Model. RESULTS: The 2001 anthrax letter attack (Amerithrax) and the 2015 Middle East Respiratory Syndrome (MERS) outbreak prompted the establishment of biodefense institutions in the United States and South Korea, respectively. Due to the different departure points and the mechanism of path dependency, the two countries' EUAs evolved in different ways-the United States EUA reinforced the Post-Exposure Prophylaxis (PEP) function, while the South Korea EUA strengthened the Non-Pharmaceutical Intervention (NPI) function. CONCLUSIONS: The evolution and outcomes of the two EUAs are different because both policies were born out of different needs. The United States EUA is primarily oriented toward protecting homeland security against CBRN (chemical, biological, radiological, and nuclear) threats, whereas the South Korea EUA is specifically designed for disease prevention against infectious disease outbreak.

The Korean 3T Practice: New Biosurveillance Model Utilizing New Information Technology and Digital Tools.

In South Korea, COVID-19 pandemic responses, namely the 3T (testing, tracing, and treating) strategy, emerged as a new biosurveillance regime actively using new information technology (IT) and digital tools. The foundation of the Korean 3T system is epidemiological investigation efforts and clinical practices exploiting the use of new digital and IT tools. Due to these unique features, the Korean 3T system can be referred to as a "contact-based biosurveillance system," which is an advanced version of the traditional biosurveillance models (indicator-based or event-based models). This article illustrates how the contact-based biosurveillance system originated from the experience with the 2015 Middle East Respiratory Syndrome (MERS) outbreak. The post-MERS Korean biosurveillance regime actively adopted the utility of new digital and IT tools to strengthen not only the ex-ante epidemic intelligence capabilities (by traditional models) but also the ex-post response and recovery capabilities (digital contact tracing and digital health intervention). However, critics claim that the Korean 3T system may violate individuals' privacy and human rights by addressing the fact that the Korean biosurveillance system would strengthen social surveillance and population control by the government as a "digital big brother" in the cyber age. Nevertheless, 3T biosurveillance promises a positive future direction for digital health practice in the current biosurveillance regimes.

Comparison of ACCEL ELISA COVID-19 with Elecsys Anti-SARS-CoV-2 for Screening of COVID-19.

OBJECTIVE: Although real-time reverse transcription-PCR (RT-PCR) is the gold standard for diagnosing coronavirus disease 2019 (COVID-19), simpler and faster antibody detection tests can be complementary for diagnosis of COVID-19. To manage the COVID-19 pandemic, the need for serologic testing has increased. In this report, the newly developed antibody detection assays ACCEL ELISA COVID-19 (ACCEL) and Elecsys anti-SARS-CoV-2 (Elecsys) were evaluated. METHODS: Serum samples submitted for routine laboratory testing were analyzed (66 and 161 PCR-positive and PCR-negative samples). After the samples were aliquoted, antibody detection tests were performed using ACCEL and Elecsys assays. RESULTS: When detection of viral RNA using RT-PCR was set as the reference method for diagnosis of COVID-19, the sensitivity was 83.3% and 75.8, and the specificity was 96.9 and 99.4% in ACCEL and Elecsys, respectively. The true positivity rates of ACCEL and Elecsys assays were 57.1%/42.9%, 57.1%/28.6%, 77.8%/66.7%, and 97.1%/97.1% among the specimens collected ≤3, 4-7, 8-14, and >14 days after symptom onset, respectively. CONCLUSIONS: The ACCEL assay showed high sensitivity in samples collected within 7 days after symptom onset. Because many patients are asymptomatic in the early stage of SARS-CoV-2 infection, the ACCEL assay could be a good screening tool due to high sensitivity in the early stage of SARS-CoV-2 infection.

Understanding the New Characteristics and Development Strategies of Coastal Tourism for Post-COVID-19: A Case Study in Korea

The COVID-19 outbreak has restricted international travel, halting tourism globally. Thus, travel demand has shifted from international to domestic destinations. The prolonged travel restriction has changed travel trends and travelers’ behaviors, adversely affecting the tourism industry worldwide. This study attempted to understand and examine the changes in travel preferences, such as choice of destinations, activities, and transportation modes, following the COVID-19 outbreak. This study used primary survey data of 200 respondents collected in June 2020 and secondary survey data collected by the Korea Tourism Organization in 2015 and 2017. The study also examined the role of the government in supporting strategies to prepare for the post-COVID tourism landscape. The analysis showed that the pandemic has caused travelers to favor short-haul destinations where non-contact (socially distanced) travel is possible. The study also found that the distributed land strategy that can make “untact” tourism a possibility could boost the struggling tourism industry.

Disinfection technology and strategies for COVID-19 hospital and bio-medical waste management.

The isolation wards, institutional quarantine centers, and home quarantine are generating a huge amount of bio-medical waste (BMW) worldwide since the outbreak of novel coronavirus disease-2019 (COVID-19). The personal protective equipment, testing kits, surgical facemasks, and nitrile gloves are the major contributors to waste volume. Discharge of a new category of BMW (COVID-waste) is of great global concern to public health and environmental sustainability if handled inappropriately. It may cause exponential spreading of this fatal disease as waste acts as a vector for SARS-CoV-2, which survives up to 7 days on COVID-waste (like facemasks). Proper disposal of COVID-waste is therefore immediately requires to lower the threat of pandemic spread and for sustainable management of the environmental hazards. Henceforth, in the present article, disinfection technologies for handling COVID-waste from its separate collection to various physical and chemical treatment steps have been reviewed. Furthermore, policy briefs on the global initiatives for COVID-waste management including the applications of different disinfection techniques have also been discussed with some potential examples effectively applied to reduce both health and environmental risks. This article can be of great significance to the strategy development for preventing/controlling the pandemic of similar episodes in the future.