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Fulltext Delay in Vaccine Access in ASEAN Countries

Subsittipong N, Choi J, Kim TH, Han E

Int J Environ Res Public Health, 2022 Mar 22;19(7).
PMID: 35409470 DOI: 10.3390/ijerph19073786

Background: The introduction of new vaccines has been delayed in some countries in the Asia-Pacific region, which has led to delays in accessing vaccines for target patients. However, the approval lag of vaccines in the Asia-Pacific region has not been assessed. The objective of this study is to assess the availability and approval lag of vaccines in Asia-Pacific countries and compare them among Asia-Pacific countries, the United States (US), and Europe (EU). Methods: The information on vaccines prequalified by the World Health Organization (WHO) between 2010 and 2019 was obtained primarily from the WHO website. The date of approval of the WHO prequalified vaccine in Australia, India, South Korea, Thailand, Singapore, Malaysia, the US, and EU was retrieved from the official website of national regulatory agencies. The vaccines were divided into two groups based on their first approval pathway, that is, vaccines that were first approved by SRA (Stringent Regulatory Authority including the US, EU, and WHO) and those that were first approved by non-SRA. The absolute approval lag represented the availability of the vaccine. Relative approval lag represented the lag time between the approval date of the country of interest and the first global approval date and was measured as the median approval lag. A Mann−Whitney U test was used to examine statistical differences between relative approval lag between the SRA first and the non-SRA first groups. Results: A total of 92 vaccines were prequalified by the WHO between 2010 and 2019, but only 61 vaccines were included in the analysis. Over 50% of vaccines were first licensed by non-SRAs. Of all the WHO-prequalified vaccines, the median approval lag in the ASEAN countries in this study was longer than those in the US and EU, with a median of 30 months in Australia, 15 months in South Korea, 52 months in Thailand, and 23 months in Singapore, compared to 0 months in the US and EU. The differences in approval lags between SRA first vaccines and non-SRA first vaccines were statistically significant in South Korea and Thailand (p < 0.05). Conclusions: The approval lag of vaccines was observed in the Asia-Pacific region, indicating a gap between the Asia-pacific region and the US and EU in regard to access to new vaccines. Future studies need to analyze the background factors related to the gap in availability and vaccine approval lag in the Asia-Pacific region and assess the impact of vaccine approval lag in the region.
Fulltext Association between prehospital field to emergency department delta shock index and in-hospital mortality in patients with torso and extremity trauma: A multinational, observational study

Kim DK, Jeong J, Shin SD, Song KJ, Hong KJ, Ro YS, et al.

PLoS One, 2021;16(10):e0258811.
PMID: 34695147 DOI: 10.1371/journal.pone.0258811

Hemorrhage, a main cause of mortality in patients with trauma, affects vital signs such as blood pressure and heart rate. Shock index (SI), calculated as heart rate divided by systolic blood pressure, is widely used to estimate the shock status of patients with hemorrhage. The difference in SI between the emergency department and prehospital field can indirectly reflect urgency after trauma. We aimed to determine the association between delta SI (DSI) and in-hospital mortality in patients with torso or extremity trauma. Patients with DSI >0.1 are expected to be associated with high mortality. This retrospective, observational study used data from the Pan-Asian Trauma Outcomes Study. Patients aged 18-85 years with abdomen, chest, upper extremity, lower extremity, or external injury location were included. Patients from China, Indonesia, Japan, Philippines, Thailand, and Vietnam; those who were transferred from another facility; those who were transferred without the use of emergency medical service; those with prehospital cardiac arrest; those with unknown exposure and outcomes were excluded. The exposure and primary outcome were DSI and in-hospital mortality, respectively. The secondary and tertiary outcome was intensive care unit (ICU) admission and massive transfusion, respectively. Multivariate logistic regression analysis was performed to test the association between DSI and outcome. In total, 21,534 patients were enrolled according to the inclusion and exclusion criteria. There were 3,033 patients with DSI >0.1. The in-hospital mortality rate in the DSI >0.1 and ≤0.1 groups was 2.0% and 0.8%, respectively. In multivariate logistic regression analysis, the DSI ≤0.1 group was considered the reference group. The unadjusted and adjusted odds ratios of in-hospital mortality in the DSI >0.1 group were 2.54 (95% confidence interval [CI] 1.88-3.42) and 2.82 (95% CI 2.08-3.84), respectively. The urgency of traumatic hemorrhage can be determined using DSI, which can help hospital staff to provide proper trauma management, such as early trauma surgery or embolization.
Association of the Emergency Medical Services-Related Time Interval with Survival Outcomes of Out-of-Hospital Cardiac Arrest Cases in Four Asian Metropolitan Cities Using the Scoop-and-Run Emergency Medical Services Model

Kim TH, Lee K, Shin SD, Ro YS, Tanaka H, Yap S, et al.

J Emerg Med, 2017 Nov;53(5):688-696.e1.
PMID: 29128033 DOI: 10.1016/j.jemermed.2017.08.076

BACKGROUND: Response time interval (RTI) and scene time interval (STI) are key time variables in the out-of-hospital cardiac arrest (OHCA) cases treated and transported via emergency medical services (EMS).
OBJECTIVE: We evaluated distribution and interactive association of RTI and STI with survival outcomes of OHCA in four Asian metropolitan cities.
METHODS: An OHCA cohort from Pan-Asian Resuscitation Outcome Study (PAROS) conducted between January 2009 and December 2011 was analyzed. Adult EMS-treated cardiac arrests with presumed cardiac origin were included. A multivariable logistic regression model with an interaction term was used to evaluate the effect of STI according to different RTI categories on survival outcomes. Risk-adjusted predicted rates of survival outcomes were calculated and compared with observed rate.
RESULTS: A total of 16,974 OHCA cases were analyzed after serial exclusion. Median RTI was 6.0 min (interquartile range [IQR] 5.0-8.0 min) and median STI was 12.0 min (IQR 8.0-16.1). The prolonged STI in the longest RTI group was associated with a lower rate of survival to discharge or of survival 30 days after arrest (adjusted odds ratio [aOR] 0.59; 95% confidence interval [CI] 0.42-0.81), as well as a poorer neurologic outcome (aOR 0.63; 95% CI 0.41-0.97) without an increasing chance of prehospital return of spontaneous circulation (aOR 1.12; 95% CI 0.88-1.45).
CONCLUSIONS: Prolonged STI in OHCA with a delayed response time had a negative association with survival outcomes in four Asian metropolitan cities using the scoop-and-run EMS model. Establishing an optimal STI based on the response time could be considered.
Fulltext Efficacy of a Novel Multiepitope Vaccine Candidate against Foot-and-Mouth Disease Virus Serotype O and A

Chathuranga WAG, Hewawaduge C, Nethmini NAN, Kim TH, Kim JH, Ahn YH, et al.

Vaccines (Basel), 2022 Dec 19;10(12).
PMID: 36560591 DOI: 10.3390/vaccines10122181

Foot-and-mouth disease (FMD) is a highly contagious and economically devastating disease in cloven-hoofed animals. To prevent the spread of FMD virus (FMDV), traditional inactivated vaccines are used to immunize susceptible animals in disease-endemic countries. However, the inactivated FMD vaccine has several limitations, including safety concerns. To overcome these limitations, subunit proteins have been studied as alternative vaccine candidates. In this study, we designed two multiepitope recombinant proteins (OVM and AVM) containing antigenic sites (residue of VP1 132-162 and residue of VP1 192-212) of three topotypes of FMDV serotype O or three topotypes of FMDV serotype A. Each recombinant protein was efficiently expressed in Escherichia coli with high solubility, and the immunogenicity and protective efficacy of the proteins as FMD vaccine candidates were evaluated. The results showed that OVM and AVM emulsified with ISA201 adjuvant induced effective antigen-specific humoral and cell-mediated immune responses and successfully protected mice from O/Jincheon/SKR/2014, O/VET/2013, and A/Malaysia/97 viruses. In addition, intramuscular immunization of pigs with the OVM and AVM emulsified with ISA201 elicited effective levels of neutralizing antibodies to the viruses with homologous epitopes. Importantly, OVM-AVM emulsified with CAvant®SOE-X adjuvant conferred 100% protection against the O/Jincheon/SKR/2014 virus with homologous residues and 75% protection against A/SKR/GP/2018 with heterologous residues. The results presented in this study suggest that the combination of OVM and AVM protein with an effective adjuvant could yield an effective and safe vaccine candidate for the prevention and control of foot-and-mouth disease. In addition, our results provide a vaccine platform that can safely, cost-efficiently, and rapidly generate protective vaccine candidates against diverse FMDVs.
Mechanical Ventilation Discontinuation Practices in Asia: A Multinational Survey

Leung CHC, Lee A, Arabi YM, Phua J, Divatia JV, Koh Y, et al.

Ann Am Thorac Soc, 2021 08;18(8):1352-1359.
PMID: 33284738 DOI: 10.1513/AnnalsATS.202008-968OC

Rationale: There are limited data on mechanical discontinuation practices in Asia. Objectives: To document self-reported mechanical discontinuation practices and determine whether there is clinical equipoise regarding protocolized weaning among Asian Intensive Care specialists. Methods: A survey using a validated questionnaire, distributed using a snowball method to Asian Intensive Care specialists. Results: Of the 2,967 invited specialists from 20 territories, 2,074 (69.9%) took part. The majority of respondents (60.5%) were from China. Of the respondents, 42% worked in intensive care units (ICUs) where respiratory therapists were present; 78.9% used a spontaneous breathing trial as the initial weaning step; 44.3% frequently/always used pressure support (PS) alone, 53.4% intermittent spontaneous breathing trials with PS in between, and 19.8% synchronized intermittent mandatory ventilation with PS as a weaning mode. Of the respondents, 56.3% routinely stopped feeds before extubation, 71.5% generally followed a sedation protocol or guideline, and 61.8% worked in an ICU with a weaning protocol. Of these, 78.2% frequently always followed the protocol. A multivariate analysis involving a modified Poisson regression analysis showed that working in an ICU with a weaning protocol and frequently/always following it was positively associated with an upper-middle-income territory, a university-affiliated hospital, or in an ICU that employed respiratory therapists; and negatively with a low-income or lower-middle-income territory or a public hospital. There was no significant association with "in-house" intensivist at night, multidisciplinary ICU, closed ICU, or nurse-patient ratio. There was heterogeneity in agreement/disagreement with the statement, "evidence clearly supports protocolized weaning over nonprotocolized weaning." Conclusions: A substantial minority of Asian Intensive Care specialists do not wean patients in accordance with the best available evidence or current guidelines. There is clinical equipoise regarding the benefit of protocolized weaning.
Fulltext 2017 Multimodality Appropriate Use Criteria for Noninvasive Cardiac Imaging: Expert Consensus of the Asian Society of Cardiovascular Imaging

ASCI Practice Guideline Working Group, Beck KS, Kim JA, Choe YH, Sim KH, Hoe J, et al.

Korean J Radiol, 2017 Nov-Dec;18(6):871-880.
PMID: 29089819 DOI: 10.3348/kjr.2017.18.6.871

In 2010, the Asian Society of Cardiovascular Imaging (ASCI) provided recommendations for cardiac CT and MRI, and this document reflects an update of the 2010 ASCI appropriate use criteria (AUC). In 2016, the ASCI formed a new working group for revision of AUC for noninvasive cardiac imaging. A major change that we made in this document is the rating of various noninvasive tests (exercise electrocardiogram, echocardiography, positron emission tomography, single-photon emission computed tomography, radionuclide imaging, cardiac magnetic resonance, and cardiac computed tomography/angiography), compared side by side for their applications in various clinical scenarios. Ninety-five clinical scenarios were developed from eight selected pre-existing guidelines and classified into four sections as follows: 1) detection of coronary artery disease, symptomatic or asymptomatic; 2) cardiac evaluation in various clinical scenarios; 3) use of imaging modality according to prior testing; and 4) evaluation of cardiac structure and function. The clinical scenarios were scored by a separate rating committee on a scale of 1-9 to designate appropriate use, uncertain use, or inappropriate use according to a modified Delphi method. Overall, the AUC ratings for CT were higher than those of previous guidelines. These new AUC provide guidance for clinicians choosing among available testing modalities for various cardiac diseases and are also unique, given that most previous AUC for noninvasive imaging include only one imaging technique. As cardiac imaging is multimodal in nature, we believe that these AUC will be more useful for clinical decision making.
Fulltext High-density genotyping of immune-related loci identifies new SLE risk variants in individuals with Asian ancestry

Sun C, Molineros JE, Looger LL, Zhou XJ, Kim K, Okada Y, et al.

Nat Genet, 2016 Mar;48(3):323-30.
PMID: 26808113 DOI: 10.1038/ng.3496

Systemic lupus erythematosus (SLE) has a strong but incompletely understood genetic architecture. We conducted an association study with replication in 4,478 SLE cases and 12,656 controls from six East Asian cohorts to identify new SLE susceptibility loci and better localize known loci. We identified ten new loci and confirmed 20 known loci with genome-wide significance. Among the new loci, the most significant locus was GTF2IRD1-GTF2I at 7q11.23 (rs73366469, Pmeta = 3.75 × 10(-117), odds ratio (OR) = 2.38), followed by DEF6, IL12B, TCF7, TERT, CD226, PCNXL3, RASGRP1, SYNGR1 and SIGLEC6. We identified the most likely functional variants at each locus by analyzing epigenetic marks and gene expression data. Ten candidate variants are known to alter gene expression in cis or in trans. Enrichment analysis highlights the importance of these loci in B cell and T cell biology. The new loci, together with previously known loci, increase the explained heritability of SLE to 24%. The new loci share functional and ontological characteristics with previously reported loci and are possible drug targets for SLE therapeutics.