Health post COVID-19: Supranational regulatory reliance and coordination

The dominant position of the U.S. Food and Drug Administration (FDA) as the most influential regulator in the world has been particularly salient during the COVID-19 pandemic, in the context of COVID-19 vaccines' emergency use authorizations. In the context of adjustment toward a post-COVID-19 regulatory order of harmonization for medicines approval, this essay proposes a critical reflection about the justifications and political dynamics behind the FDA's power and its impact in latinamerican countries' regulatory systems, considering the already regulatory reliance on the FDA. In particular, this essay asks whether regulatory 'agility' and 'coordination' will benefit countries of the region in addressing the problems of scarcity and inequitable access to medicines that have become evident with the pandemic. © 2023 The Author(s). Oxford University Press and New York University School of Law. All rights reserved.

Salud postpandemia: influencia supranacional y coordinacion regulatoria Health post COVID-19: Supranational regulatory reliance and coordination

The dominant position of the U.S. Food and Drug Administration (FDA) as the most influential regulator in the world has been particularly salient during the COVID-19 pandemic, in the context of COVID-19 vaccines' emergency use authorizations. In the context of adjustment toward a post-COVID-19 regulatory order of harmonization for medicines approval, this essay proposes a critical reflection about the justifications and political dynamics behind the FDA's power and its impact in latinamerican countries' regulatory systems, considering the already regulatory reliance on the FDA. In particular, this essay asks whether regulatory 'agility' and 'coordination' will benefit countries of the region in addressing the problems of scarcity and inequitable access to medicines that have become evident with the pandemic.

Biomarkers of COVID-19 and technologies to combat SARS-CoV-2.

Due to the unprecedented public health crisis caused by COVID-19, our first contribution to the newly launching journal, Advances in Biomarker Sciences and Technology, has abruptly diverted to focus on the current pandemic. As the number of new COVID-19 cases and deaths continue to rise steadily around the world, the common goal of healthcare providers, scientists, and government officials worldwide has been to identify the best way to detect the novel coronavirus, named SARS-CoV-2, and to treat the viral infection - COVID-19. Accurate detection, timely diagnosis, effective treatment, and future prevention are the vital keys to management of COVID-19, and can help curb the viral spread. Traditionally, biomarkers play a pivotal role in the early detection of disease etiology, diagnosis, treatment and prognosis. To assist myriad ongoing investigations and innovations, we developed this current article to overview known and emerging biomarkers for SARS-CoV-2 detection, COVID-19 diagnostics, treatment and prognosis, and ongoing work to identify and develop more biomarkers for new drugs and vaccines. Moreover, biomarkers of socio-psychological stress, the high-technology quest for new virtual drug screening, and digital applications are described.

Challenges and Recent Advancements in COVID-19 Vaccines.

Vaccination is the most effective method for the prevention of COVID-19 caused by SARS-CoV-2, which is still a global epidemic. However, the evolution of SARS-CoV-2 is so rapid that various variants, including the Alpha, Beta, Gamma, Delta, and Omicron variants, have emerged, lowering the protection rate of vaccines and even resulting in breakthrough infections. Additionally, some rare but severe adverse reactions induced by COVID-19 vaccines may raise safety concerns and hinder vaccine promotion; however, clinical studies have shown that the benefits of vaccination outweigh the risks caused by adverse reactions. Current vaccines approved with emergency use authorization (EUA) were originally adaptive for adults only, and infants, children, and adolescents are not included. New-generation vaccines are needed to overcome the challenges of limited adaptive age population, breakthrough infection (mainly due to virus variant emergencies), and critical adverse reactions. Fortunately, some advances in COVID-19 vaccines have been obtained regarding enlarged adaptive populations for clinical applications, such as the Pfizer/BioNTech vaccine and the Moderna vaccine. In this article, we provide a review on the challenges and recent advancements in COVID-19 vaccines. The development of next-generation COVID-19 vaccines should lay emphasis on the expansion of adaptive age populations in all individuals, the induction of immune responses to viral variants, the avoidance or alleviation of rare but potentially critical adverse reactions, and the discovery of subunit vaccines with adjuvants encapsulated in nanoparticles.

An update on COVID-19: SARS-CoV-2 variants, antiviral drugs, and vaccines.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a highly contagious and pathogenic virus that first appeared in late December 2019. This SARS-CoV-2 causes an infection of an acute respiratory disease called "coronavirus infectious disease-2019 (COVID-19). The World Health Organization (WHO) declared this SARS-CoV-2 outbreak a great pandemic on March 11, 2020. As of January 31, 2023, SARS-CoV-2 recorded more than 67 million cases and over 6 million deaths. Recently, novel mutated variants of SARS-CoV are also creating a serious health concern worldwide, and the future novel variant is still mysterious. As infection cases of SARS-CoV-2 are increasing daily, scientists are trying to combat the disease using numerous antiviral drugs and vaccines against SARS-CoV-2. To our knowledge, this is the first comprehensive review that summarized the dynamic nature of SARS-CoV-2 transmission, SARS-CoV-2 variants (a variant of concern and variant of interest), antiviral drugs and vaccines utilized against SARS-CoV-2 at a glance. Hopefully, this review will enable the researcher to gain knowledge on SARS-CoV-2 variants and vaccines, which will also pave the way to identify efficient novel vaccines against forthcoming SARS-CoV-2 strains.

Children's SARS-CoV-2 Infection and Their Vaccination.

SARS-CoV-2, a novel coronavirus, causes respiratory tract infections and other complications in affected individuals, and has resulted in numerous deaths worldwide. The unprecedented pace of its transmission worldwide, and the resultant heavy burden on healthcare systems everywhere, prompted efforts to have effective therapeutic strategies and vaccination candidates available to the global population. While aged and immunocompromised individuals form a high-risk group for COVID-19 and have severe disease outcome, the rate of infections among children has also increased with the emergence of the Omicron variant. In addition, recent reports of threatening SARS-CoV-2-associated complications in children have brought to the forefront an urgent necessity for vaccination. In this article, we discuss the current scenario of SARS-CoV-2 infections in children with a special focus on the differences in their immune system response as compared to adults. Further, we describe the various available COVID-19 vaccines, including the recent bivalent vaccines for children, in detail, intending to increase willingness for their acceptance.

Impact of the loss of Laboratory Developed Mass Spectrometry testing at a major academic medical center.

Background: Our laboratory historically performed immunosuppressant and definitive opioid testing in-house as laboratory developed (LDT) mass spectrometry-based tests. However, staffing constraints and supply chain challenges associated with the COVID-19 pandemic forced us to refer this testing to a national reference laboratory. The VALID Act could impose onerous requirements for laboratories to develop LDTs. To explore the potential effect of these additional regulatory hurdles, we used the loss of our own LDT tests to assess the impact on patient care and hospital budgets. Methods: Laboratory information systems data and historical data associated with test costs were used to calculate turnaround times and financial impact. Results: Referral testing has extended the reporting of immunosuppressant results by an average of approximately one day and up to two days at the 95th percentile. We estimate that discontinuing in-house opioid testing has cost our health system over half a million dollars in the year since testing was discontinued. Conclusions: Barriers that discourage laboratories from developing in-house testing, particularly in the absence of FDA-cleared alternatives, can be expected to have a detrimental effect on patient care and hospital finances.

Safety and tolerability of Evusheld in patients with CVID: The Mayo Clinic experience.

Background: The past 2 years of the COVID-19 pandemic brought with it many unknowns for patients with immunodeficiency. Because of the concern for severe infection in those with immunocompromise, patients have been eager for effective prevention, vaccination, and treatment strategies. Preexposure prophylaxis provides another means of prevention in those with immunocompromise. A combination of tixagevimab and cilgavimab (Evusheld [AstraZeneca Cambridge, United Kingdom]) was granted emergency use authorization for preexposure prophylaxis at the end of 2021, but questions remained regarding how this would be tolerated and the side effects associated with its use. Objectives: Our aim was to evaluate the safety and tolerability of Evusheld in patients with CVID from our tri-site institution. Methods: We performed an institutional review board-approved, retrospective chart review of patients with common variable immunodeficiency (CVID) who received Evusheld before March 26, 2022. Results: Of the 45 patients with CVID who received Evusheld, 41 (91%) received the recommended full dose of 600 mg. The majority of patients (39 of 45 [87%]) tolerated Evusheld without adverse events. The adverse events reported included immediate injection site pain, fatigue and cough, an episode of shingles, and chest pain. Conclusions: This is an initial report on the safety and tolerability of Evusheld injections in patients with CVID. The majority of patients tolerated the injections without adverse events. For patients with reported chest pain, the results of a subsequent cardiac workup were negative. The efficacy of Evusheld could not be evaluated owing to the short median follow-up of this study (19 days).

The problem is obtaining knowledge: a qualitative analysis of provider barriers and accelerators to rapid adoption of new treatment in a public health emergency.

Granted by the U.S. Food and Drug Administration, an Emergency Use Authorization (EUA) can only be utilized upon declaration that a specialized set of circumstances exist which justify the authorization. In 2020, the COVID-19 pandemic demanded rapid communication strategies to promote treatment options available through EUA. Despite the authorizations of available monoclonal antibody (mAb) treatments in November 2020, their rate of adoption among health care providers in the U.S. remained low well into 2021. This study examines the accelerators and barriers to provider adoption of COVID-19 treatment so that future adoption of treatments in emerging public health emergencies may be better communicated and hastened. We established a framework informed by adoption accelerators and barriers identified by Diffusion of Innovations (DoI) Theory and conducted a study during the rapidly evolving COVID-19 public health emergency. Most DoI public health research focuses on chronic health issues and has yet to be applied to provider adoption of new treatment under EUA. Through a series of guided interviews with health care providers, primarily physicians or nurse practitioners that were responsible for referring COVID-19 patients, we extracted tools, processes, or other mechanisms (accelerators) and barriers to validate against our DoI framework and fill the gap regarding emergency situations. Our research found that providers supported by large health systems were more inclined to adoption, due to many contributing factors such as the availability of collaborative support and availability of information. Further, communicating evidence-based summaries of treatment options and related processes was also critical to adoption.

Cross-Institutional Evaluation of the Abbott ARCHITECT SARS-CoV-2 IgG Immunoassay.

OBJECTIVE: To describe a cross-institutional approach to verify the Abbott ARCHITECT SARS-CoV-2 antibody assay and to document the kinetics of the serological response. METHODS: We conducted analytical performance evaluation studies using the Abbott ARCHITECT SARS-CoV-2 antibody assay on 5 Abbott ARCHITECT i2000 automated analyzers at 2 academic medical centers. RESULTS: Within-run and between-run coefficients of variance (CVs) for the antibody assay did not exceed 5.6% and 8.6%, respectively, for each institution. Quantitative and qualitative results agreed for lithium heparin plasma, EDTA-plasma and serum specimen types. Results for all SARS-CoV-2 IgG-positive and -negative specimens were concordant among analyzers except for 1 specimen at 1 institution. Qualitative and quantitative agreement was observed for specimens exchanged between institutions. All patients had detectable antibodies by day 10 from symptom onset and maintained seropositivity throughout specimen procurement. CONCLUSIONS: The analytical performance characteristics of the Abbott ARCHITECT SARS-CoV-2 antibody assay within and between 2 academic medical center clinical laboratories were acceptable for widespread clinical-laboratory use.

Parent's Hesitation with COVID-19 Vaccinations in Infants and Children Aged 6 Months to 5 Years.

We implemented an in-person survey of parents/guardians concerning COVID-19 vaccine for a predominantly African-American Medicaid pediatric patient population between the ages of 6-59 months at a Children's Hospital General Pediatric Clinic in Norfolk, VA. Vaccine hesitancy was predominantly based on concerns surrounding safety and overall need for the vaccine.

Development and evaluation of a fluidic facemask for airborne transmission mitigation.

Recently, a fluidic facemask concept was proposed to mitigate the transmission of virus-laden aerosol and droplet infections, such as SARS-CoV-2 (COVID-19). This paper describes an experimental investigation of the first practical fluidic facemask prototype, or "Air-Screen". It employs a small, high-aspect-ratio, crossflow fan mounted on the visor of a filter-covered cap to produce a rectangular air jet, or screen, in front of the wearer's face. The entire assembly weighs less than 200 g. Qualitative flow visualization experiments using a mannequin clearly illustrated the Air-Screen's ability to effectively block airborne droplets (∼100 µm) from the wearer's face. Quantitative experiments to simulate droplets produced during sneezing or a wet cough (∼102 µm) were propelled (via a transmitter) at an average velocity of 50 m/s at 1 m from the mannequin or a target. The Air-Screen blocked 62% of all droplets with a diameter of less than 150 µm. With an Air-Screen active on the transmitter, 99% of all droplets were blocked. When both mannequin and transmitter Air-Screens were active, 99.8% of all droplets were blocked. A mathematical model, based on a weakly-advected jet in a crossflow, was employed to gain greater insight into the experimental results. This investigation highlighted the remarkable blocking effect of the Air-Screen and serves as a basis for a more detailed and comprehensive experimental evaluation.

Clinician perspectives on pediatric COVID-19 vaccination: A qualitative study in central and western, Massachusetts.

We explored perspectives of clinicians in central and western Massachusetts about efforts to vaccinate pediatric patients against COVID-19 as well as best practices and challenges for vaccine delivery. We conducted semi-structured qualitative interviews (n = 16) with family practice and pediatric clinicians between late October and early December 2021. Our interviews addressed: process for vaccination and vaccine promotion, parental receptivity to COVID-19 vaccination, receptivity to other pediatric vaccines, resources needed to support vaccine promotion, and best practices developed to encourage hesitant parents. Using a multi-prong recruitment strategy we invited clinicians to participate in telephone interviews, which were audio-recorded and transcribed. We used rapid qualitative analysis to produce summary templates for each interview which were ultimately combined into a matrix summary. The majority of participants (n = 10) were offering the vaccine in their own clinics, while the remainder cited challenges related to staffing, logistics, and space that prevented them from offering the vaccine. Clinicians reported parents fall into three groups: vaccine-accepting, hesitant but potentially accepting, and refusers. Strategies they identified that worked to encourage hesitant parents were sharing personal vaccine stories, acknowledging parents' fears about the vaccine, and being persistent with the most hesitant parents. Yet resources are needed including educational materials and training in how to have these conversations. While challenges related to staffing and space will be difficult to overcome for clinics to be able to offer vaccination on-site, our results highlight the importance of developing effective messaging strategies and training clinicians in how to integrate them into routine practice.

Limited Correlation between SARS-CoV-2 Serologic Assays for Identification of High-Titer COVID-19 Convalescent Plasma Using FDA Thresholds.

In August 2020, the Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for COVID-19 convalescent plasma (CCP) specified 12 authorized serologic assays and associated assay-specific cutoff values for the selection of high-titer CCP for use in hospitalized patients. The criteria used for establishing these cutoff values remains unclear. Here, we compare the overall agreement and concordance of five serologic assays included in the August 2020 FDA EUA at both the manufacturer-recommended qualitative cutoff thresholds and at the FDA-indicated thresholds for high-titer CCP, using serum samples collected as part of the CCP Expanded Access Program (EAP). The qualitative positive percent agreement (PPA) across assays ranged from 92.3% to 98.8%. However, the high-titer categorization across assays varied significantly, with the PPA ranging from 26.5% to 82.7%. The Roche anti-NC ECLIA provided the lowest agreement compared to all other assays. Efforts to optimize high-titer cutoffs could reduce, although not eliminate, the discordance across assays. The consequences of using nonstandardized assays are apparent in our study, and the high-titer cutoffs chosen for each assay are not directly comparable to each other. The generalized findings in our study will be relevant to any future use of convalescent plasma for either COVID-19 or future pandemics of newly emerged pathogens. IMPORTANCE COVID-19 convalescent plasma (CCP) was one of the first therapeutic options available for the treatment of SARS-CoV-2 infections and continues to be used selectively for immunosuppressed patients. Given the emergence of novel SARS-CoV-2 variants which are resistant to treatment with available monoclonal antibody (MAb) therapy, CCP remains an important therapeutic consideration. The FDA has released several emergency use authorizations (EUA) that have specified which serological assays can be used for qualification of CCP, as well as assay-specific cutoffs that must be used to identify high-titer CCP. In this study, a cohort of donor CCP was assessed across multiple serological assays which received FDA EUA for qualification of CCP. This study indicates a high degree of discordance across the assays used to qualify CCP for clinical use, which may have precluded the optimal use of CCP, including during clinical trials. This study highlights the need for assay standardization early in the development of serological assays for emerging pathogens.

The Coronavirus Disease 2019 Spatial Care Path: Home, Community, and Emergency Diagnostic Portals.

This research uses mathematically derived visual logistics to interpret COVID-19 molecular and rapid antigen test (RAgT) performance, determine prevalence boundaries where risk exceeds expectations, and evaluate benefits of recursive testing along home, community, and emergency spatial care paths. Mathematica and open access software helped graph relationships, compare performance patterns, and perform recursive computations. Tiered sensitivity/specificity comprise: (T1) 90%/95%; (T2) 95%/97.5%; and (T3) 100%/≥99%, respectively. In emergency medicine, median RAgT performance peaks at 13.2% prevalence, then falls below T1, generating risky prevalence boundaries. RAgTs in pediatric ERs/EDs parallel this pattern with asymptomatic worse than symptomatic performance. In communities, RAgTs display large uncertainty with median prevalence boundary of 14.8% for 1/20 missed diagnoses, and at prevalence > 33.3-36.9% risk 10% false omissions for symptomatic subjects. Recursive testing improves home RAgT performance. Home molecular tests elevate performance above T1 but lack adequate validation. Widespread RAgT availability encourages self-testing. Asymptomatic RAgT and PCR-based saliva testing present the highest chance of missed diagnoses. Home testing twice, once just before mingling, and molecular-based self-testing, help avoid false omissions. Community and ER/ED RAgTs can identify contagiousness in low prevalence. Real-world trials of performance, cost-effectiveness, and public health impact could identify home molecular diagnostics as an optimal diagnostic portal.

Forecasting volatility of EUA futures: New evidence

In this paper, we judge the predictability of EUA's own short- and long-term asymmetry, extreme observations, as well as jump components on its volatility by comparing the GARCH mixed frequency data sampling model and its asymmetry, extreme observation and jump extensions. The in-sample estimation results show that both long- and short-term asymmetries, extreme observations, and jump information have substantial effect on the EUA volatility. The out-of-sample forecast assessment results further illustrate the predictability of these volatility components on EUA volatility. Specially, among all asymmetric extension models, the model extended by both short-term asymmetry, long-term asymmetry and long-term leverage has better predictive performance. Among all extreme observation extension models, the model extended by only short-term extreme observations has better predictive performance. Among all jump extension models, the model extended by only the short-term jump information and the model extended by both the short-term and long-term jump information perform better, and their forecasting performance outperform all the other extension models in most cases. These findings are robust even if the assessment method, the rolling window length and the lag order are changed. It is worth mentioning that the advantage of these extension models in predicting EUA volatility is mainly seen in periods of low volatility. However, even during periods of COVID-19 pandemic, the predictive performance of the two well-performing jump extension models cannot be underestimated.

Recent SARS-CoV-2 Outlook and Implications in a COVID-19 Vaccination Era

While repurposed drugs came in handy earlier in the wake of the coronavirus disease 2019 (COVID-19) pandemic, vaccination has been considered a more sustainable approach. The recent spikes have been linked to "double," "triple," and even multi-mutant variants, thus renewing calls for deeper structural and functional insights of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) as a lead to rationale design of therapeutics, vaccines, and point-of-care diagnostics. There is a repertoire of findings from the earliest SARS-CoV-2 molecular mimicry to evade host immunity cum host immune responses to the role of the viral glycocalyx in modulating the susceptibility and severity of infection through attraction and repulsive interactions. Recently, molecular studies of some viral components that aid infection in the face of vaccination seem unending. In addition, the wave of infections and the attendant case fatality ratios have necessitated the need for emergency use authorizations for COVID-19 vaccines and in vitro diagnostics. This review provides key updates of SARS-CoV-2, current antigenic and formulation strategies, with emergency use authorizations considerations for future vaccine candidates and diagnostics. We also premise that despite the difficulty in modeling and analyzing glycans, understanding and exploiting their roles in the SARS-CoV-2 architecture is fundamental to glycan-based COVID-19 vaccines devoid of inconsistent clinical outcomes.

Populismo, polarização política e a pandemia do coronavírus: Donald Trump e a opinião pública nos Estados Unidos

O enfrentamento à pandemia da Covid-19 não está somente em medidas como o isolamento social e investimento massivo na saúde pública, mas também no combate a notícias falsas e discursos que minimizam a seriedade da doença. Nos EUA, o discurso populista do presidente Donald Trump, que muitas vezes contraria as recomendações da Organização Mundial da Saúde, pode estar refletindo nas estatísticas da doença, visto que é o país com os maiores números de contaminados e de mortes. Sabendo que uma das principais consequências do discurso populista é a polarização de opiniões, este artigo tem como objetivo verificar a formação da opinião pública sobre a Covid-19 nos EUA a partir dos posicionamentos de Trump. Parte-se da hipótese de que a polarização gerada pelo populismo de direita do presidente está afetando a forma como as pessoas reagem às medidas de restrição, criando opiniões divergentes sobre a gravidade do novo coronavírus. Os dados analisados demonstram uma polarização mais do que política entre os dois grupos, tendo efeitos sobre como os dois grupos percebem a pandemia de Covid-19.Alternate : Fighting the Covid-19 pandemic does not solely rely on measures like social isolation and massive investments on public health, but also lies on combating fake news and discourses that downplay its seriousness. In the USA, the populist discourse of President Donald Trump, which frequently defies the World Health Organization’s recommendations, might be reflected on the statistics of the disease, given that the country shows the highest numbers of infected and deaths. Knowing that one of the main consequences of populist discourses is the polarization of opinions, this paper aims to verify the formation of public opinion regarding Covid-19 in the USA through Trump’s discourses. We depart from the hypothesis that the polarization created by the President’s right-wing populism is affecting the way people react to the restriction measures, by generating opposing opinions regarding the seriousness of the new coronavirus. The data analyzed suggests a polarization beyond the political level, affecting the way both groups experience the Covid-19 pandemic.Alternate : La lucha contra la pandemia de Covid-19 no se basa únicamente en medidas como el aislamiento social y las inversiones masivas en salud pública, sino que también se basa en combatir las noticias falsas y los discursos que restan importancia a su gravedad. En Estados Unidos, el discurso populista del presidente Donald Trump, que frecuentemente desafía las recomendaciones de la Organización Mundial de la Salud, podría reflejarse en las estadísticas de la enfermedad, dado que el país presenta el mayor número de infectados y muertes. Sabiendo que una de las principales consecuencias de los discursos populistas es la polarización de opiniones, este trabajo tiene como objetivo verificar la formación de la opinión pública sobre el Covid-19 en Estados Unidos a través de los discursos de Trump. Partimos de la hipótesis de que la polarización creada por el populismo de derecha del presidente está afectando la forma en que las personas reaccionan a las medidas de restricción, al generar opiniones contrarias sobre la gravedad del nuevo coronavirus. Los datos analizados sugieren una polarización más allá del nivel político, afectando la forma en que ambos grupos viven la pandemia de Covid-19.

Remdesivir use and outcomes during the FDA COVID-19 emergency use authorization period.

BACKGROUND: Remdesivir (RDV) was approved for treatment of coronavirus disease 2019 (COVID-19), in May 2020 under US Food and Drug Administration emergency use authorization (EUA). Clinical outcomes related to RDV use in hospitalized patients during the EUA period are not well described. METHODS: We conducted a retrospective study of patients who received RDV under EUA. The primary outcome was clinical recovery by day 14 as determined by an eight-category ordinal scale. Secondary outcomes included recovery and survival to day 28, and adverse events. Recovery and survival were calculated using a stratified log-rank Kaplan-Meier estimator and a Cox proportional hazards model. RESULTS: Overall, 164 patients received RDV between May and October 2020, and 153 (93.3%) had evaluable data. Most (77.1%) were hospitalized within 10 days of symptom onset, and 79.7% started RDV within 48 hours. By days 14 and 28, 96 (62.7%) and 117 patients (76.5%) met the definition of clinical recovery, respectively. Median time to recovery was 6 days [interquartile range (IQR) 4-12]. Mortality rates were 6.5% and 11.8% by days 14 and 28, respectively. Age and time to start of RDV after hospital admission were predictive of recovery and 28-day mortality. CONCLUSIONS: In this real-world experience, outcomes after 5 days of RDV therapy were comparable to those of clinical trials. Disease severity, age, and dexamethasone use influenced clinical outcomes. Time to RDV initiation appeared to affect recovery and 28-day mortality, a finding that should be explored further. Mortality rate decreased over the analysis period, which could be related to dexamethasone use and improved management of COVID-19.

A Closer Look into FDA-EUA Approved Diagnostic Techniques of Covid-19.

The 2019 coronavirus disease (COVID-19), caused by the severe acute respiratory syndrome coronavirus 2 virus, caused a worldwide pandemic in 2020 and is the most urgent health issue worldwide. In this review, we highlight the details of Food and Drug Administration-Emergency Use Authorizations approved diagnostics kits, focusing on the similarities and differences. It is essential to understand the currently available options and the advantages and disadvantages each provides to select the appropriate products that maximize the testing efficiency. We believe this work will provide a holistic evaluation of the current COVID-19 diagnostic resources, including variations across the countries, and guide developing novel diagnostic techniques to improve and optimize the current testing options.