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Introduction: Loop diuretics are the first-line treatment for volume overload in acute decompensation of congestive heart failure (AHF). Loop diuretic resistance is common due to pharmacologic tachyphylaxis. Therefore, thiazide and thiazide-like diuretics are often used as add-on therapy to combine two different pharmacologic mechanisms. This systemic review and meta-analysis aimed to synthesize the current evidence on the efficacy and safety of metolazone and other thiazide-like diuretics in AHF. Method(s): PRISMA guidelines were followed in conducting this systematic review. PubMed, Scopus, PubMed Central, and Embase databases were searched using relevant keywords for studies published before 5 Jan 2022. and title screening was performed, followed by full-text screening using the Covidence software. Data were extracted, and analysis was done using Cochrane Review Manager (RevMan v5.1). The results were reported in odds ratio and mean difference with 95% confidence intervals. Result(s): Out of 2999 studies identified by database search, eight studies met the inclusion criteria (2 RCTs and 6 cohort studies). Pooled analysis using a random-effects model showed no difference in mean difference among the metolazone group and control group for 24 hours total urine output (MD 69.32, 95% CI -638.29 to 776.94;n = 551;I2 = 84%), change in urine output in 24 hours (MD -284.09, 95% CI -583.99 to 15.81;n = 345;I2 = 0%), 48 hours total urine output (MD -465.62, 95% CI -1302.22 to 370.99;n = 242;I2 = 0%) and urine output at 72 hours (MD -13.24, 95% CI -90.88 to 64.40;n = 205;I2 = 0%). However, studies with furosemide only in the comparator arm, 24 hours of total urine outcome favored metolazone (MD 692.70, 95% CI 386.59 to 998.82;n = 334;I2 = 0%). There was no difference between the two groups in the rate of adverse events, loss of weight, mortality, or readmission rates. Conclusion(s): Metolazone therapy in diuretic resistant AHF may improves urine output and facilitates achieving a net negative balance. Thus, metolazone and thiazide-like diuretics can be used as add-on therapy in acute decompensation of heart failure, especially in diuretic resistance.Copyright © 2023 The Author(s)
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Food systems are constantly changing to accommodate the advancement of societies. Increased challenges, including the World Wars, natural disasters, and the COVID-19 pandemic, have stimulated the improvement of the economics, quantity, and quality of food around the globe. Food security was introduced to alleviate and eradicate hunger and poverty with an aim to provide access to enough food and calories to everybody all the time. In society, this was translated to an increase in food rich in carbohydrates but not specifically all the nutrients and minerals required for healthy growth and development. Agriculturally, this has resulted in a rise in large-scale production of starch and filling food that can be used as staples worldwide. While hunger is not a problem in most countries, malnutrition is rampant on many levels. There are several cohorts of people suffering from metabolic disorders related to an imbalance in nutrients, including diabetes, obesity, and anemia, amongst others. The introduction of nutritional security is to ensure that everybody has access to nutrients from all food groups;this means proteins, carbohydrates, fibers, vitamins, and minerals. Rapid development in omics research has resulted in high-throughput techniques that can profile the makeup of crops, environmental samples, food, and human biofluids. Genomics, transcriptomics, proteomics, and metabolomics all explain how the different systems behave. Multi-omics is the assembly of all the complex data recorded to explain what is happening at a macroscale. This chapter provides an overview of the most up-to-date applications of multi-omics in food and nutrition security. © The Author(s), under exclusive license to Springer Nature Switzerland AG 2023.
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Background: The COVID-19 pandemic disproportionally affected Black communities who were at greater risk of SARS-CoV-2 acquisition, morbidity, and mortality than those of White ethnicity. We describe the clinical epidemiology of COVID-19 in the GEN-AFRICA cohort of Black people with HIV in two South London clinics. Method(s): First reported episodes of COVID-19 up to 12/2021 were ascertained by direct questioning and/or medical records review. The cumulative incidence of COVID-19 and vaccination was determined by Nelson- Aalen methods. Pre-pandemic immunovirological and comorbidity status obtained prior to 01/2020 was used to identify risk factors for COVID-19 using Cox regression. We compared characteristics of participants with mild/ moderate (not requiring hospitalization) and severe (requiring hospitalization or resulting in death) COVID-19. Result(s): COVID-19 status was available for 1184 (95%) of 1289 GEN-AFRICA participants (mean age 49.1 years;55% female;median CD4 565;93% HIV RNA <200), and SARS-CoV-2 vaccination status for 1160;998 (86%) had received at least one vaccine dose (administered to 50% by 16/02/2021). A total of 310 participants (26.2%) reported a first episode of COVID-19 (any severity), with a cumulative incidence of 6%, 14%, 15% and 22% following the initial, alpha, delta, and omicron waves. Women, people of East African ancestry, and those with detectable HIV RNA were more likely to report COVID-19 (Table). CD4 (current/nadir), class of antiretroviral therapy (ART), and comorbidity status were not associated with COVID-19. Findings were similar when restricted to episodes in 2020 (prior to vaccine availability) or testconfirmed COVID-19. Severe COVID-19 cases (N=34) were more often male (p=0.002), of West-African ancestry (p=0.01), with lower CD4 cell counts (p=0.002), and they more often had a history of AIDS, diabetes mellitus, cardiovascular disease, and chronic kidney disease (all p=0.001) compared to mild/moderate cases;they were also more likely to be on protease inhibitor (PI)- containing ART (p=0.01). Conclusion(s): By the end of the second year of the pandemic, 22% of black people with HIV in South London had experienced COVID-19. Immune and comorbidity status were not associated with COVID-19 when all cases were considered but strongly associated with severe COVID-19 disease, as were West-African ancestry and being on a PI. (Table Presented).
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The COVID-19 outbreak is wreaking devastation throughout the globe. It has infected millions of people and claimed thousands of lives till now. On the other hand, vaccination has been started in many countries since December 2020. In this study, we have used deep learning models such as long short-term memory (LSTM) and gated recurrent units (GRU) to analyze and forecast the confirmed cases of COVID-19. The datasets of six countries that started vaccination earlier, including Israel, the UK, the USA, Canada, Brazil, and India, were collected from 1 September 2020 to 30 April 2021, containing 242 days and tested on 105 days from 15 January to 30 April 2021, with analysis on how data size and vaccination affect the overall trend. The performance of these models is investigated in terms of error measurements like mean absolute error (MAE) and root mean square error (RMSE). The results show that GRU outperforms LSTM in error terms like MAE and RMSE for most countries. There are many studies on the data before vaccination, and they produced noticeably higher errors. Many researchers have overfitted the forecasting models by using small datasets and creating too many predictor variables. Models constructed in this manner are unlikely to pass a validity and reliability test on a separate sample. Without seeking such validation, the researcher is unaware that overfitting has happened. We have examined these models on data before and after vaccination to verify the time-series prediction and provided a comparative analysis of our models. In addition, our models show promising results and by far outperform in comparison to other studies. For countries such as Canada and Israel, our models produce lower RMSE (1119, 1045) and MAE (752, 727) for both GRU and LSTM models, respectively. These deep learning models can be used for time-series analysis given that datasets are constantly updated with new cases for training and identifying trends and estimation of the upcoming confirmed cases. © 2023 selection and editorial matter, Anshul Verma, Pradeepika Verma, Kiran Kumar Pattanaik and Lalit Garg;individual chapters, the contributors
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Background: Pathogen surveillance is crucial but has become more challenging in the era of highly effective modulator therapy (HEMT), with many people with cystic fibrosis (PwCF) noting a considerable reduction or even absence of sputum on elexacaftor/tezacaftor/ivacaftor (ELX/TEZ/IVA). This challenge has been exacerbated by reduced face-toface contact with patients because of variable COVID-19 government restrictions on travel and social interaction (lockdowns) since March 20, relying on PwCF returning high-quality samples by mail. For those with pre-established bronchiectasis, it is likely that chronic infections and risk of new acquisition of infections remain on ELX/TEZ/IVA, although registry data suggest less prevalence of respiratory microorganisms on IVA [1]. We aimed to examine the impact of ELX/TEZ/IVA on frequency of respiratory pathogen surveillance and microorganism growth in our large, adult CF center. Method(s): A retrospective analysis of pathology results from respiratory samples received from March 19 to December 21, 2020, was completed for all patients commenced on ELX/TEZ/IVA at our CF center. Result(s): Respiratory samples from 216 PwCF who had commenced ELX/ TEZ/IVAwere analyzed. Median start date of ELX/TEZ/IVAwas October 10,2020. Before ELX/TEZ/IVA, the average number of respiratory samples per month was 108. This declined by 55% to an average of 48 per month when the first 50 PwCF commenced on ELX/TEZ/IVA and to 20 per month (82% reduction from pre-ELX/TEZ/IVA) when 100 PwCF had commenced ELX/ TEZ/IVA. The number of positive samples per month decreased from January 20, 2020, correlating with the introduction of ELX/TEZ/IVA and the reduction of respiratory samples received (Figure 1). The proportion of cough swabs and sputum samples remained similar from March 19 to December 21, 2020. (Six-month average showed that 19% of samples were cough swabs and 80% sputum for March to June 2019 and July to December 2021). We found no significant changes in proportion of samples positive for non-Pseudomonas spp. gram-negative organisms, Burkholderia spp., or gram-positive organisms (predominantly S. aureus) isolated over the period. There was a reduction by more than 50% of fungi and Candida spp. and a slight trend toward an increase in Pseudomonas spp. (mainly P. aeruginosa). Forty percent of PwCF who had one respiratory sample after ELX/TEZ/IVA initiation and 20% of those who had two or more samples showed a change in organism growth after ELX/TEZ/IVA initiation. In nearly 50% of these cases, the organism changed from gram negative to gram positive (P. aeruginosa to S. aureus in 69% of cases).(Figure Presented) Figure 1. Number of positive respiratory samples per month and number of people with cystic fibrosis on elexacaftor/tezacaftor/ivacaftor March 19 to December 21, 2020 Conclusion(s): The introduction of ELX/TEZ/IVA and its impact on sputum production has reduced surveillance of our patients' respiratory microbiology. This has been exacerbated by reduced face-to-face contact with patients due to the COVID-19 pandemic. The trends showa reduction in the isolation of fungi and yeasts and a slight increase in isolating Pseudomonas spp. In those who we have seen a change in organism growth, many have gone from gram-negative to gram-positive organisms. These data highlight the challenges of monitoring for new positive cultures and changes in microbiology cultures in the era of HEMT.Copyright © 2022, European Cystic Fibrosis Society. All rights reserved
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Introduction: Many people in the United Kingdom (UK) are turning to the internet to obtain prescription medicines. This introduces a significant public health risk and patient safety concerns, for example because the internet is a source of fake medicines. According to an estimate by the UK government, 1 in 10 people in the UK bought a fake medical product online in 2021 (1). To help address this problem, it is important to understand why people buy prescription medicines online in the first place. Aim(s): This qualitative study aimed to identify why people in the UK purchase medicines online, including their perceptions of risks posed by the availability of fake medicines online. The focus was on prescription-only medicines (POMs). Method(s): Semi-structured interviews were conducted with adults based in the UK who had previously purchased medicines online. Purposive sampling was adopted to achieve diversity regarding participants' experiences and demography. The interviews were conducted online using Microsoft Teams. The recruitment process started in April- 2021 and ended in May-2022. The recruitment was continued until no new codes were identified (data saturation was reached). Interview transcripts were analysed using thematic analysis with the Theory of Planned Behaviour (TPB) acting as a framework to develop the coding of themes (2). Result(s): Twenty participants (12 female, 8 male) were interviewed. Participant age groups were 18-29 (n = 4), 30-39 (n = 4), 40-49 (n = 5), 50-59 (n=4), and >=70 (n = 3). Participants had bought various types of POMs (e.g., antibiotics, and high-risk controlled medicines). Participants demonstrated awareness of the presence of fake medicines online, and they understood risks associated with them. The factors that influenced participants to buy medicines online were grouped into themes including advantages (Avoiding long waiting times;Bypassing gatekeepers;Medicines availability;Lower costs;Convenient process;Privacy) and disadvantages (Medicines safety concerns;Medicines quality concerns;Higher costs;Online payment risks;Lack of accountability;Engage in an illegal behaviour) of purchasing medicines online, the social influencing factors (Interactions with healthcare providers;Other consumers' reviews and experiences;Words of mouth by friends;Influencers' endorsement), the barriers (General barriers;Website specific barriers) and facilitators (Facilitators offered by the illegal sellers of medicines;Facilitators offered by various internet platforms;COVID-19 outbreak as facilitating condition;Consumer personability) of the purchase as well as factors that lead consumers to trust (Website features;Product appearance;Positive previous purchase experience) the online sellers of medicines. Conclusion(s): The in-depth insight into what could drive people in the UK to buy medicines online could enable the development of effective and evidence-based public awareness campaigns that warn consumers about the risks of buying fake medicines from online sources. The findings could also help researchers to design other interventions to prevent people from buying POMs online. A limitation of this study is that although the interviews were in-depth and data saturation was reached, the findings may not be generalisable as this was a qualitative study. However, the TPB which informed the analysis has well-established guidelines to develop a questionnaire, for a future quantitative study.
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The worldwide epidemic of Coronavirus disease 2019 (COVID-19), caused by a new virus known as severe acute respiratory syndrome (SARS) coronavirus 2, has posed a growing threat to public health (SARS-CoV-2). The only antiviral drug authorized by the FDA for treating adult and pediatric patients hospitalized with a severe disease is remdesivir, which is given intravenously (IV). Although only a few methods for estimating remdesivir in pharmaceutical formulations using high-pressure liquid chromatography (HPLC) have been described, its determination still requires an accurate, precise, quick, and easy analytical methodology. The main goal of this study was to develop and validate a reliable and accurate HPLC method for quantitative estimation of remdesivir in its intravenous dosage formulation. The separation was performed on a C18 (4.6 mm x 150 mm, 5.0 microm) column with a flow rate of 0.7 mL/min and a total run duration of 6 minutes using a simple isocratic mobile phase of acetonitrile and 0.1 percent formic acid. The method was validated for the system suitability, linearity, precision, accuracy, robustness, and others as per the International Council for Harmonization (ICH) Q2 (R1) guideline. The results show that the method for measuring remdesivir using HPLC is simple, quick, sensitive, accurate, precise and robust. The described approach was successfully used to quantify remdesivir in a commercially available pharmaceutical formulation.Copyright All © 2023 are reserved by International Journal of Pharmaceutical Sciences and Research.
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Whether at home, work, school, or traveling abroad, digital healthcare is in demand. Rapidly changing delivery models are shaping the new healthcare landscape far beyond a COVID-19 world. The papers in this minitrack present innovative digital health applications that can be administered or used in a digital health setting outside the walls of traditional healthcare facilities. These papers present apps for parolee reentry into the community, training for audiology screening, and infectious disease risk assessments. Another paper addresses optimization of at-home triage, while the final manuscript focuses on empowering patients in health consultations using an online platform. Taken together, these papers highlight the growing importance of enabling new delivery models for ubiquitous and comprehensive healthcare. © 2022 IEEE Computer Society. All rights reserved.
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Background: Emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection has given rise to COVID-19 pandemic, which has become a wreaking havoc worldwide. Therefore, there is an urgent need to find out novel drugs to combat SARS-CoV-2 in-fection. In this backdrop, the present study aimed to assess potent bioactive compounds from different fungi as potential inhibitors of SARS-CoV-2 main protease (Mpro) using an in-silico analysis. Method(s): High-Resolution Liquid Chromatography Mass Spectrometry analysis (HR-LCMS) was used for the bioactive profiling of ethanolic crude extract of Dictyophora indusiata, Geastrum tri-plex and Cyathus stercoreus. Of which, only bergenin (D. indusiata), quercitrin (G. triplex) and di-hydroartemisinin (C. stercoreus) were selected based on their medicinal uses, binding score and the active site covered. The 6LU7, a protein crystallographic structure of SARS-CoV-2 Mpro, was docked with bergenin, quercitrin and dihydroartemisinin using Autodock 4.2. Result(s): A total of 118 bioactive compounds were analyzed from the crude extract of used fungi and identified using HR LC/MS analysis. The binding energies obtained were-7.86,-10.29 and-7.20 kcal/mol, respectively, after docking analysis. Bergenin, quercitrin and dihydroartemisinin formed hydrogen bond, electrostatic interactions and hydrophobic interactions with foremost active site amino acids THR190, GLU166, GLN189, GLY143, HIS163, HIS164, CYS145 and PHE140. Conclusion(s): Present investigation suggests that these three compounds may be used as alternative inhibitors against SARS-CoV-2 Mpro. However, further research is necessary to assess in vitro potential of these compounds. To the best of our knowledge, the present investigation reported these three bioactive compounds of fungal origin for the first time.Copyright © 2021 Bentham Science Publishers.
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Background: The pattern of new drug approval is changing across the world as shown by the study using Center for Drug Evaluation and Research and European Medicines Agency data in US and UK with more drug approval for anti-cancer and immunomodulator drugs. There is a need to generate similar database for developed South East Asian countries too. Aims and Objectives: This study was conducted for one such country-Singapore for the new drug approval pattern of last 5 years (2017-2021). Material(s) and Method(s): This was a pharmacoepidemiological study, in which government drug regulatory website data available in public domain was searched. The new drug approval data were classified according to active ingredient, drug approval date, new drug application category, indication of drugs, and World Health Organization Anatomic Thoracic Classification. Result(s): In this study, 418 new drug approvals were found in last 5 years in Singapore. From this maximum, drug approvals were given to anti-neoplastic and immunomodulator category drugs. In anti-neoplastic category new drugs approval few examples were Trastuzumab deruxtecan and Tucatinib for breast cancer therapy and Tepotinib and Capmatinib for non-small cell lung cancer therapy. Conclusion(s): This study shows that drug development in anti-cancer drug and immunomodulator is significant in Singapore. This trend is quite matching with other country such as US and UK.Copyright © 2023 Priti Solanky, et al.
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Objective The aim of the present study was to assess the burden of burnout in junior medical staff working across all surgical specialities at Great Ormond Street Hospital following the first wave of the COVID-19 pandemic. Methods We conducted a cross-sectional study in surgical junior doctors at Great Ormond Street Hospital following relaxation of the COVID-19-related restrictions at the end of June 2020. Burnout was evaluated using the Maslach Burnout Inventory (MBI). This is a widely-used validated questionnaire, which evaluates burnout across three domains: emotional exhaustion depersonalisation and personal accomplishment. All responses were anonymised points (0-6) were awarded for each response and composite scores were generated using an online tool. The degree of burnout was classified as low medium or high for each of the three domains using standardised score ranges. Results A total of 25 surgical junior doctors were included in our study. The response rate was 48% and scores from 12 fully completed MBI-HSS were included in subsequent analysis. 10 of the responders (83%) reported high burnout levels in at least one domain and 6 (50%) across at least two domains. The main contributor to burnout was the lack of feeling of personal accomplishment that was found to be high in 67% medium in 25% and low in 8% of the responders. We also found significant levels of emotional exhaustion (high: 42%;medium 42%;low 17%) as well as depersonalisation (high: 42%;medium 42%;low 17%). Conclusions Our study confirms the significant burden of burnout among junior doctors working in surgical specialities at Great Ormond Street Hospital for Children during the first wave of the COVID-19 pandemic. This could have detrimental effects on both doctor health and patient outcomes. Future work needs to focus on strategies to improve junior doctor wellbeing and prevent burnout.
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Upon initial discovery in late 2019, severe acute respiratory syndrome coronavirus 2, SARS-CoV-2, has managed to spread across the planet. A plethora of symptoms affecting multiple organ systems have been described, with the most common being nonspecific upper respiratory symptoms: cough, dyspnea, and wheezing. However, the cardiovascular system is also at risk following COVID-19 infection. Numerous cardiovascular complications have been reported by physicians globally, in particular cardiac tamponade Physicians must hold a high index of suspicion in identifying and treating patients with cardiac tamponade who may have contracted the novel coronavirus. This review will describe the current epidemiology and pathophysiology of SARS-CoV-2 and cardiac tamponade, highlighting their clinical course progression and the implications it may have for the severity of both illnesses. The paper will also review published case reports of cardiac tamponade, clinical presentation, and treatment of this complication, as well as the disease as a whole. © 2022 Elsevier Inc.
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The incidence of cancer continues to rise, with an estimated 1 in 2 of the UK population born after 1960 diagnosed with malignancy at some point during their lifetime. This is in the context of an ageing population with increasing multimorbidity and polypharmacy. Cancer patients are frequent users of emergency care services and have a high rate of ambulance conveyance and hospital admission after review in emergency departments. Presentations can be a consequence of the cancer, its treatment or coexistent morbidity. Given the expanding armamentarium of cancer therapies, acute and general physicians are faced with a myriad of complex issues and require a knowledge of the broad principles of initial assessment, initial management and timely access to the wider multi-professional cancer team. © 2022
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In the COVID-19 pandemic, to minimize aerosol-generating procedures, cardiac magnetic resonance imaging (CMR) was utilized at our institution as an alternative to transesophageal echocardiography (TEE) for diagnosing infective endocarditis (IE). This retrospective study evaluated the clinical utility of CMR for detecting IE among 14 patients growing typical microorganisms on blood cultures or meeting modified Duke Criteria. Seven cases were treated for IE. In 2 cases, CMR results were notable for possible leaflet vegetations and were clinically meaningful in guiding antibiotic therapy, obtaining further imaging, and/or pursuing surgical intervention. In 2 cases, vegetations were missed on CMR but detected on TEE. In 3 cases, CMR was non-diagnostic, but patients were treated empirically. There was no difference in antibiotic duration or outcomes over 1 year. CMR demonstrated mixed results in diagnosing valvular vegetations and guiding clinical decision-making. Further prospective controlled trials of CMR Vs TEE are warranted. © 2022 Elsevier Inc.
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The global COVID-19 Pandemic caused tremendous stress in many facets of our existence from global shifts to daily life-altering impacts. Most significantly, the pandemic caused many people and organizations to rethink how they worked, that is, the pandemic was a forcing function. © 2023 IEEE Computer Society. All rights reserved.
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Background and Objective: Coronaviruses are important human and animal pathogens. At the end of 2019, a novel coronavirus was found as the cause of a bunch of pneumonia cases in Wuhan, China. It rapidly spread in the country of China resulting in an epidemic, followed by a global spread in whole world leading to the pandemic. In February 2020, the World Health Organization coined the term COVID-19, The objectives to carry out this study were 1) To determine incidence of Covid-19 in health care workers after partial or complete vaccination 2) To determine severity of Covid-19 in health care workers after partial or complete vaccination at Designated Covid Hospital and Medical College at North Gujarat, India Methods: A cross sectional retrospective study was carried out at Designated Covid Hospital and Medical College at North Gujarat, India through telephonic and personal interview of health care workers who had received partial or complete vaccination. Key variables of the study were profile of work of health care worker at medical facility, type of vaccine received and how was post vaccination covid-19 infection managed. Result(s): We enrolled total 210 health care workers with mean age of 31.5 years with 69 male and 141 female. Out of 210 health workers, 204(97.14%) were fully vaccinated with two dose of covid-19 vaccines,5(2.38%) were partially vaccinated. Symptomatic infection with Covid-19 occurred in total 12 (5.71%) health care worker >= 14 day after second dose of either vaccine. Only one required hospitalization with oxygen support, rest all are managed with home isolation. Interpretation &Conclusion: One in twenty health care workers got infected with covid-19 after vaccination in present study. Extended research required to get larger data for ascertaining predictors of infection mainly mutation in virus and effect of comorbidity on antibody response after vaccination and severity of disease. Copyright © 2022, Dr Yashwant Research Labs Pvt Ltd. All rights reserved.
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Susceptible-Infected-Recovered (SIR) models have been widely used to study the spread of Covid-19. These models have been improved to include other states (e.g., exposed, deceased) as well as geographical level transmission dynamics. In this paper, we present an extension to an existing SEVIRD (Susceptible - Exposed - Vaccinated - Infected - Recovered - Death) model to include the effect of air and maritime travel as well as travel restrictions. We use the model to simulate the spread of Covid-19 through 13 different countries. The case study shown illustrates how the model can be used for rapid prototyping at a geographical level and adapted to include changing policies. © 2022 Society for Modeling & Simulation International (SCS)
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Background. Novavax COVID-19 Vaccine, Adjuvanted (5 mug recombinant spike protein/50 mug Matrix-MTM adjuvant;NVX-CoV2373) has received regulatory authorizations for use in adults >= 18 years globally. Methods. Participants from PREVENT-19 (NCT04611802), a phase 3, randomized, observer-blinded, placebo-controlled trial that evaluated the efficacy, safety, and immunogenicity of a primary series of 2 doses of NVX-CoV2373 given 21 days apart, in adults >= 18 years in the United States and Mexico, were eligible to receive a booster dose at least 6 months after the initial vaccination series. Short-term safety and immunogenicity of the booster dose was assessed in an ad hoc analysis of 298 participants. Results. There was an incremental increase compared to the initial vaccination series in local and systemic reactogenicity, which was transient and mostly mild-to-moderate in intensity. Most unsolicited adverse events were also mild-to-moderate in severity;there were no deaths or treatment-related SAEs and 2/298 booster recipients in this analysis reported unrelated SAEs. Neutralizing, anti-S IgG, and hACE2 receptor binding inhibiting antibodies against the ancestral (Wuhan) strain 28 days after booster were higher than those 14 days after primary vaccination (Table). Overall, humoral responses were high regardless of interval between priming and booster vaccination, but a longer interval yielded stronger responses. Higher immune responses against the Omicron BA.1, BA.2, and BA.5 variants were also observed after the booster dose than after the primary series in a subset of 14-18 participants tested. Overall, humoral responses were high and broad regardless of age after any vaccination, but higher responses were observed in adults < 65 years after initial and booster vaccinations. A booster dose induced more robust antibody responses compared with the primary series in adults >= 65 years. Conclusion. A single booster dose of NVX-CoV2373 demonstrated a satisfactory safety profile, and high levels of neutralizing, anti-S IgG, and hACE2 inhibition antibody responses against the SARS-CoV-2 prototype Wuhan as well as against the Omicron variant including recently emerged sub-variants. (Table Presented).
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Background. Patients with COVID-19 and underlying malignancies, particularly those receiving immunosuppressive therapy, are at higher risk of severe COVID-19 disease. Our retrospective cohort study examines the outcomes of COVID-19 infection in patients with different underlying malignancies admitted to a 710- beds comprehensive cancer center during the first 2 years of the pandemic. Methods. All patients with cancer admitted to MD Anderson Cancer Center with a positive PCR test for SARS-CoV-2 were included in a clinical case registry from 3/22/20 (first hospitalized COVID-19 patient) to 3/31/22. This clinical registry was approved at the beginning of the COVID-19 pandemic by the Quality Improvement Assessment Board at MDACC. Clinical information including type of malignancy, date of admission, length of stay, need for invasive mechanical ventilation (IMV), and in-hospital mortality was obtained from their electronic medical records. Statistical analysis was performed using a two-proportion z-test where p< 0.05 was considered significant. Results. A total of 1748 patients with cancer and COVID-19 infection were admitted over a 2-year period (3.2% of total hospital admissions during the same period), 49% had hematological malignancies (HM) (see table). Patients with HM had significantly higher readmission rates (17.3% vs 9.1%, p< 0.0001), IMV rates (7.8% vs 4.4%, p=0.0029), and inpatient mortality rates (13.6% vs 7.1%, p< 0.0001). compared to patients with solid tumors (ST). Total mortality rate was 8.8% (154 patients), even higher in patients with different types of HM, such as lymphoma 18.1%, AML 14.2%, MM 8.4%, CML 7.1% while the mortality for ST was 7.1%. COVID-19 Hospitalized Patients at UT-MDACC (3/22/20-3/31/22) UT-MDACC: The University of Texas MD Anderson Cancer Center *p-value <0.01 for z-test of 2 proportions (one-tailed) Conclusion. HM patients hospitalized with COVID-19 infection had more severe disease and worse outcomes based on readmissions, IMV, and mortality rates. Preventive measures, prompt diagnosis and early treatments should be considered on this patient population.