Preparing Pandemic Vaccine Capacity

Among the challenges of a pandemic is the need to scale up to billions of doses, at a larger scale than typically needed for vaccines, from raw materials all the way through to the materials for the containers for fill/finish. Having adequate raw materials, building and staffing the facilities, and tech transfer are all keys to success. [...]we can plug into existing infrastructure, including services (gas, water, waste, etc.) as well as analytics and quality labs." Emergent BioSolutions says that its flexible CDMO capacity deployment model can respond quickly to demand fluctuations. The company's facilities in France, Switzerland, and the US are working on the project;at CordenPharma Colorado, unique high-pressure chromatography systems usually used for manufacturing peptides have been reallocated for purifying lipids.

Impact of ICER Assessments on Payer Decision Making in the United States

Objectives: To evaluate how payers utilize Institute for Clinical and Economic Review (ICER) assessments to inform coverage or formulary decisions. Method(s): Double-blinded, web-based survey was fielded through Xcenda's research panel, the Managed Care Network, from June to July 2022. Result(s): A total of 51 payers from health plans (n=27), integrated delivery networks (n=12), and pharmacy benefit managers (n=12) participated in the survey. When assessing the usefulness of ICER's value assessment framework (VAF) to inform formulary decisions within their organizations, 57% of payers indicated it was extremely/very useful, 33% indicated somewhat useful, and 10% indicated not at all/not very useful. Most respondents (73%) agreed that ICER assessments are aligned with their organization's internal assessment. Utilization of ICER's VAF was most prevalent in high-cost drug or disease states (78%), rare/orphan disease states (71%), and oncology/hematology disease states (67%). Payers reported less use in primary care disease states (29%), COVID-19 (8%), and digital therapeutics (4%). In the last 24 months, 20% of payers reported ICER's recommendations often influenced coverage decisions, 59% indicated occasional influence, and 22% indicated no influence. In the last 24 months, payers indicated the top 5 ICER assessments that influenced their coverage decisions included high cholesterol (38%), Alzheimer's disease (36%), atopic dermatitis (33%), multiple myeloma (31%), and chemotherapy-induced neutropenia (28%). ICER assessments that were less impactful included beta thalassemia (3%), digital health technologies (3%), and supervised injection facilities (3%). Payers reported using ICER assessments to inform both expanded and restricted coverage decisions. Conclusion(s): Payers find ICER's VAF useful to inform their organization's formulary decisions. ICER's assessments often align with payers' internal assessments and are most frequently utilized for high-cost drugs or disease states. Payers indicate ICER assessments have affected both expansion and restriction in their coverage policies.Copyright © 2023

Politics Go "Viral": A Computational Text Analysis of the Public Attribution and Attitude Regarding the COVID-19 Crisis and Governmental Responses on Twitter

The U.S. confronts an unprecedented public health crisis, the COVID-19 pandemic, in the presidential election year in 2020. In such a compound situation, a real-time dynamic examination of how the general public ascribe the crisis responsibilities taking account to their political ideologies is helpful for developing effective strategies to manage the crisis and diminish hostility toward particular groups caused by polarization. Social media, such as Twitter, provide platforms for the public's COVID-related discourse to form, accumulate, and visibly present. Meanwhile, those features also make social media a window to monitor the public responses in real-time. This research conducted a computational text analysis of 2,918,376 tweets sent by 829,686 different U.S. users regarding COVID-19 from January 24 to May 25, 2020. Results indicate that the public's crisis attribution and attitude toward governmental crisis responses are driven by their political identities. One crisis factor identified by this study (i.e., threat level) also affects the public's attribution and attitude polarization. Additionally, we note that pandemic fatigue was identified in our findings as early as in March 2020. This study has theoretical, practical, and methodological implications informing further health communication in a heated political environment. [ FROM AUTHOR] Copyright of Social Science Computer Review 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.)

TMS 2023 BACK TO BUSINESS AT TMS2023

With nearly 4,500 attendees gathered in San Diego CA, the TMS 2023 Annual Meeting & Exhibition (TMS2023) was the fourth best-attended meeting in TMS history, marking a return to business as usual (more or less) after two decidedly unusual years for the Society's biggest event. By comparison, approximately 2,600 individuals came together in person for TMS2022 in Anaheim CA. One year earlier, TMS2021--held as a fully virtual conference--attracted 2,967 attendees from around the world. This year's event, held Mar 19-23 in one of TMS's most popular meeting locations, brought the conference back closer to its pre-COVID participation numbers. The last time TMS met in San Diego was in 2020 (shortly before widespread pandemic shutdowns began) when more than 4,600 individuals came together for the largest meeting in the Society's history.

A Case of X-Linked Moesin-Associated Immune Deficiency in a Pediatric Patient

Background: X-Linked Moesin-Associated Immune Deficiency (X-MAID) is a rare severe combined immunodeficiency (SCID) subtype that can present at any age due to its variability. Depending on severity, patients demonstrate failure to thrive, recurrent bacterial and viral infections, and increased susceptibility to varicella zoster. It has been characterized by marked lymphopenia with hypogammaglobulinemia and impaired T-cell migration and proliferation. Case Presentation: This is a report of a Cuban 7-year-old male with poor weight gain and facial dysmorphia. He had a history of recurrent bacterial gastrointestinal infections and pneumonia beginning at 4 months of age. He additionally had 4-6 upper respiratory tract and ear infections annually. While still living in Cuba, he was admitted for a profound EBV infection in the setting of significant leukopenia. A bone marrow biopsy confirmed no malignancy. After he moved to the United States, his laboratory work-up revealed marked leukopenia with low absolute neutrophil and lymphocyte count with low T and B cells, very low immunoglobulin levels IgG, IgA, and IgM, and poor vaccination responses to streptococcus pneumonia, varicella zoster, and SARS-CoV-2. Genetic testing revealed a missense pathogenic variant c.511C>T (p.Arg171Trp) in the moesin (MSN) gene associated with X-MAID. He was managed with Bactrim and acyclovir prophylaxis, and immunoglobulin replacement therapy, and considered for hematopoietic stem cell transplantation. Discussion(s): Diagnosis of X-MAID should be considered in patients with recurrent infections and profound lymphopenia. As with SCID, early diagnosis and intervention is of utmost importance to prevent morbidity and mortality. This case demonstrates the importance of genetic testing in identifying this disease as it may prompt an immunologist to consider HSCT if conservative management is suboptimal. In the current literature, HSCT appears promising, but the long-term outcomes have yet to be described.Copyright © 2023 Elsevier Inc.

Supplements purchase intention: young consumer's perspective

PurposeThis study aims to investigate the factors that influence young consumers' purchase intention towards dietary supplements (DS) in Malaysia.Design/methodology/approachThe supplement industry in Malaysia has been growing rapidly recently due to a paradigm shift in healthcare management, from curative to prevention. Thus, it has sparked interest to conduct a study on the factors that influence young consumers' purchase intentions towards DS. With a response rate of 74.5%, a survey questionnaire was used to elicit data from 149 Gen-Y respondents who consume supplements on a regular basis.FindingsThe results revealed that the influencing factors towards purchase decisions among these Gen-Y respondents aged between 17 and 25 are based on product knowledge and product quality. The implications of these findings and directions for future research are outlined at the end of this paper.Originality/valueThis study offers empirical insights from the perspective of an emerging digital economy on the factors that influence young consumers' purchase intentions towards DS in Malaysia.

Stronger than partisanship and motivated reasoning: news exposure and news frames predicting US state-level preventive behaviours against COVID-19

The COVID-19 pandemic has become a partisan issue rather than an independent public health issue in the US. This study examined the behavioural consequences of motivated reasoning and framing by investigating the impacts of COVID-19 news exposure and news frames, as apparent through a Latent Dirichlet topic modelling analysis of local news coverage, on state-level preventive behaviours as understood through a nationally representative survey. Findings suggested that the media effects on various preventive behaviours differed. The overall exposure rate to all COVID-19 news articles increased mask-wearing but did not significantly impact other preventive behaviours. Four news frames significantly increased avoiding contact or avoiding public or crowded places. However, news articles discussing anxiety and stay at home order triggered resistance and countereffects and led to risky behaviours. ‘Solid Republican' state residents were less likely to avoid contact, avoid public or crowded places, and wear masks. However, partisan leanings did not interfere with the impact of differing local COVID-19 news frames on reported preventive behaviours. Plus, statements regarding pre-existing trust in Trump did not correlate with reported preventive behaviour. Attention to effect sizes revealed that news exposure and news frames could have a bigger impact on health behaviours than motivated reasoning.

Scaling law of COVID-19 cases and city size and its evolution over time

Urban scaling law quantifies the disproportional growth of urban indicators with urban population size, which is one of the simple rules behind the complex urban system. Infectious diseases are closely related to social interactions that intensify in large cities, resulting in a faster speed of transmission in large cities. However, how this scaling relationship varies in an evolving pandemic is rarely investigated and remains unclear. Here, taking the COVID- 19 epidemic in the United States as an example, we collected daily added cases and deaths from January 2020 to June 2022 in more than three thousand counties to explore the scaling law of COVID- 19 cases and city size and its evolution over time. Results show that COVID- 19 cases super- linearly scaled with population size, which means cases increased faster than population size from a small city to a large city, resulting in a higher morbidity rate of COVID- 19 in large cities. Temporally, the scaling exponent that reflects the scaling relationship stabilized at around 1.25 after a fast increase from less than one. The scaling exponent gradually decreased until it was close to one. In comparison, deaths caused by the epidemic did not show a super-linear scaling relationship with population size, which revealed that the fatality rate of COVID-19 in large cities was not higher than that in small or medium-sized cities. The scaling exponent of COVID- 19 deaths shared a similar trend with that of COVID- 19 cases but with a lag in time. We further estimated scaling exponents in each wave of the epidemic, respectively, which experienced the common evolution process of first rising, then stabilizing, and then decreasing. We also analyzed the evolution of scaling exponents over time from regional and provincial perspectives. The northeast, where New York State is located, had the highest scaling exponent, and the scaling exponent of COVID- 19 deaths was higher than that of COVID-19 cases, which indicates that large cities in this region were more prominently affected by the epidemic. This study reveals the size effect of infectious diseases based on the urban scaling law, and the evolution process of scaling exponents over time also promotes the understanding of the urban scaling law. The mechanism behind temporal variations of scaling exponents is worthy of further exploration. © 2023 Science Press. All rights reserved.

Pandemic Challenges and Opportunities for Gender Equity in Clinical Research

In the arena of clinical research, gender equity accelerates research excellence: we need multiple perspectives and all the brain power we can muster to maximize research productivity and quality. [...]women physician investigators enhance enrollment of women as participants in clinical trials, which is crucial to our ability to generalize from the data and to maintain the health of women. Women are underrepresented among academic grand rounds speakers,14 speakers at medical conferences15, and award recipients from medical specialty societies.16 Time pressure is especially intense on young women faculty. Besides spending more time on domestic chores, they spend more time at work on teaching, service, and mentoring. Female primary care physicians spend more time with patients.22 Elderly hospitalized patients treated by female internists experience lower mortality and readmission rates.23 Patients undergoing coronary artery bypass grafting had shorter hospital length of stay when treated by an all-female physician team as compared with an all-male team.24 Female patients treated by male physicians following acute myocardial infarction have higher mortality than those treated by female physicians.25 Sex discordance between patient and surgeon is associated with increased likelihood of adverse postoperative outcomes-and that observation that is driven by worse outcomes for female patients treated by male physicians.26 Clinical trials play a fundamental role in bringing new medications and interventions to our patients, yet women have often been excluded from participation. Among 60 randomized controlled trials (RCTs) of lipidlowering therapies reported between 1990 and 2018, there was a modest increase in enrollment of women over time, but women remain underrepresented compared with the relative burden of disease.30 In another study of 317 RCTs of heart failure with reduced ejection fraction published in highimpact journals over the past 20 years, only 25% of participants overall were female, and females were under-enrolled in 72% of these trials.

Social Distance with Tourists in U.S. Counties with the Highest Historical Numbers of Reported COVID-19 Cases

With destinations steadily ‘opening back up for business' (while COVID-19 cases are still high in many areas), there is an increasing need to consider residents. Integrating the cognitive appraisal theory and the affect theory of exchange, this work tests a structural model examining the degree to which residents' perceptions of COVID-19 precautionary measures explain emotions directed toward visitors, and ultimately their willingness to engage in shared behaviors with tourists. Data were collected from 530 residents in 25 U.S. counties with the highest percentages of historical COVID-19 cases per population. A total of 10 of the 12 tested hypotheses were significant, contributing to 60% and 85% of the variance explained in contending and accommodating emotions, and 53% and 50% of the variance explained in engaging in less intimate–distal and more intimate–proximal behaviors with tourists. The implications highlight the complementary use of the two frameworks in explaining residents' preference for engagement in less intimate–distal interactions with tourists.

Being a product consumer during the COVID-19 pandemic: profile of the Polish consumer in the organic dairy market

PurposeThe purpose of this paper was to determine the profile of dairy product consumers in the organic market.Design/methodology/approachThe study was based on a survey questionnaire developed by the author and administered to a total of 1,108 respondents. The statistical analysis (including descriptive statistics, the analysis of the discriminative function and the Chi2 test was performed with the use of Statistica 13.1 PL. The respondents' gender was the factor behind the differences in how they behaved.FindingsThe consumers indicated the channels they rely upon to find information on organic dairy products;in addition to trusting the opinions of their family members and experts, they also use web platforms. Further, they specified their preferred locations for buying favorite products during the pandemic: specialized organic food shops, large distribution chains and online stores.Practical implicationsThese outcomes will help in identifying target consumer segments and information channels for specific information and advertising messages. They also form an important resource for developing some potential strategies which the supply chain stakeholders could implement to promote organic consumption of dairy products.Originality/valueThis study identifies consumers' preferred dairy products;motives for purchasing organic dairy products;barriers that consumers believe exist in the market;sources of knowledge about products purchased by consumers;and consumers' preferred channels for purchasing organic dairy products. To the best of the author's knowledge, this is the first study of dairy product consumers in the organic market in Poland.

Vaccine Hesitancy Among African Americans

The limited participation of African Americans in clinical trials has been a topic of discussion among medical and scientific researchers for some time. With the testing of coronavirus vaccines, this discussion has continued, particularly given the disproportionate impact of the virus on members of the African American community. With the public health goal of achieving widespread or "herd" immunity, the concept of "vaccine hesitancy" has also been addressed with regard to the population in general, and in relation to the African American community, among others. Vaccine hesitancy has been reported among groups from healthcare workers to rural residents to the poor. As is the case with all segments of society, African Americans are not monolithic. However, there are aspects of the issue of vaccine hesitancy which are unique and specific to the African American community in the U.S. In particular, the nature of the information about the coronavirus itself and about the vaccine, and importantly, the increasing availability of the information about the Tuskegee experiment, Henrietta Lacks, and other cases, along with the prevalence of misinformation and disinformation on aspects of science, such as that involving vaccines, are relevant to understanding the nature of vaccine hesitancy among African Americans.

Turnover Intention Model: Self- Determination Theory Approach: Acces la Success

The purpose of this study is to examine and analyze the influence of mental workload and person-organization fit on turnover intention, using basic psychological needs frustration (BPNF) as the intervening variable in the hospital in Daerah Istimewa Yogyakarta. The sample of this study is vocational nurse in the hospital in Daerah Istimewa Yogyakarta. The sample is carried out through survey from 153 respondents, which is processed using Structural Equation Modeling (SEM) method. This study finds that mental workload does not have direct influence on turnover intention, but it is mediated (full mediation) by need for competence frustration and need for relatedness frustration. Person-organization fit has a positive influence on need for autonomy frustration. However, person-organization fit does not have an influence on turnover intention, and basic psychological needs does not mediate the relationship of these variables. This study also found that the category of mental workload is quite low, person-organization fit is low, basic psychological needs frustration is quite low, and turnover intention is low. Nurse has the extrinsic motivation of identified regulation, thus hospital leaders should bring their motivation from identified regulation to intrinsic motivation, through internalization by establishing supportive work environment, namely Islamic spiritual workplace (ISW), with basic psychological needs supporting in each of its dimension. This study is expected to be a reference for practitioners in human resource management, especially regarding human resource retention function through the implementation of ISW. ISW contributes to lower mental workload, the increase of person-organization fit, establishment of basic psychological need satisfaction, as well as the decrease of basic psychological needs frustration and turnover intention.

DIVERSITY IN CLINICAL TRIALS GAINS GROUND AMIDST COVID

More recent policies aim to offset years of underenrollment of minority groups by expanding enrollment criteria, including more research sites in minority communities, and engaging investigators with diverse backgrounds. FDA has also sought to promote research diversity through its Drug Trials Snapshots program, established in 2015 to increase the visibility of clinical trial enrollment by age, sex, ethnicity and race. According to a recent report on the program's impact, though, there still may be a ways to go for clinical trials to reflect the diversity of the US population.

DEBATE ACCELERATES OVER WHO GETS COVID VACCINE FIRST

At the agencies' request, the National Academy of Sciences, Engineering and Medicine iNASEMi has formed a blue-ribbon committee of leading bioethicists, economists, geneticists, and public health authorities to quickly develop a framework for priority vaccine access to assist policymakers in the U.S. and other nations achieve equitable distribution of anticipated vaccines (see: https://bit.ly/33jTCds). Individuals at higher risk will include those in higher age groups, with underlying health conditions, engaged in high-risk occupations, affected by racial and ethnic disparities, and in hardhit geographic locations. State and public health officials are wary of federal pandemic planning efforts so fair given the lack of coordination and effectiveness in distributing COVID-19 test kits and personal protective equipment to healthcare providers and facilities.

COVID ADVANCES CLINICAL TRIAL TRANSPARENCY

Growing public concerns about politics playing a role in vetting potential vaccines and therapies to combat the COVID-19 pandemic has prompted sponsors of leading clinical trials to make public their study protocols and statistical analysis plans. [...]AstraZeneca's timeframe for enrolling and assessing study participants was delayed by the need to address the report of a serious adverse event in its Phase III study. The disclosure of these usually confidential details on research endpoints, assessment timeframes, and study analysis plans aim to promote information sharing among vaccine developers, and also build public confidence.

CLINICAL TRIAL REFORM

[...]CURES' BILL PROMOTES PANDEMIC PREPAREDNESS Congressional leaders are developing the next version of the 21st Century Cures Act, including provisions to advance research related to the COVID-19 crisis as part of initiatives for bringing innovative therapies to market faster (see https://bit.ly/2SKfA4S). Cures 2.0 continues and updates some of the main themes of the first Cures Act: support development of treatments for rare diseases, patient-focused drug development, diversity in clinical trials, expanded use of digital health systems, increased health literacy, and utilization of real-world data. A public education campaign, moreover, would aim to counter concerns about the safety of vaccines to promote widespread vaccination. Because these treatments are costly and unprofitable for biopharma companies to test and market, the legislation proposes additional financial support for both pre-market studies and post-market production and subsidized higher reimbursement rates for antibiotics that address critical needs.

Differences in Disease Burden and Treatment Utilization By Socioeconomic Status Among a Large Cohort of Patients with COVID-19 Diagnosis in the United States

Objectives: Social determinants of health (SDoH) including income, education, employment, and housing are known to affect health outcomes;while use in real-world database studies are limited. This study assessed socioeconomic differences in burden of disease and utilization of COVID-19 specific medications in a large cohort of patients in the US. Method(s): A total of 17,682,111 patients having a COVID-19 diagnosis between 4/1/2020 and 4/30/2022 were identified in the IQVIA longitudinal medical and pharmacy claims databases of >277 million patients. For SDoH, a 3-digit zip code median Area Deprivation Index (ADI) (v2.0 University of Wisconsin School of Medicine and Public Health 2015) was calculated for each patient, maintaining patient privacy. The ADI is a validated tool ranking neighborhoods by socioeconomic disadvantage. Medical and pharmacy utilization was assessed and stratified by ADI pentiles, where 0-20 was the least disadvantaged, and 81-100 was the most disadvantaged. Result(s): The proportion of patients having a claim with COVID-19 diagnosis was higher in the most disadvantaged (7.75%) compared to the least disadvantaged group (5.94%) (US overall: 6.37%). Medical claims prior to COVID-19 diagnosis were highest in the least disadvantaged, while prior pharmacy utilization was highest in the most-disadvantaged group. There was sparse use of COVID-19 medications overall;the least disadvantaged patients had the lowest use of COVID-19 specific medications. Casirivimab/imdevimab use was highest in the 61-80 (2.01%) and 81-100 (1.79%) ADI groups, and remdesivir use was highest in the moderately disadvantaged (ADI 41-60 and 61-80) groups (both 2.33%). Utilization of hydroxychloroquine (unapproved for COVID-19) increased from 0.91% in the least to 2.13% in the most disadvantaged groups. Conclusion(s): This study shows unequal burden of COVID-19 prevalence by SDoH, with the most disadvantaged having a higher disease burden and utilization of certain approved and unapproved COVID-19 medications, highlighting the need for further study of the reasons for these disparities.Copyright © 2023

Variation in Demographic Characteristics, Socioeconomic Status, Clinical Presentation and Selected Treatments in Mortality Among Patients with a Diagnosis of COVID-19 in the United States

Objectives: COVID-19 infected over 150 million people and caused over 1 million deaths in the US. This study evaluates several variables thought to be associated with mortality risk in the COVID-19 population. Method(s): The IQVIA longitudinal medical and pharmacy claims databases identified 17,682,111 patients with a COVID-19 diagnosis between 4/1/2020-4/30/2022 from a population of >277 million patients in the US. Patients were linked to Veritas Data Research fact-of-death records (90% complete compared to CDC reporting) and confirmed deaths were flagged. Confirmed mortality rates (CMR) were evaluated by age group, socioeconomic status (SES) using the Area Deprivation Index (v2.0, University of Wisconsin, 2015), co-morbidities and COVID-specific (approved and unapproved) treatments. Result(s): Of the 563,744 patients (3.2%) identified as dead (3.67% in men, 2.85% in women overall), CMR was lowest in patients aged 0-17 (0.08%), highest in age 65-75 (5.92%) and >75 (16.40%). Patients in the lowest 40% of SES had CMR of 4.43% while in the highest 20% was 1.56%. Respiratory failure, pneumonia and sepsis were the most common acute diagnoses accompanying COVID-19 deaths in all SES. In patients with comorbid dementia or Alzheimer's disease, CMR were 21.62% and 23.40% respectively. Additionally, congestive heart failure (15.79%), atrial fibrillation (15.50%), chronic kidney disease (15.30%) and COPD (12.19%) were associated with high CMR. Among patients receiving approved therapies, casirivimab/imdevimab and remdesivir had CMR of 1.41% and 12.63% respectively, while for those receiving unapproved therapies, ivermectin and hydroxychloroquine had CMR of 2.54% and 2.45%. Conclusion(s): Compared to the 1.1% case-mortality rate (Johns Hopkins 2023) among US COVID-19 patients, we found CMR exceeded 3% among those with a medical claim for COVID-19. Advanced age, dementia, and cardio-renal disease were associated with mortality. Patients with the lowest SES had approximately 3 times the confirmed mortality rate compared to those in the highest SES group.Copyright © 2023

Lack of efficacy of hydroxychloroquine in covid-19

Studies in mild-to-moderate cases as well as severe disease leave us still searching for a magic pill