COVID-19 Related Hospitalization Research Articles

The potential clinical impact and cost-effectiveness of the updated COVID-19 mRNA autumn 2024 vaccines in the United Kingdom

Aims To estimate the potential clinical impact and cost-effectiveness of a United Kingdom (UK) Autumn 2024 vaccination campaign with an updated Moderna COVID-19 vaccine in adults ≥65 years and eligible persons 6 months to 64 years of age over a 1-year time horizon (September 2024-August 2025). Materials and methods A compartmental Susceptible-Exposed-Infected-Recovered model was adapted to reflect COVID-19 cases in the UK. Numbers of symptomatic infections, COVID-19–related hospitalizations and deaths, costs, and quality-adjusted life-years (QALYs) were predicted using a decision tree. The incremental cost-effectiveness ratio (ICER) of an updated Moderna mRNA vaccine (Moderna Autumn 2024 Campaign) was compared to no Autumn 2024 vaccine and to an updated Pfizer-BioNTech mRNA Autumn 2024 vaccine, from a healthcare perspective. Results The Moderna Autumn 2024 Vaccination Campaign is predicted to decrease the expected 8.3 million symptomatic infections with no vaccination by 19% to 6.7 million. Hospitalizations, long COVID cases, and deaths are expected to decline by 27,000 (-38%), 59,000 (-19%), and 6000 (-43%), respectively. The Moderna Autumn 2024 Campaign will increase QALYs by 78,000 and costs by £665 million, yielding an ICER of £8500/QALY gained. Sensitivity analyses suggest that vaccine effectiveness (VE) and waning, symptomatic infection incidence, hospitalization rates, and mortality rates drive cost-effectiveness. Vaccination remains cost-effective when lowering the target population to ≥50 years. Use of the Moderna vaccine is expected to prevent 8000 more hospitalizations and 1700 more deaths than the updated Pfizer-BioNTech vaccine. Conclusions Vaccination of the eligible population would contribute to significant reductions in hospitalizations, deaths, and long COVID in the UK in the 2024-2025 season. Expanding the target population continues to be cost-effective. Use of the Moderna Autumn 2024 Campaign is predicted to reduce SARS-CoV-2 infections and associated outcomes in a cost-effective manner and will contribute to a more resilient healthcare system in the UK.

Validation Assessment of Privacy-Preserving Synthetic Electronic Health Record Data: Comparison of Original Versus Synthetic Data on Real-World COVID-19 Vaccine Effectiveness.

To assess the validity of privacy-preserving synthetic data by comparing results from synthetic versus original EHR data analysis. A published retrospective cohort study on real-world effectiveness of COVID-19 vaccines by Maccabi Healthcare Services in Israel was replicated using synthetic data generated from the same source, and the results were compared between synthetic versus original datasets. The endpoints included COVID-19 infection, symptomatic COVID-19 infection and hospitalization due to infection and were also assessed in several demographic and clinical subgroups. In comparing synthetic versus original data estimates, several metrices were utilized: standardized mean differences (SMD), decision agreement, estimate agreement, confidence interval overlap, and Wald test. Synthetic data were generated five times to assess the stability of results. The distribution of demographic and clinical characteristics demonstrated very small difference (< 0.01 SMD). In the comparison of vaccine effectiveness assessed in relative risk reduction between synthetic versus original data, there was a 100% decision agreement, 100% estimate agreement, and a high level of confidence interval overlap (88.7%-99.7%) in all five replicates across all subgroups. Similar findings were achieved in the assessment of vaccine effectiveness against symptomatic COVID-19 Infection. In the comparison of hazard ratios for COVID 19-related hospitalization and odds ratio for symptomatic COVID-19 Infection, the Wald tests suggested no significant difference between respective effect estimates in all five replicates for all patient subgroups but there were disagreements in estimate and decision metrices in some subgroups and replicates. Overall, comparison of synthetic versus original real-world data demonstrated good validity and reliability. Transparency on the process to generate high fidelity synthetic data and assurances of patient privacy are warranted.

Associations of County-Level Social Determinants of Health with COVID-19 Related Hospitalization Among People with HIV: A Retrospective Analysis of the U.S. National COVID Cohort Collaborative (N3C)

Individually, the COVID-19 and HIV pandemics have differentially impacted minoritized groups due to the role of social determinants of health (SDoH) in the U.S. Little is known how the collision of these two pandemics may have exacerbated adverse health outcomes. We evaluated county-level SDoH and associations with hospitalization after a COVID-19 diagnosis among people with (PWH) and without HIV (PWOH) by racial/ethnic groups. We used the U.S. National COVID Cohort Collaborative (January 2020-November 2023), a nationally-sampled electronic health record repository, to identify adults who were diagnosed with COVID-19 with HIV (n = 22,491) and without HIV (n = 2,220,660). We aggregated SDoH measures at the county-level and categorized racial/ethnic groups as Non-Hispanic (NH) White, NH-Black, Hispanic/Latinx, NH-Asian and Pacific Islander (AAPI), and NH-American Indian or Alaskan Native (AIAN). To estimate associations of county-level SDoH with hospitalization after a COVID-19 diagnosis, we used multilevel, multivariable logistic regressions, calculating adjusted relative risks (aRR) with 95% confidence intervals (95% CI). COVID-19 related hospitalization occurred among 11% of PWH and 7% of PWOH, with the highest proportion among NH-Black PWH (15%). In evaluating county-level SDoH among PWH, we found higher average household size was associated with lower risk of COVID-19 related hospitalization across racial/ethnic groups. Higher mean commute time (aRR: 1.76; 95% CI 1.10–2.62) and higher proportion of adults without health insurance (aRR: 1.40; 95% CI 1.04–1.84) was associated with a higher risk of COVID-19 hospitalization among NH-Black PWH, however, NH-Black PWOH did not demonstrate these associations. Differences by race and ethnicity exist in associations of adverse county-level SDoH with COVID-19 outcomes among people with and without HIV in the U.S.

Postural balance, mobility, and handgrip strength one year after hospitalization due to COVID-19

BackgroundSymptoms such as impairment of postural balance, mobility and muscle strength can last up to 12 months post COVID-19 hospitalization, need to be better understood, as they can have repercussions in activities of daily living. Research questionWhat happens to postural balance, mobility, and handgrip strength of COVID-19 patients after hospitalization? MethodsA prospective cohort study was conducted with patients of both sexes, aged ≥18, admitted to hospital diagnosed with COVID-19. Outcomes were assessed at 1, 4, 6, and 12 months post-discharge, including: postural balance - Brief-Balance Evaluation Systems Test, mobility - Timed “Up & Go” Test, and handgrip strength – dynamometry. Prevalence values of impaired postural balance and mobility and lower-than-expected handgrip strength were calculated by point estimate and 95 % confidence interval. Shapiro-Wilk test showed that our data did not have a normal distribution, so the Friedman Test and the test of proportions were used for the statistical analysis. ResultsPerformance on postural balance was improved after four months of hospital discharge, but the improvement in mobility and handgrip strength only occurred after six months. After six months of discharge, the proportion of individuals with impairments began to decrease. A higher prevalence of impairments in postural balance and mobility occurred at one month post-discharge, which reduced over time. However, the values of impairments for postural balance and mobility were still high after 12 months of follow-up. SignificanceThere was a high prevalence of postural balance and mobility impairment 1 month after discharge, which was still high 12 months after discharge. The prevalence of lower-than-expected handgrip strength demonstrated limited change over time. Results highlight the need for assessment of postural balance, mobility and hand grip strength in post COVID-19 related hospitalization protocols, and long-term physical therapy interventions to address these impairments when identified to improve long term outcomes.

Effect of spirulina on risk of hospitalization among patients with COVID-19: the TOGETHER randomized trial

BackgroundAlgae-derived nutraceuticals, such as spirulina, have been reported to have biological activities that may minimize clinical consequences to COVID-19 infections. ObjectivesThis study aimed to determine whether spirulina is an effective treatment for high-risk patients with early COVID-19 in an outpatient setting. MethodsThe TOGETHER trial is a placebo-controlled, randomized, platform trial conducted in Brazil. Eligible participants were symptomatic adults with a positive rapid test for SARS-CoV-2 older than 50 y or with a known risk factor for disease severity. Patients were randomly assigned to receive placebo or spirulina (1 g twice daily for 14 d). The primary end point was hospitalization defined as either retention in a COVID-19 emergency setting for >6 h or transfer to tertiary hospital owing to COVID-19 at 28 d. Secondary outcomes included time-to-hospitalization, mortality, and adverse drug reactions. We used a Bayesian framework to compare spirulina with placebo. ResultsWe recruited 1126 participants, 569 randomly assigned to spirulina and 557 to placebo. The median age was 49.0 y, and 65.3% were female. The primary outcome occurred in 11.2% in the spirulina group and 8.1% in the placebo group (odds ratio [OR]: 1.24; 95% credible interval: 0.84, 1.86). There were no differences in emergency department visit (OR: 1.21; 95% credible interval: 0.81, 1.83), nor time to symptom relief (hazard ratio: 0.90; 95% credible interval: 0.79, 1.03). Spirulina also not demonstrate important treatment effects in the prespecified subgroups defined by age, sex, BMI, days since symptom onset, or vaccination status. ConclusionsSpirulina has no any clinical benefits as an outpatient therapy for COVID-19 compared with placebo with respect to reducing the retention in an emergency setting or COVID-19–related hospitalization. There are no differences between spirulina and placebo for other secondary outcomes.This trial was registered at clinicaltrials.gov as NCT04727424.

Higher intraindividual variability of body mass index is associated with elevated risk of COVID-19 related hospitalization and post-COVID conditions.

Cardiometabolic diseases are risk factors for COVID-19 severity. The extent that cardiometabolic health represents a modifiable factor to mitigate the short- and long-term consequences from SARS-CoV-2 remains unclear. Our objective was to evaluate the associations between intraindividual variability of cardiometabolic health indicators and COVID-19 related hospitalizations and post-COVID conditions (PCC) among a relatively healthy population. This retrospective, multi-site cohort study was a post-hoc analysis among individuals with cardiometabolic health data collected during routine blood donation visits in 24 US states (2009-2018) and who responded to COVID-19 questionnaires (2021-2023). Intraindividual variability of blood pressure (systolic, diastolic), total circulating cholesterol, and body mass index (BMI) were defined as the coefficient of variation (CV) across all available donation timepoints (ranging from 3 to 74); participants were categorized into CV quartiles. Associations were evaluated by multivariable binomial regressions. Overall, 3344 participants provided 42,090 donations (median 9 [IQR 5, 17]). The median age was 48 years (38, 56) at the first study donation. 1.2% (N = 40) were hospitalized due to COVID-19 and 15.5% (N = 519) had PCC. Higher BMI variability was associated with greater risk of COVID-19 hospitalization (4th quartile aRR 4.15 [95% CI 1.31, 13.11], p = 0.02; 3rd quartile aRR 3.41 [95% CI 1.09, 10.69], p = 0.04). Participants with higher variability of BMI had greater risk of PCC (4th quartile aRR 1.29 [95% CI 1.02, 1.64]; p = 0.04). Intraindividual variability of blood pressure (systolic, diastolic) and total circulating cholesterol were not associated with COVID-19 hospitalization or PCC risk (all p > 0.05). From causal mediation analysis, the association between the highest quartiles of BMI variability and PCC was not mediated by hospitalization (p > 0.05). Higher intraindividual variability of BMI was associated with COVID-19 hospitalization and PCC risk. Our findings underscore the need for further elucidating mechanisms that explain these associations and importance for consistent maintenance of body weight.

COVID-19–related hospitalizations among Aotearoa, New Zealand children during the Omicron era of SARS-CoV-2

ObjectivesThis multicenter cohort study describes Aotearoa New Zealand children hospitalized during the country's first wave of sustained SARS-CoV-2 transmission, Omicron variant. MethodsChildren younger than 16 years, hospitalized for >6 hours with COVID-19 across New Zealand from January to May 2022 were included. Admissions for all Māori and Pacific and every second non-Maori non-Pacific children were selected to support equal explanatory power for ethnic grouping. Attribution of hospital admission, demography, clinical presentation, comorbidity, treatment, and outcome data were collected. ResultsOf 444 hospitalizations of children positive for COVID-19, 292 (65.5%) from 290 children were considered admissions attributable to COVID-19. Of these admissions, 126 (43.4%) were aged under 1; 118 (40.7%), 99 (34.1%), and 87 (30.0%) were children of Māori, Pacific, and non-Maori non-Pacific ethnicity, respectively. Underlying respiratory disease was the most common comorbidity, present in 22 children (7.6%); 16 children (5.5%) were immunosuppressed. Median length of stay was 1 day (interquartile range 0.0-2.0). Four children received antiviral, 69 (24%) antibacterial, and 24 (8%) supplemental oxygen. Although eight children required intensive care, there were no deaths. ConclusionsChildren hospitalized during the first significant wave of SARS-CoV-2 infection in New Zealand presented with a multi-system viral illness and rarely with severe disease.

Prevalence of Self-Reported COVID-19 Infection in Persons with Complicated Mild to Severe Traumatic Brain Injury (TBI): A TBI Model Systems Study.

To describe the incidence of self-reported COVID-19 history in a longitudinal cohort of individuals with complicated mild to severe traumatic brain injury (TBI) and describe demographic, injury and functional differences based on history of COVID-19 infection. Individuals with complicated mild to severe TBI aged 16 or older at time of injury who were enrolled in the TBI Model Systems longitudinal cohort study, completed a baseline or follow-up interview between October 1, 2021-March 31, 2023, and provided information about COVID-19 history and timing of COVID-19 infection was collected. Of the 3,627 individuals included in the analysis, 29.5% reported a history of COVID-19 infection. Those with reported COVID-19 history tended to be younger, not of a racial/ethnic minority background, and greater functional status at follow up based on the Glasgow Outcome Scale-Extended scale compared to those with no reported COVID-19 history (p < 0.05). Among those with COVID-19 history, 61.8% did not receive medical care, 27.6% received medical care but no hospitalization, and 10.5% were hospitalized. Of those hospitalized, 21.4% required ventilator use. Incidence of COVID-19 diagnosis and related hospitalization characteristics in persons with complicated mild to severe TBI was similar to national incidence between March 2020-2023. Secondary effects of the COVID-19 pandemic on persons with TBI require investigation.

COVID-19 vaccine immunogenicity and safety surrounding fourth and subsequent vaccine doses in patients with hematologic malignancies

BackgroundImmune response to COVID-19 vaccine is diminished in patients with hematologic malignancy. There is limited data regarding response to vaccine doses in these patients. PurposeTo quantify the humoral immune response engendered by 4th and subsequent doses of SARS-CoV-2 vaccination as measured by anti-Spike (anti-S) antibody levels, based on dried blood spot (DBS) testing, in patients with hematologic malignancies. Anti-S binds to the spike protein of the SARS-CoV-2 virus and is indicative of vaccine immunogenicity. MethodsWe conducted a prospective study of hematologic malignancies between August 2021 and January 2023 at 12 sites across Canada. Participants were followed longitudinally and submitted finger-prick DBS cards at set intervals associated with vaccination. Samples were processed via high throughput ELISA assay to detect serum antibodies against nucleocapsid (N) and spike (S) proteins. ResultsWe obtained 3071 samples on 790 unique patients. Of these, 372 unique participants with 1840 samples had anti-S results available post-4th, 5th or 6th COVID-19 vaccine dose and were included for analysis.Three hundred thirty-three patients of the 372 participants submitted a DBS sample post 4th dose. Of these, 257 patients (77.2%) had a positive anti-S antibody. A total of 198 patients had paired samples pre- and post-dose 4, of which 59 (29.7%) had a negative anti-S antibody pre-dose 4. Of these, 20 (33.4%) developed positive anti-S antibody post-dose 4. One hundred forty-nine patients submitted a DBS sample post-dose 5. Of these, 135 patients (90.6%) had positive anti-S antibody. A total of 52 had paired samples pre- and post-dose 5. Six (8.7%) had a negative anti-S antibody pre-dose 5, of which two (33.3%) developed positive anti-S antibody post-dose 5.Of these 372 patients, 123 (34%) reported COVID-19 infection and 4 (1%) had a COVID-19 related hospitalization. There were no reported deaths from COVID-19. ConclusionsThis prospective cohort study showed that humoral immune response improved with subsequent doses of COVID-19 vaccines.

1065-P: Comparative Effectiveness of the Bivalent COVID-19 mRNA Vaccines mRNA1273-222 and BNT162b2 in Adults with Diabetes in the U.S.

Introduction &amp; Objective: Diabetes is associated with an increased risk for severe COVID-19. A subanalysis of a retrospective observational cohort study was conducted to evaluate the relative vaccine effectiveness (rVE) of 2 previously approved bivalent vaccines that target the ancestral SARS-CoV-2 and the omicron BA.4/BA.5 variant, mRNA-1273.222 (Moderna, Inc.) and BNT162b2 bivalent (Pfizer-BioNTech), in US adults with diabetes. Methods: The study used a US electronic health record dataset (Veradigm) linked with medical claims data of adults aged ≥18 years with ≥1 underlying medical condition associated with increased risk of severe COVID-19 who received a dose of mRNA-1273.222 or BNT162b2 bivalent vaccines between August 31, 2022, and February 28, 2023. The current analysis included a subgroup of individuals with type 1 or type 2 diabetes identified in the dataset by ICD-10 diagnostic code. The rVE was measured against COVID-19-related hospitalizations and COVID-19-related outpatient visits. Follow-up started 7 days after vaccination until May 31, 2023. Propensity score weighting was used to adjust for baseline differences between groups. Results: Of 639,868 individuals with diabetes included in the analysis, 252,635 received mRNA-1273.222, and 387,233 received BNT162b2 bivalent (post-weighting). After weighting, no variables had an SMD &amp;gt;0.1 therefore no adjustments were made to rVE estimates. The adjusted rVEs of mRNA-1273.222 versus BNT162b2 bivalent vaccine against COVID-19-related hospitalizations and outpatient visits were 15.1% (95% CI, 8.7%-21.0%) and 3.7% (95% CI, 1.2%-6.2%), respectively. Conclusion: We found greater effectiveness of mRNA-1273.222 compared with the BNT162b2 bivalent vaccine in preventing COVID-19—related hospitalizations in this cohort of individuals with diabetes. This study emphasizes the importance of assessing COVID-19 vaccine formulations in high-risk adults, including those with diabetes. Disclosure H. Kopel: Employee; Moderna, Inc. Stock/Shareholder; Moderna, Inc. V. Nguyen: Employee; VHN Consulting Inc. Other Relationship; Moderna, Inc. A. Bogdanov: Employee; Veradigm. Other Relationship; Moderna, Inc. I. Winer: Employee; Veradigm. Other Relationship; Moderna, Inc. C. Boileau: Employee; VHN Consulting Inc. Other Relationship; Moderna, Inc. T. Ducruet: Employee; VHN Consulting Inc. Other Relationship; Moderna, Inc. N. Zeng: Employee; Veradigm. Other Relationship; Moderna, Inc. M. Bausch-Jurken: Employee; Moderna, Inc. Stock/Shareholder; Moderna, Inc. D.B. Esposito: Employee; Moderna, Inc. Stock/Shareholder; Moderna, Inc. E. Beck: Employee; Moderna, Inc. Stock/Shareholder; Moderna, Inc. M. Bonafede: Employee; Veradigm. Other Relationship; Moderna, Inc. J.A. Mansi: Employee; Moderna, Inc. Stock/Shareholder; Moderna, Inc.

Increased disease severity during COVID-19 related hospitalization in black non-hispanic, hispanic and medicaid-insured young children.

The COVID-19 pandemic has disproportionately affected marginalized groups in the United States. Although most children have mild or asymptomatic COVID-19, some experience severe disease and long-term complications. However, few studies have examined health disparities in severe COVID-19 outcomes among US children. To examine disparities in the clinical outcomes of infants and children aged <5 years hospitalized with COVID-19 by race/ethnicity and payer status. Children aged <5 years hospitalized with an admission diagnosis of COVID-19 (April 2021-February 2023) were selected from the PINC AI™ Healthcare Database. Hospital outcomes included length of stay (LOS), intensive care unit (ICU) admission, oxygen supplementation, invasive mechanical ventilation (IMV), and prolonged duration of each outcome. Multivariable logistic regression models compared hospitalization outcomes by race/ethnicity and payer status. Among 10,190 children (mean age: 0.9 years, 56.5% male, 66.7% Medicaid-insured), race/ethnicity was distributed as follows: White non-Hispanic (35.1%), Hispanic (any or Unknown race; 28.3%), Black non-Hispanic (15.2%), Other race/ethnicity (8.9%) and Unknown (12.5%). Payer status varied by race/ethnicity. White non-Hispanic children had the highest proportion with commercial insurance (42.9%) while other racial/ethnic groups ranged between 13.8% to 26.1%. Black non-Hispanic children had the highest proportion with Medicaid (82.3%) followed by Hispanic children (76.9%). Black non-Hispanic children had higher odds of prolonged outcomes: LOS (adjusted odds ratio [aOR] = 1.20, 95% confidence interval [CI]:1.05-1.38), ICU days (aOR = 1.44, 95% CI: 1.07-1.93), and IMV days (aOR = 1.80, 95% CI: 1.09-2.97) compared to White non-Hispanic children. Similar patterns were observed for Hispanic and children of Other race/ethnicity. Medicaid-insured and children with other insurance had higher odds of prolonged LOS and oxygen days than commercially insured patients. There were disparities in clinical outcomes of COVID-19 by race/ethnicity and insurance type, particularly for prolonged-duration outcomes. Further research is required to fully comprehend the causes and consequences of these disparities and develop strategies to reduce them while ensuring equitable healthcare delivery.

Progressive Evolutionary Dynamics of Gene-Specific ω Led to the Emergence of Novel SARS-CoV-2 Strains Having Super-Infectivity and Virulence with Vaccine Neutralization.

An estimation of the proportion of nonsynonymous to synonymous mutation (dn/ds, ω) of the SARS-CoV-2 genome would indicate the evolutionary dynamics necessary to evolve into novel strains with increased infection, virulence, and vaccine neutralization. A temporal estimation of ω of the whole genome, and all twenty-nine SARS-CoV-2 genes of major virulent strains of alpha, delta and omicron demonstrates that the SARS-CoV-2 genome originally emerged (ω ~ 0.04) with a strong purifying selection (ω < 1) and reached (ω ~ 0.85) in omicron towards diversifying selection (ω > 1). A marked increase in the ω occurred in the spike gene from alpha (ω = 0.2) to omicron (ω = 1.97). The ω of the replication machinery genes including RDRP, NSP3, NSP4, NSP7, NSP8, NSP10, NSP13, NSP14, and ORF9 are markedly increased, indicating that these genes/proteins are yet to be evolutionary stabilized and are contributing to the evolution of novel virulent strains. The delta-specific maximum increase in ω in the immunomodulatory genes of NSP8, NSP10, NSP16, ORF4, ORF5, ORF6, ORF7A, and ORF8 compared to alpha or omicron indicates delta-specific vulnerabilities for severe COVID-19 related hospitalization and death. The maximum values of ω are observed for spike (S), NSP4, ORF8 and NSP15, which indicates that the gene-specific temporal estimation of ω identifies specific genes for its super-infectivity and virulency that could be targeted for drug development.

Comparative effectiveness of the bivalent COVID-19 mRNA vaccines, mRNA1273-222 and BNT162b2, in immunocompromised adults in the US.

e23057 Background: Despite the decline in COVID-19–related hospitalizations and mortality during the period of omicron predominance, immunocompromised individuals, including those with cancer, remain at an increased risk for severe COVID-19 outcomes. A subanalysis of a retrospective observational cohort study assessed the relative vaccine effectiveness (rVE) of 2 previously approved bivalent vaccines targeting the ancestral SARS-CoV-2 and the omicron BA.4/BA.5 variant, mRNA-1273.222 (Moderna, Inc., Cambridge, MA, USA) and BNT162b2 bivalent (Pfizer Inc., New York, NY, USA; BioNTech GmbH, Mainz, Germany), in immunocompromised adults in the United States. Methods: The study used a US electronic health record dataset (Veradigm) linked with medical and pharmacy claims data of adults aged ≥18 years with at least 1 underlying medical condition associated with increased risk of severe COVID-19 who received a dose of mRNA-1273.222 or BNT162b2 bivalent vaccines between August 31, 2022, and February 28, 2023. A subgroup analysis was conducted among an immunocompromised population, encompassing cancer patients, organ or stem cell transplant recipients, individuals with primary immunodeficiency, individuals with HIV, and individuals receiving immunosuppressing medications. Comorbid conditions were based on prior medical encounters in the 365 days before vaccination. The outcomes measured were rVE of the two bivalent mRNA vaccines against COVID-19-related hospitalizations (primary outcome) and outpatient visits (secondary outcome). Follow-up started 7 days after vaccination until May 31, 2023 (end of available claims data). Propensity score weighting was used to adjust for baseline differences between groups. Results: The subanalysis included 427,260 immunocompromised individuals, of which 250,573 (58.6%) were identified as having cancer. In the overall weighted immunocompromised population, 169,509 individuals received mRNA-1273.222, and 257,751 received BNT162b2 bivalent. The adjusted rVEs of mRNA-1273.222 versus BNT162b2 bivalent vaccine against COVID-19–related hospitalizations and outpatient visits were 15.0% (95% CI, 7.2%-22.0%; P&lt; 0.001) and 4.8% (95% CI, 1.8%-7.7%; P= 0.002), respectively. Conclusions: In this study, the mRNA-1273.222 vaccine offered greater protection against COVID-19–related hospitalization compared with the BNT162b2 bivalent vaccine among immunocompromised individuals. This study emphasizes the importance of assessing COVID-19 vaccine formulations and optimizing protection, especially in immunocompromised adults, including those with cancer.

Predictors of COVID-19 infection and hospitalization in group homes for individuals with intellectual and/or developmental disabilities

BackgroundMore than seven million people with intellectual and/or developmental disabilities (ID/DD) live in the US and may face an elevated risk for COVID-19. ObjectiveTo identify correlates of COVID-19 and related hospitalizations among people with ID/DD in group homes in Massachusetts. MethodsWe collected data during March 1, 2020–June 30, 2020 (wave 1) and July 1, 2020–March 31, 2021 (wave 2) from the Massachusetts Department of Public Health and six organizations administering 206 group homes for 1035 residents with ID/DD. The main outcomes were COVID-19 infections and related hospitalizations. We fit multilevel Cox proportional hazards models to estimate associations with observed predictors and assess contextual home- and organizational-level effects. ResultsCompared with Massachusetts residents, group home residents had a higher age-adjusted rate of COVID-19 in wave 1 (incidence rate ratio [IRR], 12.06; 95 % confidence interval [CI], 10.51–13.84) and wave 2 (IRR, 2.47; 95 % CI, 2.12–2.88) and a higher age-adjusted rate of COVID-19 hospitalizations in wave 1 (IRR, 17.64; 95 % CI, 12.59–24.70) and wave 2 (IRR, 4.95; 95 % CI, 3.23–7.60). COVID-19 infections and hospitalizations were more likely among residents aged 65+ and in group homes with 6+ resident beds and recent infection among staff and residents. ConclusionsAggressive efforts to decrease resident density, staff-to-resident ratios, and staff infections through efforts such as vaccination, in addition to ongoing access to personal protective equipment and COVID-19 testing, may reduce COVID-19 and related hospitalizations in people with ID/DD living in group homes.

Direct impact of COVID-19 vaccination in Chile: averted cases, hospitalizations, ICU admissions, and deaths

BackgroundChile rapidly implemented an extensive COVID-19 vaccination campaign, deploying a diversity of vaccines with a strategy that prioritized the elderly and individuals with comorbidities. This study aims to assess the direct impact of vaccination on the number of COVID-19 related cases, hospital admissions, ICU admissions and deaths averted during the first year and a half of the campaign.MethodsVia Chile’s transparency law, we obtained access to weekly event counts categorized by vaccination status and age. Integrating this data with publicly available census and vaccination coverage information, we conducted a comparative analysis of weekly incidence rates between vaccinated and unvaccinated groups from December 20, 2020 to July 2, 2022 to estimate the direct impact of vaccination in terms of the number of cases, hospitalizations, ICU admissions and deaths averted, using an approach that avoids the need to explicitly specify the effectiveness of each vaccine deployed.ResultsWe estimated that, from December 20, 2020 to July 2, 2022 the vaccination campaign directly prevented 1,030,648 (95% Confidence Interval: 1,016,975-1,044,321) cases, 268,784 (95% CI: 264,524-273,045) hospitalizations, 85,830 (95% CI: 83,466-88,194) ICU admissions and 75,968 (95% CI: 73,909-78,028) deaths related to COVID-19 among individuals aged 16 years and older. This corresponds to a reduction of 26% of cases, 66% of hospital admissions, 70% of ICU admissions and 67% of deaths compared to a scenario without vaccination. Individuals 55 years old or older represented 67% of hospitalizations, 73% of ICU admissions and 89% of deaths related to COVID-19 prevented.ConclusionsThis study highlights the role of Chile's vaccination campaign in reducing COVID-19 disease burden, with the most substantial reductions observed in severe outcomes.

The Potential Economic Impact of the Updated COVID-19 mRNA Fall 2023 Vaccines in Japan.

This analysis estimates the economic and clinical impact of a Moderna updated COVID-19 mRNA Fall 2023 vaccine for adults ≥18 years in Japan. A previously developed Susceptible-Exposed-Infected-Recovered (SEIR) model with a one-year analytic time horizon (September 2023-August 2024) and consequences decision tree were used to estimate symptomatic infections, COVID-19 related hospitalizations, deaths, quality-adjusted life years (QALYs), costs, and incremental cost-effectiveness ratio (ICER) for a Moderna updated Fall 2023 vaccine versus no additional vaccination, and versus a Pfizer-BioNTech updated mRNA Fall 2023 vaccine. The Moderna vaccine is predicted to prevent 7.2 million symptomatic infections, 272,100 hospitalizations and 25,600 COVID-19 related deaths versus no vaccine. In the base case (healthcare perspective), the ICER was ¥1,300,000/QALY gained ($9400 USD/QALY gained). Sensitivity analyses suggest results are most affected by COVID-19 incidence, initial vaccine effectiveness (VE), and VE waning against infection. Assuming the relative VE between both bivalent vaccines apply to updated Fall 2023 vaccines, the base case suggests the Moderna version will prevent an additional 1,100,000 symptomatic infections, 27,100 hospitalizations, and 2600 deaths compared to the Pfizer-BioNTech vaccine. The updated Moderna vaccine is expected to be highly cost-effective at a ¥5 million willingness-to-pay threshold across a wide range of scenarios.

A single dose for me, A wealth of protection for us: The public health cost of individualism in the rollout of COVID-19 vaccine

ObjectiveThis study examines whether individualism weakens the effectiveness of the COVID-19 vaccine eligibility expansions in the United States in 2021, and assesses the associated social benefits or costs associated with individualism. MethodsWe construct a county-level composite individualism index as a proxy of culture and the fraction of vaccine eligible population as a proxy of vaccination campaign (mean: 41.34%). We estimate whether the COVID-19 vaccine eligibility policy is less effective in promoting vaccine coverage, reducing in COVID-19 related hospitalization and death using a linear two-way fixed effect model in a sample of 2866 counties for the period between early December 2020 and July 1, 2021. We also test whether individualism shapes people's attitudes towards vaccine using a linear probability model in a sample of 625,308 individuals aged 18–65 (mean age: 43.3; 49% male; 59.1% non-Hispanic white, 19.1% Hispanic, 12% African American; 5.9% Asian) from the Household Pulse Survey. ResultsThe effects of expanded vaccine eligibility are diminished in counties with greater individualism, as evidenced by lower effectiveness in increasing vaccination rates and reducing outpatient doctor visits primarily for COVID-related symptoms and COVID deaths. Moreover, our results show that this cultural influence on attitudes towards vaccine is more pronounced among the less educated, but unrelated to race. ConclusionAssuming an average level of vaccine eligibility policies and an average intensity of individualism across the nation, we calculate that the average social cost associated with an individualistic culture amid the pandemic is approximately $50.044 billion, equivalent to 1.32% of the total U.S. health care spending in 2019. Our paper suggests that strategies to promote public policy compliance should be tailored to accommodate cultural and social contexts.

Molnupiravir versus favipiravir in at-risk outpatients with COVID-19: A randomized controlled trial in Thailand

ObjectivesEvaluate and compare the efficacy and safety of molnupiravir and favipiravir in outpatients with mild to moderate COVID-19 and at risk of severe COVID-19. MethodsIn an open-label, parallel-group, multicenter trial in Thailand, participants with moderate COVID-19 and at least one factor associated with severe COVID-19 were randomly assigned 1:1 to receive oral molnupiravir or oral favipiravir (standard of care). Phone calls for remote symptom assessment were made on Days 6, 15, and 29. Participants with worsening symptoms were instructed to return to the hospital. The primary endpoint was pulmonary involvement by Day 29, as evidenced by ≥2 of the following: dyspnea, oxygen saturation <92% or imaging. ResultsNine hundred seventy-seven participants (487 molnupiravir, 490 favipiravir) were enrolled from 8 July 2022 to 19 January 2023. 98% had received ≥1 dose of COVID-19 vaccine and 83% ≥3 doses. By Day 29, pulmonary involvement occurred in 0% (0/483) in molnupiravir arm versus 1% (5/482) in favipiravir arm (−1.0%; Newcombe 95.2% CI: −2.4% to −0.0%; P = 0.021); all-cause death in 0% (0/483) and <1% (1/482); COVID-19 related hospitalization in <1% (1/483) and 1% (3/482); treatment-related adverse event in 1% (5/483) and 1% (4/486); and serious adverse event in 1% (4/483) and 1% (4/486). ConclusionsFavipiravir and molnupiravir had a similar efficacy and safety profile. Whether either of the two reduced the risk of complications during the omicron era in this population with a low risk of pulmonary involvement and a high vaccine coverage remains unclear. There were no differences in any of the safety endpoints. Thai Clinical Trials Registry IDTCTR20230111009.

Post COVID-19 condition imposes significant burden in patients with advanced chronic kidney disease: A nested case-control study

BackgroundThe burden of post COVID-19 condition (PCC) is not well studied in patients with advanced kidney disease. MethodsA large prospective cohort of SARS-CoV-2 vaccinated patients with chronic kidney disease stages G4–G5 (CKD G4/5), on dialysis, and kidney transplant recipients (KTR) were included. Antibody levels were determined after vaccination. Presence of long-lasting symptoms was assessed in patients with and without prior COVID-19 and compared using logistic regression. In patients with prior COVID-19, PCC was defined according to the WHO definition. ResultsTwo hundred sixteen CKD G4/5 patients, 375 dialysis patients, and 2005 KTR were included. Long-lasting symptoms were reported in 204/853 (24%) patients with prior COVID-19 and in 297/1743 (17%) patients without prior COVID-19 (aOR: 1.45 (1.17–1.78)], P < 0.001). PCC was prevalent in 29% of CKD G4/5 patients, 21% of dialysis patients, and 24% of KTR. In addition, 69% of patients with PCC reported (very) high symptom burden. Odds of PCC was lower per 10-fold increase in antibody level after vaccination (aOR 0.82 [0.70–0.96], P = 0.01) and higher in case of COVID-19 related hospital admission (aOR 4.64 [2.61–8.25], P = 0.003). ConclusionsCKD G4/5 patients, dialysis patients, and KTR are at risk for PCC with high symptom burden after SARS-CoV-2 vaccination, especially if antibody levels are low and in case of hospitalization due to COVID-19.

Mental health and risk of death and hospitalization in COVID-19 patients. Results from a large-scale population-based study in Spain.

The COVID-19 pandemic has created unprecedented challenges for health care systems globally. This study aimed to explore the presence of mental illness in a Spanish cohort of COVID-19-infected population and to evaluate the association between the presence of specific mental health conditions and the risk of death and hospitalization. This is a retrospective cohort study including all individuals with confirmed infection by SARS-CoV-2 from the PRECOVID (Prediction in COVID-19) Study (Aragon, Spain). Mental health illness was defined as the presence of schizophrenia and other psychotic disorders, anxiety, cognitive disorders, depression and mood disorders, substance abuse, and personality and eating disorders. Multivariable logistic regression models were used to examine the likelihood of 30-day all-cause mortality and COVID-19 related hospitalization based on baseline demographic and clinical variables, including the presence of specific mental conditions, by gender. We included 144,957 individuals with confirmed COVID-19 from the PRECOVID Study (Aragon, Spain). The most frequent diagnosis in this cohort was anxiety. However, some differences were observed by sex: substance abuse, personality disorders and schizophrenia were more frequently diagnosed in men, while eating disorders, depression and mood, anxiety and cognitive disorders were more common among women. The presence of mental illness, specifically schizophrenia spectrum and cognitive disorders in men, and depression and mood disorders, substance abuse, anxiety and cognitive and personality disorders in women, increased the risk of mortality or hospitalization after COVID-19, in addition to other well-known risk factors such as age, morbidity and treatment burden. Identifying vulnerable patient profiles at risk of serious outcomes after COVID-19 based on their mental health status will be crucial to improve their access to the healthcare system and the establishment of public health prevention measures for future outbreaks.