The emergence of Omicron variants coincided with declining vaccine-induced protection against SARS-CoV-2. Two bivalent mRNA vaccines, mRNA-1273.222 (Moderna) and BNT162b2 Bivalent (Pfizer-BioNTech), were developed to provide greater protection against the predominate circulating variants by including mRNA that encodes both the ancestral (original) strain and BA.4/BA.5. We estimated their relative vaccine effectiveness (rVE) in preventing COVID-19-related outcomes in the US using a nationwide dataset linking primary care electronic health records and pharmacy/medical claims data. The study population (aged ≥18 years) received either vaccine between 31 August 2022 and 28 February 2023. We used propensity score weighting to adjust for baseline differences between groups. We estimated the rVE against COVID-19-related hospitalizations (primary outcome) and outpatient visits (secondary) for 1,034,538 mRNA-1273.222 and 1,670,666 BNT162b2 Bivalent vaccine recipients, with an adjusted rVE of 9.8% (95% confidence interval: 2.6–16.4%) and 5.1% (95% CI: 3.2–6.9%), respectively, for mRNA-1273.222 versus BNT162b2 Bivalent. The incremental relative effectiveness was greater among adults ≥ 65; the rVE against COVID-19-related hospitalizations and outpatient visits in these patients was 13.5% (95% CI: 5.5–20.8%) and 10.7% (8.2–13.1%), respectively. Overall, we found greater effectiveness of mRNA-1273.222 compared with the BNT162b2 Bivalent vaccine in preventing COVID-19-related hospitalizations and outpatient visits, with increased benefits in older adults.

This study aimed to evaluate the vaccine effectiveness (VE) of mRNA-1273.815, a 2023-2024 Omicron XBB.1.5-containing mRNA COVID-19 vaccine, at preventing COVID-19-related hospitalizations and any medically attended COVID-19 in adults. In a linked EHR-claims dataset, we identified US adults (≥18 years) who received the mRNA-1273.815 vaccine (exposed cohort) between September 12 and December 15, 2023, matched 1:1 to individuals who did not receive a 2023-2024 updated COVID-19 vaccine (unexposed cohort). Cohorts were balanced using inverse probability of treatment weighting on demographics, vaccination and infection history, and underlying medical conditions. Study cohorts were followed until December 31, 2023 for COVID-19-related hospitalizations and medically attended COVID-19. Cox regression was used to estimate hazard ratios (HR) and VE. Subgroup analyses were performed for adults ≥50, adults ≥65, and individuals with underlying medical conditions. Overall, 859,335 matched pairs of mRNA-1273.815 recipients and unexposed adults were identified. The mean (SD) age was 63 (16) years. More than 60% of individuals in both cohorts had an underlying medical condition. Among the overall adult population, VE was 60.2% (95% CI: 53.4-66.0%) against COVID-19-related hospitalization and 33.1% (30.2%-35.9%) against medically attended COVID-19 over a median follow-up of 63 (IQR: 44-78) days. VE estimates by age and underlying medical conditions were similar. These results demonstrate the significant protection provided by mRNA-1273.815 against COVID-19-related hospitalizations and any medically attended COVID-19 in adults, regardless of vaccination history, and support CDC recommendations to stay up-to-date with COVID-19 vaccination to prevent COVID-19-related outcomes, including hospitalizations.

INTRODUCTION: Cyclic vomiting syndrome (CVS) imposes a substantial burden, but epidemiological data are scarce. This study aimed to estimate the incidence and prevalence of CVS, comorbid conditions, and treatment patterns, using administrative databases in the United States. METHODS: This cross-sectional study used claims data from Merative MarketScan Commercial/Medicare Supplemental and Medicaid databases in all health care settings. Incidence and prevalence rates for 2019 were calculated and stratified by age, sex, region, and race/ethnicity. Patient characteristics were reported among newly diagnosed patients with CVS (i.e., no documented claims for CVS before 2019). CVS was defined as having 1+ inpatient and/or 2+ outpatient CVS claims that were 7+ days apart. RESULTS: The estimated prevalence of CVS was 16.7 (Commercial/Medicare) and 42.9 (Medicaid) per 100,000 individuals. The incidence of CVS was estimated to be 10.6 (Commercial/Medicare) and 26.6 (Medicaid) per 100,000 individuals. Both prevalence and incidence rates were higher among female individuals (for both Commercial/Medicare and Medicaid). Comorbid conditions were common and included abdominal pain (56%–64%), anxiety (32%–39%), depression (26%–34%), cardiac conditions (39%–42%), and gastroesophageal reflux disease (30%–40%). Despite a diagnosis of CVS, only 32%–35% had prescriptions for prophylactic treatment and 47%–55% for acute treatment within the first 30-day period following diagnosis. DISCUSSION: This study provides the first population-level estimates of CVS incidence and prevalence in the United States. Comorbid conditions are common, and most patients with CVS do not receive adequate treatment. These findings underscore the need for improving disease awareness and developing better screening strategies and effective treatments.

Background/Objectives: This retrospective cohort study evaluated the relative vaccine effectiveness (rVE) of two bivalent (original/Omicron BA.4/BA.5) vaccines mRNA-1273.222 versus the BNT162b2 Bivalent in preventing COVID-19-related outcomes in adults with underlying medical conditions associated with increased risk for severe COVID-19. Methods: In a linked electronic health record/claims dataset, US adults (≥18 years) with ≥1 underlying medical condition of interest who received either the bivalent vaccine between 31 August 2022 and 28 February 2023 were identified. The inverse probability of treatment weighting was used to adjust for cohort differences. Cohorts were followed up for COVID-19-related hospitalizations and outpatient encounters until 31 May 2023. Hazard ratios and rVEs were estimated using Cox regression. Subgroup analyses were performed on individuals with pre-specified comorbid conditions. Results: 757,572 mRNA-1273.222 and 1,204,975 BNT162b2 Bivalent recipients were identified. The adjusted rVE over a median follow-up of 198 days was 10.9% (6.2%–15.2%) against COVID-19-related hospitalization and 3.2% (1.7%–4.7%) against COVID-19-related outpatient encounters. rVE estimates for COVID-19 hospitalizations among subgroups with comorbid conditions were as follows: diabetes 15.1% (8.7%–21.0%), cerebro- and cardiovascular disease 14.7% (9.0%–20.1%), chronic lung disease 11.9% (5.1%–18.2%), immunocompromised 15.0% (7.2%–22.2%), chronic kidney disease 8.4% (0.5%–15.7%). Conclusions: Overall, among adults with underlying medical conditions, mRNA-1273.222 was more effective than BNT162b2 Bivalent, especially in preventing COVID-19-related hospitalizations.

BackgroundUnderdiagnosis and the absence of a condition-specific diagnostic code have made the economic burden of adult growth hormone deficiency (AGHD) difficult to capture. This study measured the all-cause and disease-specific healthcare utilization and costs of AGHD among individuals stratified by diagnosis status and receipt of growth hormone (GH) treatment.MethodsAdults meeting ≥1 of the following criteria (1/1/2017-12/31/2021): diagnosis of hypopituitarism or related condition, ≥3 pituitary hormone deficiencies, ≥3 pituitary hormone treatments, or ≥1 GH prescription were identified in the Veradigm Network EHR linked to claims. Individuals were stratified by GH level on or before the earliest qualifying event: confirmed (GH < 3 ng/mL), at-risk (no test result), ruled-out (GH ≥ 3 ng/mL). Confirmed and at-risk individuals were further stratified by GH treatment. An age and gender-matched control cohort without AGHD was identified. Healthcare utilization and costs were measured in the 12 months following the index date. Multivariable modeling compared all-cause and AGHD-related healthcare costs, excluding cost of GH, among diagnosis or treatment status stratified cohorts while adjusting for baseline characteristics.ResultsAmong 54,310 individuals at risk for AGHD and 268 with confirmed AGHD, 3.1% and 9.7% received GH treatment, respectively. Study subjects were, on average, 50 years old and majority female. Adjusted all-cause healthcare costs were higher among at-risk individuals (cost ratio [95% confidence interval]: 2.37 [2.26-2.49]) and among confirmed individuals (2.11 [1.52-3.43]) compared to controls. Adjusted annual AGHD-related costs were lower among confirmed individuals compared to at-risk individuals (0.62 [0.52-0.76]) and among treated individuals compared to untreated individuals (0.55 [0.47-0.64]) for those initiating GH therapy.ConclusionsAll-cause healthcare costs were higher among individuals with confirmed AGHD or at risk for AGHD than among adults without GHD. After excluding the cost of GH therapy, lower adjusted AGHD-related costs were associated with both a confirmed AGHD diagnosis and receipt of GH treatment.

This retrospective cohort study evaluated the relative vaccine effectiveness (rVE) of two bivalent (Original/Omicron BA.4/BA.5) vaccines mRNA-1273.222 versus BNT162b2 Bivalent in preventing COVID-19-related outcomes in adults with underlying medical conditions associated with increased risk for severe COVID-19. In a linked EHR-claims dataset, US adults (≥18 years) with ≥1 underlying medical condition of interest who received either bivalent vaccine between August 31, 2022, and February 28, 2023, were identified. Inverse probability of treatment weighting was used to adjust for cohort differences. Cohorts were followed up for COVID-19-related hospitalizations and outpatient encounters until May 31, 2023. Hazard ratios and rVEs were estimated using Cox regression. Subgroup analyses were performed on individuals with pre-specified comorbid conditions. 757,572 mRNA-1273.222 and 1,204,975 BNT162b2 Bivalent recipients were identified. The adjusted rVE over a median follow-up of 198 days was 10.9% (6.2%-15.2%) against COVID-19-related hospitalization and 3.2% (1.7%-4.7%) against COVID-19-related outpatient encounters. rVE estimates for COVID-19 hospitalizations among subgroups with comorbid conditions were: diabetes 15.1% (8.7%–21.0%), cardiovascular disease 14.7% (9.0%–20.1%), chronic lung disease 11.9% (5.1%–18.2%), immunocompromised 15.0% (7.2%–22.2%), chronic kidney disease 8.4% (0.5%–15.7%). Overall, among adults with underlying medical conditions, mRNA-1273.222 was more effective than BNT162b2 Bivalent, especially in preventing COVID-19-related hospitalizations.