38 results on '"Arndorfer J"'
Search Results
2. Chronic renal failure after transplantation of a nonrenal organ.
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Ojo AO, Held PJ, Port FK, Wolfe RA, Leichtman AB, Young EW, Arndorfer J, Christensen L, and Merion RM
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- 2003
3. Influenza Vaccine Effectiveness Against Influenza A-Associated Emergency Department, Urgent Care, and Hospitalization Encounters Among US Adults, 2022-2023.
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Tenforde MW, Weber ZA, Yang DH, DeSilva MB, Dascomb K, Irving SA, Naleway AL, Gaglani M, Fireman B, Lewis N, Zerbo O, Goddard K, Timbol J, Hansen JR, Grisel N, Arndorfer J, McEvoy CE, Essien IJ, Rao S, Grannis SJ, Kharbanda AB, Natarajan K, Ong TC, Embi PJ, Ball SW, Dunne MM, Kirshner L, Wiegand RE, Dickerson M, Patel P, Ray C, Flannery B, Garg S, Adams K, and Klein NP
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- Humans, Middle Aged, Adult, Male, Female, United States epidemiology, Aged, Young Adult, Adolescent, Influenza A Virus, H3N2 Subtype immunology, Influenza A Virus, H1N1 Subtype immunology, Ambulatory Care statistics & numerical data, Vaccination statistics & numerical data, Seasons, Influenza, Human prevention & control, Influenza, Human epidemiology, Influenza Vaccines immunology, Influenza Vaccines administration & dosage, Hospitalization statistics & numerical data, Emergency Service, Hospital statistics & numerical data, Vaccine Efficacy
- Abstract
Background: The 2022-2023 United States influenza season had unusually early influenza activity with high hospitalization rates. Vaccine-matched A(H3N2) viruses predominated, with lower levels of A(H1N1)pdm09 activity also observed., Methods: Using the test-negative design, we evaluated influenza vaccine effectiveness (VE) during the 2022-2023 season against influenza A-associated emergency department/urgent care (ED/UC) visits and hospitalizations from October 2022 to March 2023 among adults (aged ≥18 years) with acute respiratory illness (ARI). VE was estimated by comparing odds of seasonal influenza vaccination among case-patients (influenza A test positive by molecular assay) and controls (influenza test negative), applying inverse-propensity-to-be-vaccinated weights., Results: The analysis included 85 389 ED/UC ARI encounters (17.0% influenza A positive; 37.8% vaccinated overall) and 19 751 hospitalizations (9.5% influenza A positive; 52.8% vaccinated overall). VE against influenza A-associated ED/UC encounters was 44% (95% confidence interval [CI], 40%-47%) overall and 45% and 41% among adults aged 18-64 and ≥65 years, respectively. VE against influenza A-associated hospitalizations was 35% (95% CI, 27%-43%) overall and 23% and 41% among adults aged 18-64 and ≥65 years, respectively., Conclusions: VE was moderate during the 2022-2023 influenza season, a season characterized with increased burden of influenza and co-circulation with other respiratory viruses. Vaccination is likely to substantially reduce morbidity, mortality, and strain on healthcare resources., Competing Interests: Potential conflicts of interest. During the conduct of the study, all Westat- and Kaiser Permanente Northern California Division of Research–affiliated authors reported receiving contractual support from the CDC via payments made to their respective institutions. Additionally, all authors affiliated with Baylor Scott & White Health, Children's Minnesota, Columbia University Irving Medical Center, HealthPartners Institute, Intermountain Healthcare, Kaiser Permanente Center for Health Research, Regenstrief Institute, University of Colorado Anschutz Medical Campus, and Vanderbilt University Medical Center reported receiving contractual support from the CDC during the conduct of the study, via subcontracts from Westat, Inc, with payments made to their respective institutions. Unrelated to the submitted work, the following disclosures were reported from the past 36 months: A. L. N. received grants from Pfizer and Vir Biotechnology; M. N. received grants directly from CDC and from CDC via subcontracts from Abt Associates and Vanderbilt University Medical Center to her institution; C. E. M. received grants AstraZeneca; S. R. received grants from GSK; and N. P. K. received research support from Pfizer, Merck, GlaxoSmithKline, Sanofi Pasteur, and Seqirus. All other authors report no potential conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed., (Published by Oxford University Press on behalf of Infectious Diseases Society of America 2023.)
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- 2024
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4. Vaccine Effectiveness Against Pediatric Influenza-A-Associated Urgent Care, Emergency Department, and Hospital Encounters During the 2022-2023 Season: VISION Network.
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Adams K, Weber ZA, Yang DH, Klein NP, DeSilva MB, Dascomb K, Irving SA, Naleway AL, Rao S, Gaglani M, Flannery B, Garg S, Kharbanda AB, Grannis SJ, Ong TC, Embi PJ, Natarajan K, Fireman B, Zerbo O, Goddard K, Timbol J, Hansen JR, Grisel N, Arndorfer J, Ball SW, Dunne MM, Kirshner L, Chung JR, and Tenforde MW
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- Adolescent, Child, Humans, United States epidemiology, Influenza A Virus, H3N2 Subtype, Seasons, Vaccine Efficacy, Hospitalization, Vaccination, Emergency Service, Hospital, Hospitals, Influenza, Human epidemiology, Influenza, Human prevention & control, Influenza Vaccines
- Abstract
Background: During the 2022-2023 influenza season, the United States experienced the highest influenza-associated pediatric hospitalization rate since 2010-2011. Influenza A/H3N2 infections were predominant., Methods: We analyzed acute respiratory illness (ARI)-associated emergency department or urgent care (ED/UC) encounters or hospitalizations at 3 health systems among children and adolescents aged 6 months-17 years who had influenza molecular testing during October 2022-March 2023. We estimated influenza A vaccine effectiveness (VE) using a test-negative approach. The odds of vaccination among influenza-A-positive cases and influenza-negative controls were compared after adjusting for confounders and applying inverse-propensity-to-be-vaccinated weights. We developed overall and age-stratified VE models., Results: Overall, 13 547 of 44 787 (30.2%) eligible ED/UC encounters and 263 of 1862 (14.1%) hospitalizations were influenza-A-positive cases. Among ED/UC patients, 15.2% of influenza-positive versus 27.1% of influenza-negative patients were vaccinated; VE was 48% (95% confidence interval [CI], 44-52%) overall, 53% (95% CI, 47-58%) among children aged 6 months-4 years, and 38% (95% CI, 30-45%) among those aged 9-17 years. Among hospitalizations, 17.5% of influenza-positive versus 33.4% of influenza-negative patients were vaccinated; VE was 40% (95% CI, 6-61%) overall, 56% (95% CI, 23-75%) among children ages 6 months-4 years, and 46% (95% CI, 2-70%) among those 5-17 years., Conclusions: During the 2022-2023 influenza season, vaccination reduced the risk of influenza-associated ED/UC encounters and hospitalizations by almost half (overall VE, 40-48%). Influenza vaccination is a critical tool to prevent moderate-to-severe influenza illness in children and adolescents., Competing Interests: Potential conflicts of interest . N. P. K. reports research support from Sanofi Pasteur and Seqirus for unrelated adult influenza vaccine effectiveness studies, and from Pfizer, Merck, and GlaxoSmithKline for unrelated studies. S. R. received funds from GlaxoSmithKline. M. G. reports a research grant and contract for the CDC Ambulatory US Flu/COVID VE Network, a grant for HAIVEN Adult Inpatient Flu/COVID VE, a contract for SYNERGY FLU/COVID study, and subcontracts for the IVY COVID/FLU VE PHS project and RECOVER-PROTECT COVID Cohort studies. D.-H. Y., L. K., M. M. D., S. W. B., and Z. A. W. report payments made to Westat via CDC contract number 200-2019-F-06819. A. B. K., A. L. N., J. A., K. D., K. N., M. B. D., M. G., N. G., P. J. E., S. A. I, S. J. G., S. R., and T. C. O. report payments made to their institution by CDC via Westat. All other authors report no potential conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed., (Published by Oxford University Press on behalf of Infectious Diseases Society of America 2023.)
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- 2024
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5. Risk of COVID-19 Hospitalization and Protection Associated With mRNA Vaccination Among US Adults With Psychiatric Disorders.
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Levy ME, Yang DH, Dunne MM, Miley K, Irving SA, Grannis SJ, Weber ZA, Griggs EP, Spark TL, Bassett E, Embi PJ, Gaglani M, Natarajan K, Valvi NR, Ong TC, Naleway AL, Stenehjem E, Klein NP, Link-Gelles R, DeSilva MB, Kharbanda AB, Raiyani C, Beaton MA, Dixon BE, Rao S, Dascomb K, Patel P, Mamawala M, Han J, Fadel WF, Barron MA, Grisel N, Dickerson M, Liao IC, Arndorfer J, Najdowski M, Murthy K, Ray C, Tenforde MW, and Ball SW
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- Adult, Humans, COVID-19 Vaccines, Retrospective Studies, Vaccination, Hospitalization, RNA, Messenger, COVID-19 epidemiology, COVID-19 prevention & control, Mental Disorders epidemiology
- Abstract
Background: Although psychiatric disorders have been associated with reduced immune responses to other vaccines, it remains unknown whether they influence COVID-19 vaccine effectiveness (VE). This study evaluated risk of COVID-19 hospitalization and estimated mRNA VE stratified by psychiatric disorder status., Methods: In a retrospective cohort analysis of the VISION Network in four US states, the rate of laboratory-confirmed COVID-19-associated hospitalization between December 2021 and August 2022 was compared across psychiatric diagnoses and by monovalent mRNA COVID-19 vaccination status using Cox proportional hazards regression., Results: Among 2,436,999 adults, 22.1% had ≥1 psychiatric disorder. The incidence of COVID-19-associated hospitalization was higher among patients with any versus no psychiatric disorder (394 vs. 156 per 100,000 person-years, p < 0.001). Any psychiatric disorder (adjusted hazard ratio [aHR], 1.27; 95% CI, 1.18-1.37) and mood (aHR, 1.25; 95% CI, 1.15-1.36), anxiety (aHR, 1.33, 95% CI, 1.22-1.45), and psychotic (aHR, 1.41; 95% CI, 1.14-1.74) disorders were each significant independent predictors of hospitalization. Among patients with any psychiatric disorder, aHRs for the association between vaccination and hospitalization were 0.35 (95% CI, 0.25-0.49) after a recent second dose, 0.08 (95% CI, 0.06-0.11) after a recent third dose, and 0.33 (95% CI, 0.17-0.66) after a recent fourth dose, compared to unvaccinated patients. Corresponding VE estimates were 65%, 92%, and 67%, respectively, and were similar among patients with no psychiatric disorder (68%, 92%, and 79%)., Conclusion: Psychiatric disorders were associated with increased risk of COVID-19-associated hospitalization. However, mRNA vaccination provided similar protection regardless of psychiatric disorder status, highlighting its benefit for individuals with psychiatric disorders., (© 2024 The Authors. Influenza and Other Respiratory Viruses published by John Wiley & Sons Ltd.)
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- 2024
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6. Clinical Epidemiology and Risk Factors for Critical Outcomes Among Vaccinated and Unvaccinated Adults Hospitalized With COVID-19-VISION Network, 10 States, June 2021-March 2023.
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Griggs EP, Mitchell PK, Lazariu V, Gaglani M, McEvoy C, Klein NP, Valvi NR, Irving SA, Kojima N, Stenehjem E, Crane B, Rao S, Grannis SJ, Embi PJ, Kharbanda AB, Ong TC, Natarajan K, Dascomb K, Naleway AL, Bassett E, DeSilva MB, Dickerson M, Konatham D, Fireman B, Allen KS, Barron MA, Beaton M, Arndorfer J, Vazquez-Benitez G, Garg S, Murthy K, Goddard K, Dixon BE, Han J, Grisel N, Raiyani C, Lewis N, Fadel WF, Stockwell MS, Mamawala M, Hansen J, Zerbo O, Patel P, Link-Gelles R, Adams K, and Tenforde MW
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- Adult, Humans, Adolescent, Middle Aged, Aged, COVID-19 Vaccines, Hospitalization, Immunity, Herd, Risk Factors, COVID-19 epidemiology, COVID-19 prevention & control
- Abstract
Background: The epidemiology of coronavirus disease 2019 (COVID-19) continues to develop with emerging variants, expanding population-level immunity, and advances in clinical care. We describe changes in the clinical epidemiology of COVID-19 hospitalizations and risk factors for critical outcomes over time., Methods: We included adults aged ≥18 years from 10 states hospitalized with COVID-19 June 2021-March 2023. We evaluated changes in demographics, clinical characteristics, and critical outcomes (intensive care unit admission and/or death) and evaluated critical outcomes risk factors (risk ratios [RRs]), stratified by COVID-19 vaccination status., Results: A total of 60 488 COVID-19-associated hospitalizations were included in the analysis. Among those hospitalized, median age increased from 60 to 75 years, proportion vaccinated increased from 18.2% to 70.1%, and critical outcomes declined from 24.8% to 19.4% (all P < .001) between the Delta (June-December, 2021) and post-BA.4/BA.5 (September 2022-March 2023) periods. Hospitalization events with critical outcomes had a higher proportion of ≥4 categories of medical condition categories assessed (32.8%) compared to all hospitalizations (23.0%). Critical outcome risk factors were similar for unvaccinated and vaccinated populations; presence of ≥4 medical condition categories was most strongly associated with risk of critical outcomes regardless of vaccine status (unvaccinated: adjusted RR, 2.27 [95% confidence interval {CI}, 2.14-2.41]; vaccinated: adjusted RR, 1.73 [95% CI, 1.56-1.92]) across periods., Conclusions: The proportion of adults hospitalized with COVID-19 who experienced critical outcomes decreased with time, and median patient age increased with time. Multimorbidity was most strongly associated with critical outcomes., Competing Interests: Potential conflicts of interest. M. G. reports additional grants or institutional contracts with the CDC Ambulatory US Flu/COVID Vaccine Effectiveness (VE) Network, Hospitalized Adult Influenza Vaccine Effectiveness Network (HAIVEN) Adult Inpatient Flu/COVID VE, Investigating Respiratory Viruses in the Acutely Ill Public Health Surveillance Network, and Researching COVID to Enhance Recovery and Health and Human Services Protect. C. M. reports an institutional grant or contract from AstraZeneca (AZD1222) for a COVID-19 vaccination trial. A. L. N. reports institutional research funding from Pfizer for an unrelated study of meningococcal B vaccine safety during pregnancy and Vir Biotechnology for an unrelated influenza study. S. A. I. reports an additional pending contract with CDC (200-2012-53584, Vaccine Safety Datalink). G. V.-B. reports grants or contracts from CDC (Vaccine Safety Datalink) and Sanofi (Tdap Vaccine Safety). A. B. K. reports a subcontract through HealthPartners for VISION payment made to Children's Minnesota. B. E. D. reports a grant from the National Institutes of Health to evaluate Health Information Exchange (HIE) technologies, a grant from CDC to use HIE data for public health surveillance, an R21 grant from the US Agency for Healthcare Research and Quality to evaluate HIE technologies, a grant from the US Department of Veterans Affairs to evaluate HIE technologies, royalties from Elsevier and Springer Nature for books on HIE and public health informatics, and consulting fees for advisory panel on human papillomavirus vaccination from Merck and Co. K. M. reports 2 additional contracts with CDC (Ambulatory US Flu VE Network and HAIVEN). N. P. K. has received grants from Pfizer, Merck, GlaxoSmithKline, and Sanofi Pasteur. S. R. has received grant funds from GlaxoSmithKline. P. K. M., V. L., and E. B. report payments made to Westat via CDC (contract number 200-2019-F-06819). C. M., C. R., D. K., E. S., G. V.-B., J. A., J. Han., K. S. A., K. N., K. D., M. B., M. B. D., M. M., M. S. S., N. G., N. R. V., P. J. E., S. G., T. C. O., and W. F. F. report payments made to their institution by CDC via Westat. All other authors report no potential conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed., (Published by Oxford University Press on behalf of Infectious Diseases Society of America 2023.)
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- 2024
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7. Effectiveness of COVID-19 vaccines at preventing emergency department or urgent care encounters and hospitalizations among immunocompromised adults: An observational study of real-world data across 10 US states from August-December 2021.
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Embi PJ, Levy ME, Patel P, DeSilva MB, Gaglani M, Dascomb K, Dunne MM, Klein NP, Ong TC, Grannis SJ, Natarajan K, Yang DH, Stenehjem E, Zerbo O, McEvoy C, Rao S, Thompson MG, Konatham D, Irving SA, Dixon BE, Han J, Schrader KE, Grisel N, Lewis N, Kharbanda AB, Barron MA, Reynolds S, Liao IC, Fadel WF, Rowley EA, Arndorfer J, Goddard K, Murthy K, Valvi NR, Weber ZA, Fireman B, Reese SE, Ball SW, and Naleway AL
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- Humans, Adult, COVID-19 Vaccines, SARS-CoV-2, Emergency Service, Hospital, Hospitalization, RNA, Messenger, COVID-19 prevention & control, Viral Vaccines
- Abstract
Background: Immunocompromised (IC) persons are at increased risk for severe COVID-19 outcomes and are less protected by 1-2 COVID-19 vaccine doses than are immunocompetent (non-IC) persons. We compared vaccine effectiveness (VE) against medically attended COVID-19 of 2-3 mRNA and 1-2 viral-vector vaccine doses between IC and non-IC adults., Methods: Using a test-negative design among eight VISION Network sites, VE against laboratory-confirmed COVID-19-associated emergency department (ED) or urgent care (UC) events and hospitalizations from 26 August-25 December 2021 was estimated separately among IC and non-IC adults and among specific IC condition subgroups. Vaccination status was defined using number and timing of doses. VE for each status (versus unvaccinated) was adjusted for age, geography, time, prior positive test result, and local SARS-CoV-2 circulation., Results: We analyzed 8,848 ED/UC events and 18,843 hospitalizations among IC patients and 200,071 ED/UC events and 70,882 hospitalizations among non-IC patients. Among IC patients, 3-dose mRNA VE against ED/UC (73% [95% CI: 64-80]) and hospitalization (81% [95% CI: 76-86]) was lower than that among non-IC patients (ED/UC: 94% [95% CI: 93-94]; hospitalization: 96% [95% CI: 95-97]). Similar patterns were observed for viral-vector vaccines. Transplant recipients had lower VE than other IC subgroups., Conclusions: During B.1.617.2 (Delta) variant predominance, IC adults received moderate protection against COVID-19-associated medical events from three mRNA doses, or one viral-vector dose plus a second dose of any product. However, protection was lower in IC versus non-IC patients, especially among transplant recipients, underscoring the need for additional protection among IC adults., Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: All authors have completed and submitted the International Committee of Medical Journal Editors form for disclosure of potential conflicts of interest. Nicola P. Klein reports institutional support from Pfizer for COVID-19 vaccine clinical trials. Charlene McEvoy reports institutional support from AstraZeneca for an AZD1222 COVID-19 vaccine trial. Suchitra Rao reports grant support from GlaxoSmithKline and Biofire Diagnostics. Dr. Brian Dixon reports past consulting fees from Merck & Co. for serving on an advisory panel for HPV vaccination. Manjusha Gaglani reports past support from the CDC for the IVY-3 vaccine research. Kempapura Murthy reports past support from the CDC HAIVEN – Hospitalized Adult Influenza Vaccine Effectiveness Network. All other authors report no disclosures relevant to the current manuscript., (Copyright © 2023. Published by Elsevier Ltd.)
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- 2023
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8. Effectiveness of Monovalent and Bivalent mRNA Vaccines in Preventing COVID-19-Associated Emergency Department and Urgent Care Encounters Among Children Aged 6 Months-5 Years - VISION Network, United States, July 2022-June 2023.
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Link-Gelles R, Ciesla AA, Rowley EAK, Klein NP, Naleway AL, Payne AB, Kharbanda A, Natarajan K, DeSilva MB, Dascomb K, Irving SA, Zerbo O, Reese SE, Wiegand RE, Najdowski M, Ong TC, Rao S, Stockwell MS, Stephens A, Goddard K, Martinez YC, Weber ZA, Fireman B, Hansen J, Timbol J, Grannis SJ, Barron MA, Embi PJ, Ball SW, Gaglani M, Grisel N, Arndorfer J, Tenforde MW, and Fleming-Dutra KE
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- United States epidemiology, Child, Humans, COVID-19 Vaccines, Vaccines, Combined, COVID-19 Testing, SARS-CoV-2 genetics, Emergency Service, Hospital, RNA, Messenger, mRNA Vaccines, COVID-19 epidemiology, COVID-19 prevention & control
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On June 19, 2022, the original monovalent mRNA COVID-19 vaccines were approved as a primary series for children aged 6 months-4 years (Pfizer-BioNTech) and 6 months-5 years (Moderna) based on safety, immunobridging, and limited efficacy data from clinical trials. On December 9, 2022, CDC expanded recommendations for use of updated bivalent vaccines to children aged ≥6 months. mRNA COVID-19 vaccine effectiveness (VE) against emergency department or urgent care (ED/UC) encounters was evaluated within the VISION Network during July 4, 2022-June 17, 2023, among children with COVID-19-like illness aged 6 months-5 years. Among children aged 6 months-5 years who received molecular SARS-CoV-2 testing during August 1, 2022-June 17, 2023, VE of 2 monovalent Moderna doses against ED/UC encounters was 29% (95% CI = 12%-42%) ≥14 days after dose 2 (median = 100 days after dose 2; IQR = 63-155 days). Among children aged 6 months-4 years with a COVID-19-like illness who received molecular testing during September 19, 2022-June 17, 2023, VE of 3 monovalent Pfizer-BioNTech doses was 43% (95% CI = 17%-61%) ≥14 days after dose 3 (median = 75 days after dose 3; IQR = 40-139 days). Effectiveness of ≥1 bivalent dose, comparing children with at least a complete primary series and ≥1 bivalent dose to unvaccinated children, irrespective of vaccine manufacturer, was 80% (95% CI = 42%-96%) among children aged 6 months-5 years a median of 58 days (IQR = 32-83 days) after the dose. All children should stay up to date with recommended COVID-19 vaccines, including initiation of COVID-19 vaccination immediately when they are eligible., Competing Interests: All authors have completed and submitted the International Committee of Medical Journal Editors form for disclosure of potential conflicts of interest. Nicola P. Klein reports institutional support from Pfizer, Merck, GSK, Sanofi Pasteur, and Protein Sciences (now Sanofi Pasteur). Allison L. Naleway reports institutional support from Pfizer for an unrelated study of meningococcal B vaccine safety during pregnancy study and from Vir Biotechnology for an unrelated influenza study. Suchitra Rao reports grant support from GSK. No other potential conflicts of interest were disclosed.
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- 2023
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9. Vaccine Effectiveness Against Influenza-Associated Urgent Care, Emergency Department, and Hospital Encounters During the 2021-2022 Season, VISION Network.
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Tenforde MW, Weber ZA, DeSilva MB, Stenehjem E, Yang DH, Fireman B, Gaglani M, Kojima N, Irving SA, Rao S, Grannis SJ, Naleway AL, Kirshner L, Kharbanda AB, Dascomb K, Lewis N, Dalton AF, Ball SW, Natarajan K, Ong TC, Hartmann E, Embi PJ, McEvoy CE, Grisel N, Zerbo O, Dunne MM, Arndorfer J, Goddard K, Dickerson M, Patel P, Timbol J, Griggs EP, Hansen J, Thompson MG, Flannery B, and Klein NP
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- Adult, Humans, United States epidemiology, Child, Preschool, Influenza A Virus, H3N2 Subtype, Seasons, Vaccine Efficacy, SARS-CoV-2, Vaccination, Emergency Service, Hospital, Ambulatory Care, Hospitals, Case-Control Studies, Influenza, Human epidemiology, Influenza, Human prevention & control, Influenza A Virus, H1N1 Subtype, COVID-19 epidemiology, COVID-19 prevention & control, Influenza Vaccines
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Background: Following historically low influenza activity during the 2020-2021 season, the United States saw an increase in influenza circulating during the 2021-2022 season. Most viruses belonged to the influenza A(H3N2) 3C.2a1b 2a.2 subclade., Methods: We conducted a test-negative case-control analysis among adults ≥18 years of age at 3 sites within the VISION Network. Encounters included emergency department/urgent care (ED/UC) visits or hospitalizations with ≥1 acute respiratory illness (ARI) discharge diagnosis codes and molecular testing for influenza. Vaccine effectiveness (VE) was calculated by comparing the odds of influenza vaccination ≥14 days before the encounter date between influenza-positive cases (type A) and influenza-negative and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-negative controls, applying inverse probability-to-be-vaccinated weights, and adjusting for confounders., Results: In total, 86 732 ED/UC ARI-associated encounters (7696 [9%] cases) and 16 805 hospitalized ARI-associated encounters (649 [4%] cases) were included. VE against influenza-associated ED/UC encounters was 25% (95% confidence interval (CI), 20%-29%) and 25% (95% CI, 11%-37%) against influenza-associated hospitalizations. VE against ED/UC encounters was lower in adults ≥65 years of age (7%; 95% CI, -5% to 17%) or with immunocompromising conditions (4%; 95% CI, -45% to 36%)., Conclusions: During an influenza A(H3N2)-predominant influenza season, modest VE was observed. These findings highlight the need for improved vaccines, particularly for A(H3N2) viruses that are historically associated with lower VE., Competing Interests: Potential conflicts of interest. S. R. received grants from GlaxoSmithKline. A. L. N. received grants from Pfizer and Vir Biotechnology. C. M. received grants from AstraZeneca. N. P. K. received grants from Pfizer, Merck, GlaxoSmithKline, and Sanofi Pasteur. All other authors report no potential conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed., (Published by Oxford University Press on behalf of Infectious Diseases Society of America 2023.)
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- 2023
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10. Estimates of Bivalent mRNA Vaccine Durability in Preventing COVID-19-Associated Hospitalization and Critical Illness Among Adults with and Without Immunocompromising Conditions - VISION Network, September 2022-April 2023.
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Link-Gelles R, Weber ZA, Reese SE, Payne AB, Gaglani M, Adams K, Kharbanda AB, Natarajan K, DeSilva MB, Dascomb K, Irving SA, Klein NP, Grannis SJ, Ong TC, Embi PJ, Dunne MM, Dickerson M, McEvoy C, Arndorfer J, Naleway AL, Goddard K, Dixon BE, Griggs EP, Hansen J, Valvi N, Najdowski M, Timbol J, Rogerson C, Fireman B, Fadel WF, Patel P, Ray CS, Wiegand R, Ball S, and Tenforde MW
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- Adult, Humans, Hospitalization, mRNA Vaccines, Critical Illness, COVID-19 prevention & control
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- 2023
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11. Number needed to vaccinate with a COVID-19 booster to prevent a COVID-19-associated hospitalization during SARS-CoV-2 Omicron BA.1 variant predominance, December 2021-February 2022, VISION Network: a retrospective cohort study.
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Adams K, Riddles JJ, Rowley EAK, Grannis SJ, Gaglani M, Fireman B, Hartmann E, Naleway AL, Stenehjem E, Hughes A, Dalton AF, Natarajan K, Dascomb K, Raiyani C, Irving SA, Sloan-Aagard C, Kharbanda AB, DeSilva MB, Dixon BE, Ong TC, Keller J, Dickerson M, Grisel N, Murthy K, Nanez J, Fadel WF, Ball SW, Patel P, Arndorfer J, Mamawala M, Valvi NR, Dunne MM, Griggs EP, Embi PJ, Thompson MG, Link-Gelles R, and Tenforde MW
- Abstract
Background: Understanding the usefulness of additional COVID-19 vaccine doses-particularly given varying disease incidence-is needed to support public health policy. We characterize the benefits of COVID-19 booster doses using number needed to vaccinate (NNV) to prevent one COVID-19-associated hospitalization or emergency department encounter., Methods: We conducted a retrospective cohort study of immunocompetent adults at five health systems in four U.S. states during SARS-CoV-2 Omicron BA.1 predominance (December 2021-February 2022). Included patients completed a primary mRNA COVID-19 vaccine series and were either eligible to or received a booster dose. NNV were estimated using hazard ratios for each outcome (hospitalization and emergency department encounters), with results stratified by three 25-day periods and site., Findings: 1,285,032 patients contributed 938 hospitalizations and 2076 emergency department encounters. 555,729 (43.2%) patients were aged 18-49 years, 363,299 (28.3%) 50-64 years, and 366,004 (28.5%) ≥65 years. Most patients were female (n = 765,728, 59.6%), White (n = 990,224, 77.1%), and non-Hispanic (n = 1,063,964, 82.8%). 37.2% of patients received a booster and 62.8% received only two doses. Median estimated NNV to prevent one hospitalization was 205 (range 44-615) and NNV was lower across study periods for adults aged ≥65 years (110, 46, and 88, respectively) and those with underlying medical conditions (163, 69, and 131, respectively). Median estimated NNV to prevent one emergency department encounter was 156 (range 75-592)., Interpretation: The number of patients needed to receive a booster dose was highly dependent on local disease incidence, outcome severity, and patient risk factors for moderate-to-severe disease., Funding: Funding was provided by the Centers for Disease Control and Prevention though contract 75D30120C07986 to Westat, Inc. and contract 75D30120C07765 to Kaiser Foundation Hospitals., Competing Interests: All authors have completed and submitted the International Committee of Medical Journal Editors form for disclosure of potential conflicts of interest. M.G. reports additional contracts with CDC Ambulatory US Flu/COVID VE Network, HAIVEN Adult Inpatient Flu/COVID VE, IVY-3 PHS, and RECOVER. A.L.N. reports research funding from Pfizer for an unrelated study of meningococcal B vaccine safety during pregnancy and Vir Biotechnology for an unrelated influenza study. S.A.I. reports an additional contract with Centers for Disease Control and Prevention, 200-2012-53584 (Vaccine Safety Datalink). A.K. reports a subcontract through HealthPartners for VISION payment made to Children’s Minnesota. B.E.D. reports a grant from NIH to evaluate HIE technologies, a grant from CDC to use HIE data for public health surveillance, an R21 grant from U.S. Agency for Healthcare Research Quality to evaluate HIE technologies, a grant from the U.S Department of Veterans Affairs to evaluate HIE technologies, royalties from Elsevier and Springer Nature for books on HIE and Public Health Informatics, and consulting fees for advisory panel on HPV vaccination from Merk and Co. K.M. reports two additional contracts with CDC: Ambulatory US Flu VE Network and HAIVEN Hospitalized Adult Influenza Vaccine Effectiveness Network. J.J.R., E.A.K.R., A.H., J.K., S.W.B., and M.M.D. report payments made to Westat via CDC Contract #200-2019-F-06819. B.F., E.H., E.S., K.N., K.D., C.R., C.S-A., M.B.D., T.C.O., N.G., J.N., J.A., N.R.V., and P.J.E. report payments made to their institution by CDC via Westat. No other potential conflicts of interest were disclosed.
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- 2023
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12. Protection From COVID-19 mRNA Vaccination and Prior SARS-CoV-2 Infection Against COVID-19-Associated Encounters in Adults During Delta and Omicron Predominance.
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Bozio CH, Butterfield KA, Briggs Hagen M, Grannis S, Drawz P, Hartmann E, Ong TC, Fireman B, Natarajan K, Dascomb K, Gaglani M, DeSilva MB, Yang DH, Midgley CM, Dixon BE, Naleway AL, Grisel N, Liao IC, Reese SE, Fadel WF, Irving SA, Lewis N, Arndorfer J, Murthy K, Riddles J, Valvi NR, Mamawala M, Embi PJ, Thompson MG, and Stenehjem E
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- Humans, Adult, SARS-CoV-2 genetics, COVID-19 Vaccines, Cohort Studies, Vaccination, RNA, Messenger genetics, COVID-19 epidemiology, COVID-19 prevention & control
- Abstract
Background: Data assessing protection conferred from COVID-19 mRNA vaccination and/or prior SARS-CoV-2 infection during Delta and Omicron predominance periods in the United States are limited., Methods: This cohort study included persons ≥18 years who had ≥1 health care encounter across 4 health systems and had been tested for SARS-CoV-2 before 26 August 2021. COVID-19 mRNA vaccination and prior SARS-CoV-2 infection defined the exposure. Cox regression estimated hazard ratios (HRs) for the Delta and Omicron periods; protection was calculated as (1-HR)×100%., Results: Compared to unvaccinated and previously uninfected persons, during Delta predominance, protection against COVID-19-associated hospitalizations was high for those 2- or 3-dose vaccinated and previously infected, 3-dose vaccinated alone, and prior infection alone (range, 91%-97%, with overlapping 95% confidence intervals [CIs]); during Omicron predominance, estimates were lower (range, 77%-90%). Protection against COVID-19-associated emergency department/urgent care (ED/UC) encounters during Delta predominance was high for those exposure groups (range, 86%-93%); during Omicron predominance, protection remained high for those 3-dose vaccinated with or without a prior infection (76%; 95% CI = 67%-83% and 71%; 95% CI = 67%-73%, respectively)., Conclusions: COVID-19 mRNA vaccination and/or prior SARS-CoV-2 infection provided protection against COVID-19-associated hospitalizations and ED/UC encounters regardless of variant. Staying up-to-date with COVID-19 vaccination still provides protection against severe COVID-19 disease, regardless of prior infection., Competing Interests: Potential conflicts of interest. S. A. I., M. G., K. M., and B. E. D. report institutional support from Westat. A. L. N. reports institutional support from Pfizer for a study of meningococcal B vaccine safety during pregnancy and from Vir Biotechnology for an influenza study, unrelated to the current work. K. M. reports institutional support from CDC for 2 influenza studies, unrelated to the current work. M. G. reports institutional support from CDC for 2 influenza studies and 2 COVID-19 studies, all unrelated to the current work. B. E. D. reports support from US National Institutes of Health, CDC, Agency for Healthcare Research and Quality, and Department of Veterans Affairs related to use and evaluation of health information exchange technologies; royalties from Elsevier and Springer Nature for books; and consulting fees from Merck and Co. for advisory panel on HPV vaccination. All other authors report no potential conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed., (Published by Oxford University Press on behalf of Infectious Diseases Society of America 2023.)
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- 2023
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13. Relationships Between Social Vulnerability and Coronavirus Disease 2019 Vaccination Coverage and Vaccine Effectiveness.
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Dalton AF, Weber ZA, Allen KS, Stenehjem E, Irving SA, Spark TL, Adams K, Zerbo O, Lazariu V, Dixon BE, Dascomb K, Hartmann E, Kharbanda AB, Ong TC, DeSilva MB, Beaton M, Gaglani M, Patel P, Naleway AL, Kish MNS, Grannis SJ, Grisel N, Sloan-Aagard C, Rao S, Raiyani C, Dickerson M, Bassett E, Fadel WF, Arndorfer J, Nanez J, Barron MA, Vazquez-Benitez G, Liao IC, Griggs EP, Reese SE, Valvi NR, Murthy K, Rowley EAK, Embi PJ, Ball S, Link-Gelles R, and Tenforde MW
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- Adult, Humans, Social Vulnerability, SARS-CoV-2, COVID-19 Vaccines, Vaccination Coverage, Vaccine Efficacy, COVID-19 epidemiology, COVID-19 prevention & control
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Background: Coronavirus disease 2019 (COVID-19) vaccination coverage remains lower in communities with higher social vulnerability. Factors such as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) exposure risk and access to healthcare are often correlated with social vulnerability and may therefore contribute to a relationship between vulnerability and observed vaccine effectiveness (VE). Understanding whether these factors impact VE could contribute to our understanding of real-world VE., Methods: We used electronic health record data from 7 health systems to assess vaccination coverage among patients with medically attended COVID-19-like illness. We then used a test-negative design to assess VE for 2- and 3-dose messenger RNA (mRNA) adult (≥18 years) vaccine recipients across Social Vulnerability Index (SVI) quartiles. SVI rankings were determined by geocoding patient addresses to census tracts; rankings were grouped into quartiles for analysis., Results: In July 2021, primary series vaccination coverage was higher in the least vulnerable quartile than in the most vulnerable quartile (56% vs 36%, respectively). In February 2022, booster dose coverage among persons who had completed a primary series was higher in the least vulnerable quartile than in the most vulnerable quartile (43% vs 30%). VE among 2-dose and 3-dose recipients during the Delta and Omicron BA.1 periods of predominance was similar across SVI quartiles., Conclusions: COVID-19 vaccination coverage varied substantially by SVI. Differences in VE estimates by SVI were minimal across groups after adjusting for baseline patient factors. However, lower vaccination coverage among more socially vulnerable groups means that the burden of illness is still disproportionately borne by the most socially vulnerable populations., Competing Interests: Potential conflicts of interest. B. E. D. reported consulting fees for advisory panel on HPV vaccination from Merck & Co and book royalties from Elsevier (book on HIE) as well as Springer Nature (book on Public Health Informatics), and grant to evaluate HIE technologies from US National Institutes of Health (NIH), grant to use HIE data for public health surveillance from CDC, R21 grant to evaluate HIE technologies from US Agency for Healthcare Research and Quality, grant to evaluate HIE technologies from US Department of Veterans Affairs. G. V. B. reported grants or contracts from Sanofi for Tdap Vaccine Safety and from CDC for Vaccine Safety Datalink. A. I. N. received institutional support from Pfizer for an unrelated study of meningococcal B vaccine safety during pregnancy and institutional research funding from Vir Biotechnology for unrelated influenza study. S. Rao received grant funding from GlaxoSmithKline. S. A. I. reports contract no. 200-2012-53584 (Vaccine Safety Datalink) from CDC. M. B. reports Columbia University is part of the VISION surveillance network and receives funding from Westat to support work done at Columbia as part of VISION. M. G. reports Ambulatory US Flu/COVID VE Network institutional grant, HAIVEN Adult Inpatient Flu/COVID VE institutional grant from CDC, IVY-3 PHS project institutional subcontract from CDC-Vanderbilt, and RECOVER study institutional subcontract from CDC-Abt. K. M. reports contracts or grants paid to institution from US CDC Ambulatory US Flu VE Network and US CDC HAIVEN—Hospitalized Adult Influenza Vaccine Effectiveness Network. All other authors report no potential conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed., (Published by Oxford University Press on behalf of Infectious Diseases Society of America 2023.)
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- 2023
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14. Effectiveness of BNT162b2 COVID-19 Vaccination in Children and Adolescents.
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Klein NP, Demarco M, Fleming-Dutra KE, Stockwell MS, Kharbanda AB, Gaglani M, Rao S, Lewis N, Irving SA, Hartmann E, Natarajan K, Dalton AF, Zerbo O, DeSilva MB, Konatham D, Stenehjem E, Rowley EAK, Ong TC, Grannis SJ, Sloan-Aagard C, Han J, Verani JR, Raiyani C, Dascomb K, Reese SE, Barron MA, Fadel WF, Naleway AL, Nanez J, Dickerson M, Goddard K, Murthy K, Grisel N, Weber ZA, Dixon BE, Patel P, Fireman B, Arndorfer J, Valvi NR, Griggs EP, Hallowell C, Embi PJ, Ball SW, Thompson MG, Tenforde MW, and Link-Gelles R
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- Humans, Adolescent, Child, Child, Preschool, COVID-19 Vaccines, Case-Control Studies, Vaccination, BNT162 Vaccine, COVID-19 epidemiology, COVID-19 prevention & control
- Abstract
Objectives: We assessed BNT162b2 vaccine effectiveness (VE) against mild to moderate and severe coronavirus disease 2019 (COVID-19) in children and adolescents through the Omicron BA.4/BA.5 period., Methods: Using VISION Network records from April 2021 to September 2022, we conducted a test-negative, case-control study assessing VE against COVID-19-associated emergency department/urgent care (ED/UC) encounters and hospitalizations using logistic regression, conditioned on month and site, adjusted for covariates., Results: We compared 9800 ED/UC cases with 70 232 controls, and 305 hospitalized cases with 2612 controls. During Delta, 2-dose VE against ED/UC encounters at 12 to 15 years was initially 93% (95% confidence interval 89 to 95), waning to 77% (69% to 84%) after ≥150 days. At ages 16 to 17, VE was initially 93% (86% to 97%), waning to 72% (63% to 79%) after ≥150 days. During Omicron, VE at ages 12 to 15 was initially 64% (44% to 77%), waning to 13% (3% to 23%) after ≥150 days; at ages 16 to 17 VE was 31% (10% to 47%) during days 60 to 149, waning to 7% (-8 to 20%) after 150 days. A monovalent booster increased VE to 54% (40% to 65%) at ages 12 to 15 and 46% (30% to 58%) at ages 16 to 17. At ages 5 to 11, 2-dose VE was 49% (33% to 61%) initially and 41% (29% to 51%) after 150 days. During Delta, VE against hospitalizations at ages 12 to 17 was high (>97%), and at ages 16 to 17 remained 98% (73% to 100%) beyond 150 days; during Omicron, hospitalizations were too infrequent to precisely estimate VE., Conclusions: BNT162b2 protected children and adolescents against mild to moderate and severe COVID-19. VE was lower during Omicron predominance including BA.4/BA.5, waned after dose 2 but increased after a monovalent booster. Children and adolescents should receive all recommended COVID-19 vaccinations., (Copyright © 2023 by the American Academy of Pediatrics.)
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- 2023
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15. Protection of Two and Three mRNA Vaccine Doses Against Severe Outcomes Among Adults Hospitalized With COVID-19-VISION Network, August 2021 to March 2022.
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DeSilva MB, Mitchell PK, Klein NP, Dixon BE, Tenforde MW, Thompson MG, Naleway AL, Grannis SJ, Ong TC, Natarajan K, Reese SE, Zerbo O, Kharbanda AB, Patel P, Stenehjem E, Raiyani C, Irving SA, Fadel WF, Rao S, Han J, Reynolds S, Davis JM, Lewis N, McEvoy C, Dickerson M, Dascomb K, Valvi NR, Barron MA, Goddard K, Vazquez-Benitez G, Grisel N, Mamawala M, Embi PJ, Fireman B, Essien IJ, Griggs EP, Arndorfer J, and Gaglani M
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- Humans, Adult, Adolescent, SARS-CoV-2, COVID-19 Vaccines, Hospital Mortality, mRNA Vaccines, COVID-19 prevention & control
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Background: We assessed coronavirus disease 2019 (COVID-19) vaccination impact on illness severity among adults hospitalized with COVID-19, August 2021-March 2022., Methods: We evaluated differences in intensive care unit (ICU) admission, in-hospital death, and length of stay among vaccinated (2 or 3 mRNA vaccine doses) versus unvaccinated patients aged ≥18 years hospitalized for ≥24 hours with COVID-19-like illness and positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) molecular testing. We calculated odds ratios (ORs) for ICU admission and death and subdistribution hazard ratios (SHR) for time to hospital discharge adjusted for age, geographic region, calendar time, and local virus circulation., Results: We included 27 149 SARS-CoV-2-positive hospitalizations. During both Delta- and Omicron-predominant periods, protection against ICU admission was strongest among 3-dose vaccinees compared with unvaccinated patients (Delta OR, 0.52 [95% CI, .28-.96]; Omicron OR, 0.69 [95% CI, .54-.87]). During both periods, risk of in-hospital death was lower among vaccinated compared with unvaccinated patients but ORs overlapped across vaccination strata. We observed SHR >1 across all vaccination strata in both periods indicating faster discharge for vaccinated patients., Conclusions: COVID-19 vaccination was associated with lower rates of ICU admission and in-hospital death in both Delta and Omicron periods compared with being unvaccinated., Competing Interests: Potential conflicts of interest. N. P. K. reported receiving grants from Pfizer, Merck, GlaxoSmithKline, Sanofi Pasteur, and Protein Science (now Sanofi Pasteur) outside the submitted work. B. E. D. reported consulting fees for advisory panel on HPV vaccination from Merck & Co and book royalties from Elsevier as well as Springer Nature. A. L. N. received institutional support from Pfizer for an unrelated study of meningococcal B vaccine safety during pregnancy and from Vir Biotechnology for an unrelated influenza study. S. R. received grant funding from GlaxoSmithKline. C. M. received institutional support from AstraZeneca for a COVID vaccine trial. G. V.-B. reported Sanofi for Tdap Vaccine Safety. M. G. reported receiving institutional support from CDC for the ambulatory US Flu/COVID VE network and HAIVEN adult inpatient flu/COVID VE network; from CDC-Vanderbilt for the IVY-3 PHS project and from CDC-Abt for the RECOVER study. All other authors declare no financial relationships with any organizations that might have an interest in the submitted work in the previous three years, and no other relationships or activities that could appear to have influenced the submitted work. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed., (Published by Oxford University Press on behalf of Infectious Diseases Society of America 2022.)
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- 2023
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16. Early Estimates of Bivalent mRNA Vaccine Effectiveness in Preventing COVID-19-Associated Emergency Department or Urgent Care Encounters and Hospitalizations Among Immunocompetent Adults - VISION Network, Nine States, September-November 2022.
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Tenforde MW, Weber ZA, Natarajan K, Klein NP, Kharbanda AB, Stenehjem E, Embi PJ, Reese SE, Naleway AL, Grannis SJ, DeSilva MB, Ong TC, Gaglani M, Han J, Dickerson M, Fireman B, Dascomb K, Irving SA, Vazquez-Benitez G, Rao S, Konatham D, Patel P, Schrader KE, Lewis N, Grisel N, McEvoy C, Murthy K, Griggs EP, Rowley EAK, Zerbo O, Arndorfer J, Dunne MM, Goddard K, Ray C, Zhuang Y, Timbol J, Najdowski M, Yang DH, Hansen J, Ball SW, and Link-Gelles R
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- Humans, Adult, Adolescent, SARS-CoV-2 genetics, Vaccine Efficacy, Emergency Service, Hospital, Hospitalization, RNA, Messenger, Vaccines, Combined, COVID-19 epidemiology, COVID-19 prevention & control
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During June-October 2022, the SARS-CoV-2 Omicron BA.5 sublineage accounted for most of the sequenced viral genomes in the United States, with further Omicron sublineage diversification through November 2022.* Bivalent mRNA vaccines contain an ancestral SARS-CoV-2 strain component plus an updated component of the Omicron BA.4/BA.5 sublineages. On September 1, 2022, a single bivalent booster dose was recommended for adults who had completed a primary vaccination series (with or without subsequent booster doses), with the last dose administered ≥2 months earlier (1). During September 13-November 18, the VISION Network evaluated vaccine effectiveness (VE) of a bivalent mRNA booster dose (after 2, 3, or 4 monovalent doses) compared with 1) no previous vaccination and 2) previous receipt of 2, 3, or 4 monovalent-only mRNA vaccine doses, among immunocompetent adults aged ≥18 years with an emergency department/urgent care (ED/UC) encounter or hospitalization for a COVID-19-like illness.
† VE of a bivalent booster dose (after 2, 3, or 4 monovalent doses) against COVID-19-associated ED/UC encounters was 56% compared with no vaccination, 32% compared with monovalent vaccination only with last dose 2-4 months earlier, and 50% compared with monovalent vaccination only with last dose ≥11 months earlier. VE of a bivalent booster dose (after 2, 3, or 4 monovalent doses) against COVID-19-associated hospitalizations was 59% compared with no vaccination, 42% compared with monovalent vaccination only with last dose 5-7 months earlier, and 48% compared with monovalent vaccination only with last dose ≥11 months earlier. Bivalent vaccines administered after 2, 3, or 4 monovalent doses were effective in preventing medically attended COVID-19 compared with no vaccination and provided additional protection compared with past monovalent vaccination only, with relative protection increasing with time since receipt of the last monovalent dose. All eligible persons should stay up to date with recommended COVID-19 vaccinations, including receiving a bivalent booster dose. Persons should also consider taking additional precautions to avoid respiratory illness this winter season, such as masking in public indoor spaces, especially in areas where COVID-19 community levels are high., Competing Interests: All authors have completed and submitted the International Committee of Medical Journal Editors form for disclosure of potential conflicts of interest. Nicola P. Klein received grants from Pfizer, Merck, GlaxoSmithKline, and Sanofi Pasteur. Allison L. Naleway received grants from Pfizer and Vir Biotechnology. Suchitra Rao received grants from GlaxoSmithKline. Charlene McEvoy received grants from AztraZeneca. No other potential conflicts of interest were disclosed.- Published
- 2023
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17. Estimation of COVID-19 mRNA Vaccine Effectiveness and COVID-19 Illness and Severity by Vaccination Status During Omicron BA.4 and BA.5 Sublineage Periods.
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Link-Gelles R, Levy ME, Natarajan K, Reese SE, Naleway AL, Grannis SJ, Klein NP, DeSilva MB, Ong TC, Gaglani M, Hartmann E, Dickerson M, Stenehjem E, Kharbanda AB, Han J, Spark TL, Irving SA, Dixon BE, Zerbo O, McEvoy CE, Rao S, Raiyani C, Sloan-Aagard C, Patel P, Dascomb K, Uhlemann AC, Dunne MM, Fadel WF, Lewis N, Barron MA, Murthy K, Nanez J, Griggs EP, Grisel N, Annavajhala MK, Akinseye A, Valvi NR, Goddard K, Mamawala M, Arndorfer J, Yang DH, Embí PJ, Fireman B, Ball SW, and Tenforde MW
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- Adult, Humans, Female, Middle Aged, Aged, Male, Case-Control Studies, Hospital Mortality, Vaccine Efficacy, SARS-CoV-2, Vaccination, COVID-19 Vaccines, COVID-19 epidemiology, COVID-19 prevention & control
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Importance: Recent SARS-CoV-2 Omicron variant sublineages, including BA.4 and BA.5, may be associated with greater immune evasion and less protection against COVID-19 after vaccination., Objectives: To evaluate the estimated vaccine effectiveness (VE) of 2, 3, or 4 doses of COVID-19 mRNA vaccination among immunocompetent adults during a period of BA.4 or BA.5 predominant circulation; and to evaluate the relative severity of COVID-19 in hospitalized patients across Omicron BA.1, BA.2 or BA.2.12.1, and BA.4 or BA.5 sublineage periods., Design, Setting, and Participants: This test-negative case-control study was conducted in 10 states with data from emergency department (ED) and urgent care (UC) encounters and hospitalizations from December 16, 2021, to August 20, 2022. Participants included adults with COVID-19-like illness and molecular testing for SARS-CoV-2. Data were analyzed from August 2 to September 21, 2022., Exposures: mRNA COVID-19 vaccination., Main Outcomes and Measures: The outcomes of interest were COVID-19 ED or UC encounters, hospitalizations, and admission to the intensive care unit (ICU) or in-hospital death. VE associated with protection against medically attended COVID-19 was estimated, stratified by care setting and vaccine doses (2, 3, or 4 doses vs 0 doses as the reference group). Among hospitalized patients with COVID-19, demographic and clinical characteristics and in-hospital outcomes were compared across sublineage periods., Results: During the BA.4 and BA.5 predominant period, there were 82 229 eligible ED and UC encounters among patients with COVID-19-like illness (median [IQR] age, 51 [33-70] years; 49 682 [60.4%] female patients), and 19 114 patients (23.2%) had test results positive for SARS-CoV-2; among 21 007 hospitalized patients (median [IQR] age, 71 [58-81] years; 11 209 [53.4%] female patients), 3583 (17.1 %) had test results positive for SARS-CoV-2. Estimated VE against hospitalization was 25% (95% CI, 17%-32%) for receipt of 2 vaccine doses at 150 days or more after receipt, 68% (95% CI, 50%-80%) for a third dose 7 to 119 days after receipt, and 36% (95% CI, 29%-42%) for a third dose 120 days or more (median [IQR], 235 [204-262] days) after receipt. Among patients aged 65 years or older who had received a fourth vaccine dose, VE was 66% (95% CI, 53%-75%) at 7 to 59 days after vaccination and 57% (95% CI, 44%-66%) at 60 days or more (median [IQR], 88 [75-105] days) after vaccination. Among hospitalized patients with COVID-19, ICU admission or in-hospital death occurred in 21.4% of patients during the BA.1 period vs 14.7% during the BA.4 and BA.5 period (standardized mean difference: 0.17)., Conclusions and Relevance: In this case-control study of COVID-19 vaccines and illness, VE associated with protection against medically attended COVID-19 illness was lower with increasing time since last dose; estimated VE was higher after receipt of 1 or 2 booster doses compared with a primary series alone.
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- 2023
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18. Early Estimates of Bivalent mRNA Vaccine Effectiveness in Preventing COVID-19-Associated Emergency Department or Urgent Care Encounters and Hospitalizations Among Immunocompetent Adults - VISION Network, Nine States, September-November 2022.
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Tenforde MW, Weber ZA, Natarajan K, Klein NP, Kharbanda AB, Stenehjem E, Embi PJ, Reese SE, Naleway AL, Grannis SJ, DeSilva MB, Ong TC, Gaglani M, Han J, Dickerson M, Fireman B, Dascomb K, Irving SA, Vazquez-Benitez G, Rao S, Konatham D, Patel P, Schrader KE, Lewis N, Grisel N, McEvoy C, Murthy K, Griggs EP, Rowley EAK, Zerbo O, Arndorfer J, Dunne MM, Goddard K, Ray C, Zhuang Y, Timbol J, Najdowski M, Yang DH, Hansen J, Ball SW, and Link-Gelles R
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- Humans, Adult, Adolescent, SARS-CoV-2 genetics, Vaccine Efficacy, Emergency Service, Hospital, Hospitalization, RNA, Messenger, Vaccines, Combined, COVID-19 epidemiology, COVID-19 prevention & control
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During June-October 2022, the SARS-CoV-2 Omicron BA.5 sublineage accounted for most of the sequenced viral genomes in the United States, with further Omicron sublineage diversification through November 2022.* Bivalent mRNA vaccines contain an ancestral SARS-CoV-2 strain component plus an updated component of the Omicron BA.4/BA.5 sublineages. On September 1, 2022, a single bivalent booster dose was recommended for adults who had completed a primary vaccination series (with or without subsequent booster doses), with the last dose administered ≥2 months earlier (1). During September 13-November 18, the VISION Network evaluated vaccine effectiveness (VE) of a bivalent mRNA booster dose (after 2, 3, or 4 monovalent doses) compared with 1) no previous vaccination and 2) previous receipt of 2, 3, or 4 monovalent-only mRNA vaccine doses, among immunocompetent adults aged ≥18 years with an emergency department/urgent care (ED/UC) encounter or hospitalization for a COVID-19-like illness.
† VE of a bivalent booster dose (after 2, 3, or 4 monovalent doses) against COVID-19-associated ED/UC encounters was 56% compared with no vaccination, 31% compared with monovalent vaccination only with last dose 2-4 months earlier, and 50% compared with monovalent vaccination only with last dose ≥11 months earlier. VE of a bivalent booster dose (after 2, 3, or 4 monovalent doses) against COVID-19-associated hospitalizations was 57% compared with no vaccination, 38% compared with monovalent vaccination only with last dose 5-7 months earlier, and 45% compared with monovalent vaccination only with last dose ≥11 months earlier. Bivalent vaccines administered after 2, 3, or 4 monovalent doses were effective in preventing medically attended COVID-19 compared with no vaccination and provided additional protection compared with past monovalent vaccination only, with relative protection increasing with time since receipt of the last monovalent dose. All eligible persons should stay up to date with recommended COVID-19 vaccinations, including receiving a bivalent booster dose. Persons should also consider taking additional precautions to avoid respiratory illness this winter season, such as masking in public indoor spaces, especially in areas where COVID-19 community levels are high., Competing Interests: All authors have completed and submitted the International Committee of Medical Journal Editors form for disclosure of potential conflicts of interest. Nicola P. Klein received grants from Pfizer, Merck, GlaxoSmithKline, and Sanofi Pasteur. Allison L. Naleway received grants from Pfizer and Vir Biotechnology. Suchitra Rao received grants from GlaxoSmithKline. Charlene McEvoy received grants from AztraZeneca. No other potential conflicts of interest were disclosed.- Published
- 2022
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19. Effectiveness of COVID-19 mRNA Vaccines Against COVID-19-Associated Hospitalizations Among Immunocompromised Adults During SARS-CoV-2 Omicron Predominance - VISION Network, 10 States, December 2021-August 2022.
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Britton A, Embi PJ, Levy ME, Gaglani M, DeSilva MB, Dixon BE, Dascomb K, Patel P, Schrader KE, Klein NP, Ong TC, Natarajan K, Hartmann E, Kharbanda AB, Irving SA, Dickerson M, Dunne MM, Raiyani C, Grannis SJ, Stenehjem E, Zerbo O, Rao S, Han J, Sloan-Aagard C, Griggs EP, Weber ZA, Murthy K, Fadel WF, Grisel N, McEvoy C, Lewis N, Barron MA, Nanez J, Reese SE, Mamawala M, Valvi NR, Arndorfer J, Goddard K, Yang DH, Fireman B, Ball SW, Link-Gelles R, Naleway AL, and Tenforde MW
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- Adult, Humans, SARS-CoV-2, Antiviral Agents, Hospitalization, Vaccines, Combined, RNA, Messenger, mRNA Vaccines, COVID-19 Vaccines, COVID-19 epidemiology, COVID-19 prevention & control
- Abstract
Persons with moderate-to-severe immunocompromising conditions might have reduced protection after COVID-19 vaccination, compared with persons without immunocompromising conditions (1-3). On August 13, 2021, the Advisory Committee on Immunization Practices (ACIP) recommended that adults with immunocompromising conditions receive an expanded primary series of 3 doses of an mRNA COVID-19 vaccine. ACIP followed with recommendations on September 23, 2021, for a fourth (booster) dose and on September 1, 2022, for a new bivalent mRNA COVID-19 vaccine booster dose, containing components of the BA.4 and BA.5 sublineages of the Omicron (B.1.1.529) variant (4). Data on vaccine effectiveness (VE) of monovalent COVID-19 vaccines among persons with immunocompromising conditions since the emergence of the Omicron variant in December 2021 are limited. In the multistate VISION Network,
§ monovalent 2-, 3-, and 4-dose mRNA VE against COVID-19-related hospitalization were estimated among adults with immunocompromising conditions¶ hospitalized with COVID-19-like illness,** using a test-negative design comparing odds of previous vaccination among persons with a positive or negative molecular test result (case-patients and control-patients) for SARS-CoV-2 (the virus that causes COVID-19). During December 16, 2021-August 20, 2022, among SARS-CoV-2 test-positive case-patients, 1,815 (36.3%), 1,387 (27.7%), 1,552 (31.0%), and 251 (5.0%) received 0, 2, 3, and 4 mRNA COVID-19 vaccine doses, respectively. Among test-negative control-patients during this period, 6,928 (23.7%), 7,411 (25.4%), 12,734 (43.6%), and 2,142 (7.3%) received these respective doses. Overall, VE against COVID-19-related hospitalization among adults with immunocompromising conditions hospitalized for COVID-like illness during Omicron predominance was 36% ≥14 days after dose 2, 69% 7-89 days after dose 3, and 44% ≥90 days after dose 3. Restricting the analysis to later periods when Omicron sublineages BA.2/BA.2.12.1 and BA.4/BA.5 were predominant and 3-dose recipients were eligible to receive a fourth dose, VE was 32% ≥90 days after dose 3 and 43% ≥7 days after dose 4. Protection offered by vaccination among persons with immunocompromising conditions during Omicron predominance was moderate even after a 3-dose monovalent primary series or booster dose. Given the incomplete protection against hospitalization afforded by monovalent COVID-19 vaccines, persons with immunocompromising conditions might benefit from updated bivalent vaccine booster doses that target recently circulating Omicron sublineages, in line with ACIP recommendations. Further, additional protective recommendations for persons with immunocompromising conditions, including the use of prophylactic antibody therapy, early access to and use of antivirals, and enhanced nonpharmaceutical interventions such as well-fitting masks or respirators, should also be considered., Competing Interests: All authors have completed and submitted the International Committee of Medical Journal Editors form for disclosure of potential conflicts of interest. Brian E. Dixon reported grant support from the National Institutes of Health, Agency for Healthcare Research and Quality, and the U.S. Department of Veterans Affairs; personal fees from Elsevier and Springer Nature; and consulting fees from Merck. Nicola P. Klein reported institutional grant support from Pfizer, Inc., Merck, GSK, and Sanofi Pasteur. Allison L. Naleway reported institutional support from Pfizer, Inc. and Vir Biotechnology. Suchitra Rao reported grant support from GSK. Charlene McEvoy reported institutional support from AstraZeneca. No other potential conflicts of interest were disclosed.- Published
- 2022
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20. Waning of vaccine effectiveness against moderate and severe covid-19 among adults in the US from the VISION network: test negative, case-control study.
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Ferdinands JM, Rao S, Dixon BE, Mitchell PK, DeSilva MB, Irving SA, Lewis N, Natarajan K, Stenehjem E, Grannis SJ, Han J, McEvoy C, Ong TC, Naleway AL, Reese SE, Embi PJ, Dascomb K, Klein NP, Griggs EP, Liao IC, Yang DH, Fadel WF, Grisel N, Goddard K, Patel P, Murthy K, Birch R, Valvi NR, Arndorfer J, Zerbo O, Dickerson M, Raiyani C, Williams J, Bozio CH, Blanton L, Link-Gelles R, Barron MA, Gaglani M, Thompson MG, and Fireman B
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- BNT162 Vaccine, Case-Control Studies, Humans, SARS-CoV-2, Vaccine Efficacy, Young Adult, COVID-19 epidemiology, COVID-19 prevention & control
- Abstract
Objective: To estimate the effectiveness of mRNA vaccines against moderate and severe covid-19 in adults by time since second, third, or fourth doses, and by age and immunocompromised status., Design: Test negative case-control study., Setting: Hospitals, emergency departments, and urgent care clinics in 10 US states, 17 January 2021 to 12 July 2022., Participants: 893 461 adults (≥18 years) admitted to one of 261 hospitals or to one of 272 emergency department or 119 urgent care centers for covid-like illness tested for SARS-CoV-2., Main Outcome Measures: The main outcome was waning of vaccine effectiveness with BNT162b2 (Pfizer-BioNTech) or mRNA-1273 (Moderna) vaccine during the omicron and delta periods, and the period before delta was dominant using logistic regression conditioned on calendar week and geographic area while adjusting for age, race, ethnicity, local virus circulation, immunocompromised status, and likelihood of being vaccinated., Results: 45 903 people admitted to hospital with covid-19 (cases) were compared with 213 103 people with covid-like illness who tested negative for SARS-CoV-2 (controls), and 103 287 people admitted to emergency department or urgent care with covid-19 (cases) were compared with 531 168 people with covid-like illness who tested negative for SARS-CoV-2. In the omicron period, vaccine effectiveness against covid-19 requiring admission to hospital was 89% (95% confidence interval 88% to 90%) within two months after dose 3 but waned to 66% (63% to 68%) by four to five months. Vaccine effectiveness of three doses against emergency department or urgent care visits was 83% (82% to 84%) initially but waned to 46% (44% to 49%) by four to five months. Waning was evident in all subgroups, including young adults and individuals who were not immunocompromised; although waning was morein people who were immunocompromised. Vaccine effectiveness increased among most groups after a fourth dose in whom this booster was recommended., Conclusions: Effectiveness of mRNA vaccines against moderate and severe covid-19 waned with time after vaccination. The findings support recommendations for a booster dose after a primary series and consideration of additional booster doses., Competing Interests: Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/disclosure-of-interest/ and declare: NPK reports institutional support from Pfizer, Merck, GlaxoSmithKline, Sanofi Pasteur, and Protein Sciences (now Sanofi Pasteur) for unrelated studies and institutional support from Pfizer for a covid-19 vaccine trial. CM received institutional support from AstraZeneca for a covid-19 vaccine trial. ALN received institutional support from Pfizer for an unrelated study of meningococcal B vaccine safety during pregnancy. SR received grant funding from GlaxoSmithKline and Biofire Diagnostics. Authors declare no financial relationships with any organizations that might have an interest in the submitted work in the previous three years, and no other relationships or activities that could appear to have influenced the submitted work., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2022
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21. Estimation of COVID-19 mRNA Vaccine Effectiveness Against Medically Attended COVID-19 in Pregnancy During Periods of Delta and Omicron Variant Predominance in the United States.
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Schrag SJ, Verani JR, Dixon BE, Page JM, Butterfield KA, Gaglani M, Vazquez-Benitez G, Zerbo O, Natarajan K, Ong TC, Lazariu V, Rao S, Beaver R, Ellington SR, Klein NP, Irving SA, Grannis SJ, Kiduko S, Barron MA, Midturi J, Dickerson M, Lewis N, Stockwell MS, Stenehjem E, Fadel WF, Link-Gelles R, Murthy K, Goddard K, Grisel N, Valvi NR, Fireman B, Arndorfer J, Konatham D, Ball S, Thompson MG, and Naleway AL
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- Adult, COVID-19 Vaccines, Case-Control Studies, Female, Humans, Pregnancy, RNA, Messenger, Stored, SARS-CoV-2 genetics, United States epidemiology, Vaccines, Synthetic, mRNA Vaccines, COVID-19 epidemiology, COVID-19 prevention & control, Influenza Vaccines, Influenza, Human prevention & control, Pregnancy Complications, Infectious epidemiology, Pregnancy Complications, Infectious prevention & control
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Importance: Pregnant people are at high risk for severe COVID-19 but were excluded from mRNA vaccine trials; data on COVID-19 vaccine effectiveness (VE) are needed., Objective: To evaluate the estimated effectiveness of mRNA vaccination against medically attended COVID-19 among pregnant people during Delta and Omicron predominance., Design, Setting, and Participants: This test-negative, case-control study was conducted from June 2021 to June 2022 in a network of 306 hospitals and 164 emergency department and urgent care (ED/UC) facilities across 10 US states, including 4517 ED/UC encounters and 975 hospitalizations among pregnant people with COVID-19-like illness (CLI) who underwent SARS-CoV-2 molecular testing., Exposures: Two doses (14-149 and ≥150 days prior) and 3 doses (7-119 and ≥120 days prior) of COVID-19 mRNA vaccine (≥1 dose received during pregnancy) vs unvaccinated., Main Outcomes and Measures: Estimated VE against laboratory-confirmed COVID-19-associated ED/UC encounter or hospitalization, based on the adjusted odds ratio (aOR) for prior vaccination; VE was calculated as (1 - aOR) × 100%., Results: Among 4517 eligible CLI-associated ED/UC encounters and 975 hospitalizations, 885 (19.6%) and 334 (34.3%) were SARS-CoV-2 positive, respectively; the median (IQR) patient age was 28 (24-32) years and 31 (26-35) years, 537 (12.0%) and 118 (12.0%) were non-Hispanic Black and 1189 (26.0%) and 240 (25.0%) were Hispanic. During Delta predominance, the estimated VE against COVID-19-associated ED/UC encounters was 84% (95% CI, 69% to 92%) for 2 doses within 14 to 149 days, 75% (95% CI, 5% to 93%) for 2 doses 150 or more days prior, and 81% (95% CI, 30% to 95%) for 3 doses 7 to 119 days prior; estimated VE against COVID-19-associated hospitalization was 99% (95% CI, 96% to 100%), 96% (95% CI, 86% to 99%), and 97% (95% CI, 79% to 100%), respectively. During Omicron predominance, for ED/UC encounters, the estimated VE of 2 doses within 14 to 149 days, 2 doses 150 or more days, 3 doses within 7 to 119 days, and 3 doses 120 or more days prior was 3% (95% CI, -49% to 37%), 42% (95% CI, -16% to 72%), 79% (95% CI, 59% to 89%), and -124% (95% CI, -414% to 2%), respectively; for hospitalization, estimated VE was 86% (95% CI, 41% to 97%), 64% (95% CI, -102% to 93%), 86% (95% CI, 28% to 97%), and -53% (95% CI, -1254% to 83%), respectively., Conclusions and Relevance: In this study, maternal mRNA COVID-19 vaccination, including booster dose, was associated with protection against medically attended COVID-19. VE estimates were higher against COVID-19-associated hospitalization than ED/UC visits and lower against the Omicron variant than the Delta variant. Protection waned over time, particularly during Omicron predominance.
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- 2022
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22. Effectiveness of 2, 3, and 4 COVID-19 mRNA Vaccine Doses Among Immunocompetent Adults During Periods when SARS-CoV-2 Omicron BA.1 and BA.2/BA.2.12.1 Sublineages Predominated - VISION Network, 10 States, December 2021-June 2022.
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Link-Gelles R, Levy ME, Gaglani M, Irving SA, Stockwell M, Dascomb K, DeSilva MB, Reese SE, Liao IC, Ong TC, Grannis SJ, McEvoy C, Patel P, Klein NP, Hartmann E, Stenehjem E, Natarajan K, Naleway AL, Murthy K, Rao S, Dixon BE, Kharbanda AB, Akinseye A, Dickerson M, Lewis N, Grisel N, Han J, Barron MA, Fadel WF, Dunne MM, Goddard K, Arndorfer J, Konatham D, Valvi NR, Currey JC, Fireman B, Raiyani C, Zerbo O, Sloan-Aagard C, Ball SW, Thompson MG, and Tenforde MW
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- Adult, BNT162 Vaccine, COVID-19 Vaccines, Humans, SARS-CoV-2 genetics, United States epidemiology, Vaccines, Synthetic, mRNA Vaccines, COVID-19 epidemiology, COVID-19 prevention & control, Influenza Vaccines, Influenza, Human
- Abstract
The Omicron variant (B.1.1.529) of SARS-CoV-2, the virus that causes COVID-19, was first identified in the United States in November 2021, with the BA.1 sublineage (including BA.1.1) causing the largest surge in COVID-19 cases to date. Omicron sublineages BA.2 and BA.2.12.1 emerged later and by late April 2022, accounted for most cases.* Estimates of COVID-19 vaccine effectiveness (VE) can be reduced by newly emerging variants or sublineages that evade vaccine-induced immunity (1), protection from previous SARS-CoV-2 infection in unvaccinated persons (2), or increasing time since vaccination (3). Real-world data comparing VE during the periods when the BA.1 and BA.2/BA.2.12.1 predominated (BA.1 period and BA.2/BA.2.12.1 period, respectively) are limited. The VISION network
† examined 214,487 emergency department/urgent care (ED/UC) visits and 58,782 hospitalizations with a COVID-19-like illness§ diagnosis among 10 states during December 18, 2021-June 10, 2022, to evaluate VE of 2, 3, and 4 doses of mRNA COVID-19 vaccines (BNT162b2 [Pfizer-BioNTech] or mRNA-1273 [Moderna]) compared with no vaccination among adults without immunocompromising conditions. VE against COVID-19-associated hospitalization 7-119 days and ≥120 days after receipt of dose 3 was 92% (95% CI = 91%-93%) and 85% (95% CI = 81%-89%), respectively, during the BA.1 period, compared with 69% (95% CI = 58%-76%) and 52% (95% CI = 44%-59%), respectively, during the BA.2/BA.2.12.1 period. Patterns were similar for ED/UC encounters. Among adults aged ≥50 years, VE against COVID-19-associated hospitalization ≥120 days after receipt of dose 3 was 55% (95% CI = 46%-62%) and ≥7 days (median = 27 days) after a fourth dose was 80% (95% CI = 71%-85%) during BA.2/BA.2.12.1 predominance. Immunocompetent persons should receive recommended COVID-19 booster doses to prevent moderate to severe COVID-19, including a first booster dose for all eligible persons and second booster dose for adults aged ≥50 years at least 4 months after an initial booster dose. Booster doses should be obtained immediately when persons become eligible.¶ ., Competing Interests: All authors have completed and submitted the International Committee of Medical Journal Editors form for disclosure of potential conflicts of interest. Stephanie A. Irving reports institutional support from Westat. Nicola P. Klein reports institutional support from Pfizer, Merck, GlaxoSmithKline, Sanofi Pasteur, and Protein Science, unrelated to the current work, and institutional support from Pfizer for COVID-19 vaccine clinical trials. Allison L. Naleway reports institutional support from Pfizer for a study of meningococcal B vaccine safety during pregnancy, unrelated to the current work. Charlene McEvoy reports institutional support from AstraZeneca for an AZD1222 COVID-19 vaccine trial. Suchitra Rao reports grant support from GlaxoSmithKline and Biofire Diagnostics. No other potential conflicts of interest were disclosed.- Published
- 2022
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23. Effectiveness of Homologous and Heterologous COVID-19 Booster Doses Following 1 Ad.26.COV2.S (Janssen [Johnson & Johnson]) Vaccine Dose Against COVID-19-Associated Emergency Department and Urgent Care Encounters and Hospitalizations Among Adults - VISION Network, 10 States, December 2021-March 2022.
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Natarajan K, Prasad N, Dascomb K, Irving SA, Yang DH, Gaglani M, Klein NP, DeSilva MB, Ong TC, Grannis SJ, Stenehjem E, Link-Gelles R, Rowley EA, Naleway AL, Han J, Raiyani C, Benitez GV, Rao S, Lewis N, Fadel WF, Grisel N, Griggs EP, Dunne MM, Stockwell MS, Mamawala M, McEvoy C, Barron MA, Goddard K, Valvi NR, Arndorfer J, Patel P, Mitchell PK, Smith M, Kharbanda AB, Fireman B, Embi PJ, Dickerson M, Davis JM, Zerbo O, Dalton AF, Wondimu MH, Azziz-Baumgartner E, Bozio CH, Reynolds S, Ferdinands J, Williams J, Schrag SJ, Verani JR, Ball S, Thompson MG, and Dixon BE
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- Adolescent, Adult, Ambulatory Care, COVID-19 Vaccines, Emergency Service, Hospital, Hospitalization, Humans, Immunization, Secondary, SARS-CoV-2, Vaccines, Synthetic, mRNA Vaccines, COVID-19 prevention & control, Influenza Vaccines
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CDC recommends that all persons aged ≥18 years receive a single COVID-19 vaccine booster dose ≥2 months after receipt of an Ad.26.COV2.S (Janssen [Johnson & Johnson]) adenovirus vector-based primary series vaccine; a heterologous COVID-19 mRNA vaccine is preferred over a homologous (matching) Janssen vaccine for booster vaccination. This recommendation was made in light of the risks for rare but serious adverse events following receipt of a Janssen vaccine, including thrombosis with thrombocytopenia syndrome and Guillain-Barré syndrome
† (1), and clinical trial data indicating similar or higher neutralizing antibody response following heterologous boosting compared with homologous boosting (2). Data on real-world vaccine effectiveness (VE) of different booster strategies following a primary Janssen vaccine dose are limited, particularly during the period of Omicron variant predominance. The VISION Network§ determined real-world VE of 1 Janssen vaccine dose and 2 alternative booster dose strategies: 1) a homologous booster (i.e., 2 Janssen doses) and 2) a heterologous mRNA booster (i.e., 1 Janssen dose/1 mRNA dose). In addition, VE of these booster strategies was compared with VE of a homologous booster following mRNA primary series vaccination (i.e., 3 mRNA doses). The study examined 80,287 emergency department/urgent care (ED/UC) visits¶ and 25,244 hospitalizations across 10 states during December 16, 2021-March 7, 2022, when Omicron was the predominant circulating variant.** VE against laboratory-confirmed COVID-19-associated ED/UC encounters was 24% after 1 Janssen dose, 54% after 2 Janssen doses, 79% after 1 Janssen/1 mRNA dose, and 83% after 3 mRNA doses. VE for the same vaccination strategies against laboratory-confirmed COVID-19-associated hospitalizations were 31%, 67%, 78%, and 90%, respectively. All booster strategies provided higher protection than a single Janssen dose against ED/UC visits and hospitalizations during Omicron variant predominance. Vaccination with 1 Janssen/1 mRNA dose provided higher protection than did 2 Janssen doses against COVID-19-associated ED/UC visits and was comparable to protection provided by 3 mRNA doses during the first 120 days after a booster dose. However, 3 mRNA doses provided higher protection against COVID-19-associated hospitalizations than did other booster strategies during the same time interval since booster dose. All adults who have received mRNA vaccines for their COVID-19 primary series vaccination should receive an mRNA booster dose when eligible. Adults who received a primary Janssen vaccine dose should preferentially receive a heterologous mRNA vaccine booster dose ≥2 months later, or a homologous Janssen vaccine booster dose if mRNA vaccine is contraindicated or unavailable. Further investigation of the durability of protection afforded by different booster strategies is warranted., Competing Interests: All authors have completed and submitted the International Committee of Medical Journal Editors form for disclosure of potential conflicts of interest. Manjusha Gaglani reports support from Janssen (Johnson & Johnson) for the Baylor Scott & White Health respiratory syncytial virus observational cohort study and uncompensated service as co-chair of the Infectious Diseases and Immunization Committee of the Texas Pediatric Society, Texas Chapter of the American Academy of Pediatrics. Nicola P. Klein reports institutional support from Pfizer, Merck, GlaxoSmithKline, Sanofi Pasteur, and Protein Sciences (now Sanofi Pasteur) for unrelated studies, and institutional support from Pfizer for COVID-19 vaccine clinical trials. Allison L. Naleway reports institutional support from Pfizer for an unrelated study of meningococcal B vaccine safety during pregnancy and research funding from Vir Biotechnology. Suchitra Rao reports grant support from GlaxoSmithKline and Biofire Diagnostics. No other potential conflicts of interest were disclosed.- Published
- 2022
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24. Effectiveness of COVID-19 Pfizer-BioNTech BNT162b2 mRNA Vaccination in Preventing COVID-19-Associated Emergency Department and Urgent Care Encounters and Hospitalizations Among Nonimmunocompromised Children and Adolescents Aged 5-17 Years - VISION Network, 10 States, April 2021-January 2022.
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Klein NP, Stockwell MS, Demarco M, Gaglani M, Kharbanda AB, Irving SA, Rao S, Grannis SJ, Dascomb K, Murthy K, Rowley EA, Dalton AF, DeSilva MB, Dixon BE, Natarajan K, Stenehjem E, Naleway AL, Lewis N, Ong TC, Patel P, Konatham D, Embi PJ, Reese SE, Han J, Grisel N, Goddard K, Barron MA, Dickerson M, Liao IC, Fadel WF, Yang DH, Arndorfer J, Fireman B, Griggs EP, Valvi NR, Hallowell C, Zerbo O, Reynolds S, Ferdinands J, Wondimu MH, Williams J, Bozio CH, Link-Gelles R, Azziz-Baumgartner E, Schrag SJ, Thompson MG, and Verani JR
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- Adolescent, Ambulatory Care statistics & numerical data, Child, Child, Preschool, Emergency Service, Hospital statistics & numerical data, Female, Hospitalization statistics & numerical data, Humans, Immunization, Secondary, Male, United States, BNT162 Vaccine administration & dosage, COVID-19 prevention & control, COVID-19 Vaccines administration & dosage, SARS-CoV-2 immunology, Vaccine Efficacy statistics & numerical data
- Abstract
The efficacy of the BNT162b2 (Pfizer-BioNTech) vaccine against laboratory-confirmed COVID-19 exceeded 90% in clinical trials that included children and adolescents aged 5-11, 12-15, and 16-17 years (1-3). Limited real-world data on 2-dose mRNA vaccine effectiveness (VE) in persons aged 12-17 years (referred to as adolescents in this report) have also indicated high levels of protection against SARS-CoV-2 (the virus that causes COVID-19) infection and COVID-19-associated hospitalization (4-6); however, data on VE against the SARS-CoV-2 B.1.1.529 (Omicron) variant and duration of protection are limited. Pfizer-BioNTech VE data are not available for children aged 5-11 years. In partnership with CDC, the VISION Network* examined 39,217 emergency department (ED) and urgent care (UC) encounters and 1,699 hospitalizations
† among persons aged 5-17 years with COVID-19-like illness across 10 states during April 9, 2021-January 29, 2022,§ to estimate VE using a case-control test-negative design. Among children aged 5-11 years, VE against laboratory-confirmed COVID-19-associated ED and UC encounters 14-67 days after dose 2 (the longest interval after dose 2 in this age group) was 46%. Among adolescents aged 12-15 and 16-17 years, VE 14-149 days after dose 2 was 83% and 76%, respectively; VE ≥150 days after dose 2 was 38% and 46%, respectively. Among adolescents aged 16-17 years, VE increased to 86% ≥7 days after dose 3 (booster dose). VE against COVID-19-associated ED and UC encounters was substantially lower during the Omicron predominant period than the B.1.617.2 (Delta) predominant period among adolescents aged 12-17 years, with no significant protection ≥150 days after dose 2 during Omicron predominance. However, in adolescents aged 16-17 years, VE during the Omicron predominant period increased to 81% ≥7 days after a third booster dose. During the full study period, including pre-Delta, Delta, and Omicron predominant periods, VE against laboratory-confirmed COVID-19-associated hospitalization among children aged 5-11 years was 74% 14-67 days after dose 2, with wide CIs that included zero. Among adolescents aged 12-15 and 16-17 years, VE 14-149 days after dose 2 was 92% and 94%, respectively; VE ≥150 days after dose 2 was 73% and 88%, respectively. All eligible children and adolescents should remain up to date with recommended COVID-19 vaccinations, including a booster dose for those aged 12-17 years., Competing Interests: All authors have completed and submitted the International Committee of Medical Journal Editors form for disclosure of potential conflicts of interest. Stephanie A. Irving and Elizabeth A. Rowley report institutional support from Westat. Nicola P. Klein reports institutional support from Pfizer, Merck, GlaxoSmithKline (GSK), Sanofi Pasteur, and Protein Scient (now Sanofi Pasteur) for unrelated studies, and institutional support from Pfizer for COVID-19 vaccine clinical trials. Allison L. Naleway reports institutional support from Pfizer for unrelated study of meningococcal B vaccine safety during pregnancy. Suchitra Rao reports grants from GSK and Biofire Diagnostics. No other potential conflicts of interest were disclosed.- Published
- 2022
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25. Waning 2-Dose and 3-Dose Effectiveness of mRNA Vaccines Against COVID-19-Associated Emergency Department and Urgent Care Encounters and Hospitalizations Among Adults During Periods of Delta and Omicron Variant Predominance - VISION Network, 10 States, August 2021-January 2022.
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Ferdinands JM, Rao S, Dixon BE, Mitchell PK, DeSilva MB, Irving SA, Lewis N, Natarajan K, Stenehjem E, Grannis SJ, Han J, McEvoy C, Ong TC, Naleway AL, Reese SE, Embi PJ, Dascomb K, Klein NP, Griggs EP, Konatham D, Kharbanda AB, Yang DH, Fadel WF, Grisel N, Goddard K, Patel P, Liao IC, Birch R, Valvi NR, Reynolds S, Arndorfer J, Zerbo O, Dickerson M, Murthy K, Williams J, Bozio CH, Blanton L, Verani JR, Schrag SJ, Dalton AF, Wondimu MH, Link-Gelles R, Azziz-Baumgartner E, Barron MA, Gaglani M, Thompson MG, and Fireman B
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- Adult, Aged, Aged, 80 and over, Case-Control Studies, Emergency Service, Hospital, Female, Humans, Male, Middle Aged, Time Factors, United States, Young Adult, Ambulatory Care statistics & numerical data, COVID-19 prevention & control, COVID-19 Vaccines administration & dosage, Hospitalization statistics & numerical data, SARS-CoV-2 immunology, Vaccine Efficacy, mRNA Vaccines administration & dosage
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CDC recommends that all persons aged ≥12 years receive a booster dose of COVID-19 mRNA vaccine ≥5 months after completion of a primary mRNA vaccination series and that immunocompromised persons receive a third primary dose.* Waning of vaccine protection after 2 doses of mRNA vaccine has been observed during the period of the SARS-CoV-2 B.1.617.2 (Delta) variant predominance
† (1-5), but little is known about durability of protection after 3 doses during periods of Delta or SARS-CoV-2 B.1.1.529 (Omicron) variant predominance. A test-negative case-control study design using data from eight VISION Network sites§ examined vaccine effectiveness (VE) against COVID-19 emergency department/urgent care (ED/UC) visits and hospitalizations among U.S. adults aged ≥18 years at various time points after receipt of a second or third vaccine dose during two periods: Delta variant predominance and Omicron variant predominance (i.e., periods when each variant accounted for ≥50% of sequenced isolates).¶ Persons categorized as having received 3 doses included those who received a third dose in a primary series or a booster dose after a 2 dose primary series (including the reduced-dosage Moderna booster). The VISION Network analyzed 241,204 ED/UC encounters** and 93,408 hospitalizations across 10 states during August 26, 2021-January 22, 2022. VE after receipt of both 2 and 3 doses was lower during the Omicron-predominant than during the Delta-predominant period at all time points evaluated. During both periods, VE after receipt of a third dose was higher than that after a second dose; however, VE waned with increasing time since vaccination. During the Omicron period, VE against ED/UC visits was 87% during the first 2 months after a third dose and decreased to 66% among those vaccinated 4-5 months earlier; VE against hospitalizations was 91% during the first 2 months following a third dose and decreased to 78% ≥4 months after a third dose. For both Delta- and Omicron-predominant periods, VE was generally higher for protection against hospitalizations than against ED/UC visits. All eligible persons should remain up to date with recommended COVID-19 vaccinations to best protect against COVID-19-associated hospitalizations and ED/UC visits., Competing Interests: All authors have completed and submitted the International Committee of Medical Journal Editors form for disclosure of potential conflicts of interest. Nicola P. Klein reports institutional support from Pfizer, Merck, GlaxoSmithKline, Sanofi Pasteur, and Protein Sciences (now Sanofi Pasteur) for unrelated studies and institutional support from Pfizer for a COVID-19 vaccine trial. Charlene McEvoy reports institutional support from AstraZeneca for a COVID-19 vaccine trial. Allison L. Naleway reports institutional support from Pfizer for an unrelated study of meningococcal B vaccine safety during pregnancy. Suchitra Rao reports grant funding from GlaxoSmithKline and Biofire Diagnostics. No other potential conflicts of interest were disclosed.- Published
- 2022
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26. Effectiveness of a Third Dose of mRNA Vaccines Against COVID-19-Associated Emergency Department and Urgent Care Encounters and Hospitalizations Among Adults During Periods of Delta and Omicron Variant Predominance - VISION Network, 10 States, August 2021-January 2022.
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Thompson MG, Natarajan K, Irving SA, Rowley EA, Griggs EP, Gaglani M, Klein NP, Grannis SJ, DeSilva MB, Stenehjem E, Reese SE, Dickerson M, Naleway AL, Han J, Konatham D, McEvoy C, Rao S, Dixon BE, Dascomb K, Lewis N, Levy ME, Patel P, Liao IC, Kharbanda AB, Barron MA, Fadel WF, Grisel N, Goddard K, Yang DH, Wondimu MH, Murthy K, Valvi NR, Arndorfer J, Fireman B, Dunne MM, Embi P, Azziz-Baumgartner E, Zerbo O, Bozio CH, Reynolds S, Ferdinands J, Williams J, Link-Gelles R, Schrag SJ, Verani JR, Ball S, and Ong TC
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- Adult, Aged, Aged, 80 and over, Ambulatory Care statistics & numerical data, Emergency Service, Hospital statistics & numerical data, Female, Hospitalization statistics & numerical data, Humans, Male, Middle Aged, United States epidemiology, COVID-19 prevention & control, COVID-19 Vaccines administration & dosage, Immunization, Secondary, SARS-CoV-2 immunology, Vaccine Efficacy statistics & numerical data, mRNA Vaccines administration & dosage
- Abstract
Estimates of COVID-19 mRNA vaccine effectiveness (VE) have declined in recent months (1,2) because of waning vaccine induced immunity over time,* possible increased immune evasion by SARS-CoV-2 variants (3), or a combination of these and other factors. CDC recommends that all persons aged ≥12 years receive a third dose (booster) of an mRNA vaccine ≥5 months after receipt of the second mRNA vaccine dose and that immunocompromised individuals receive a third primary dose.
† A third dose of BNT162b2 (Pfizer-BioNTech) COVID-19 vaccine increases neutralizing antibody levels (4), and three recent studies from Israel have shown improved effectiveness of a third dose in preventing COVID-19 associated with infections with the SARS-CoV-2 B.1.617.2 (Delta) variant (5-7). Yet, data are limited on the real-world effectiveness of third doses of COVID-19 mRNA vaccine in the United States, especially since the SARS-CoV-2 B.1.1.529 (Omicron) variant became predominant in mid-December 2021. The VISION Network§ examined VE by analyzing 222,772 encounters from 383 emergency departments (EDs) and urgent care (UC) clinics and 87,904 hospitalizations from 259 hospitals among adults aged ≥18 years across 10 states from August 26, 2021¶ to January 5, 2022. Analyses were stratified by the period before and after the Omicron variant became the predominant strain (>50% of sequenced viruses) at each study site. During the period of Delta predominance across study sites in the United States (August-mid-December 2021), VE against laboratory-confirmed COVID-19-associated ED and UC encounters was 86% 14-179 days after dose 2, 76% ≥180 days after dose 2, and 94% ≥14 days after dose 3. Estimates of VE for the same intervals after vaccination during Omicron variant predominance were 52%, 38%, and 82%, respectively. During the period of Delta variant predominance, VE against laboratory-confirmed COVID-19-associated hospitalizations was 90% 14-179 days after dose 2, 81% ≥180 days after dose 2, and 94% ≥14 days after dose 3. During Omicron variant predominance, VE estimates for the same intervals after vaccination were 81%, 57%, and 90%, respectively. The highest estimates of VE against COVID-19-associated ED and UC encounters or hospitalizations during both Delta- and Omicron-predominant periods were among adults who received a third dose of mRNA vaccine. All unvaccinated persons should get vaccinated as soon as possible. All adults who have received mRNA vaccines during their primary COVID-19 vaccination series should receive a third dose when eligible, and eligible persons should stay up to date with COVID-19 vaccinations., Competing Interests: All authors have completed and submitted the International Committee of Medical Journal Editors form for disclosure of potential conflicts of interest. Stephanie A. Irving reports institutional support from Westat. Nicola P. Klein reports institutional support from Pfizer, Merck, GlaxoSmithKline, Sanofi Pasteur, and Protein Scient (unrelated to the current work), and institutional support from Pfizer for COVID-19 vaccine clinical trials. Allison L. Naleway reports institutional support from Pfizer for a study of meningococcal B vaccine safety during pregnancy (unrelated to the current work). Charlene McEvoy reports institutional support from AztraZeneca for an AZD1222 COVID-19 vaccine trial. Suchitra Rao reports grant support from GlaxoSmithKline, Biofire Diagnostics. No other potential conflicts of interest were disclosed.- Published
- 2022
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27. Effectiveness of two-dose vaccination with mRNA COVID-19 vaccines against COVID-19-associated hospitalizations among immunocompromised adults-Nine States, January-September 2021.
- Author
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Embi PJ, Levy ME, Naleway AL, Patel P, Gaglani M, Natarajan K, Dascomb K, Ong TC, Klein NP, Liao IC, Grannis SJ, Han J, Stenehjem E, Dunne MM, Lewis N, Irving SA, Rao S, McEvoy C, Bozio CH, Murthy K, Dixon BE, Grisel N, Yang DH, Goddard K, Kharbanda AB, Reynolds S, Raiyani C, Fadel WF, Arndorfer J, Rowley EA, Fireman B, Ferdinands J, Valvi NR, Ball SW, Zerbo O, Griggs EP, Mitchell PK, Porter RM, Kiduko SA, Blanton L, Zhuang Y, Steffens A, Reese SE, Olson N, Williams J, Dickerson M, McMorrow M, Schrag SJ, Verani JR, Fry AM, Azziz-Baumgartner E, Barron MA, Thompson MG, and DeSilva MB
- Subjects
- Adult, Hospitalization, Humans, RNA, Messenger, SARS-CoV-2, United States, Vaccination, COVID-19, COVID-19 Vaccines
- Published
- 2022
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28. Laboratory-Confirmed COVID-19 Among Adults Hospitalized with COVID-19-Like Illness with Infection-Induced or mRNA Vaccine-Induced SARS-CoV-2 Immunity - Nine States, January-September 2021.
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Bozio CH, Grannis SJ, Naleway AL, Ong TC, Butterfield KA, DeSilva MB, Natarajan K, Yang DH, Rao S, Klein NP, Irving SA, Dixon BE, Dascomb K, Liao IC, Reynolds S, McEvoy C, Han J, Reese SE, Lewis N, Fadel WF, Grisel N, Murthy K, Ferdinands J, Kharbanda AB, Mitchell PK, Goddard K, Embi PJ, Arndorfer J, Raiyani C, Patel P, Rowley EA, Fireman B, Valvi NR, Griggs EP, Levy ME, Zerbo O, Porter RM, Birch RJ, Blanton L, Ball SW, Steffens A, Olson N, Williams J, Dickerson M, McMorrow M, Schrag SJ, Verani JR, Fry AM, Azziz-Baumgartner E, Barron M, Gaglani M, Thompson MG, and Stenehjem E
- Subjects
- Adolescent, Adult, Aged, Aged, 80 and over, COVID-19 therapy, COVID-19 Vaccines administration & dosage, COVID-19 Vaccines immunology, Female, Hospitalization statistics & numerical data, Humans, Laboratories, Male, Middle Aged, SARS-CoV-2 immunology, Vaccines, Synthetic administration & dosage, Vaccines, Synthetic immunology, Young Adult, mRNA Vaccines, COVID-19 diagnosis, COVID-19 immunology, SARS-CoV-2 isolation & purification
- Abstract
Previous infection with SARS-CoV-2 (the virus that causes COVID-19) or COVID-19 vaccination can provide immunity and protection from subsequent SARS-CoV-2 infection and illness. CDC used data from the VISION Network* to examine hospitalizations in adults with COVID-19-like illness and compared the odds of receiving a positive SARS-CoV-2 test result, and thus having laboratory-confirmed COVID-19, between unvaccinated patients with a previous SARS-CoV-2 infection occurring 90-179 days before COVID-19-like illness hospitalization, and patients who were fully vaccinated with an mRNA COVID-19 vaccine 90-179 days before hospitalization with no previous documented SARS-CoV-2 infection. Hospitalized adults aged ≥18 years with COVID-19-like illness were included if they had received testing at least twice: once associated with a COVID-19-like illness hospitalization during January-September 2021 and at least once earlier (since February 1, 2020, and ≥14 days before that hospitalization). Among COVID-19-like illness hospitalizations in persons whose previous infection or vaccination occurred 90-179 days earlier, the odds of laboratory-confirmed COVID-19 (adjusted for sociodemographic and health characteristics) among unvaccinated, previously infected adults were higher than the odds among fully vaccinated recipients of an mRNA COVID-19 vaccine with no previous documented infection (adjusted odds ratio [aOR] = 5.49; 95% confidence interval [CI] = 2.75-10.99). These findings suggest that among hospitalized adults with COVID-19-like illness whose previous infection or vaccination occurred 90-179 days earlier, vaccine-induced immunity was more protective than infection-induced immunity against laboratory-confirmed COVID-19. All eligible persons should be vaccinated against COVID-19 as soon as possible, including unvaccinated persons previously infected with SARS-CoV-2., Competing Interests: All authors have completed and submitted the International Committee of Medical Journal Editors form for disclosure of potential conflicts of interest. Stephanie A. Irving reports support from Westat to Kaiser Permanente Northwest Center for Health Research. Nicola P. Klein reports support from Pfizer to Kaiser Permanente, Northern California for COVID-19 vaccine clinical trials, and institutional support from Merck, GlaxoSmithKline, and Sanofi Pasteur outside the current study. Charlene McEvoy reports support from AstraZeneca to HealthPartners Institute for COVID-19 vaccine trials. Allison L. Naleway reports Pfizer Research funding to Kaiser Permanente Northwest for unrelated study of meningococcal B vaccine safety during pregnancy. Suchitra Rao reports grants from GlaxoSmithKline and Biofire Diagnostics. No other potential conflicts of interest were disclosed.
- Published
- 2021
- Full Text
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29. Effectiveness of 2-Dose Vaccination with mRNA COVID-19 Vaccines Against COVID-19-Associated Hospitalizations Among Immunocompromised Adults - Nine States, January-September 2021.
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Embi PJ, Levy ME, Naleway AL, Patel P, Gaglani M, Natarajan K, Dascomb K, Ong TC, Klein NP, Liao IC, Grannis SJ, Han J, Stenehjem E, Dunne MM, Lewis N, Irving SA, Rao S, McEvoy C, Bozio CH, Murthy K, Dixon BE, Grisel N, Yang DH, Goddard K, Kharbanda AB, Reynolds S, Raiyani C, Fadel WF, Arndorfer J, Rowley EA, Fireman B, Ferdinands J, Valvi NR, Ball SW, Zerbo O, Griggs EP, Mitchell PK, Porter RM, Kiduko SA, Blanton L, Zhuang Y, Steffens A, Reese SE, Olson N, Williams J, Dickerson M, McMorrow M, Schrag SJ, Verani JR, Fry AM, Azziz-Baumgartner E, Barron MA, Thompson MG, and DeSilva MB
- Subjects
- Adolescent, Adult, Aged, Aged, 80 and over, COVID-19 epidemiology, COVID-19 immunology, COVID-19 therapy, COVID-19 Vaccines immunology, Female, Humans, Immunization Schedule, Laboratories, Male, Middle Aged, SARS-CoV-2 immunology, SARS-CoV-2 isolation & purification, United States epidemiology, Vaccines, Synthetic administration & dosage, Young Adult, mRNA Vaccines, COVID-19 prevention & control, COVID-19 Vaccines administration & dosage, Hospitalization statistics & numerical data, Immunocompromised Host immunology
- Abstract
Immunocompromised persons, defined as those with suppressed humoral or cellular immunity resulting from health conditions or medications, account for approximately 3% of the U.S. adult population (1). Immunocompromised adults are at increased risk for severe COVID-19 outcomes (2) and might not acquire the same level of protection from COVID-19 mRNA vaccines as do immunocompetent adults (3,4). To evaluate vaccine effectiveness (VE) among immunocompromised adults, data from the VISION Network* on hospitalizations among persons aged ≥18 years with COVID-19-like illness from 187 hospitals in nine states during January 17-September 5, 2021 were analyzed. Using selected discharge diagnoses,
† VE against COVID-19-associated hospitalization conferred by completing a 2-dose series of an mRNA COVID-19 vaccine ≥14 days before the index hospitalization date§ (i.e., being fully vaccinated) was evaluated using a test-negative design comparing 20,101 immunocompromised adults (10,564 [53%] of whom were fully vaccinated) and 69,116 immunocompetent adults (29,456 [43%] of whom were fully vaccinated). VE of 2 doses of mRNA COVID-19 vaccine against COVID-19-associated hospitalization was lower among immunocompromised patients (77%; 95% confidence interval [CI] = 74%-80%) than among immunocompetent patients (90%; 95% CI = 89%-91%). This difference persisted irrespective of mRNA vaccine product, age group, and timing of hospitalization relative to SARS-CoV-2 (the virus that causes COVID-19) B.1.617.2 (Delta) variant predominance in the state of hospitalization. VE varied across immunocompromising condition subgroups, ranging from 59% (organ or stem cell transplant recipients) to 81% (persons with a rheumatologic or inflammatory disorder). Immunocompromised persons benefit from mRNA COVID-19 vaccination but are less protected from severe COVID-19 outcomes than are immunocompetent persons, and VE varies among immunocompromised subgroups. Immunocompromised persons receiving mRNA COVID-19 vaccines should receive 3 doses and a booster, consistent with CDC recommendations (5), practice nonpharmaceutical interventions, and, if infected, be monitored closely and considered early for proven therapies that can prevent severe outcomes., Competing Interests: All authors have completed and submitted the International Committee of Medical Journal Editors form for disclosure of potential conflicts of interest. Allison L. Naleway reports institutional support from Pfizer outside the submitted work. Anupam B. Kharbanda reports institutional support through HealthPartners to Children’s Minnesota for VISION. Charlene McEvoy reports institutional support from AstraZeneca for the AZD1222 COVID-19 vaccine trial. Jill Ferdinands reports travel support from Institute for Influenza Epidemiology, funded in part by Sanofi Pasteur. Nicola P. Klein reports institutional support from Pfizer for COVID-19 vaccine clinical trials and institutional support from Pfizer, Merck, GlaxoSmithKline, Sanofi Pasteur, and Protein Sciences (now Sanofi Pasteur) outside the submitted work. Suchitra Rao reports grant support from GlaxoSmithKline and Biofire Diagnostics. No other potential conflicts of interest were disclosed.- Published
- 2021
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30. Effectiveness of Covid-19 Vaccines in Ambulatory and Inpatient Care Settings.
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Thompson MG, Stenehjem E, Grannis S, Ball SW, Naleway AL, Ong TC, DeSilva MB, Natarajan K, Bozio CH, Lewis N, Dascomb K, Dixon BE, Birch RJ, Irving SA, Rao S, Kharbanda E, Han J, Reynolds S, Goddard K, Grisel N, Fadel WF, Levy ME, Ferdinands J, Fireman B, Arndorfer J, Valvi NR, Rowley EA, Patel P, Zerbo O, Griggs EP, Porter RM, Demarco M, Blanton L, Steffens A, Zhuang Y, Olson N, Barron M, Shifflett P, Schrag SJ, Verani JR, Fry A, Gaglani M, Azziz-Baumgartner E, and Klein NP
- Subjects
- 2019-nCoV Vaccine mRNA-1273, Ad26COVS1, Aged, Aged, 80 and over, BNT162 Vaccine, COVID-19 epidemiology, Female, Humans, Intensive Care Units statistics & numerical data, Male, Middle Aged, Patient Readmission statistics & numerical data, United States epidemiology, Ambulatory Care statistics & numerical data, COVID-19 prevention & control, COVID-19 Vaccines immunology, Hospitalization statistics & numerical data
- Abstract
Background: There are limited data on the effectiveness of the vaccines against symptomatic coronavirus disease 2019 (Covid-19) currently authorized in the United States with respect to hospitalization, admission to an intensive care unit (ICU), or ambulatory care in an emergency department or urgent care clinic., Methods: We conducted a study involving adults (≥50 years of age) with Covid-19-like illness who underwent molecular testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). We assessed 41,552 admissions to 187 hospitals and 21,522 visits to 221 emergency departments or urgent care clinics during the period from January 1 through June 22, 2021, in multiple states. The patients' vaccination status was documented in electronic health records and immunization registries. We used a test-negative design to estimate vaccine effectiveness by comparing the odds of a positive test for SARS-CoV-2 infection among vaccinated patients with those among unvaccinated patients. Vaccine effectiveness was adjusted with weights based on propensity-for-vaccination scores and according to age, geographic region, calendar time (days from January 1, 2021, to the index date for each medical visit), and local virus circulation., Results: The effectiveness of full messenger RNA (mRNA) vaccination (≥14 days after the second dose) was 89% (95% confidence interval [CI], 87 to 91) against laboratory-confirmed SARS-CoV-2 infection leading to hospitalization, 90% (95% CI, 86 to 93) against infection leading to an ICU admission, and 91% (95% CI, 89 to 93) against infection leading to an emergency department or urgent care clinic visit. The effectiveness of full vaccination with respect to a Covid-19-associated hospitalization or emergency department or urgent care clinic visit was similar with the BNT162b2 and mRNA-1273 vaccines and ranged from 81% to 95% among adults 85 years of age or older, persons with chronic medical conditions, and Black or Hispanic adults. The effectiveness of the Ad26.COV2.S vaccine was 68% (95% CI, 50 to 79) against laboratory-confirmed SARS-CoV-2 infection leading to hospitalization and 73% (95% CI, 59 to 82) against infection leading to an emergency department or urgent care clinic visit., Conclusions: Covid-19 vaccines in the United States were highly effective against SARS-CoV-2 infection requiring hospitalization, ICU admission, or an emergency department or urgent care clinic visit. This vaccine effectiveness extended to populations that are disproportionately affected by SARS-CoV-2 infection. (Funded by the Centers for Disease Control and Prevention.)., (Copyright © 2021 Massachusetts Medical Society.)
- Published
- 2021
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31. Changes in the accuracy of administrative data for the detection of surgical site infections.
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Bucher BT, Yang M, Arndorfer J, Frame C, Orton J, Samore MH, and Dascomb KK
- Subjects
- Colectomy, Female, Humans, Hysterectomy adverse effects, Retrospective Studies, International Classification of Diseases, Surgical Wound Infection diagnosis, Surgical Wound Infection epidemiology
- Abstract
We performed a retrospective analysis of the changes in accuracy of International Classification of Diseases, Clinical Modification (ICD-CM) diagnosis codes for colectomy and hysterectomy surgical site infection surveillance. After the transition from ICD-CM ninth edition to tenth edition codes, there was no significant change in the accuracy of these codes for SSI surveillance.
- Published
- 2021
- Full Text
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32. Differences in etiology for graft loss in female renal transplant recipients.
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Meier-Kriesche H, Ojo AO, Leavey SF, Cibrik DM, Arndorfer JA, Leichtman AB, Punch JD, Armstrong DR, and Kaplan B
- Subjects
- Adult, Age Factors, Aged, Chronic Disease, Female, Follow-Up Studies, Graft Rejection mortality, Humans, Male, Middle Aged, Odds Ratio, Regression Analysis, Risk Factors, Sex Factors, Transplantation, Homologous, Graft Rejection etiology, Graft Survival, Kidney Transplantation immunology, Kidney Transplantation mortality
- Published
- 2001
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- View/download PDF
33. Recipient age as an independent risk factor for chronic renal allograft failure.
- Author
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Meier-Kriesche H, Ojo AO, Arndorfer JA, Port FK, Magee JC, Leichtman AB, Punch JD, and Kaplan B
- Subjects
- Adolescent, Adult, Age Distribution, Aged, Chronic Disease, Graft Survival, Humans, Middle Aged, Proportional Hazards Models, Risk Factors, Transplantation, Homologous, Age Factors, Graft Rejection etiology, Kidney Transplantation statistics & numerical data
- Published
- 2001
- Full Text
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34. Mycophenolate mofetil decreases the risk for chronic renal allograft failure.
- Author
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Meier-Kriesche H, Ojo AO, Arndorfer JA, Magee JC, Cibrik DM, Leichtman AB, Campbell DA, and Kaplan B
- Subjects
- Azathioprine therapeutic use, Chronic Disease, Cyclosporine therapeutic use, Graft Rejection epidemiology, Humans, Kidney Transplantation statistics & numerical data, Multivariate Analysis, Mycophenolic Acid analogs & derivatives, Proportional Hazards Models, Registries, Risk Factors, Transplantation, Homologous, United States epidemiology, Graft Rejection drug therapy, Immunosuppressive Agents therapeutic use, Kidney Transplantation immunology, Mycophenolic Acid therapeutic use
- Published
- 2001
- Full Text
- View/download PDF
35. Need for individualized immunosuppression in elderly renal transplant recipients.
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Meier-Kriesche H, Ojo AO, Arndorfer JA, Leichtman AB, Lake K, Cibrik DM, Punch JD, Armstrong DR, and Kaplan B
- Subjects
- Acute Disease, Adolescent, Adult, Age Distribution, Age Factors, Aged, Follow-Up Studies, Humans, Immunosuppression Therapy, Middle Aged, Proportional Hazards Models, Regression Analysis, Retrospective Studies, Risk, Graft Rejection immunology, Kidney Transplantation immunology, Opportunistic Infections etiology
- Published
- 2001
- Full Text
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36. Deleterious effect of waiting time on renal transplant outcome.
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Meier-Kriesche H, Port FK, Ojo AO, Leichtman AB, Rudich SM, Arndorfer JA, Punch JD, and Kaplan B
- Subjects
- Follow-Up Studies, Humans, Kidney Transplantation physiology, Proportional Hazards Models, Registries, Renal Dialysis mortality, Risk Assessment, Time Factors, United States epidemiology, Graft Survival physiology, Kidney Transplantation mortality, Renal Dialysis adverse effects
- Published
- 2001
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37. Time to first graft loss as a risk factor for second renal allograft loss.
- Author
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Arndorfer JA, Meier-Kriesche HU, Ojo AO, Gruber SA, Cibrik DM, Lake KD, Kaplan B, and Leichtman AB
- Subjects
- Adult, Black People, Female, Graft Rejection ethnology, Graft Rejection mortality, Humans, Kidney Transplantation mortality, Male, Proportional Hazards Models, Reoperation, Risk, Risk Factors, Time Factors, Transplantation, Homologous, White People, Graft Rejection physiopathology, Graft Survival physiology, Kidney Transplantation physiology
- Published
- 2001
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38. Long-term benefit of kidney-pancreas transplants in type 1 diabetics.
- Author
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Ojo AO, Meier-Kriesche HU, Arndorfer JA, Leichtman AB, Magee JC, Cibrik DM, Wolfe RA, Port FK, Agodoa L, Kaufman DB, and Kaplan B
- Subjects
- Adult, Diabetes Mellitus, Type 1 surgery, Female, Follow-Up Studies, Humans, Life Expectancy, Male, Risk, Survival Analysis, Diabetes Mellitus, Type 1 mortality, Kidney Transplantation mortality, Pancreas Transplantation mortality
- Published
- 2001
- Full Text
- View/download PDF
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