Last data update: Oct 28, 2024. (Total: 48004 publications since 2009)
Records 1-30 (of 87 Records) |
Query Trace: Dixon S[original query] |
---|
Respiratory syncytial virus (RSV) vaccine effectiveness against RSV-associated hospitalisations and emergency department encounters among adults aged 60 years and older in the USA, October, 2023, to March, 2024: a test-negative design analysis
Payne AB , Watts JA , Mitchell PK , Dascomb K , Irving SA , Klein NP , Grannis SJ , Ong TC , Ball SW , DeSilva MB , Natarajan K , Sheffield T , Bride D , Arndorfer J , Naleway AL , Koppolu P , Fireman B , Zerbo O , Timbol J , Goddard K , Dixon BE , Fadel WF , Rogerson C , Allen KS , Rao S , Mayer D , Barron M , Reese SE , Rowley EAK , Najdowski M , Ciesla AA , Mak J , Reeves EL , Akinsete OO , McEvoy CE , Essien IJ , Tenforde MW , Fleming-Dutra KE , Link-Gelles R . Lancet 2024 404 (10462) 1547-1559 BACKGROUND: Respiratory syncytial virus vaccines first recommended for use during 2023 were efficacious against lower respiratory tract disease in clinical trials. Limited real-world data regarding respiratory syncytial virus vaccine effectiveness are available. To inform vaccine policy and address gaps in evidence from the clinical trials, we aimed to assess the effectiveness against respiratory syncytial virus-associated hospitalisations and emergency department encounters among adults aged at least 60 years. METHODS: We conducted a test-negative design analysis in an electronic health records-based network in eight states in the USA, including hospitalisations and emergency department encounters with respiratory syncytial virus-like illness among adults aged at least 60 years who underwent respiratory syncytial virus testing from Oct 1, 2023, to March 31, 2024. Respiratory syncytial virus vaccination status at the time of the encounter was derived from electronic health record documentation, state and city immunisation registries, and, for some sites, medical claims. Vaccine effectiveness was estimated by immunocompromise status, comparing the odds of vaccination among respiratory syncytial virus-positive case patients and respiratory syncytial virus-negative control patients, and adjusting for age, race and ethnicity, sex, calendar day, social vulnerability index, number of underlying non-respiratory medical conditions, presence of respiratory underlying medical conditions, and geographical region. FINDINGS: Among 28 271 hospitalisations for respiratory syncytial virus-like illness among adults aged at least 60 years without immunocompromising conditions, vaccine effectiveness was 80% (95% CI 71-85) against respiratory syncytial virus-associated hospitalisations, and vaccine effectiveness was 81% (52-92) against respiratory syncytial virus-associated critical illness (ICU admission or death, or both). Among 8435 hospitalisations for respiratory syncytial virus-like illness among adults with immunocompromising conditions, vaccine effectiveness was 73% (48-85) against associated hospitalisation. Among 36 521 emergency department encounters for respiratory syncytial virus-like illness among adults aged at least 60 years without an immunocompromising condition, vaccine effectiveness was 77% (70-83) against respiratory syncytial virus-associated emergency department encounters. Vaccine effectiveness estimates were similar by age group and product type. INTERPRETATION: Respiratory syncytial virus vaccination was effective in preventing respiratory syncytial virus-associated hospitalisations and emergency department encounters among adults aged at least 60 years in the USA during the 2023-24 respiratory syncytial virus season, which was the first season after respiratory syncytial virus vaccine was approved. FUNDING: The Centers for Disease Control and Prevention. |
Effectiveness of the original monovalent and bivalent COVID-19 vaccines against COVID-19-associated emergency department and urgent care encounters in pregnant persons who were not immunocompromised: VISION Network, June 2022-August 2023
Avrich Ciesla A , Lazariu V , Dascomb K , Irving SA , Dixon BE , Gaglani M , Naleway AL , Grannis SJ , Ball S , Kharbanda AB , Vazquez-Benitez G , Klein NP , Natarajan K , Ong TC , Embi PJ , Fleming-Dutra KE , Link-Gelles R , Zerbo O . Open Forum Infect Dis 2024 11 (9) ofae481 Pregnant people face increased risk of severe COVID-19. Current guidelines recommend updated COVID-19 vaccination (2023-2024) for those aged ≥6 months, irrespective of pregnancy status. To refine recommendations for pregnant people, further data are needed. Using a test-negative design, we evaluated COVID-19 vaccine effectiveness against medically attended COVID-19 with COVID-19-like illness among pregnant people aged 18 to 45 years during June 2022 to August 2023. When doses were received during pregnancy, vaccine effectiveness was 52% (95% CI, 29%-67%); when received <6 months prior to pregnancy, 28% (95% CI, 11%-42%); and when received ≥6 months prior to pregnancy, 6% (95% CI, -11% to 21%). Pregnant people should stay up-to-date with recommended COVID-19 vaccination. |
Tracking the burden, distribution, and impact of Post-COVID conditions in diverse populations for children, adolescents, and adults (Track PCC): passive and active surveillance protocols
Jones RM , Andrews JG , Dalton AF , Dixon BE , Dzomba BJ , Fernando SI , Pogreba-Brown KM , Ortiz MR , Sharma V , Simmons N , Saydah SH . BMC Public Health 2024 24 (1) 2345 BACKGROUND: Track PCC includes five geographic surveillance sites to conduct standardized population-based surveillance to estimate and track Post-COVID Conditions (PCC) by age, sex, race/ethnicity, geographic area, severity of initial infection, and risk factors among persons with evidence of SARS-CoV-2 infection (based on the Council of State and Territorial Epidemiologist [CSTE] case definitions for confirmed cases or laboratory-confirmed evidence of infection). METHODS: The study will estimate the incidence, prevalence, including temporal trends, and duration and severity of PCC symptoms, among children, adolescents, and adults. PCCs include a broad range of symptoms and conditions that continue or develop after acute SARS-CoV-2 infection or COVID-19 illness. Surveillance includes both passive and active components for diverse populations in Arizona, Indiana, and Utah as well as the Bronx Borough, NY, and part of Philadelphia County, PA. Passive surveillance will utilize electronic health records and health information exchanges within each site catchment area to longitudinally follow persons with COVID-19 to estimate PCC occurring at least 30 days after acute COVID-19 illness. Active surveillance will utilize self-report of PCCs from detailed surveys of persons ages 7 years and older with evidence of SARS-CoV-2 infection in the past 3 months. Respondents will complete follow-up surveys at 6-, 12- and 18-months post-infection. DISCUSSION: These data can help identify which groups are most affected by PCC, and what health differences among demographic groups exist, as well as indicate potential barriers to care. These additional levels of granularity can inform public health action and help direct needed clinical care for patients. |
Interim effectiveness of updated 2023-2024 (monovalent XBB.1.5) COVID-19 vaccines against COVID-19-associated hospitalization among adults aged ≥18 years with immunocompromising conditions - VISION Network, September 2023-February 2024
Link-Gelles R , Rowley EAK , DeSilva MB , Dascomb K , Irving SA , Klein NP , Grannis SJ , Ong TC , Weber ZA , Fleming-Dutra KE , McEvoy CE , Akinsete O , Bride D , Sheffield T , Naleway AL , Zerbo O , Fireman B , Hansen J , Goddard K , Dixon BE , Rogerson C , Fadel WF , Duszynski T , Rao S , Barron MA , Reese SE , Ball SW , Dunne MM , Natarajan K , Okwuazi E , Shah AB , Wiegand R , Tenforde MW , Payne AB . MMWR Morb Mortal Wkly Rep 2024 73 (12) 271-276 In September 2023, CDC's Advisory Committee on Immunization Practices recommended updated 2023-2024 (monovalent XBB.1.5) COVID-19 vaccination for all persons aged ≥6 months to prevent COVID-19, including severe disease. As with past COVID-19 vaccines, additional doses may be considered for persons with immunocompromising conditions, who are at higher risk for severe COVID-19 and might have decreased response to vaccination. In this analysis, vaccine effectiveness (VE) of an updated COVID-19 vaccine dose against COVID-19-associated hospitalization was evaluated during September 2023-February 2024 using data from the VISION VE network. Among adults aged ≥18 years with immunocompromising conditions, VE against COVID-19-associated hospitalization was 38% in the 7-59 days after receipt of an updated vaccine dose and 34% in the 60-119 days after receipt of an updated dose. Few persons (18%) in this high-risk study population had received updated COVID-19 vaccine. All persons aged ≥6 months should receive updated 2023-2024 COVID-19 vaccination; persons with immunocompromising conditions may get additional updated COVID-19 vaccine doses ≥2 months after the last recommended COVID-19 vaccine. |
Risk of COVID-19 hospitalization and protection associated with mRNA vaccination among US adults with psychiatric disorders
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 , Ball SW . Influenza Other Respir Viruses 2024 18 (3) e13269 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. |
Interim effectiveness of updated 2023-2024 (monovalent xbb.1.5) COVID-19 vaccines against COVID-19-associated emergency department and urgent care encounters and hospitalization among immunocompetent adults aged ≥18 years - VISION and IVY Networks, September 2023-January 2024
DeCuir J , Payne AB , Self WH , Rowley EAK , Dascomb K , DeSilva MB , Irving SA , Grannis SJ , Ong TC , Klein NP , Weber ZA , Reese SE , Ball SW , Barron MA , Naleway AL , Dixon BE , Essien I , Bride D , Natarajan K , Fireman B , Shah AB , Okwuazi E , Wiegand R , Zhu Y , Lauring AS , Martin ET , Gaglani M , Peltan ID , Brown SM , Ginde AA , Mohr NM , Gibbs KW , Hager DN , Prekker M , Mohamed A , Srinivasan V , Steingrub JS , Khan A , Busse LW , Duggal A , Wilson JG , Chang SY , Mallow C , Kwon JH , Exline MC , Columbus C , Vaughn IA , Safdar B , Mosier JM , Harris ES , Casey JD , Chappell JD , Grijalva CG , Swan SA , Johnson C , Lewis NM , Ellington S , Adams K , Tenforde MW , Paden CR , Dawood FS , Fleming-Dutra KE , Surie D , Link-Gelles R . MMWR Morb Mortal Wkly Rep 2024 73 (8) 180-188 In September 2023, CDC's Advisory Committee on Immunization Practices recommended updated 2023-2024 (monovalent XBB.1.5) COVID-19 vaccination for all persons aged ≥6 months to prevent COVID-19, including severe disease. However, few estimates of updated vaccine effectiveness (VE) against medically attended illness are available. This analysis evaluated VE of an updated COVID-19 vaccine dose against COVID-19-associated emergency department (ED) or urgent care (UC) encounters and hospitalization among immunocompetent adults aged ≥18 years during September 2023-January 2024 using a test-negative, case-control design with data from two CDC VE networks. VE against COVID-19-associated ED/UC encounters was 51% (95% CI = 47%-54%) during the first 7-59 days after an updated dose and 39% (95% CI = 33%-45%) during the 60-119 days after an updated dose. VE estimates against COVID-19-associated hospitalization from two CDC VE networks were 52% (95% CI = 47%-57%) and 43% (95% CI = 27%-56%), with a median interval from updated dose of 42 and 47 days, respectively. Updated COVID-19 vaccine provided increased protection against COVID-19-associated ED/UC encounters and hospitalization among immunocompetent adults. These results support CDC recommendations for updated 2023-2024 COVID-19 vaccination. All persons aged ≥6 months should receive updated 2023-2024 COVID-19 vaccine. |
Treatment rates for chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) in a metropolitan area: Observational cohort analysis
Dixon BE , Price J , Valvi NR , Allen KS , Heumann CL , Titus MK , Duszynski TJ , Wiensch A , Tao G . Sex Transm Dis 2024 BACKGROUND: Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) are the two most common sexually transmitted infections in the United States (US). The Centers for Disease Control and Prevention (CDC) regularly publishes and updates Sexually Transmitted Infection (STI) Treatment Guidelines. The purpose of this study is to measure and compare treatment rates for CT and GC among public and private providers. METHODS: Data from multiple sources, including electronic health records (EHRs) and Medicaid claims, were linked and integrated. Cases observed during 2016-2020 were defined based on positive laboratory results. We calculated descriptive statistics and odd ratios based on characteristics of providers and patients, stratifying by public versus private providers. Univariate logistic regression models were used to examine the factors associated with recommended treatment. RESULTS: Overall, we found that 82.2% and 63.0% of initial CT and GC episodes, respectively, received CDC-recommended treatment. The public STI clinic treated over 90% of CT and GC cases consistently across the 5-year time period. Private providers were significantly less likely to treat first episodes for CT (79.6%) and GC (53.3%), p < 0.01. Other factors associated with higher likelihood of recommended treatment included being male, being HIV positive, and identifying as Black or multi-racial. Among GC cases, 10.8% received non-recommended treatment; all CT cases with treatment occurred per guidelines. CONCLUSIONS: Although these treatment rates are higher than previous studies, there remain significant gaps in STI treatment that require intervention from public health. |
Fostering governance and information partnerships for chronic disease surveillance: The Multi-State EHR-Based Network for Disease Surveillance
Kraus EM , Saintus L , Martinez AK , Brand B , Begley E , Merritt RK , Hamilton A , Rubin R , Sullivan A , Karras BT , Grannis S , Brooks IM , Mui JY , Carton TW , Hohman KH , Klompas M , Dixon BE . J Public Health Manag Pract 2024 30 (2) 244-254 CONTEXT: Electronic health records (EHRs) are an emerging chronic disease surveillance data source and facilitating this data sharing is complex. PROGRAM: Using the experience of the Multi-State EHR-Based Network for Disease Surveillance (MENDS), this article describes implementation of a governance framework that aligns technical, statutory, and organizational requirements to facilitate EHR data sharing for chronic disease surveillance. IMPLEMENTATION: MENDS governance was cocreated with data contributors and health departments representing Texas, New Orleans, Louisiana, Chicago, Washington, and Indiana through engagement from 2020 to 2022. MENDS convened a governance body, executed data-sharing agreements, and developed a master governance document to codify policies and procedures. RESULTS: The MENDS governance committee meets regularly to develop policies and procedures on data use and access, timeliness and quality, validation, representativeness, analytics, security, small cell suppression, software implementation and maintenance, and privacy. Resultant policies are codified in a master governance document. DISCUSSION: The MENDS governance approach resulted in a transparent governance framework that cultivates trust across the network. MENDS's experience highlights the time and resources needed by EHR-based public health surveillance networks to establish effective governance. |
Using electronic health records to enhance surveillance of diabetes in children, adolescents and young adults: a study protocol for the DiCAYA Network
Hirsch AG , Conderino S , Crume TL , Liese AD , Bellatorre A , Bendik S , Divers J , Anthopolos R , Dixon BE , Guo Y , Imperatore G , Lee DC , Reynolds K , Rosenman M , Shao H , Utidjian L , Thorpe LE . BMJ Open 2024 14 (1) e073791 INTRODUCTION: Traditional survey-based surveillance is costly, limited in its ability to distinguish diabetes types and time-consuming, resulting in reporting delays. The Diabetes in Children, Adolescents and Young Adults (DiCAYA) Network seeks to advance diabetes surveillance efforts in youth and young adults through the use of large-volume electronic health record (EHR) data. The network has two primary aims, namely: (1) to refine and validate EHR-based computable phenotype algorithms for accurate identification of type 1 and type 2 diabetes among youth and young adults and (2) to estimate the incidence and prevalence of type 1 and type 2 diabetes among youth and young adults and trends therein. The network aims to augment diabetes surveillance capacity in the USA and assess performance of EHR-based surveillance. This paper describes the DiCAYA Network and how these aims will be achieved. METHODS AND ANALYSIS: The DiCAYA Network is spread across eight geographically diverse US-based centres and a coordinating centre. Three centres conduct diabetes surveillance in youth aged 0-17 years only (component A), three centres conduct surveillance in young adults aged 18-44 years only (component B) and two centres conduct surveillance in components A and B. The network will assess the validity of computable phenotype definitions to determine diabetes status and type based on sensitivity, specificity, positive predictive value and negative predictive value of the phenotypes against the gold standard of manually abstracted medical charts. Prevalence and incidence rates will be presented as unadjusted estimates and as race/ethnicity, sex and age-adjusted estimates using Poisson regression. ETHICS AND DISSEMINATION: The DiCAYA Network is well positioned to advance diabetes surveillance methods. The network will disseminate EHR-based surveillance methodology that can be broadly adopted and will report diabetes prevalence and incidence for key demographic subgroups of youth and young adults in a large set of regions across the USA. |
Impact of SARS-CoV-2 infection on the association between laboratory tests and severe outcomes among hospitalized children
Xie J , Kuppermann N , Florin TA , Tancredi DJ , Funk AL , Kim K , Salvadori MI , Yock-Corrales A , Shah NP , Breslin KA , Chaudhari PP , Bergmann KR , Ahmad FA , Nebhrajani JR , Mintegi S , Gangoiti I , Plint AC , Avva UR , Gardiner MA , Malley R , Finkelstein Y , Dalziel SR , Bhatt M , Kannikeswaran N , Caperell K , Campos C , Sabhaney VJ , Chong SL , Lunoe MM , Rogers AJ , Becker SM , Borland ML , Sartori LF , Pavlicich V , Rino PB , Morrison AK , Neuman MI , Poonai N , Simon NE , Kam AJ , Kwok MY , Morris CR , Palumbo L , Ambroggio L , Navanandan N , Eckerle M , Klassen TP , Payne DC , Cherry JC , Waseem M , Dixon AC , Ferre IB , Freedman SB . Open Forum Infect Dis 2023 10 (10) ofad485 BACKGROUND: To assist clinicians with identifying children at risk of severe outcomes, we assessed the association between laboratory findings and severe outcomes among severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-infected children and determined if SARS-CoV-2 test result status modified the associations. METHODS: We conducted a cross-sectional analysis of participants tested for SARS-CoV-2 infection in 41 pediatric emergency departments in 10 countries. Participants were hospitalized, had laboratory testing performed, and completed 14-day follow-up. The primary objective was to assess the associations between laboratory findings and severe outcomes. The secondary objective was to determine if the SARS-CoV-2 test result modified the associations. RESULTS: We included 1817 participants; 522 (28.7%) SARS-CoV-2 test-positive and 1295 (71.3%) test-negative. Seventy-five (14.4%) test-positive and 174 (13.4%) test-negative children experienced severe outcomes. In regression analysis, we found that among SARS-CoV-2-positive children, procalcitonin ≥0.5 ng/mL (adjusted odds ratio [aOR], 9.14; 95% CI, 2.90-28.80), ferritin >500 ng/mL (aOR, 7.95; 95% CI, 1.89-33.44), D-dimer ≥1500 ng/mL (aOR, 4.57; 95% CI, 1.12-18.68), serum glucose ≥120 mg/dL (aOR, 2.01; 95% CI, 1.06-3.81), lymphocyte count <1.0 × 10(9)/L (aOR, 3.21; 95% CI, 1.34-7.69), and platelet count <150 × 10(9)/L (aOR, 2.82; 95% CI, 1.31-6.07) were associated with severe outcomes. Evaluation of the interaction term revealed that a positive SARS-CoV-2 result increased the associations with severe outcomes for elevated procalcitonin, C-reactive protein (CRP), D-dimer, and for reduced lymphocyte and platelet counts. CONCLUSIONS: Specific laboratory parameters are associated with severe outcomes in SARS-CoV-2-infected children, and elevated serum procalcitonin, CRP, and D-dimer and low absolute lymphocyte and platelet counts were more strongly associated with severe outcomes in children testing positive compared with those testing negative. |
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
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 , Tenforde MW . Clin Infect Dis 2023 BACKGROUND: The epidemiology of 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 hospitalized COVID-19 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 when multiple SARS-CoV-2 variants or sub-lineages predominated. We evaluated changes in baseline demographic and clinical characteristics and critical outcomes (intensive care unit admission and/or death) and used regression models to evaluate critical outcomes risk factors (risk ratios) stratified by COVID-19 vaccination status. RESULTS: 60,488 COVID-19-associated hospitalizations were included in the analysis. Among those hospitalized, from Delta period (June-December 2021) to the Omicron post-BA.4/BA.5 period (September 2022-March 2023), median age increased from 60 to 75 years, proportion vaccinated increased from 18.2% to 70.1%, while critical outcomes declined from 24.8% to 19.4% (all p < 0.001). Compared to all hospitalization events, those with critical outcomes had a higher proportion of four or more categories of medical conditions categories assessed (32.8% critical versus 23.0% all hospitalized). 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 aRR 2.27 [95% CI: 2.14-2.41]; vaccinated aRR 1.73 [95% CI: 1.56-1.92]) across periods. CONCLUSION: The proportion of adults hospitalized with COVID-19 who experienced critical outcomes decreased with time and median patient age increased with time. Multimorbidity was mostly strongly associated with critical outcomes. |
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
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 , Naleway AL . Vaccine 2023 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. |
Self-Reported Mask Use among Persons with or without SARS CoV-2 Vaccination -United States, December 2020-August 2021 (preprint)
Calamari LE , Weintraub WS , Santos R , Gibbs M , Bertoni AG , Ward LM , Saydah S , Plumb ID , Runyon MS , Wierzba TF , Sanders JW , Herrington D , Espeland MA , Williamson J , Mongraw-Chaffin M , Bertoni A , Alexander-Miller MA , Castri P , Mathews A , Munawar I , Seals AL , Ostasiewski B , Ballard CAP , Gurcan M , Ivanov A , Zapata GM , Westcott M , Blinson K , Blinson L , Mistysyn M , Davis D , Doomy L , Henderson P , Jessup A , Lane K , Levine B , McCanless J , McDaniel S , Melius K , O'Neill C , Pack A , Rathee R , Rushing S , Sheets J , Soots S , Wall M , Wheeler S , White J , Wilkerson L , Wilson R , Wilson K , Burcombe D , Saylor G , Lunn M , Ordonez K , O'Steen A , Wagner L , McCurdy LH , Gibbs MA , Taylor YJ , Calamari L , Tapp H , Ahmed A , Brennan M , Munn L , Dantuluri KL , Hetherington T , Lu LC , Dunn C , Hogg M , Price A , Leonidas M , Manning M , Rossman W , Gohs FX , Harris A , Priem JS , Tochiki P , Wellinsky N , Silva C , Ludden T , Hernandez J , Spencer K , McAlister L , Weintraub W , Miller K , Washington C , Moses A , Dolman S , Zelaya-Portillo J , Erkus J , Blumenthal J , Romero Barrientos RE , Bennett S , Shah S , Mathur S , Boxley C , Kolm P , Franklin E , Ahmed N , Larsen M , Oberhelman R , Keating J , Kissinger P , Schieffelin J , Yukich J , Beron A , Teigen J , Kotloff K , Chen WH , Friedman-Klabanoff D , Berry AA , Powell H , Roane L , Datar R , Correa A , Navalkele B , Min YI , Castillo A , Ward L , Santos RP , Anugu P , Gao Y , Green J , Sandlin R , Moore D , Drake L , Horton D , Johnson KL , Stover M , Lagarde WH , Daniel L , Maguire PD , Hanlon CL , McFayden L , Rigo I , Hines K , Smith L , Harris M , Lissor B , Cook V , Eversole M , Herrin T , Murphy D , Kinney L , Diehl P , Abromitis N , Pierre TSt , Heckman B , Evans D , March J , Whitlock B , Moore W , Arthur S , Conway J , Gallaher TR , Johanson M , Brown S , Dixon T , Reavis M , Henderson S , Zimmer M , Oliver D , Jackson K , Menon M , Bishop B , Roeth R , King-Thiele R , Hamrick TS , Ihmeidan A , Hinkelman A , Okafor C , Bray Brown RB , Brewster A , Bouyi D , Lamont K , Yoshinaga K , Vinod P , Peela AS , Denbel G , Lo J , Mayet-Khan M , Mittal A , Motwani R , Raafat M , Schultz E , Joseph A , Parkeh A , Patel D , Afridi B , Uschner D , Edelstein SL , Santacatterina M , Strylewicz G , Burke B , Gunaratne M , Turney M , Zhou SQ , Tjaden AH , Fette L , Buahin A , Bott M , Graziani S , Soni A , Mores C , Porzucek A , Laborde R , Acharya P , Guill L , Lamphier D , Schaefer A , Satterwhite WM , McKeague A , Ward J , Naranjo DP , Darko N , Castellon K , Brink R , Shehzad H , Kuprianov D , McGlasson D , Hayes D , Edwards S , Daphnis S , Todd B , Goodwin A , Berkelman R , Hanson K , Zeger S , Hopkins J , Reilly C , Edwards K , Gayle H , Redd S . medRxiv 2022 10 Wearing a facemask can help to decrease the transmission of COVID-19. We investigated self-reported mask use among subjects aged 18 years and older participating in the COVID-19 Community Research Partnership (CRP), a prospective longitudinal COVID-19 surveillance study in the mid-Atlantic and southeastern United States. We included those participants who completed >=5 daily surveys each month from December 1, 2020 through August 31, 2021. Mask use was defined as self-reported use of a face mask or face covering on every interaction with others outside the household within a distance of less than 6 feet. Participants were considered vaccinated if they reported receiving >=1 COVID-19 vaccine dose. Participants (n=17,522) were 91% non-Hispanic White, 68% female, median age 57 years, 26% healthcare workers, with 95% self-reported receiving >=1 COVID-19 vaccine dose through August; mean daily survey response was 85%. Mask use was higher among vaccinated than unvaccinated participants across the study period, regardless of the month of the first dose. Mask use remained relatively stable from December 2020 through April (range 71-80% unvaccinated; 86-93% vaccinated) and declined in both groups beginning in mid-May 2021 to 34% and 42% respectively in June 2021; mask use has increased again since July 2021. Mask use by all was lower during weekends and on Christmas and Easter, regardless of vaccination status. Independent predictors of higher mask use were vaccination, age >=65 years, female sex, racial or ethnic minority group, and healthcare worker occupation, whereas a history of self-reported prior COVID-19 illness was associated with lower use. Copyright The copyright holder for this preprint is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. This article is a US Government work. It is not subject to copyright under 17 USC 105 and is also made available for use under a CC0 license. |
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 (preprint)
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 , Naleway AL . medRxiv 2022 21 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. Method(s): 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. Result(s): 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. Conclusion(s): 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. Copyright The copyright holder for this preprint is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. This article is a US Government work. It is not subject to copyright under 17 USC 105 and is also made available for use under a CC0 license. |
Transmission potential of vaccinated and unvaccinated persons infected with the SARS-CoV-2 Delta variant in a federal prison, July-August 2021 (preprint)
Salvatore PP , Lee CC , Sleweon S , McCormick DW , Nicolae L , Knipe K , Dixon T , Banta R , Ogle I , Young C , Dusseau C , Salmonson S , Ogden C , Godwin E , Ballom T , Ross T , Wynn NT , David E , Bessey TK , Kim G , Suppiah S , Tamin A , Harcourt JL , Sheth M , Lowe L , Browne H , Tate JE , Kirking HL , Hagan LM . medRxiv 2021 19 Background The extent to which vaccinated persons who become infected with SARS-CoV-2 contribute to transmission is unclear. During a SARS-CoV-2 Delta variant outbreak among incarcerated persons with high vaccination rates in a federal prison, we assessed markers of viral shedding in vaccinated and unvaccinated persons. Methods Consenting incarcerated persons with confirmed SARS-CoV-2 infection provided mid-turbinate nasal specimens daily for 10 consecutive days and reported symptom data via questionnaire. Real-time reverse transcription-polymerase chain reaction (RT-PCR), viral whole genome sequencing, and viral culture was performed on these nasal specimens. Duration of RT-PCR positivity and viral culture positivity was assessed using survival analysis. Results A total of 978 specimens were provided by 95 participants, of whom 78 (82%) were fully vaccinated and 17 (18%) were not fully vaccinated. No significant differences were detected in duration of RT-PCR positivity among fully vaccinated participants (median: 13 days) versus those not fully vaccinated (median: 13 days; p=0.50), or in duration of culture positivity (medians: 5 days and 5 days; p=0.29). Among fully vaccinated participants, overall duration of culture positivity was shorter among Moderna vaccine recipients versus Pfizer (p=0.048) or Janssen (p=0.003) vaccine recipients. Conclusions As this field continues to develop, clinicians and public health practitioners should consider vaccinated persons who become infected with SARS-CoV-2 to be no less infectious than unvaccinated persons. These findings are critically important, especially in congregate settings where viral transmission can lead to large outbreaks. Copyright The copyright holder for this preprint is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. This article is a US Government work. It is not subject to copyright under 17 USC 105 and is also made available for use under a CC0 license. |
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
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 , Tenforde MW . Lancet Reg Health Am 2023 23 100530 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. |
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
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 , Tenforde MW . MMWR Morb Mortal Wkly Rep 2023 72 (21) 579-588 On September 1, 2022, CDC's Advisory Committee on Immunization Practices (ACIP) recommended a single bivalent mRNA COVID-19 booster dose for persons aged ≥12 years who had completed at least a monovalent primary series. Early vaccine effectiveness (VE) estimates among adults aged ≥18 years showed receipt of a bivalent booster dose provided additional protection against COVID-19-associated emergency department and urgent care visits and hospitalizations compared with that in persons who had received only monovalent vaccine doses (1); however, insufficient time had elapsed since bivalent vaccine authorization to assess the durability of this protection. The VISION Network* assessed VE against COVID-19-associated hospitalizations by time since bivalent vaccine receipt during September 13, 2022-April 21, 2023, among adults aged ≥18 years with and without immunocompromising conditions. During the first 7-59 days after vaccination, compared with no vaccination, VE for receipt of a bivalent vaccine dose among adults aged ≥18 years was 62% (95% CI = 57%-67%) among adults without immunocompromising conditions and 28% (95% CI = 10%-42%) among adults with immunocompromising conditions. Among adults without immunocompromising conditions, VE declined to 24% (95% CI = 12%-33%) among those aged ≥18 years by 120-179 days after vaccination. VE was generally lower for adults with immunocompromising conditions. A bivalent booster dose provided the highest protection, and protection was sustained through at least 179 days against critical outcomes, including intensive care unit (ICU) admission or in-hospital death. These data support updated recommendations allowing additional optional bivalent COVID-19 vaccine doses for certain high-risk populations. All eligible persons should stay up to date with recommended COVID-19 vaccines. |
Effectiveness of BNT162b2 COVID-19 Vaccination in Children and Adolescents.
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 , Link-Gelles R . Pediatrics 2023 151 (5) 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. |
Food and Drug Administration public workshop summary-development considerations of antifungal drugs to address unmet medical need
Yasinskaya Y , Bala S , Waack U , Dixon C , Higgins K , Moore JN , Jjingo CJ , O'Shaughnessy E , Colangelo P , Botgros R , Nambiar S , Angulo D , Dane A , Chiller T , Hodges MR , Sandison T , Hope W , Walsh TJ , Pappas P , Katragkou A , Kovanda L , Rex JH , Marr KA , Ostrosky-Zeichner L , Sekine S , Deshpande M , Shukla SJ , Farley J . Clin Infect Dis 2023 77 (3) 380-387 Pressing challenges in the treatment of invasive fungal infections (IFI) include emerging and rare pathogens, resistant/refractory infections, and antifungal armamentarium limited by toxicity, drug-drug interactions, and lack of oral formulations. Development of new antifungal drugs is hampered by the limitations of the available diagnostics; clinical trial endpoints; prolonged trial duration; difficulties in patient recruitment, including subpopulations (e.g., pediatrics); and heterogeneity of the IFIs. On August 4, 2020, the U.S. Food and Drug Administration convened a workshop that included IFI experts from academia, industry, and other government agencies to discuss the IFI landscape, unmet need, and potential strategies to facilitate the development of antifungal drugs for treatment and prophylaxis. This paper summarizes the key topics presented and discussed during the workshop, such as incentives and research support for drug developers, nonclinical development, clinical trial design challenges, lessons learned from industry, and potential collaborations to facilitate antifungal drug development. |
Recommendations for use of video directly observed therapy during tuberculosis treatment - United States, 2023
Mangan JM , Woodruff RS , Winston CA , Nabity SA , Haddad MB , Dixon MG , Parvez FM , Sera-Josef C , Salmon-Trejo LAT , Lam CK . MMWR Morb Mortal Wkly Rep 2023 72 (12) 313-316 U.S. clinical practice guidelines recommend directly observed therapy (DOT) as the standard of care for tuberculosis (TB) treatment (1). DOT, during which a health care worker observes a patient ingesting the TB medications, has typically been conducted in person. Video DOT (vDOT) uses video-enabled devices to facilitate remote interactions between patients and health care workers to promote medication adherence and clinical monitoring. Published systematic reviews, a published meta-analysis, and a literature search through 2022 demonstrate that vDOT is associated with a higher proportion of medication doses being observed and similar proportions of cases with treatment completion and microbiologic resolution when compared with in-person DOT (2-5). Based on this evidence, CDC has updated the recommendation for DOT during TB treatment to include vDOT as an equivalent alternative to in-person DOT. vDOT can assist health department TB programs meet the U.S. standard of care for patients undergoing TB treatment, while using resources efficiently. |
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.
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 , Tenforde MW . JAMA Netw Open 2023 6 (3) e232598 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 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. |
Protection from COVID-19 mRNA vaccination and prior SARS-CoV-2 infection against COVID-19-associated encounters in adults during Delta and Omicron predominance.
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 , Stenehjem E . J Infect Dis 2023 227 (12) 1348-1363 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 U.S. are limited. METHODS: This cohort study included persons ≥18 years who had ≥1 healthcare encounter across four health systems and had been tested for SARS-CoV-2 before August 26, 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)x100%. 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 (95%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. |
Past as prologue-use of rubella vaccination program lessons to inform COVID-19 vaccination
Dixon MG , Reef SE , Zimmerman LA , Grant GB . Emerg Infect Dis 2022 28 (13) S225-s231 The rapid rollout of vaccines against COVID-19 as a key mitigation strategy to end the global pandemic might be informed by lessons learned from rubella vaccine implementation in response to the global rubella epidemic of 1963-1965. That rubella epidemic led to the development of a rubella vaccine that has been introduced in all but 21 countries worldwide and has led to elimination of rubella in 93 countries. Although widespread introduction and use of rubella vaccines was slower than that for COVID-19 vaccines, the process can provide valuable insights for the continued battle against COVID-19. Experiences from the rubella disease control program highlight the critical and evolving elements of a vaccination program, including clearly delineated goals and strategies, regular data-driven revisions to the program based on disease and vaccine safety surveillance, and evaluations to identify the vaccine most capable of achieving disease control targets. |
Relationships between social vulnerability and COVID-19 vaccination coverage and vaccine effectiveness
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 , Sam Kish MN , 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 , Tenforde MW . Clin Infect Dis 2023 76 (9) 1615-1625 BACKGROUND: COVID-19 vaccination coverage remains lower in communities with higher social vulnerability. Factors such as SARS-CoV-2 exposure risk and access to health care 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 seven 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 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. |
Findings from a scoping review: Presumptive treatment for chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) in the USA, 2006-2021
Allen KS , Hinrichs R , Heumann CL , Titus MK , Duszynski TJ , Valvi NR , Wiensch A , Tao G , Dixon BE . Sex Transm Dis 2022 50 (4) 209-214 Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) are the two most common reported sexually transmitted infections in the USA. Current recommendations are to presumptively treat CT and/or GC in persons with symptoms or known contact. This review characterizes the literature around studies with presumptive treatment, including identifying rates of presumptive treatment and over- and under-treatment rates. Of the 18 articles that met our inclusion criteria, six pertained to outpatient settings. In the outpatient setting, presumptive treatment rates, for both asymptomatic and symptomic patients, varied from 12% - 100%, and the percent positive of those presumptively treated ranged from 25% - 46%. Three studies also reported data on positive results in patients not presumptively treated, which ranged from 2% - 9%. Two studies reported median follow-up time for untreated, which was roughly nine days. The remaining 12 articles pertained to the emergency setting where presumptive treatment rates, for both asymptomatic and symptomic patients, varied from 16% - 91%, the percent positive following presumptive treatment ranged from 14% - 59%. Positive results without presumptive treatment ranged from 4% - 52%. Two studies reported the percent positive without any treatment (6% and 32% respectively) and one reported follow-up time for untreated infections (median: 4.8 days). Rates of presumptive treatment, as well as rates of over- or under- treatment vary widely across studies and within care settings. Given large variability in presumptive treatment, the focus on urban settings, and minimal focus on social determinants of health, additional studies are needed to guide treatment practices for CT and GC in outpatient and emergency settings. |
Transmission potential of vaccinated and unvaccinated persons infected with the SARS-CoV-2 Delta variant in a federal prison, July-August 2021.
Salvatore PP , Lee CC , Sleweon S , McCormick DW , Nicolae L , Knipe K , Dixon T , Banta R , Ogle I , Young C , Dusseau C , Salmonson S , Ogden C , Godwin E , Ballom T , Rhodes T , Wynn NT , David E , Bessey TK , Kim G , Suppiah S , Tamin A , Harcourt JL , Sheth M , Lowe L , Browne H , Tate JE , Kirking HL , Hagan LM . Vaccine 2022 41 (11) 1808-1818 BACKGROUND: The extent to which vaccinated persons who become infected with SARS-CoV-2 contribute to transmission is unclear. During a SARS-CoV-2 Delta variant outbreak among incarcerated persons with high vaccination rates in a federal prison, we assessed markers of viral shedding in vaccinated and unvaccinated persons. METHODS: Consenting incarcerated persons with confirmed SARS-CoV-2 infection provided mid-turbinate nasal specimens daily for 10 consecutive days and reported symptom data via questionnaire. Real-time reverse transcription-polymerase chain reaction (RT-PCR), viral whole genome sequencing, and viral culture was performed on these nasal specimens. Duration of RT-PCR positivity and viral culture positivity was assessed using survival analysis. RESULTS: A total of 957 specimens were provided by 93 participants, of whom 78 (84 %) were vaccinated and 17 (16 %) were unvaccinated. No significant differences were detected in duration of RT-PCR positivity among vaccinated participants (median: 13 days) versus those unvaccinated (median: 13 days; p = 0.50), or in duration of culture positivity (medians: 5 days and 5 days; p = 0.29). Among vaccinated participants, overall duration of culture positivity was shorter among Moderna vaccine recipients versus Pfizer (p = 0.048) or Janssen (p = 0.003) vaccine recipients. In post-hoc analyses, Moderna vaccine recipients demonstrated significantly shorter duration of culture positivity compared to unvaccinated participants (p = 0.02). When restricted to participants without reported prior infection, the difference between Moderna vaccine recipients and unvaccinated participants was more pronounced (medians: 3 days and 6 days, p = 0.002). CONCLUSIONS: Infectious periods for vaccinated and unvaccinated persons who become infected with SARS-CoV-2 are similar and can be highly variable, though some vaccinated persons are likely infectious for shorter durations. These findings are critically important, especially in congregate settings where viral transmission can lead to large outbreaks. In such settings, clinicians and public health practitioners should consider vaccinated, infected persons to be no less infectious than unvaccinated, infected persons. |
Factors Associated with Intention to Vaccinate Children 0-11 Years of Age Against COVID-19.
Stockwell MS , Porucznik CA , Dixon A , Duque J , Stanford JB , Veguilla V , Dawood FS . J Am Board Fam Med 2022 35 (6) 1174-1178 BACKGROUND: Millions of children have tested positive for SARS-CoV-2, and over 1000 children have died in the US. However, vaccination rates for children 5 to 11 years old are low. METHODS: Starting in August 2020, we conducted a prospective SARS-CoV-2 household surveillance study in Spanish and English-speaking households in New York City and Utah. From October 21 to 25, 2021, we asked caregivers about their likelihood of getting COVID-19 vaccine for their child, and reasons that they might or might not vaccinate that child. We compared intent to vaccinate by site, demographic characteristics, SARS-CoV-2 infection detected by study surveillance, and parents' COVID-19 vaccination status using Chi-square tests and a multivariable logistic regression model, accounting for within-household clustering. RESULTS: Among parents or caregivers of 309 children (0 to 11 years) in 172 households, 87% were very or somewhat likely to intend to vaccinate their child. The most prevalent reasons for intending to vaccinate were to protect family and friends and the community; individual prevention was mentioned less often. The most prevalent reasons for not intending to vaccinate were side effect concerns and wanting to wait and see.In multivariable analysis, parents had much lower odds of intending to vaccinate if someone in the household had tested SARS-CoV-2-positive during the study (adjusted odds ratio = 0.09; 95% confidence interval, 0.03-0.3). CONCLUSION: This study highlighted several themes for clinicians and public health officials to consider including the importance and safety of vaccination for this age-group even if infected previously, and the benefits of vaccination to protect family, friends, and community. |
Use of a rapid digital microfluidics-powered immunoassay for assessing measles and rubella infection and immunity in outbreak settings in the Democratic Republic of the Congo
Knipes AK , Summers A , Sklavounos AA , Lamanna J , de Campos RPS , Narahari T , Dixon C , Fobel R , Ndjakani YD , Lubula L , Magazani A , Muyembe JJ , Lay Y , Pukuta E , Waku-Kouomou D , Hao L , Kayembe JK , Fobel C , Dahmer J , Lee A , Ho M , Valenzuela JGC , Rackus DG , Shih R , Seale B , Chang A , Paluku G , Rota PA , Wheeler AR , Scobie HM . PLoS One 2022 17 (12) e0278749 The Democratic Republic of the Congo (DRC) has a high measles incidence despite elimination efforts and has yet to introduce rubella vaccine. We evaluated the performance of a prototype rapid digital microfluidics powered (DMF) enzyme-linked immunoassay (ELISA) assessing measles and rubella infection, by testing for immunoglobulin M (IgM), and immunity from natural infection or vaccine, by testing immunoglobulin G (IgG), in outbreak settings. Field evaluations were conducted during September 2017, in Kinshasa province, DRC. Blood specimens were collected during an outbreak investigation of suspected measles cases and tested for measles and rubella IgM and IgG using the DMF-ELISA in the field. Simultaneously, a household serosurvey for measles and rubella IgG was conducted in a recently confirmed measles outbreak area. DMF-ELISA results were compared with reference ELISA results tested at DRC's National Public Health Laboratory and the US Centers for Disease Control and Prevention. Of 157 suspected measles cases, rubella IgM was detected in 54% while measles IgM was detected in 13%. Measles IgG-positive cases were higher among vaccinated persons (87%) than unvaccinated persons (72%). In the recent measles outbreak area, measles IgG seroprevalence was 93% overall, while rubella seroprevalence was lower for children (77%) than women (98%). Compared with reference ELISA, DMF-ELISA sensitivity and specificity were 82% and 78% for measles IgG; 88% and 89% for measles IgM; 85% and 85% for rubella IgG; and 81% and 83% for rubella IgM, respectively. Rubella infection was detected in more than half of persons meeting the suspected measles case definition during a presumed measles outbreak, suggesting substantial unrecognized rubella incidence, and highlighting the need for rubella vaccine introduction into the national schedule. The performance of the DMF-ELISA suggested that this technology can be used to develop rapid diagnostic tests for measles and rubella. |
COVID-19 Outbreaks Linked to Workplaces, 23 US Jurisdictions, August-October 2021.
Luckhaupt SE , Horter L , Groenewold MR , dePerio MA , Robbins CL , Sweeney MH , Thomas I , Valencia D , Ingram A , Heinzerling A , Nguyen A , Townsend EB , Weber RC , Reichbind D , Dishman H , Kerins JL , Lendacki FR , Austin C , Dixon L , Spillman B , Simonson S , Tonzel J , Krueger A , Duwell M , Bachaus B , Rust B , Barrett C , Morrison B , OwersBonner KA , Karlsson ND , Angelon-Gaetz K , McClure ES , Kline KE , Dangar D , Reed C , Karpowicz J , Anderson SM , Cantor S , Chaudhary I , Ellis EM , Taylor ML , Sedon A , Kocharian A , Morris C , Samson ME , Mangla AT . Public Health Rep 2022 138 (2) 333549221138294 OBJECTIVES: Early in the COVID-19 pandemic, several outbreaks were linked with facilities employing essential workers, such as long-term care facilities and meat and poultry processing facilities. However, timely national data on which workplace settings were experiencing COVID-19 outbreaks were unavailable through routine surveillance systems. We estimated the number of US workplace outbreaks of COVID-19 and identified the types of workplace settings in which they occurred during August-October 2021. METHODS: The Centers for Disease Control and Prevention collected data from health departments on workplace COVID-19 outbreaks from August through October 2021: the number of workplace outbreaks, by workplace setting, and the total number of cases among workers linked to these outbreaks. Health departments also reported the number of workplaces they assisted for outbreak response, COVID-19 testing, vaccine distribution, or consultation on mitigation strategies. RESULTS: Twenty-three health departments reported a total of 12 660 workplace COVID-19 outbreaks. Among the 12 470 workplace types that were documented, 35.9% (n = 4474) of outbreaks occurred in health care settings, 33.4% (n = 4170) in educational settings, and 30.7% (n = 3826) in other work settings, including non-food manufacturing, correctional facilities, social services, retail trade, and food and beverage stores. Eleven health departments that reported 3859 workplace outbreaks provided information about workplace assistance: 3090 (80.1%) instances of assistance involved consultation on COVID-19 mitigation strategies, 1912 (49.5%) involved outbreak response, 436 (11.3%) involved COVID-19 testing, and 185 (4.8%) involved COVID-19 vaccine distribution. CONCLUSIONS: These findings underscore the continued impact of COVID-19 among workers, the potential for work-related transmission, and the need to apply layered prevention strategies recommended by public health officials. |
SARS-CoV-2 viral shedding in vaccinated and unvaccinated persons: A case series.
McCormick DW , Hagan LM , Salvatore PP , Magleby R , Lee C , Sleweon S , Nicolae L , Dixon T , Banta R , Ogle I , Young C , Dusseau C , Ogden C , Browne H , Michael Metz J , Chen MH , Solano MI , Rogers S , Burgin A , Sheth M , Bankamp B , Tamin A , Harcourt JL , Tate JE , Kirking HL . Vaccine 2022 41 (11) 1769-1773 The preclinical time course of SARS-CoV-2 shedding is not well-described. Understanding this time course will help to inform risk of SARS-CoV-2 transmission. During an outbreak in a congregate setting, we collected paired mid-turbinate nasal swabs for antigen testing and reverse-transcription polymerase chain reaction (RT-PCR) every other day from all consenting infected and exposed persons. Among 12 persons tested prospectively before and during SARS-CoV-2 infection, ten of 12 participants (83%) had completed a primary COVID-19 vaccination series prior to the outbreak. We recovered SARS-CoV-2 in viral culture from 9/12 (75%) of participants. All three persons from whom we did not recover SARS-CoV-2 in viral culture had completed their primary vaccination series. We recovered SARS-CoV-2 from viral culture in 6/9 vaccinated persons and before symptom onset in 3/6 symptomatic persons. These findings underscore the need for both non-pharmaceutical interventions and vaccination to mitigate transmission. |
- Page last reviewed:Feb 1, 2024
- Page last updated:Oct 28, 2024
- Content source:
- Powered by CDC PHGKB Infrastructure