Last data update: Apr 18, 2025. (Total: 49119 publications since 2009)
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New COVID-19 Vaccine Cost and Access Barriers Add Challenges to Immunizing Post-Acute and Long-Term Care Staff
Sobczyk EA , Parker Fiebelkorn A , Schultz EM , Casey DM , Roney HL , Davis RC , Nace DA . J Am Med Dir Assoc 2025 26 (4) 105519 |
Vaccine Effectiveness Against Influenza A(H1N1), A(H3N2), and B-Associated Hospitalizations-United States, September 1, 2023-May 31, 2024
Lewis NM , Harker EJ , Cleary S , Zhu Y , Grijalva CG , Chappell JD , Rhoads JP , Baughman A , Casey JD , Blair PW , Jones ID , Johnson CA , Halasa NB , Lauring AS , Martin ET , Gaglani M , Ghamande S , Columbus C , Steingrub JS , Duggal A , Felzer JR , Prekker ME , Peltan ID , Brown SM , Hager DN , Gong MN , Mohamed A , Exline MC , Khan A , Ferguson SAN , Mosier J , Qadir N , Chang SY , Ginde AA , Zepeski A , Mallow C , Harris ES , Johnson NJ , Gibbs KW , Kwon JH , Vaughn IA , Ramesh M , Safdar B , Surie D , Dawood FS , Ellington S , Self WH . J Infect Dis 2025 BACKGROUND: The 2023-2024 influenza season included sustained elevated activity from December 2023-February 2024 and continued activity through May 2024. Influenza A(H1N1), A(H3N2), and B viruses circulated during the season. METHODS: During September 1, 2023-May 31, 2024, a multistate sentinel surveillance network of 24 medical centers in 20 U.S. states enrolled adults aged ≥18 years hospitalized with acute respiratory illness (ARI). Consistent with a test-negative design, cases tested positive for influenza viruses by molecular or antigen test, and controls tested negative for influenza viruses and SARS-CoV-2. Vaccine effectiveness (VE) against influenza-associated hospitalization was calculated as (1 - adjusted odds ratio for vaccination) × 100%. RESULTS: Among 7690 patients, including 1170 influenza cases (33% vaccinated) and 6520 controls, VE was 40% (95% CI: 31%-48%) with varying estimates by age (18-49 years: 53% [34%-67%]; 50-64 years: 47% [31%-60%]; ≥65 years: 31% [16%-43%]). Protection was similar among immunocompetent patients (40% [30%-49%]) and immunocompromised patients (32% [7-50%]). VE was statistically significant against influenza B (67% [35%-84%]) and A(H1N1) (36% [21%-48%]) and crossed the null against A(H3N2) (19% [-8%-39%]). VE was higher for patients 14-60 days from vaccination (54% [40%-65%]) than >120 days (18% [-1%-33%]). CONCLUSIONS: During 2023-2024, influenza vaccination reduced the risk of influenza A(H1N1)- and influenza B-associated hospitalizations among adults; effectiveness was lower in patients vaccinated >120 days prior to illness onset compared with those vaccinated 14-60 days prior. |
Risk of transmission of vaccine-strain rotavirus in a neonatal intensive care unit that routinely vaccinates
Zalot MA , Cortese MM , O'Callaghan KP , Casey-Moore MC , L'Etoile N , Smart SL , Honeywood MJ , Mijatovic-Rustempasic S , Tate JE , Davis A , Wittmeyer N , McGann C , Sadaf S , Wilson K , Bowen MD , Gautam R , Parashar UD , Coffin SE , Gibbs KA . Pediatrics 2024 ![]() ![]() BACKGROUND AND OBJECTIVES: Many neonatal intensive care units (NICUs) do not give rotavirus vaccines to inpatients due to a theoretical risk of horizontal transmission of vaccine strains. We aimed to determine incidence and clinical significance of vaccine-strain transmission to unvaccinated infants in a NICU that routinely administers pentavalent rotavirus vaccine (RV5). METHODS: This prospective cohort study included all patients admitted to a 100-bed NICU for 1 year. Stool specimens were collected weekly; real-time quantitative reverse-transcription polymerase chain reaction was used to detect any RV5 strain. Incidence of transmission to unvaccinated infants was calculated assuming each unvaccinated patient's stool contributed 1 patient-day at risk for transmission. Investigations and geospatial analyses were conducted for suspected transmission events. RESULTS: Of 1238 infants admitted, 560 (45%) were premature and 322 (26%) had gastrointestinal pathology. During observation, 226 RV5 doses were administered. Overall, 3448 stool samples were tested, including 2252 from 686 unvaccinated patients. Most (681, 99.3%) unvaccinated patients never tested positive for RV5 strain. Five (<1%) tested RV5 strain positive. The estimated rate of transmission to unvaccinated infants was 5/2252 stools or 2.2/1000 patient-days at risk (95% CI: 0.7-5.2). No gastroenteritis symptoms were identified in transmission cases within 7 days of collection of RV5-positive stool. Of 126 patients for whom the RV5 series was initiated before the discharge date, 55% would have become age-ineligible to start the series if vaccination was allowed only at discharge. CONCLUSIONS: Transmission of RV5 strain was infrequent and without clinical consequences. Benefits of allowing vaccine-induced protection against rotavirus disease in infants through in-NICU RV5 vaccination appear to have outweighed risks from vaccine-strain transmission. |
Benefit of early oseltamivir therapy for adults hospitalized with influenza A: an observational study
Lewis NM , Harker EJ , Grant LB , Zhu Y , Grijalva CG , Chappell JD , Rhoads JP , Baughman A , Casey JD , Blair PW , Jones ID , Johnson CA , Lauring AS , Gaglani M , Ghamande S , Columbus C , Steingrub JS , Shapiro NI , Duggal A , Busse LW , Felzer J , Prekker ME , Peltan ID , Brown SM , Hager DN , Gong MN , Mohamed A , Exline MC , Khan A , Hough CL , Wilson JG , Mosier J , Qadir N , Chang SY , Ginde AA , Martinez A , Mohr NM , Mallow C , Harris ES , Johnson NJ , Srinivasan V , Gibbs KW , Kwon JH , Vaughn IA , Ramesh M , Safdar B , Goyal A , DeLamielleure LE , DeCuir J , Surie D , Dawood FS , Tenforde MW , Uyeki TM , Garg S , Ellington S , Self WH . Clin Infect Dis 2024 BACKGROUND: clinical guidelines recommend initiation of antiviral therapy as soon as possible for patients hospitalized with confirmed or suspected influenza. METHODS: A multicenter US observational sentinel surveillance network prospectively enrolled adults (aged ≥18 years) hospitalized with laboratory-confirmed influenza at 24 hospitals during October 1, 2022-July 21, 2023. A multivariable proportional odds model was used to compare peak pulmonary disease severity (no oxygen support, standard supplemental oxygen, high-flow oxygen/non-invasive ventilation, invasive mechanical ventilation, or death) after the day of hospital admission among patients starting oseltamivir treatment on the day of admission (early) versus those who did not (late or not treated), adjusting for baseline (admission day) severity, age, sex, site, and vaccination status. Multivariable logistic regression models were used to evaluate the odds of intensive care unit (ICU) admission, acute kidney replacement therapy or vasopressor use, and in-hospital death. RESULTS: A total of 840 influenza-positive patients were analyzed, including 415 (49%) who started oseltamivir treatment on the day of admission, and 425 (51%) who did not. Compared with late or not treated patients, those treated early had lower peak pulmonary disease severity (proportional aOR: 0.60, 95% CI: 0.49-0.72), and lower odds of intensive care unit admission (aOR: 0.24, 95% CI: 0.13-0.47), acute kidney replacement therapy or vasopressor use (aOR: 0.40, 95% CI: 0.22-0.67), and in-hospital death (aOR: 0.36, 95% CI: 0.18-0.72). CONCLUSION: Among adults hospitalized with influenza, treatment with oseltamivir on day of hospital admission was associated reduced risk of disease progression, including pulmonary and extrapulmonary organ failure and death. |
Assessment and mitigation of bias in influenza and COVID-19 vaccine effectiveness analyses - IVY Network, September 1, 2022-March 30, 2023
Lewis NM , Harker EJ , Leis A , Zhu Y , Talbot HK , Grijalva CG , Halasa N , Chappell JD , Johnson CA , Rice TW , Casey JD , Lauring AS , Gaglani M , Ghamande S , Columbus C , Steingrub JS , Shapiro NI , Duggal A , Felzer J , Prekker ME , Peltan ID , Brown SM , Hager DN , Gong MN , Mohamed A , Exline MC , Khan A , Wilson JG , Mosier J , Qadir N , Chang SY , Ginde AA , Mohr NM , Mallow C , Harris ES , Johnson NJ , Srinivasan V , Gibbs KW , Kwon JH , Vaughn IA , Ramesh M , Safdar B , DeCuir J , Surie D , Dawood FS , Ellington S , Self WH , Martin ET . Vaccine 2024 43 126492 BACKGROUND: In test-negative studies of vaccine effectiveness (VE), including patients with co-circulating, vaccine-preventable, respiratory pathogens in the control group for the pathogen of interest can introduce a downward bias on VE estimates. METHODS: A multicenter sentinel surveillance network in the US prospectively enrolled adults hospitalized with acute respiratory illness from September 1, 2022-March 31, 2023. We evaluated bias in estimates of VE against influenza-associated and COVID-19-associated hospitalization based on: inclusion vs exclusion of patients with a co-circulating virus among VE controls; observance of VE against the co-circulating virus (rather than the virus of interest), unadjusted and adjusted for vaccination against the virus of interest; and observance of influenza or COVID-19 against a sham outcome of respiratory syncytial virus (RSV). RESULTS: Overall VE against influenza-associated hospitalizations was 6 percentage points lower when patients with COVID-19 were included in the control group, and overall VE against COVID-19-associated hospitalizations was 2 percentage points lower when patients with influenza were included in the control group. Analyses of VE against the co-circulating virus and against the sham outcome of RSV showed that downward bias was largely attributable the correlation of vaccination status across pathogens, but also potentially attributable to other sources of residual confounding in VE models. CONCLUSION: Excluding cases of confounding respiratory pathogens from the control group in VE analysis for a pathogen of interest can reduce downward bias. This real-world analysis demonstrates that such exclusion is a helpful bias mitigation strategy, especially for measuring influenza VE, which included a high proportion of COVID-19 cases among controls. |
Effectiveness of original monovalent and bivalent COVID-19 vaccines against COVID-19-associated hospitalization and severe in-hospital outcomes among adults in the United States, September 2022-August 2023
DeCuir J , Surie D , Zhu Y , Lauring AS , Gaglani M , McNeal T , Ghamande S , Peltan ID , Brown SM , Ginde AA , Steinwand A , Mohr NM , Gibbs KW , Hager DN , Ali H , Frosch A , Gong MN , Mohamed A , Johnson NJ , Srinivasan V , Steingrub JS , Khan A , Busse LW , Duggal A , Wilson JG , Qadir N , Chang SY , Mallow C , Kwon JH , Exline MC , Shapiro NI , Columbus C , Vaughn IA , Ramesh M , Safdar B , Mosier JM , Casey JD , Talbot HK , Rice TW , Halasa N , Chappell JD , Grijalva CG , Baughman A , Womack KN , Rhoads JP , Swan SA , Johnson C , Lewis N , Ellington S , Dawood FS , McMorrow M , Self WH . Influenza Other Respir Viruses 2024 18 (11) e70027 ![]() ![]() BACKGROUND: Assessments of COVID-19 vaccine effectiveness are needed to monitor the protection provided by updated vaccines against severe COVID-19. We evaluated the effectiveness of original monovalent and bivalent (ancestral strain and Omicron BA.4/5) COVID-19 vaccination against COVID-19-associated hospitalization and severe in-hospital outcomes. METHODS: During September 8, 2022 to August 31, 2023, adults aged ≥ 18 years hospitalized with COVID-19-like illness were enrolled at 26 hospitals in 20 US states. Using a test-negative case-control design, we estimated vaccine effectiveness (VE) with multivariable logistic regression adjusted for age, sex, race/ethnicity, admission date, and geographic region. RESULTS: Among 7028 patients, 2924 (41.6%) were COVID-19 case patients, and 4104 (58.4%) were control patients. Compared to unvaccinated patients, absolute VE against COVID-19-associated hospitalization was 6% (-7%-17%) for original monovalent doses only (median time since last dose [IQR] = 421 days [304-571]), 52% (39%-61%) for a bivalent dose received 7-89 days earlier, and 13% (-10%-31%) for a bivalent dose received 90-179 days earlier. Absolute VE against COVID-19-associated invasive mechanical ventilation or death was 51% (34%-63%) for original monovalent doses only, 61% (35%-77%) for a bivalent dose received 7-89 days earlier, and 50% (11%-71%) for a bivalent dose received 90-179 days earlier. CONCLUSION: Bivalent vaccination provided protection against COVID-19-associated hospitalization and severe in-hospital outcomes within 3 months of receipt, followed by a decline in protection to a level similar to that remaining from previous original monovalent vaccination by 3-6 months. These results underscore the benefit of remaining up to date with recommended COVID-19 vaccines. |
Effectiveness of updated 2023-2024 (monovalent XBB.1.5) COVID-19 vaccination against SARS-CoV-2 Omicron XBB and BA.2.86/JN.1 lineage hospitalization and a comparison of clinical severity-IVY Network, 26 hospitals, October 18, 2023-March 9, 2024
Ma KC , Surie D , Lauring AS , Martin ET , Leis AM , Papalambros L , Gaglani M , Columbus C , Gottlieb RL , Ghamande S , Peltan ID , Brown SM , Ginde AA , Mohr NM , Gibbs KW , Hager DN , Saeed S , Prekker ME , Gong MN , Mohamed A , Johnson NJ , Srinivasan V , Steingrub JS , Khan A , Hough CL , Duggal A , Wilson JG , Qadir N , Chang SY , Mallow C , Kwon JH , Parikh B , Exline MC , Vaughn IA , Ramesh M , Safdar B , Mosier J , Harris ES , Shapiro NI , Felzer J , Zhu Y , Grijalva CG , Halasa N , Chappell JD , Womack KN , Rhoads JP , Baughman A , Swan SA , Johnson CA , Rice TW , Casey JD , Blair PW , Han JH , Ellington S , Lewis NM , Thornburg N , Paden CR , Atherton LJ , Self WH , Dawood FS , DeCuir J . Clin Infect Dis 2024 ![]() ![]() BACKGROUND: Assessing variant-specific COVID-19 vaccine effectiveness (VE) and severity can inform public health risk assessments and decisions about vaccine composition. BA.2.86 and its descendants, including JN.1 (referred to collectively as "JN lineages"), emerged in late 2023 and exhibited substantial divergence from co-circulating XBB lineages. METHODS: We analyzed patients hospitalized with COVID-19-like illness at 26 hospitals in 20 U.S. states admitted October 18, 2023-March 9, 2024. Using a test-negative, case-control design, we estimated effectiveness of an updated 2023-2024 (Monovalent XBB.1.5) COVID-19 vaccine dose against sequence-confirmed XBB and JN lineage hospitalization using logistic regression. Odds of severe outcomes, including intensive care unit (ICU) admission and invasive mechanical ventilation (IMV) or death, were compared for JN versus XBB lineage hospitalizations using logistic regression. RESULTS: 585 case-patients with XBB lineages, 397 case-patients with JN lineages, and 4,580 control-patients were included. VE in the first 7-89 days after receipt of an updated dose was 54.2% (95% CI = 36.1%-67.1%) against XBB lineage hospitalization and 32.7% (95% CI = 1.9%-53.8%) against JN lineage hospitalization. Odds of ICU admission (adjusted odds ratio [aOR] 0.80; 95% CI = 0.46-1.38) and IMV or death (aOR 0.69; 95% CI = 0.34-1.40) were not significantly different among JN compared to XBB lineage hospitalizations. CONCLUSIONS: Updated 2023-2024 COVID-19 vaccination provided protection against both XBB and JN lineage hospitalization, but protection against the latter may be attenuated by immune escape. Clinical severity of JN lineage hospitalizations was not higher relative to XBB. |
Reusable respirators: the impact on safety climate across health settings
Haas EJ , Edirisooriya M , Furek A , Casey M . Prof Saf 2024 69 (5) 20-26 Key Takeaways: Receiving reusable respirators and corresponding ongoing communication and training may improve worker well-being, serving as a tangible indicator of organizational support. From an emergency preparedness standpoint, organizations may consider stockpiling reusable elastomeric half-mask respirators and updating their respiratory protection program (RPP) to include education about these respirators. From a health promotion standpoint, it may behoove organizations to develop comprehensive programs that emphasize management practices to increase worker perceptions of safety climate and, consequently, worker mental health and well-being. Supervisor or frontline leadership communication and engagement in the implementation of RPPs is critical to foster trust and adoption of new respirators. Ongoing role modeling and support by management to comply with the RPP or other safety and health plans are necessary to garner employee-wide participation in respiratory protection. |
Notes from the field: Rapid linkage of a salmonella livingstone outbreak to a restaurant, using open-ended interviews and patient purchase histories - Utah, 2023-2024
Keisling C , Hatfield J , Moore D , Graves S , Smith B , Wagner J , Casey R , Young EL , Oakeson K , Lanier W . MMWR Morb Mortal Wkly Rep 2024 73 (23) 536-537 |
Shiga toxin-producing Escherichia coli o157:H7 illness outbreak associated with untreated, pressurized, municipal irrigation water - Utah, 2023
Osborn B , Hatfield J , Lanier W , Wagner J , Oakeson K , Casey R , Bullough J , Kache P , Miko S , Kunz J , Pederson G , Leeper M , Strockbine N , McKeel H , Hofstetter J , Roundtree A , Kahler A , Mattioli M . MMWR Morb Mortal Wkly Rep 2024 73 (18) 411-416 ![]() During July-September 2023, an outbreak of Shiga toxin-producing Escherichia coli O157:H7 illness among children in city A, Utah, caused 13 confirmed illnesses; seven patients were hospitalized, including two with hemolytic uremic syndrome. Local, state, and federal public health partners investigating the outbreak linked the illnesses to untreated, pressurized, municipal irrigation water (UPMIW) exposure in city A; 12 of 13 ill children reported playing in or drinking UPMIW. Clinical isolates were genetically highly related to one another and to environmental isolates from multiple locations within city A's UPMIW system. Microbial source tracking, a method to indicate possible contamination sources, identified birds and ruminants as potential sources of fecal contamination of UPMIW. Public health and city A officials issued multiple press releases regarding the outbreak reminding residents that UPMIW is not intended for drinking or recreation. Public education and UPMIW management and operations interventions, including assessing and mitigating potential contamination sources, covering UPMIW sources and reservoirs, indicating UPMIW lines and spigots with a designated color, and providing conspicuous signage to communicate risk and intended use might help prevent future UPMIW-associated illnesses. |
Reframing fall prevention and risk management as a chronic condition through the lens of the expanded chronic care model: Will integrating clinical care and public health improve outcomes?
Vincenzo JL , Bergen G , Casey CM , Eckstrom E . Gerontologist 2024 Falls are a leading cause of morbidity and mortality among adults aged 65 years and older (older adults) and are increasingly recognized as a chronic condition. Yet, fall-related care is infrequently provided in a chronic care context despite fall-related death rates increasing 41% between 2012 and 2021. One of the many challenges to addressing falls is the absence of fall-focused chronic disease management programs, which improve outcomes of other chronic conditions, like diabetes. Policies, information systems, and clinical-community connections help form the backbone of chronic disease management programs, yet these elements are often missing in fall prevention. Reframing fall prevention through the Expanded Chronic Care Model (ECCM) guided by implementation science to simultaneously support the uptake of evidence-based practices could help improve the care of older adults at risk for falling. The ECCM includes seven components: 1) self-management/develop personal skills, 2) decision support, 3) delivery system design/re-orient health services, 4) information systems, 5) build healthy public policy, 6) create supportive environments, and 7) strengthen community action. Applying the ECCM to falls-related care by integrating healthcare delivery system changes, community resources, and public policies to support patient-centered engagement for self-management offers the potential to prevent falls more effectively among older adults. |
Severity of respiratory syncytial virus vs COVID-19 and influenza among hospitalized US adults
Surie D , Yuengling KA , DeCuir J , Zhu Y , Lauring AS , Gaglani M , Ghamande S , Peltan ID , Brown SM , Ginde AA , Martinez A , Mohr NM , Gibbs KW , Hager DN , Ali H , Prekker ME , Gong MN , Mohamed A , Johnson NJ , Srinivasan V , Steingrub JS , Leis AM , Khan A , Hough CL , Bender WS , Duggal A , Bendall EE , Wilson JG , Qadir N , Chang SY , Mallow C , Kwon JH , Exline MC , Shapiro NI , Columbus C , Vaughn IA , Ramesh M , Mosier JM , Safdar B , Casey JD , Talbot HK , Rice TW , Halasa N , Chappell JD , Grijalva CG , Baughman A , Womack KN , Swan SA , Johnson CA , Lwin CT , Lewis NM , Ellington S , McMorrow ML , Martin ET , Self WH . JAMA Netw Open 2024 7 (4) e244954 IMPORTANCE: On June 21, 2023, the Centers for Disease Control and Prevention recommended the first respiratory syncytial virus (RSV) vaccines for adults aged 60 years and older using shared clinical decision-making. Understanding the severity of RSV disease in adults can help guide this clinical decision-making. OBJECTIVE: To describe disease severity among adults hospitalized with RSV and compare it with the severity of COVID-19 and influenza disease by vaccination status. DESIGN, SETTING, AND PARTICIPANTS: In this cohort study, adults aged 18 years and older admitted to the hospital with acute respiratory illness and laboratory-confirmed RSV, SARS-CoV-2, or influenza infection were prospectively enrolled from 25 hospitals in 20 US states from February 1, 2022, to May 31, 2023. Clinical data during each patient's hospitalization were collected using standardized forms. Data were analyzed from August to October 2023. EXPOSURES: RSV, SARS-CoV-2, or influenza infection. MAIN OUTCOMES AND MEASURES: Using multivariable logistic regression, severity of RSV disease was compared with COVID-19 and influenza severity, by COVID-19 and influenza vaccination status, for a range of clinical outcomes, including the composite of invasive mechanical ventilation (IMV) and in-hospital death. RESULTS: Of 7998 adults (median [IQR] age, 67 [54-78] years; 4047 [50.6%] female) included, 484 (6.1%) were hospitalized with RSV, 6422 (80.3%) were hospitalized with COVID-19, and 1092 (13.7%) were hospitalized with influenza. Among patients with RSV, 58 (12.0%) experienced IMV or death, compared with 201 of 1422 unvaccinated patients with COVID-19 (14.1%) and 458 of 5000 vaccinated patients with COVID-19 (9.2%), as well as 72 of 699 unvaccinated patients with influenza (10.3%) and 20 of 393 vaccinated patients with influenza (5.1%). In adjusted analyses, the odds of IMV or in-hospital death were not significantly different among patients hospitalized with RSV and unvaccinated patients hospitalized with COVID-19 (adjusted odds ratio [aOR], 0.82; 95% CI, 0.59-1.13; P = .22) or influenza (aOR, 1.20; 95% CI, 0.82-1.76; P = .35); however, the odds of IMV or death were significantly higher among patients hospitalized with RSV compared with vaccinated patients hospitalized with COVID-19 (aOR, 1.38; 95% CI, 1.02-1.86; P = .03) or influenza disease (aOR, 2.81; 95% CI, 1.62-4.86; P < .001). CONCLUSIONS AND RELEVANCE: Among adults hospitalized in this US cohort during the 16 months before the first RSV vaccine recommendations, RSV disease was less common but similar in severity compared with COVID-19 or influenza disease among unvaccinated patients and more severe than COVID-19 or influenza disease among vaccinated patients for the most serious outcomes of IMV or death. |
Prevention of zoonotic spillover: From relying on response to reducing the risk at source
Wanda M , Thomas CM , Wiku BA , Salama A , Casey BB , Pépé B , Salome AB , Natalia C , Natalia CB , Dominique FC , Abhishek C , Janice RCZ , Andrew AC , Osman D , Nitish D , Baptiste D , Elmoubasher F , George FG , David TSH , Margaret K , Marion PGK , Catherine M , John SM , Serge M , Vyacheslav S , Zhou L , Giraudoux P . PLoS Pathog 2023 19 (10) e1011504 ![]() |
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. |
The real-world foundation of adapting clinical guidelines for the digital age
Michaels M , Jakhmola P , Lubin IM , Fochtmann LJ , Casey DE Jr , Opelka FG , Skapik J , Larsen K , Tailor A , Matson-Koffman D . Am J Med Qual 2024 39 (2) 89-90 |
Correlates of rotavirus vaccine shedding and seroconversion in a U.S. cohort of healthy infants
Burke RM , Payne DC , McNeal M , Conrey SC , Burrell AR , Mattison CP , Casey-Moore MC , Mijatovic-Rustempasic S , Gautam R , Esona MD , Thorman AW , Bowen MD , Parashar UD , Tate JE , Morrow AL , Staat MA . J Infect Dis 2024 BACKGROUND: Rotavirus is a leading cause of severe pediatric gastroenteritis; two highly effective vaccines are used in the US. We aimed to identify correlates of immune response to rotavirus vaccination in a US cohort. METHODS: PREVAIL is a birth cohort of 245 mother-child pairs enrolled 2017-2018 and followed for 2 years. Infant stool samples and symptom information were collected weekly. Shedding was defined as RT-PCR detection of rotavirus vaccine virus in stools collected 4-28 days after dose one. Seroconversion was defined as a threefold rise in IgA between the six-week and six-month blood draws. Correlates were analyzed using generalized estimating equations and logistic regression. RESULTS: Pre-vaccination IgG (OR=0.84, 95% CI [0.75-0.94] per 100-unit increase) was negatively associated with shedding. Shedding was also less likely among infants with a single-nucleotide polymorphism inactivating FUT2 antigen secretion ("non-secretors") with non-secretor mothers, versus all other combinations (OR 0.37 [0.16-0.83]). Of 141 infants with data, 105 (74%) seroconverted; 78 (77%) had shed vaccine virus following dose one. Pre-vaccination IgG and secretor status were significantly associated with seroconversion. Neither shedding nor seroconversion significantly differed by vaccine product. DISCUSSION: In this US cohort, pre-vaccination IgG and maternal and infant secretor status were associated with rotavirus vaccine response. |
Immunological response to fractional-dose yellow fever vaccine administered during an outbreak in Kinshasa, Democratic Republic of the Congo: results 5 years after vaccination from a prospective cohort study
Doshi RH , Mukadi PK , Casey RM , Kizito GM , Gao H , Nguete UB , Laven J , Sabi L , Kaba DK , Muyembe-Tamfum JJ , Hyde TB , Ahuka-Mundeke S , Staples JE . Lancet Infect Dis 2024 BACKGROUND: In 2016, outbreaks of yellow fever in Angola and the Democratic Republic of the Congo led to a global vaccine shortage. A fractional dose of 17DD yellow fever vaccine (containing one-fifth [0·1 ml] of the standard dose) was used during a pre-emptive mass campaign in August, 2016, in Kinshasa, Democratic Republic of the Congo among children aged 2 years and older and non-pregnant adults (ie, those aged 18 years and older). 1 year following vaccination, 97% of participants were seropositive; however, the long-term durability of the immune response is unknown. We aimed to conduct a prospective cohort study and invited participants enrolled in the previous evaluation to return 5 years after vaccination to assess durability of the immune response. METHODS: Participants returned to one of six health facilities in Kinshasa in 2021, where study staff collected a brief medical history and blood specimen. We assessed neutralising antibody titres against yellow fever virus using a plaque reduction neutralisation test with a 50% cutoff (PRNT(50)). Participants with a PRNT(50) titre of 10 or higher were considered seropositive. The primary outcome was the proportion of participants seropositive at 5 years. FINDINGS: Among the 764 participants enrolled, 566 (74%) completed the 5-year visit. 5 years after vaccination, 539 (95·2%, 95% CI 93·2-96·7) participants were seropositive, including 361 (94·3%, 91·5-96·2) of 383 who were seronegative and 178 (97·3%, 93·8-98·8) of 183 who were seropositive at baseline. Geometric mean titres (GMTs) differed significantly across age groups for those who were initially seronegative with the lowest GMT among those aged 2-5 years and highest among those aged 13 years and older. INTERPRETATION: A fractional dose of the 17DD yellow fever vaccine induced an immunologic response with detectable titres at 5 years among the majority of participants in the Democratic Republic of the Congo. These findings support the use of fractional-dose vaccination for outbreak prevention with the potential for sustained immunity. FUNDING: Gavi, the Vaccine Alliance through the CDC Foundation. TRANSLATION: For the French translation of the abstract see Supplementary Materials section. |
Covid-19 pandemic and equity of global human papillomavirus vaccination: descriptive study of World Health Organization-Unicef vaccination coverage estimates
Casey RM , Akaba H , Hyde TB , Bloem P . BMJ Med 2024 3 (1) e000726 OBJECTIVE: To analyse progress in global vaccination against human papillomavirus (HPV) during the covid-19 pandemic, with a particular focus on equity. DESIGN: Descriptive study of World Health Organization-Unicef vaccination coverage estimates. SETTING: WHO-Unicef estimates of global, regional, and national HPV vaccination coverage, before (2010-19) and during (2020-21) the covid-19 pandemic. PARTICIPANTS: Girls aged 9-14 years who received a HPV vaccine globally before (12.3 million in 2019) and during (2020-21) the covid-19 pandemic (10.6 million in 2021). MAIN OUTCOME MEASURES: Mean programme and population adjusted coverage for first dose HPV vaccine (HPV1) by country, country income (World Bank income categories), sex, and WHO region, before (2010-19) and during (2020-21) the covid-19 pandemic, based on WHO-Unicef estimates of HPV vaccination coverage. Annual number of national HPV vaccine programme introduced since the first HPV vaccine licence was granted in 2006, based on data reported to WHO-Unicef. Number of girls vaccinated before (2019) versus during (2020-21) the covid-19 pandemic period. RESULTS: Mean coverage of HPV vaccination programmes among girls decreased from 65% in 2010-19 to 50% in 2020-21 in low and middle income countries compared with an increase in high income countries from 61% to 69% for the same periods. Population adjusted HPV1 coverage was higher among girls in high income countries before and during the covid-19 pandemic than in girls in low and middle income countries. During the covid-19 pandemic, population adjusted HPV1 coverage among boys in high income countries was higher and remained higher than coverage among girls in low and middle income countries. Globally, 23 countries recorded a severe reduction in their HPV programme (≥50% reduction in coverage), and another 3.8 million girls globally did not receive a HPV vaccine in countries with existing HPV vaccination programmes in 2020-21 compared with 2019. A reduction was seen in the annual rate of new introductions of national HPV vaccine programmes during 2020-21, affecting countries in all income categories, followed by an increase in introductions during 2022. During the second half of 2023, several low and middle income countries with large birth cohorts and a high relative burden of cervical cancer have yet to introduce HPV vaccination. CONCLUSIONS: Although HPV vaccines have been available for more than 15 years, global HPV vaccination coverage is low. During the covid-19 pandemic period (2020-21 globally), worsening coverage, delayed introductions of national vaccine programmes, and an increase in missed girls globally (ie, girls who did not receive a HPV vaccine compared with the previous year in countries with an existing HPV vaccination programme) that disproportionately affected girls in low and middle income countries were found. Urgent and innovative recovery efforts are needed to accelerate national introduction of HPV vaccination programmes and achieve high coverage of HPV vaccination worldwide. |
Using the number of N95® filtering facepiece respirator models as an indicator of supply chain stability in a US health-care system
Furek A , Edirisooriya M , Casey M , Haas EJ . Disaster Med Public Health Prep 2024 18 e10 OBJECTIVES: Personal protective equipment (PPE) supply chain disruptions force US health-care entities to adopt conservation strategies such as procurement from different respirator manufacturers. This research seeks to better understand how the number of respirator models on hand can serve as an indicator of N95 filtering facepiece respirator (FFR) supply chain stability or disruption. METHODS: Researchers looked at differences in the mean number of N95 FFR models, averaged weekly, from 10 hospitals in a health-care system over 15 wk from June 1 to September 10, 2020. Participating hospitals entered near-daily PPE inventory data by manufacturer and model number. RESULTS: A linear mixed effect model was run in SPSS v. 26 using a random intercept for hospitals, with week as a fixed predictor and mean number of respirator models (averaged weekly) on hand as the dependent variable. Each week showed a small but significant effect compared with the past week (P < 0.001), where the average weekly number of respirator models on hand decreased. CONCLUSIONS: The limited data may indicate a resolution of supply chain disruptions and warrant further investigation. Consequently, the number of respirator models may be applicable as an indicator of supply chain stability and be more easily ascertained and tracked by health-care entities. |
The role of funded partnerships in working towards decreasing COVID-19 vaccination disparities, United States, March 2021-December 2022
Fiebelkorn AP , Adelsberg S , Anthony R , Ashenafi S , Asif AF , Azzarelli M , Bailey T , Boddie TT , Boyer AP , Bungum NW , Burstin H , Burton JL , Casey DM , Chaumont Menendez C , Courtot B , Cronin K , Dowdell C , Downey LH , Fields M , Fitzsimmons T , Frank A , Gustafson E , Gutierrez-Nkomo M , Harris BL , Hill J , Holmes K , Huerta Migus L , Jacob Kuttothara J , Johns N , Johnson J , Kelsey A , Kingangi L , Landrum CM , Lee JT , Martinez PD , Medina Martínez G , Nicholls R , Nilson JR , Ohiaeri N , Pegram L , Perkins C , Piasecki AM , Pindyck T , Price S , Rodgers MS , Roney H , Schultz EM , Sobczyk E , Thierry JM , Toledo C , Weiss NE , Wiatr-Rodriguez A , Williams L , Yang C , Yao A , Zajac J . Vaccine 2024 During the COVID-19 vaccination rollout from March 2021- December 2022, the Centers for Disease Control and Prevention funded 110 primary and 1051 subrecipient partners at the national, state, local, and community-based level to improve COVID-19 vaccination access, confidence, demand, delivery, and equity in the United States. The partners implemented evidence-based strategies among racial and ethnic minority populations, rural populations, older adults, people with disabilities, people with chronic illness, people experiencing homelessness, and other groups disproportionately impacted by COVID-19. CDC also expanded existing partnerships with healthcare professional societies and other core public health partners, as well as developed innovative partnerships with organizations new to vaccination, including museums and libraries. Partners brought COVID-19 vaccine education into farm fields, local fairs, churches, community centers, barber and beauty shops, and, when possible, partnered with local healthcare providers to administer COVID-19 vaccines. Inclusive, hyper-localized outreach through partnerships with community-based organizations, faith-based organizations, vaccination providers, and local health departments was critical to increasing COVID-19 vaccine access and building a broad network of trusted messengers that promoted vaccine confidence. Data from monthly and quarterly REDCap reports and monthly partner calls showed that through these partnerships, more than 295,000 community-level spokespersons were trained as trusted messengers and more than 2.1 million COVID-19 vaccinations were administered at new or existing vaccination sites. More than 535,035 healthcare personnel were reached through outreach strategies. Quality improvement interventions were implemented in healthcare systems, long-term care settings, and community health centers resulting in changes to the clinical workflow to incorporate COVID-19 vaccine assessments, recommendations, and administration or referrals into routine office visits. Funded partners' activities improved COVID-19 vaccine access and addressed community concerns among racial and ethnic minority groups, as well as among people with barriers to vaccination due to chronic illness or disability, older age, lower income, or other factors. |
Role of pre-farrow natural planned exposure of gilts in shaping the passive antibody response to rotavirus a in piglets
Kumar D , Anderson Reever AV , Pittman JS , Springer NL , Mallen K , Roman-Sosa G , Sangewar N , Casey-Moore MC , Bowen MD , Mwangi W , Marthaler DG . Vaccines (Basel) 2023 11 (12) Natural planned exposure (NPE) remains one of the most common methods in swine herds to boost lactogenic immunity against rotaviruses. However, the efficacy of NPE protocols in generating lactogenic immunity has not been investigated before. A longitudinal study was conducted to investigate the dynamics of genotype-specific antibody responses to different doses (3, 2 and 1) of Rotavirus A (RVA) NPE (genotypes G4, G5, P[7] and P[23]) in gilts and the transfer of lactogenic immunity to their piglets. Group 1 gilts received three doses of NPE at 5, 4 and 3 weeks pre-farrow (WPF), group 2 received two doses at 5 and 3 WPF, group 3 received one dose at 5 WPF, and group 4 received no NPE (control group). VP7 (G4 and G5) and truncated VP4* (P[7] and P[23]) antigens of RVA were expressed in mammalian and bacterial expression systems, respectively, and used to optimize indirect ELISAs to determine antibody levels against RVA in gilts and piglets. In day-0 colostrum samples, group 1 had significantly higher IgG titers compared to the control group for all four antigens, and either significantly or numerically higher IgG titers than groups 2 and 3. Group 1 also had significantly higher colostrum IgA levels than the control group for all antigens (except G4), and either significantly or numerically higher IgA levels compared to groups 2 and 3. In piglet serum, group 1 piglets had higher IgG titers for all four antigens at day 0 than the other groups. Importantly, RVA NPE stimulated antibodies in all groups regardless of the treatment doses and prevented G4, G5, P[7] and P[23] RVA fecal shedding prior to weaning in piglets in the absence of viral challenge. The G11 and P[34] RVA genotypes detected from pre-weaning piglets differed at multiple amino acid positions with parent NPE strains. In conclusion, the results of this study suggest that the group 1 NPE regimen (three doses of NPE) resulted in the highest anti-RVA antibody (IgG and IgA) levels in the colostrum/milk, and the highest IgG levels in piglet serum. |
Vaccine effectiveness against influenza a-associated hospitalization, organ failure, and death: United States, 2022-2023
Lewis NM , Zhu Y , Peltan ID , Gaglani M , McNeal T , Ghamande S , Steingrub JS , Shapiro NI , Duggal A , Bender WS , Taghizadeh L , Brown SM , Hager DN , Gong MN , Mohamed A , Exline MC , Khan A , Wilson JG , Qadir N , Chang SY , Ginde AA , Mohr NM , Mallow C , Lauring AS , Johnson NJ , Gibbs KW , Kwon JH , Columbus C , Gottlieb RL , Raver C , Vaughn IA , Ramesh M , Johnson C , Lamerato L , Safdar B , Casey JD , Rice TW , Halasa N , Chappell JD , Grijalva CG , Talbot HK , Baughman A , Womack KN , Swan SA , Harker E , Price A , DeCuir J , Surie D , Ellington S , Self WH . Clin Infect Dis 2023 BACKGROUND: Influenza circulation during the 2022-2023 season in the United States largely returned to pre-coronavirus disease 2019 (COVID-19)-pandemic patterns and levels. Influenza A(H3N2) viruses were detected most frequently this season, predominately clade 3C.2a1b.2a, a close antigenic match to the vaccine strain. METHODS: To understand effectiveness of the 2022-2023 influenza vaccine against influenza-associated hospitalization, organ failure, and death, a multicenter sentinel surveillance network in the United States prospectively enrolled adults hospitalized with acute respiratory illness between 1 October 2022, and 28 February 2023. Using the test-negative design, vaccine effectiveness (VE) estimates against influenza-associated hospitalization, organ failures, and death were measured by comparing the odds of current-season influenza vaccination in influenza-positive case-patients and influenza-negative, SARS-CoV-2-negative control-patients. RESULTS: A total of 3707 patients, including 714 influenza cases (33% vaccinated) and 2993 influenza- and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-negative controls (49% vaccinated) were analyzed. VE against influenza-associated hospitalization was 37% (95% confidence interval [CI]: 27%-46%) and varied by age (18-64 years: 47% [30%-60%]; ≥65 years: 28% [10%-43%]), and virus (A[H3N2]: 29% [6%-46%], A[H1N1]: 47% [23%-64%]). VE against more severe influenza-associated outcomes included: 41% (29%-50%) against influenza with hypoxemia treated with supplemental oxygen; 65% (56%-72%) against influenza with respiratory, cardiovascular, or renal failure treated with organ support; and 66% (40%-81%) against influenza with respiratory failure treated with invasive mechanical ventilation. CONCLUSIONS: During an early 2022-2023 influenza season with a well-matched influenza vaccine, vaccination was associated with reduced risk of influenza-associated hospitalization and organ failure. |
Coding-complete genome sequences of rotavirus A reference strains EDIM, Ph158, and CC425
Casey-Moore MC , Katz E , Mijatovic-Rustempasic S , Jaimes J , Gautam R , Bowen MD . Microbiol Resour Announc 2023 12 (11) e0063023 ![]() ![]() This study reports the coding-complete genome sequences of three rotavirus A (RVA) reference strains previously adapted in tissue culture: RVA/Mouse-tc/USA/EDIM/XXXX/G16P[16] with a G16-P[16]-I7-R7-C7-M8-A7-N7-T10-E7-H9 genotype constellation, RVA/Human-tc/USA/Ph158/1998/G9P[6] with a G9-P[6]-I2-R2-C2-M2-A2-N2-T2-E2-H2 genotype constellation, and RVA/Human-tc/USA/CC425/1998/G3P[9] with a G3-P[9]-I2-R2-C2-M2-A3-N2-T1-E2-H3 genotype constellation. |
Disease severity of respiratory syncytial virus compared with COVID-19 and influenza among hospitalized adults aged ≥60 years - IVY Network, 20 U.S. States, February 2022-May 2023
Surie D , Yuengling KA , DeCuir J , Zhu Y , Gaglani M , Ginde AA , Talbot HK , Casey JD , Mohr NM , Ghamande S , Gibbs KW , Files DC , Hager DN , Ali H , Prekker ME , Gong MN , Mohamed A , Johnson NJ , Steingrub JS , Peltan ID , Brown SM , Leis AM , Khan A , Hough CL , Bender WS , Duggal A , Wilson JG , Qadir N , Chang SY , Mallow C , Kwon JH , Exline MC , Lauring AS , Shapiro NI , Columbus C , Vaughn IA , Ramesh M , Safdar B , Halasa N , Chappell JD , Grijalva CG , Baughman A , Rice TW , Womack KN , Han JH , Swan SA , Mukherjee I , Lewis NM , Ellington S , McMorrow ML , Martin ET , Self WH . MMWR Morb Mortal Wkly Rep 2023 72 (40) 1083-1088 On June 21, 2023, CDC's Advisory Committee on Immunization Practices recommended respiratory syncytial virus (RSV) vaccination for adults aged ≥60 years, offered to individual adults using shared clinical decision-making. Informed use of these vaccines requires an understanding of RSV disease severity. To characterize RSV-associated severity, 5,784 adults aged ≥60 years hospitalized with acute respiratory illness and laboratory-confirmed RSV, SARS-CoV-2, or influenza infection were prospectively enrolled from 25 hospitals in 20 U.S. states during February 1, 2022-May 31, 2023. Multivariable logistic regression was used to compare RSV disease severity with COVID-19 and influenza severity on the basis of the following outcomes: 1) standard flow (<30 L/minute) oxygen therapy, 2) high-flow nasal cannula (HFNC) or noninvasive ventilation (NIV), 3) intensive care unit (ICU) admission, and 4) invasive mechanical ventilation (IMV) or death. Overall, 304 (5.3%) enrolled adults were hospitalized with RSV, 4,734 (81.8%) with COVID-19 and 746 (12.9%) with influenza. Patients hospitalized with RSV were more likely to receive standard flow oxygen, HFNC or NIV, and ICU admission than were those hospitalized with COVID-19 or influenza. Patients hospitalized with RSV were more likely to receive IMV or die compared with patients hospitalized with influenza (adjusted odds ratio = 2.08; 95% CI = 1.33-3.26). Among hospitalized older adults, RSV was less common, but was associated with more severe disease than COVID-19 or influenza. High disease severity in older adults hospitalized with RSV is important to consider in shared clinical decision-making regarding RSV vaccination. |
An integrated process for co-developing and implementing written and computable clinical practice guidelines
Matson-Koffman DM , Robinson SJ , Jakhmola P , Fochtmann LJ , Willett D , Lubin IM , Burton MM , Tailor A , Pitts DL , Casey DE Jr , Opelka FG , Mullins R , Elder R , Michaels M . Am J Med Qual 2023 38 S12-s34 The goal of this article is to describe an integrated parallel process for the co-development of written and computable clinical practice guidelines (CPGs) to accelerate adoption and increase the impact of guideline recommendations in clinical practice. From February 2018 through December 2021, interdisciplinary work groups were formed after an initial Kaizen event and using expert consensus and available literature, produced a 12-phase integrated process (IP). The IP includes activities, resources, and iterative feedback loops for developing, implementing, disseminating, communicating, and evaluating CPGs. The IP incorporates guideline standards and informatics practices and clarifies how informaticians, implementers, health communicators, evaluators, and clinicians can help guideline developers throughout the development and implementation cycle to effectively co-develop written and computable guidelines. More efficient processes are essential to create actionable CPGs, disseminate and communicate recommendations to clinical end users, and evaluate CPG performance. Pilot testing is underway to determine how this IP expedites the implementation of CPGs into clinical practice and improves guideline uptake and health outcomes. |
Adverse events following immunization (AEFI) with fractional one-fifth and one-half doses of yellow fever vaccine compared to full dose in children 9-23 months old in Uganda, 2019-2020 - Preliminary report
Casey RM , Najjengo MS , Lubega I , Sekiziyivu AB , Twinomuhwezi-Oyet E , Nakato WN , Sciarratta CN , Chu SY , Doshi RH , Kambugu A , Gidudu JF . Vaccine 2024 42 (22) 126197 BACKGROUND: In 2016, the World Health Organization recommended that a fractional dose of yellow fever (YF) vaccine could be used in persons 2 years of age or older in response to an emergency that resulted in a global shortage of available YF vaccine. However, this recommendation did not extend to the youngest age group licensed for YF vaccine because there were no published data on the use or safety of fractional dose YF vaccination in children aged 9-23 months. We conducted a single-blind randomized controlled trial, comparing the immunogenicity and safety of fractional one-fifth and one-half doses of Bio-Manguinhos 17DD YF vaccine with full dose in children aged 9-23 months old in Uganda. In this paper, we present the interim analysis on safety. METHODS: Children aged 9-23 months presenting for routine well-child services were recruited for inclusion at one of three study sites. We collected data during March 26, 2019-August 31, 2020, on all adverse events following immunization (AEFI) during active surveillance for 28 days post-vaccination using multiple collection tools including a diary card with an objective measurement of fever. An independent team from the Uganda national AEFI Committee investigated and classified serious AEFI (SAE) according to Brighton Collaboration Criteria. RESULTS: Among 1053 enrolled children, 672 (64%) were reported to have a non-serious AEFI (NSAE) and 17 (2%) were reported to have a SAE. The most common AEFI were diarrhoea, fever, and rash, each reported by 355 (34%), 338 (33%), and 188 (18%) participants, respectively. Among 17 participants with SAE, eight were reported to have had seizures and five were hospitalised for seizures or other causes (respiratory symptoms, gastrointestinal illness, malaria). Four SAEs (deaths) occurred >28 days after vaccination. There were no reported cases of pre-specified or vaccine-related SAEs. We observed no significant difference in frequency or severity of adverse events among the study groups. CONCLUSIONS: Using comprehensive active surveillance monitoring, we did not identify any unexpected safety concerns among children aged <2 years receiving YF vaccination, including with the fractional doses. Although we identified a high number of both serious and non-serious AEFI, none were determined to be causally related to YF vaccination. These results provide evidence for the safety of fractional dose YF vaccination among children aged 9-23 months. |
Development of a standards-based city-wide health information exchange for public health in response to COVID-19 (preprint)
Hota B , Casey P , McIntyre AF , Khan J , Rab S , Chopra A , Lateef O , Layden JE . medRxiv 2020 2020.08.12.20173559 Background Disease surveillance is a critical function of public health, provides essential information about disease burden, clinical and epidemiologic parameters of disease, and is an important element to effective and timely case and contact tracing. The COVID-19 pandemic has demonstrated the essential role these functions have to preserve public health. Syndromic surveillance, electronic laboratory reporting in the meaningful use program, and the growth of the National Healthcare Safety Network (NHSN) have created linkages between hospitals, commercial labs, and public health that can collect and organize data, often through EHR and order workflows, to improve the timeliness and completeness of reporting. In theory, the standard data formats and exchange methods provided by meaningful use should enable rapid healthcare data exchange in the setting of disruptive healthcare events like a pandemic. In reality, access to data remains challenging, and even if available, often lack conformity to regulated standards.Objective We sought to use regulated interoperability standards already in production to generate regional bed capacity awareness, enhance the capture of epidemiological risk factors and clinical variables among COVID-19 tested patients, and reduce the administrative burden of reporting for stakeholders in a manner that could be replicated by other public health agencies.Methods Following a public health order mandating data submission, we developed technical infrastructure to combine multiple data feeds from electronic health record systems. We measured the completeness of each feed, and the match rate between feeds.Results A cloud-based environment was created that received data from electronic lab reporting, consolidated clinical data architecture, and bed capacity data feeds from sites. Data governance was planned from the project beginning to aid in consensus and principles for data use. 88,906 total persons from CCDA data among 14 facilities, and 408,741 persons from ELR records among 88 facilities, were submitted. Fields routinely absent from ELR feeds included travel histories, clinical symptoms, and comorbidities. CCDA data provided an improvement in the quality of data available for surveillance and was highly complete with <5% for all records types with the exception of patient cell phone. 90.1% of records could be matched between CCDA and ELR feeds.Conclusions We describe the development of a city-wide public health data hub for the surveillance of COVID-19 infection. We were able to assess the completeness of existing ELR feeds, augment these feeds with CCDA documents, establish secure transfer methods for data exchange, develop cloud-based architecture to enable secure data storage and analytics, and produced meaningful dashboards for the monitoring of capacity and disease burden. We see this public health and clinical data registry as an informative example of the power of common standards across electronic records, and a potential template for future extension of the use of standards to improve public health surveillance.Competing Interest StatementThe authors have declared no competing interest.Funding StatementNo external funding was received for this work.Author DeclarationsI confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.YesThe details of the IRB/oversight body that provided approval or exemption for the research described are given below:This work was conducted under a public health exemption through the Chicago Department of Public HealthAll necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived.YesI understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectiv ly, please provide a statement in the trial ID field explaining why the study was not registered in advance).YesI have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.YesThe data used for this study was reported to the health department and is not publicly available at this time. |
Pneumoconiosis incidence and prevalence among US Medicare beneficiaries, 1999-2019
Kurth L , Casey ML , Mazurek JM , Blackley DJ . Am J Ind Med 2023 66 (10) 831-841 BACKGROUND: Pneumoconiosis is a group of occupational lung diseases caused by dust and fiber exposure. This study analyzes Medicare claims to estimate the burden of pneumoconiosis among fee-for-service (FFS; Medicare Parts A and B) Medicare beneficiaries during 1999-2019 in the United States. METHODS: Claim and enrollment information from 81 million continuously enrolled FFS Medicare beneficiaries were analyzed. Beneficiaries with any pneumoconiosis and cause-specific pneumoconiosis (e.g., asbestosis, silicosis) were identified using three case definitions (broad, intermediate, and narrow) with varying diagnostic criteria based on claim International Classification of Diseases, Clinical Modification (ICD-CM) diagnosis codes and Healthcare Common Procedure Coding System codes. Results are presented as ranges of values for the three case definitions. RESULTS: The 21-year prevalence range for any pneumoconiosis was 345,383-677,361 (412-833 per 100,000 beneficiaries) using the three case definitions. The highest prevalence was among those ≥75 years of age, males, Whites, and North American Natives. Most claims (70.0%-72.5%) included an ICD-CM diagnosis code for asbestosis. The broad pneumoconiosis prevalence rate increased significantly (p < 0.001) during 2002-2009 by 3%-10% annually and declined significantly by 3%-5% annually starting in 2009. The average annual broad incidence rate declined significantly by 7% annually during 2009-2019. CONCLUSIONS: Despite the decline in rate for any pneumoconiosis among Medicare beneficiaries, which is primarily attributed to a decline in asbestosis, pneumoconiosis is prevalent among FFS Medicare beneficiaries. |
Vaccine Effectiveness of Primary Series and Booster Doses against Omicron Variant COVID-19-Associated Hospitalization in the United States (preprint)
Adams K , Rhoads JP , Surie D , Gaglani M , Ginde AA , McNeal T , Ghamande S , Huynh D , Talbot HK , Casey JD , Mohr NM , Zepeski A , Shapiro NI , Gibbs KW , Files DC , Hicks M , Hager DN , Ali H , Prekker ME , Frosch AE , Exline MC , Gong MN , Mohamed A , Johnson NJ , Srinivasan V , Steingrub JS , Peltan ID , Brown SM , Martin ET , Monto AS , Lauring AS , Khan A , Hough CL , Busse LW , ten Lohuis CC , Duggal A , Wilson JG , Gordon AJ , Qadir N , Chang SY , Mallow C , Rivas C , Babcock HM , Kwon JH , Chappell JD , Halasa N , Grijalva CG , Rice TW , Stubblefield WB , Baughman A , Lindsell CJ , Hart KW , Lester SN , Thornburg NJ , Park S , McMorrow ML , Patel MM , Tenforde MW , Self WH . medRxiv 2022 14 Objectives: To compare the effectiveness of a primary COVID-19 vaccine series plus a booster dose with a primary series alone for the prevention of Omicron variant COVID-19 hospitalization. Design(s): Multicenter observational case-control study using the test-negative design to evaluate vaccine effectiveness (VE). Setting(s): Twenty-one hospitals in the United States (US). Participant(s): 3,181 adults hospitalized with an acute respiratory illness between December 26, 2021 and April 30, 2022, a period of SARS-CoV-2 Omicron variant (BA.1, BA.2) predominance. Participants included 1,572 (49%) case-patients with laboratory confirmed COVID-19 and 1,609 (51%) control patients who tested negative for SARS-CoV-2. Median age was 64 years, 48% were female, and 21% were immunocompromised; 798 (25%) were vaccinated with a primary series plus booster, 1,326 (42%) were vaccinated with a primary series alone, and 1,057 (33%) were unvaccinated. Main Outcome Measure(s): VE against COVID-19 hospitalization was calculated for a primary series plus a booster and a primary series alone by comparing the odds of being vaccinated with each of these regimens versus being unvaccinated among cases versus controls. VE analyses were stratified by immune status (immunocompetent; immunocompromised) because the recommended vaccine schedules are different for these groups. The primary analysis evaluated all COVID-19 vaccine types combined and secondary analyses evaluated specific vaccine products. Result(s): Among immunocompetent patients, VE against Omicron COVID-19 hospitalization for a primary series plus one booster of any vaccine product dose was 77% (95% CI: 71-82%), and for a primary series alone was 44% (95% CI: 31-54%) (p<0.001). VE was higher for a boosted regimen than a primary series alone for both mRNA vaccines used in the US (BNT162b2: primary series plus booster VE 80% (95% CI: 73-85%), primary series alone VE 46% (95% CI: 30-58%) [p<0.001]; mRNA-1273: primary series plus booster VE 77% (95% CI: 67-83%), primary series alone VE 47% (95% CI: 30-60%) [p<0.001]). Among immunocompromised patients, VE for a primary series of any vaccine product against Omicron COVID-19 hospitalization was 60% (95% CI: 41-73%). Insufficient sample size has accumulated to calculate effectiveness of boosted regimens for immunocompromised patients. Conclusion(s): Among immunocompetent people, a booster dose of COVID-19 vaccine provided additional benefit beyond a primary vaccine series alone for preventing COVID-19 hospitalization due to the Omicron variant. Copyright The copyright holder for this preprint is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. All rights reserved. No reuse allowed without permission. |
Effectiveness of SARS-CoV-2 mRNA Vaccines for Preventing Covid-19 Hospitalizations in the United States (preprint)
Tenforde MW , Patel MM , Ginde AA , Douin DJ , Talbot HK , Casey JD , Mohr NM , Zepeski A , Gaglani M , McNeal T , Ghamande S , Shapiro NI , Gibbs KW , Files DC , Hager DN , Shehu A , Prekker ME , Erickson HL , Exline MC , Gong MN , Mohamed A , Henning DJ , Steingrub JS , Peltan ID , Brown SM , Martin ET , Monto AS , Khan A , Hough CT , Busse L , Lohuis CCT , Duggal A , Wilson JG , Gordon AJ , Qadir N , Chang SY , Mallow C , Gershengorn HB , Babcock HM , Kwon JH , Halasa N , Chappell JD , Lauring AS , Grijalva CG , Rice TW , Jones ID , Stubblefield WB , Baughman A , Womack KN , Lindsell CJ , Hart KW , Zhu Y , Olson SM , Stephenson M , Schrag SJ , Kobayashi M , Verani JR , Self WH . medRxiv 2021 BACKGROUND: As SARS-CoV-2 vaccination coverage increases in the United States (US), there is a need to understand the real-world effectiveness against severe Covid-19 and among people at increased risk for poor outcomes. METHODS: In a multicenter case-control analysis of US adults hospitalized March 11 - May 5, 2021, we evaluated vaccine effectiveness to prevent Covid-19 hospitalizations by comparing odds of prior vaccination with an mRNA vaccine (Pfizer-BioNTech or Moderna) between cases hospitalized with Covid-19 and hospital-based controls who tested negative for SARS-CoV-2. RESULTS: Among 1210 participants, median age was 58 years, 22.8% were Black, 13.8% were Hispanic, and 20.6% had immunosuppression. SARS-CoV-2 lineage B.1.1.7 was most common variant (59.7% of sequenced viruses). Full vaccination (receipt of two vaccine doses ≥14 days before illness onset) had been received by 45/590 (7.6%) cases and 215/620 (34.7%) controls. Overall vaccine effectiveness was 86.9% (95% CI: 80.4 to 91.2%). Vaccine effectiveness was similar for Pfizer-BioNTech and Moderna vaccines, and highest in adults aged 18-49 years (97.3%; 95% CI: 78.9 to 99.7%). Among 45 patients with vaccine-breakthrough Covid hospitalizations, 44 (97.8%) were ≥50 years old and 20 (44.4%) had immunosuppression. Vaccine effectiveness was lower among patients with immunosuppression (59.2%; 95% CI: 11.9 to 81.1%) than without immunosuppression (91.3%; 95% CI: 85.5 to 94.7%). CONCLUSION: During March-May 2021, SARS-CoV-2 mRNA vaccines were highly effective for preventing Covid-19 hospitalizations among US adults. SARS-CoV-2 vaccination was beneficial for patients with immunosuppression, but effectiveness was lower in the immunosuppressed population. |
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