162 results on '"Justin R. Ortiz"'
Search Results
2. Model-estimated impacts of pediatric respiratory syncytial virus prevention programs in Mali on asthma prevalence
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Justin R. Ortiz, MD, Rachel S. Laufer, MPH, Steven M. Brunwasser, PhD, Flanon Coulibaly, MD, Fatoumata Diallo, MD, Moussa Doumbia, MD, Amanda J. Driscoll, PhD, Deshayne B. Fell, PhD, Fadima C. Haidara, MD, Tina V. Hartert, MD, Adama M. Keita, MD, Kathleen M. Neuzil, MD, Brittney M. Snyder, PhD, Samba Sow, MD, and Meagan C. Fitzpatrick, PhD
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Respiratory syncytial virus (RSV) ,lower respiratory tract infection ,immunoprophylaxis ,asthma ,global health ,pediatrics ,Immunologic diseases. Allergy ,RC581-607 - Abstract
Background: Respiratory syncytial virus (RSV) is a leading cause of lower respiratory tract infection (LRTI) in young children and is associated with subsequent recurrent wheezing illness and asthma (wheeze/asthma). RSV prevention may therefore reduce wheeze/asthma prevalence. Objectives: We estimated the contribution of RSV LRTI and the impact of RSV prevention on recurrent wheeze/asthma in Mali. Methods: We simulated 12 consecutive monthly birth cohorts in Mali and estimated RSV LRTI cases through 2 years and recurrent wheeze/asthma prevalence at 6 years under different RSV prevention scenarios: status quo, seasonal birth-dose extended half-life mAb, and seasonal birth-dose extended half-life mAb followed by 2 doses of pediatric vaccine (mAb + vaccine). We used World Health Organization (WHO) Preferred Product Characteristics for RSV prevention, demographic and RSV epidemiologic data from Mali, regional recurrent wheeze/asthma prevalence, and relative risk of recurrent wheeze/asthma given early childhood RSV LRTI. Results: Among the simulated cohort of 778,680 live births, 10.0% had RSV LRTI by 2 years and 89.6% survived to 6 years. We estimated that 13.4% of all recurrent wheeze/asthma at 6 years was attributable to RSV LRTI. Recurrent wheeze/asthma prevalence at 6 years was 145.0 per 10,000 persons (RSV LRTI attributable) and 1084.2 per 10,000 persons (total). In mAb and mAb + vaccine scenarios, RSV LRTI cases decreased by 11.8% and 44.4%, respectively, and recurrent wheeze/asthma prevalence decreased by 11.8% and 44.4% (RSV LRTI attributable) and 1.6% and 5.9% (total). Conclusion: In Mali, RSV prevention programs may have a meaningful impact on chronic respiratory disease, strengthening the case for investment in RSV prevention.
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- 2023
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3. Global, regional and national estimates of influenza-attributable ischemic heart disease mortalityResearch in context
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Sandra S. Chaves, Joshua Nealon, Katrin G. Burkart, Daniel Modin, Tor Biering-Sørensen, Justin R. Ortiz, Victor M. Vilchis-Tella, Lindsey E. Wallace, Gregory Roth, Cedric Mahe, and Michael Brauer
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Influenza ,Ischemic heart disease ,Mortality ,Cardiovascular ,Global disease burden ,Medicine (General) ,R5-920 - Abstract
Summary: Background: Influenza virus infection is associated with incident ischemic heart disease (IHD) events. Here, we estimate the global, regional, and national IHD mortality burden attributable to influenza. Methods: We used vital registration data from deaths in adults ≥50 years (13.2 million IHD deaths as underlying cause) to assess the relationship between influenza activity and IHD mortality in a non-linear meta-regression framework from 2010 to 2019. This derived relationship was then used to estimate the global influenza attributable IHD mortality. We estimated the population attributable fraction (PAF) of influenza for IHD deaths based on the relative risk associated with a given level of weekly influenza test positivity rate and multiplied PAFs by IHD mortality from the Global Burden of Disease study. Findings: Influenza activity was associated with increased risk of IHD mortality across all countries analyzed. The mean PAF of influenza for IHD mortality was 3.9% (95% uncertainty interval [UI] 2.5–5.3%), ranging from
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- 2023
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4. Complicated hospitalization due to influenza: results from the Global Hospital Influenza Network for the 2017–2018 season
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Bruno Lina, Alexandre Georges, Elena Burtseva, Marta C. Nunes, Melissa K. Andrew, Shelly A. McNeil, Guillermo M. Ruiz-Palacios, Luzhao Feng, Jan Kyncl, Philippe Vanhems, Justin R. Ortiz, John Paget, Robert C. Reiner, and on behalf of the GIHSN 2017–2018 study collaborators
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Influenza ,Hospitalization ,Mortality ,Risk factors ,Epidemiology ,Infectious and parasitic diseases ,RC109-216 - Abstract
Abstract Background Since 2011, the Global Influenza Hospital Surveillance Network (GIHSN) has used active surveillance to prospectively collect epidemiological and virological data on patients hospitalized with influenza virus infection. Here, we describe influenza virus strain circulation in the GIHSN participant countries during 2017–2018 season and examine factors associated with complicated hospitalization among patients admitted with laboratory-confirmed influenza illness. Methods The study enrolled patients who were hospitalized in a GIHSN hospital in the previous 48 h with acute respiratory symptoms and who had symptoms consistent with influenza within the 7 days before admission. Enrolled patients were tested by reverse transcription-polymerase chain reaction to confirm influenza virus infection. “Complicated hospitalization” was defined as a need for mechanical ventilation, admission to an intensive care unit, or in-hospital death. In each of four age strata (
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- 2020
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5. Effects of Air Pollution and Other Environmental Exposures on Estimates of Severe Influenza Illness, Washington, USA
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Ranjani Somayaji, Moni B. Neradilek, Adam A. Szpiro, Kathryn H. Lofy, Michael L. Jackson, Christopher H. Goss, Jeffrey S. Duchin, Kathleen M. Neuzil, and Justin R. Ortiz
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influenza ,hospitalization ,air pollution ,epidemiology ,respiratory syncytial virus ,RSV ,Medicine ,Infectious and parasitic diseases ,RC109-216 - Abstract
Ecologic models of influenza burden may be confounded by other exposures that share winter seasonality. We evaluated the effects of air pollution and other environmental exposures in ecologic models estimating influenza-associated hospitalizations. We linked hospitalization data, viral surveillance, and environmental data, including temperature, relative humidity, dew point, and fine particulate matter for 3 counties in Washington, USA, for 2001–2012. We used negative binomial regression models to estimate the incidence of influenza-associated respiratory and circulatory (RC) hospitalizations and to assess the effect of adjusting for environmental exposures on RC hospitalization estimates. The modeled overall incidence rate of influenza-associated RC hospitalizations was 31/100,000 person-years. The environmental parameters were statistically associated with RC hospitalizations but did not appreciably affect the event rate estimates. Modeled influenza-associated RC hospitalization rates were similar to published estimates, and inclusion of environmental covariates in the model did not have a clinically important effect on severe influenza estimates.
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- 2020
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6. Performance Analysis of the National Early Warning Score and Modified Early Warning Score in the Adaptive COVID-19 Treatment Trial Cohort
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Christopher J. Colombo, MD, MA, FACP, FCCM, Rhonda E. Colombo, MD, MHS, FACP, FIDSA, Ryan C. Maves, MD, FCCM, FCCP, FIDSA, Angela R. Branche, MD, Stuart H. Cohen, MD, Marie-Carmelle Elie, MD, Sarah L. George, MD, Hannah J. Jang, PhD, RN, CNL, PHN, Andre C. Kalil, MD, MPH, David A. Lindholm, MD, FACP, Richard A. Mularski, MD, MSHS, MCR, ATSF, FCCP, FACP, Justin R. Ortiz, MD, MS, FACP, FCCP, Victor Tapson, MD, C. Jason Liang, PhD, On behalf of the ACTT-1 Study Group, Aneesh K. Mehta, Nadine G. Rouphael, Jessica J. Traenkner, Valeria D Cantos, Ghina Alaaeddine, Barry S. Zingman, Robert Grossberg, Paul F. Riska, Elizabeth Hohmann, Mariam Torres-Soto, Nikolaus Jilg, Helen Y. Chu, Anna Wald, Margaret Green, Annie Luetkemeyer, Pierre-Cedric B. Crouch, Hannah Jang, Susan Kline, Joanne Billings, Brooke Noren, Diego Lopez de Castilla, Jason W. Van Winkle, Francis X. Riedo, Robert W. Finberg, Jennifer P. Wang, Mireya Wessolossky, Kerry Dierberg, Benjamin Eckhardt, Henry J Neumann, Victor Tapson, Jonathan Grein, Fayyaz Sutterwala, Lanny Hsieh, Alpesh N. Amin, Thomas F. Patterson, Heta Javeri, Trung Vu, Roger Paredes, Lourdes Mateu, Daniel A. Sweeney, Constance A. Benson, Farhana Ali, William R. Short, Pablo Tebas, Jessie Torgersen, Giota Touloumi, Vicky Gioukari, David Chien Lye, Sean WX Ong, Norio Ohmagari, Ayako Mikami, Gerd Fätkenheuer, Jakob J. Malin, Philipp Koehler, Andre C. Kalil, LuAnn Larson, Angela Hewlett, Mark G. Kortepeter, C. Buddy Creech, Isaac Thomsen, Todd W. Rice, Babafemi Taiwo, Karen Krueger, Stuart H. Cohen, George R. Thompson, 3rd, Cameron Wolfe, Emmanuel B. Walter, Maria Frank, Heather Young, Ann R. Falsey, Angela R. Branche, Paul Goepfert, Nathaniel Erdmann, Otto O. Yang, Jenny Ahn, Anna Goodman, Blair Merrick, Richard M. Novak, Andrea Wendrow, Henry Arguinchona, Christa Arguinchona, Sarah L. George, Janice Tennant, Robert L. Atmar, Hana M. El Sahly, Jennifer Whitaker, D. Ashley Price, Christopher J. A. Duncan, Simeon Metallidis, Theofilos Chrysanthidis, F. McLellan, Myoung-don Oh, Wan Beom Park, Eu Suk Kim, Jongtak Jung, Justin R. Ortiz, Karen L. Kotloff, Brian Angus, Jack David Germain Seymour, Noreen A. Hynes, Lauren M. Sauer, Neera Ahuja, Kari Nadeau, Patrick E. H. Jackson, Taison D. Bell, Anastasia Antoniadou, Konstantinos Protopapas, Richard T Davey, Jocelyn D. Voell, Jose Muñoz, Montserrat Roldan, Ioannis Kalomenidis, Spyros G. Zakynthinos, Catharine I. Paules, Fiona McGill, Jane Minton, Nikolaos Koulouris, Zafeiria Barmparessou, Edwin Swiatlo, Kyle Widmer, Nikhil Huprikar, Anuradha Ganesan, Guillermo M. Ruiz-Palacios, Alfredo Ponce de León, Sandra Rajme, Justino Regalado Pineda, José Arturo Martinez-Orozco, Mark Holodniy, Aarthi Chary, Timo Wolf, Christoph Stephan, Jan-Christian Wasmuth, Christoph Boesecke, Martin Llewelyn, Barbara Philips, Christopher J. Colombo, Rhonda E. Colombo, David A. Lindholm, Katrin Mende, Tida Lee, Tahaniyat Lalani, Ryan C. Maves, Gregory C. Utz, Jens Lundgren, Marie Helleberg, Jan Gerstoft, Thomas Benfield, Tomas Jensen, Birgitte Lindegaard, Lothar Weise, Lene Knudsen, Isik Johansen, Lone W Madsen, Lars Østergaard, Nina Stærke, Henrik Nielsen, Timothy H. Burgess, Michelle Green, Mat Makowski, Jennifer L. Ferreira, Michael R. Wierzbicki, Tyler Bonnett, Nikki Gettinger, Theresa Engel, Jing Wang, John H. Beigel, Kay M. Tomashek, Seema Nayak, Lori E. Dodd, Walla Dempsey, Effie Nomicos, Marina Lee, Peter Wolff, Rhonda PikaartTautges, Mohamed Elsafy, Robert Jurao, Hyung Koo, Michael Proschan, Dean Follmann, and H. Clifford Lane
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Medical emergencies. Critical care. Intensive care. First aid ,RC86-88.9 - Abstract
OBJECTIVES:. We sought to validate prognostic scores in coronavirus disease 2019 including National Early Warning Score, Modified Early Warning Score, and age-based modifications, and define their performance characteristics. DESIGN:. We analyzed prospectively collected data from the Adaptive COVID-19 Treatment Trial. National Early Warning Score was collected daily during the trial, Modified Early Warning Score was calculated, and age applied to both scores. We assessed prognostic value for the end points of recovery, mechanical ventilation, and death for score at enrollment, average, and slope of score over the first 48 hours. SETTING:. A multisite international inpatient trial. PATIENTS:. A total of 1,062 adult nonpregnant inpatients with severe coronavirus disease 2019 pneumonia. INTERVENTIONS:. Adaptive COVID-19 Treatment Trial 1 randomized participants to receive remdesivir or placebo. The prognostic value of predictive scores was evaluated in both groups separately to assess for differential performance in the setting of remdesivir treatment. MEASUREMENTS AND MAIN RESULTS:. For mortality, baseline National Early Warning Score and Modified Early Warning Score were weakly to moderately prognostic (c-index, 0.60–0.68), and improved with addition of age (c-index, 0.66–0.74). For recovery, baseline National Early Warning Score and Modified Early Warning Score demonstrated somewhat better prognostic ability (c-index, 0.65–0.69); however, National Early Warning Score+age and Modified Early Warning Score+age further improved performance (c-index, 0.68–0.71). For deterioration, baseline National Early Warning Score and Modified Early Warning Score were weakly to moderately prognostic (c-index, 0.59–0.69) and improved with addition of age (c-index, 0.63–0.70). All prognostic performance improvements due to addition of age were significant (p < 0.05). CONCLUSIONS:. In the Adaptive COVID-19 Treatment Trial 1 cohort, National Early Warning Score and Modified Early Warning Score demonstrated moderate prognostic performance in patients with severe coronavirus disease 2019, with improvement in predictive ability for National Early Warning Score+age and Modified Early Warning Score+age. Area under receiver operating curve for National Early Warning Score and Modified Early Warning Score improved in patients receiving remdesivir versus placebo early in the pandemic for recovery and mortality. Although these scores are simple and readily obtainable in myriad settings, in our data set, they were insufficiently predictive to completely replace clinical judgment in coronavirus disease 2019 and may serve best as an adjunct to triage, disposition, and resourcing decisions.
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- 2021
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7. Relative Vaccine Effectiveness of Adjuvanted Trivalent Influenza Vaccine over Three Consecutive Influenza Seasons in the United States
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Constantina Boikos, Ian McGovern, Justin R. Ortiz, Joan Puig-Barberà, Eve Versage, and Mendel Haag
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influenza ,influenza vaccines ,relative vaccine effectiveness ,immunosenescence ,Medicine - Abstract
Traditional influenza vaccines may be less immunogenic in adults ≥65 years of age due to immunosenescence. Two influenza vaccines—MF59®-adjuvanted trivalent inactivated influenza vaccine (aIIV3) and high-dose influenza vaccine (HD-IIV3)—were developed to overcome this problem. We summarize estimates of the relative vaccine effectiveness (rVE) of aIIV3 vs. HD-IIV3 and aIIV3 vs. standard, egg-based quadrivalent influenza vaccines (IIV4e) during the 2017–2018, 2018–2019, and 2019–2020 US influenza seasons using the same underlying electronic medical record and linked claims dataset for all three seasons. The primary outcome was influenza-related medical encounters (IRMEs), defined by diagnostic codes specific to influenza (ICD J09*-J11*). rVE was estimated using propensity score methods adjusting for demographics and health status. rVE estimates demonstrated consistent benefit for aIIV3 over IIV4e in the overall and at-risk populations. Relative to HD-IIV3, aIIV3 provided improved benefit in the overall study population and comparable benefit in the at-risk population across each season.
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- 2022
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8. Pregnancy as a risk factor for severe influenza infection: an individual participant data meta-analysis
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Dominik Mertz, Calvin Ka-Fung Lo, Lyubov Lytvyn, Justin R. Ortiz, Mark Loeb, and for the FLURISK-INVESTIGATORS
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Influenza ,Vaccine ,Pregnancy ,Severity ,Meta-analysis ,Infectious and parasitic diseases ,RC109-216 - Abstract
Abstract Background WHO identifies pregnant women to be at increased risk for severe outcomes from influenza virus infections and recommends that they be prioritized for influenza vaccination. The evidence supporting this, however, is inconsistent. Ecologic studies in particular suggest more severe outcomes from influenza infection during pregnancy than studies based on individual patient data. Individual studies however may be underpowered and, as reported in a previous systematic review, confounding factors could not be adjusted for. We therefore conducted an individual participant data meta-analysis to assess the risk for severe outcomes of influenza infection in pregnant women while adjusting for other prognostic factors. Methods We contacted authors of studies included in a recently published systematic review. We pooled the individual participant data of women of reproductive age and laboratory confirmation of influenza virus infection. We used a generalized linear mixed model and reported odds ratios (OR) and 95% confidence intervals (CI). Results A total of 33 datasets with data on 186,656 individuals were available, including 36,498 eligible women of reproductive age and known pregnancy status. In the multivariable model, pregnancy was associated with a 7 times higher risk of hospital admission (OR 6.80, 95%CI 6.02–7.68), among patients receiving medical care as in- or outpatients, pregnancy was associated with a lower risk of admission to intensive care units (ICU; OR 0.57, 95%CI 0.48–0.69), and was not significantly associated with death (OR 1.00, 95%CI 0.75–1.34). Conclusions Our study found a higher risk of influenza associated hospitalization among pregnant women as compared to non-pregnant women. We did not find a higher mortality rate or higher likelihood of ICU admission among pregnant women who sought medical care. However, this study did not address whether a true community based cohort of pregnant women is at higher risk of influenza associated complications.
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- 2019
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9. Review of Analyses Estimating Relative Vaccine Effectiveness of Cell-Based Quadrivalent Influenza Vaccine in Three Consecutive US Influenza Seasons
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Constantina Boikos, Ian McGovern, Deborah Molrine, Justin R. Ortiz, Joan Puig-Barberà, and Mendel Haag
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cell-based quadrivalent influenza vaccine ,egg-based influenza vaccine ,relative vaccine effectiveness ,influenza ,Medicine - Abstract
The adaptation of influenza seed viruses in egg culture can result in a variable antigenic vaccine match each season. The cell-based quadrivalent inactivated influenza vaccine (IIV4c) contains viruses grown in mammalian cell lines rather than eggs. IIV4c is not subject to egg-adaptive changes and therefore may offer improved protection relative to egg-based vaccines, depending on the degree of match with circulating influenza viruses. We summarize the relative vaccine effectiveness (rVE) of IIV4c versus egg-based quadrivalent influenza vaccines (IIV4e) to prevent influenza-related medical encounters (IRMEs) from three retrospective observational cohort studies conducted during the 2017–2018, 2018–2019, and 2019–2020 US influenza seasons using the same underlying electronic medical record dataset for all three seasons—with the addition of linked medical claims for the latter two seasons. We identified IRMEs using diagnostic codes specific to influenza disease (ICD J09*-J11*) from the records of over 10 million people. We estimated rVE using propensity score methods adjusting for age, sex, race, ethnicity, geographic location, week of vaccination, and health status. Subgroup analyses included specific age groups. IIV4c consistently had higher relative effectiveness than IIV4e across all seasons assessed, which were characterized by different dominant circulating strains and variable antigenic drift or egg adaptation.
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- 2022
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10. Integrating Electronic Medical Records and Claims Data for Influenza Vaccine Research
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Constantina Boikos, Mahrukh Imran, Simon De Lusignan, Justin R. Ortiz, Peter A. Patriarca, and James A. Mansi
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influenza vaccines ,citizen science ,medical records systems ,computerized ,insurance ,health ,Medicine - Abstract
Real-world evidence (RWE) increasingly informs public health and healthcare decisions worldwide. A large database has been created (“Integrated Dataset”) that integrates primary care electronic medical records with pharmacy and medical claims data on >123 million US patients since 2014. This article describes the components of the Integrated Dataset and evaluates its representativeness to the US population and its potential use in evaluating influenza vaccine effectiveness. Representativeness to the US population (2014–2019) was evaluated by comparison with demographic information from the 2019 US census and the National Ambulatory Medical Care Survey (NAMCS). Variables included in the Integrated Dataset were evaluated against World Health Organization (WHO) defined key and non-critical variables for evaluating influenza vaccine performance. The Integrated Dataset contains a variety of information, including demographic data, patient medical history, diagnoses, immunizations, and prescriptions. Distributions of most age categories and sex were comparable with the US Census and NAMCS populations. The Integrated Dataset was less diverse by race and ethnicity. Additionally, WHO key and non-critical variables for the estimation of influenza vaccine effectiveness are available in the Integrated Dataset. In summary, the Integrated Dataset is generally representative of the US population and contains key variables for the assessment of influenza vaccine effectiveness.
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- 2022
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11. Incidence of influenza virus infection among pregnant women: a systematic review
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Mark A. Katz, Bradford D. Gessner, Jeanene Johnson, Becky Skidmore, Marian Knight, Niranjan Bhat, Helen Marshall, David J. Horne, Justin R. Ortiz, and Deshayne B. Fell
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Gynecology and obstetrics ,RG1-991 - Abstract
Abstract Background The World Health Organization (WHO) considers pregnant women to be a risk group for severe influenza disease. We conducted a systematic review to evaluate influenza disease incidence in pregnant women in order to inform estimates of influenza vaccine impact for low-resource countries. Methods We performed electronic literature searches, targeting studies on the following outcomes in pregnant women: attack rate, hospitalization rate, intensive care unit admission rate, mortality rate, and disability-adjusted life years lost. Only original studies published in peer-reviewed journals that had laboratory confirmation for influenza virus infection and included population-based incidence rates with denominator data were included. We summarized study characteristics in descriptive tables and outcome-specific Forest plots. We generated summary incidence rates using random effects models and assessed statistical heterogeneity by visual examination of Forest plots, and by χ 2 and I2 tests. Results We identified 1543 articles, of which nine articles met the study inclusion criteria. Five were case series, three were cohort studies, and one was a randomized controlled trial. Eight studies were from high-income countries, and one was from an upper middle-income country. Six studies reported results for pandemic influenza, and three reported seasonal influenza. Statistical heterogeneity was high for all outcomes, and methodologies and duration of surveillance varied considerably among studies; therefore, we did not perform meta-analyses. Conclusions Study quality was very low according to GRADE criteria. More data on influenza disease incidence in pregnant women, particularly in low- and middle-income countries and for seasonal influenza disease, are needed to inform public health decision-making.
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- 2017
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12. Strategy to Enhance Influenza Surveillance Worldwide
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Justin R. Ortiz, Viviana Sotomayor, Osvaldo C. Uez, Otavio Oliva, Deborah Bettels, Margaret McCarron, Joseph S. Bresee, and Anthony W. Mounts
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influenza ,human influenza influenza A virus ,avian influenza ,H5N1 subtype ,sentinel surveillance ,epidemiology ,Medicine ,Infectious and parasitic diseases ,RC109-216 - Abstract
The emergence of a novel strain of influenza virus A (H1N1) in April 2009 focused attention on influenza surveillance capabilities worldwide. In consultations before the 2009 outbreak of influenza subtype H1N1, the World Health Organization had concluded that the world was unprepared to respond to an influenza pandemic, due in part to inadequate global surveillance and response capacity. We describe a sentinel surveillance system that could enhance the quality of influenza epidemiologic and laboratory data and strengthen a country’s capacity for seasonal, novel, and pandemic influenza detection and prevention. Such a system would 1) provide data for a better understanding of the epidemiology and extent of seasonal influenza, 2) provide a platform for the study of other acute febrile respiratory illnesses, 3) provide virus isolates for the development of vaccines, 4) inform local pandemic planning and vaccine policy, 5) monitor influenza epidemics and pandemics, and 6) provide infrastructure for an early warning system for outbreaks of new virus subtypes.
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- 2009
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13. Oseltamivir Prescribing in Pharmacy-Benefits Database, United States, 2004–2005
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Justin R. Ortiz, Laurie Kamimoto, Ronald E. Aubert, Jianying Yao, David K. Shay, Joseph S. Bresee, and Robert S. Epstein
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Human influenza ,influenza A virus ,avian influenza ,influenza A drug therapy ,influenza A virus subtype H5N1 ,dispatch ,Medicine ,Infectious and parasitic diseases ,RC109-216 - Abstract
We reviewed information from a US pharmacy benefits manager database from 2004 through 2005 during periods with little influenza activity. We calculated rates of oseltamivir prescriptions to enrollees. Prescription rates increased significantly from 27.3/100,000 in 2004 to 134/100,000 in 2005 (p
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- 2008
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14. Erratum to: Incidence of influenza virus infection among pregnant women: a systematic review
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Mark A. Katz, Bradford D. Gessner, Jeanene Johnson, Becky Skidmore, Marian Knight, Niranjan Bhat, Helen Marshall, David J. Horne, Justin R. Ortiz, and Deshayne B. Fell
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Gynecology and obstetrics ,RG1-991 - Published
- 2017
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15. No Evidence of Avian Influenza A H5N1 among Returning US Travelers
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Justin R. Ortiz, Teresa R. Wallis, Mark A. Katz, LaShondra S. Berman, Amanda Balish, Stephen E. Lindstrom, Vic Veguilla, Kathryn S. Teates, Jacqueline M. Katz, Alexander Klimov, and Timothy M. Uyeki
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Influenza ,human ,influenza A virus ,H5N1 ,human/diagnosis ,tropical medicine ,Medicine ,Infectious and parasitic diseases ,RC109-216 - Abstract
We reviewed reports to the Centers for Disease Control and Prevention of US travelers suspected of having avian influenza A H5N1 virus infection from February 2003 through May 2006. Among the 59 reported patients, no evidence of H5N1 virus infection was found; none had had direct contact with poultry, but 42% had evidence of human influenza A.
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- 2007
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16. Age differences in comorbidities, presenting symptoms and outcomes of influenza illness requiring hospitalization: a worldwide perspective from the Global Influenza Hospital Surveillance Network
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Melissa K Andrew, Henrique Pott, Lisa Staadegaard, John Paget, Sandra S Chaves, Justin R Ortiz, John McCauley, Joseph Bresee, Marta C Nunes, Elsa Baumeister, Sonia Mara Raboni, Heloisa I G Giamberardino, Shelly A McNeil, Doris Gomez, Tao Zhang, Philippe Vanhems, Parvaiz A Koul, Daouda Coulibaly, Nancy A Otieno, Ghassan Dbaibo, Maria Lourdes Guerrero Almeida, Victor Alberto Laguna-Torres, Anca Cristina Drăgănescu, Elena Burtseva, Anna Sominina, Daria Danilenko, Snežana Medić, Javier Diez-Domingo, and Bruno Lina
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Infectious Diseases ,Oncology - Abstract
Background The Global Influenza Hospital Surveillance Network (GIHSN) was established in 2012 to conduct coordinated worldwide influenza surveillance. Here we describe underlying comorbidities, symptoms, and outcomes in hospitalized patients with influenza. Methods Between November/2018 and October/2019, GIHSN included 19 sites in 18 countries using a standardized surveillance protocol. Influenza infection was laboratory-confirmed with RT-PCR. A multivariate logistic regression model was utilized to analyze the extent to which various risk factors predict severe outcomes. Results Of 16,022 enrolled patients, 21,9% had laboratory-confirmed influenza; 49.2% of influenza cases were A/H1N1pdm09. Fever and cough were the most common symptoms, though they decreased with age (p Conclusions Both virus and host factors contributed to influenza burden. We identified age differences in comorbidities, presenting symptoms, and adverse clinical outcomes among those hospitalized with influenza, and benefit from influenza vaccination in protecting against adverse clinical outcomes. The GIHSN provides an ongoing platform for global understanding of hospitalized influenza illness.
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- 2023
17. Safety and immunogenicity of monovalent H7N9 influenza vaccine with AS03 adjuvant given sequentially or simultaneously with a seasonal influenza vaccine: A randomized clinical trial
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Justin R. Ortiz, Paul W. Spearman, Paul A. Goepfert, Kaitlyn Cross, C. Buddy Creech, Wilbur H. Chen, Susan Parker, Edgar T. Overton, Michelle Dickey, Heather L. Logan, Ashley Wegel, and Kathleen M. Neuzil
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Adult ,Squalene ,General Veterinary ,General Immunology and Microbiology ,alpha-Tocopherol ,Public Health, Environmental and Occupational Health ,Polysorbates ,Hemagglutination Inhibition Tests ,Antibodies, Viral ,Influenza A Virus, H7N9 Subtype ,Article ,Drug Combinations ,Immunogenicity, Vaccine ,Infectious Diseases ,Adjuvants, Immunologic ,Vaccines, Inactivated ,Influenza Vaccines ,Influenza in Birds ,Influenza, Human ,Animals ,Humans ,Molecular Medicine ,Seasons - Abstract
BACKGROUND: Influenza A/H7N9 viruses have pandemic potential. METHODS: We conducted an open-label, randomized, controlled trial of AS03-adjuvanted 2017 inactivated influenza A/H7N9 vaccine (H7N9 IIV) in healthy adults. Group 1 received H7N9 IIV and seasonal quadrivalent influenza vaccine (IIV4) simultaneously, followed by H7N9 IIV three weeks later. Group 2 received IIV4 alone and then two doses of H7N9 IIV at three-week intervals. Group 3 received one dose of IIV4. We used hemagglutination inhibition (HAI) and microneutralization (MN) assays to measure geometric mean titers and seroprotection (≥1:40 titer) to vaccine strains and monitored for safety. RESULTS: Among 149 subjects, seroprotection by HAI three weeks after H7N9 IIV dose 2 was 51% (95 %CI 37%-65%) for Group 1 and 40% (95 %CI 25%-56%) for Group 2. Seroprotection by MN at the same timepoint was 84% (95 %CI 72%-93%) for Group 1 and 74% (95 %CI 60%-86%) for Group 2. By 180 days after H7N9 IIV dose 2, seroprotection by HAI or MN was low for Groups 1 and 2. Responses measured by HAI and MN against each IIV4 strain three weeks after IIV4 vaccination were similar in all groups. Solicited local and systemic reactions were similar after a single vaccination, while those receiving simultaneous H7N9 and IIV4 had slightly more reactogenicity. There were no serious adverse events or medically-attended adverse events related to study product receipt. CONCLUSIONS: Adjuvanted H7N9 IIV was modestly immunogenic whether administered simultaneously or sequentially with IIV4, though responses declined by 180 days. IIV4 was immunogenic regardless of schedule. CLINICAL TRIALS REGISTRATION: NCT03318315
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- 2022
18. Validation of International Classification of Diseases criteria to identify severe influenza hospitalizations
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Brittney M. Snyder, Megan F. Patterson, Tebeb Gebretsadik, Pingsheng Wu, Tan Ding, Rees L. Lee, Kathryn M. Edwards, Lindsay A. Somerville, Thomas J. Braciale, Justin R. Ortiz, and Tina V. Hartert
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Cohort Studies ,Hospitalization ,Pulmonary and Respiratory Medicine ,Infectious Diseases ,International Classification of Diseases ,Predictive Value of Tests ,Epidemiology ,Influenza, Human ,Public Health, Environmental and Occupational Health ,Humans - Abstract
In this cohort study of hospitalized patients with linked medical record data, we developed International Classification of Diseases (ICD) criteria that accurately identified laboratory-confirmed, severe influenza hospitalizations (positive predictive value [PPV] 80%, 95% confidence interval [CI] 71-87%), which we validated through medical record documentation. These criteria identify patients with clinically important influenza illness outcomes to inform evaluation of preventive and therapeutic interventions and public health policy recommendations.
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- 2022
19. A Multicenter, Controlled Human Infection Study of Influenza A(H1N1)pdm09 in Healthy Adults
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Justin R Ortiz, David I Bernstein, Daniel F Hoft, Christopher W Woods, Micah T McClain, Sharon E Frey, Rebecca C Brady, Christopher Bryant, Ashley Wegel, Robert W Frenck, Emmanuel B Walter, Getahun Abate, Sarah R Williams, Robert L Atmar, Wendy A Keitel, Nadine Rouphael, Mathew J Memoli, Mamodikoe K Makhene, Paul C Roberts, and Kathleen M Neuzil
- Subjects
Infectious Diseases ,Immunology and Allergy - Abstract
Background We evaluated the associations between baseline influenza virus–specific hemagglutination inhibition (HAI) and microneutralization (MN) titers and subsequent symptomatic influenza virus infection in a controlled human infection study. Methods We inoculated unvaccinated healthy adults aged 18–49 years with an influenza A/California/04/2009/H1N1pdm-like virus (NCT04044352). We collected serial safety labs, serum for HAI and MN, and nasopharyngeal swabs for reverse-transcription polymerase chain reaction (RT-PCR) testing. Analyses used the putative seroprotective titer of ≥40 for HAI and MN. The primary clinical outcome was mild-to-moderate influenza disease (MMID), defined as ≥1 postchallenge positive qualitative RT-PCR test with a qualifying symptom/clinical finding. Results Of 76 participants given influenza virus challenge, 54 (71.1%) experienced MMID. Clinical illness was generally very mild. MMID attack rates among participants with baseline titers ≥40 by HAI and MN were 64.9% and 67.9%, respectively, while MMID attack rates among participants with baseline titers Conclusions We achieved a 71.1% attack rate of MMID. High baseline HAI and MN were associated with protection from illness. Clinical Trials Registration. NCT04044352.
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- 2023
20. Need for improved global measurement of early childhood respiratory syncytial virus disease
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Tina V, Hartert and Justin R, Ortiz
- Subjects
Child, Preschool ,Humans ,Respiratory Syncytial Virus Infections ,General Medicine ,Communicable Diseases ,Respiratory Syncytial Viruses - Published
- 2022
21. A Multi-Center, Controlled Human Infection Study of Influenza A (H1N1)pdm09 in Healthy Adults
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Justin R. Ortiz, David I. Bernstein, Daniel F. Hoft, Christopher W. Woods, Micah T. McClain, Sharon E. Frey, Rebecca C. Brady, Christopher Bryant, Ashley Wegel, Robert W Frenck, Emmanuel B. Walter, Getahun Abate, Sarah R. Williams, Robert L. Atmar, Wendy A. Keitel, Nadine Rouphael, Mathew J. Memoli, Mamodikoe K. Makhene, Paul C. Roberts, and Kathleen M. Neuzil
- Abstract
BackgroundInfluenza controlled human infection model (CHIM) studies can advance development of vaccines and therapeutics. Our objective was to evaluate the associations between baseline challenge virus-specific hemagglutination inhibition (HAI) and microneutralization (MN) titers and subsequent symptomatic influenza virus infection.MethodsWe enrolled healthy adults aged 18 through 49 years in a multisite CHIM study using influenza A/Bethesda/MM2/H1N1, an A/California/04/2009/H1N1pdm-like virus (NCT04044352). We excluded persons vaccinated against influenza within the previous six months. We collected serial safety labs, serum for HAI and MN, and nasopharyngeal swabs for RT-PCR testing. Analyses used the putative seroprotective titer of ≥40 for HAI and MN. The primary clinical outcome was mild-to-moderate influenza disease (MMID), defined as ≥1 post-challenge positive qualitative RT-PCR test with a qualifying symptom/clinical finding.FindingsOf 76 participants given influenza virus challenge, 54 (71.1%) experienced MMID. Clinical illness post-challenge was generally very mild. MMID attack rates among participants with baseline titers ≥40 by HAI and MN were 64.9% and 67.9%, respectively, while MMID attack rates among participants with baseline titers InterpretationIn a multi-site influenza CHIM study, we assured the safety of our participants and achieved a 71.1% attack rate of MMID. High baseline HAI and MN were associated with protection from illness.
- Published
- 2022
22. Safety and Immunogenicity of Influenza A/H5N8 Virus Vaccine in Healthy Adults: Durability and Cross-reactivity of Antibody Responses
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Kathleen M, Neuzil, Evan J, Anderson, Robert W, Frenck, Sharon E, Frey, Emmanuel B, Walter, Richard, Rupp, Elizabeth T, Rotrosen, Nadine G, Rouphael, Rebecca C, Brady, Irene, Graham, Kenneth E, Schmader, Laura, Porterfield, Justin R, Ortiz, Geeta K, Swamy, Hana M, El Sahly, Trushar, Jeevan, Ranjan, Sitaula, Ashley, Wegel, Richard J, Webby, Christopher, Bryant, and James E, Crowe
- Subjects
Microbiology (medical) ,Infectious Diseases - Abstract
Background Influenza A/H5N8 viruses infect poultry and wild birds in many countries. In 2021, the first human A/H5N8 cases were reported. Methods We conducted a phase I, cohort-randomized, double-blind, controlled trial of inactivated influenza A/H5N8 vaccine (clade 2.3.4.4c) administered with or without adjuvant. Cohort 1 subjects received either two doses of AS03-adjuvanted vaccine containing 3.75 μg or 15 μg hemagglutinin (HA); two doses of 15 μg HA unadjuvanted vaccine; or one dose of AS03-adjuvanted vaccine (3.75 μg or 15 μg HA), followed by one dose of non-adjuvanted vaccine (same HA content). Cohort 2 subjects received two doses of MF59-adjuvanted vaccine containing 3.75 μg or 15 μg HA, or 15 μg HA of non-adjuvanted vaccine. Subjects were followed for 13 months for safety and immunogenicity. Results We enrolled 386 adult subjects in good health. Solicited adverse events were generally mild and more common among subjects who received adjuvanted vaccines. Antibody responses (hemagglutination inhibition or microneutralization assays) were highest in the two-dose AS03 group, followed by the one-dose AS03 group, the MF59 groups, and the non-adjuvanted groups. Antibody levels returned to baseline 12 months after the second vaccination in all groups except the 15 μg AS03-adjuvanted group. Cross-reactive antibodies to clade 2.3.4.4b strains isolated from recent human cases were demonstrated in a subset of both 15 μg adjuvanted groups. Conclusions Two doses of influenza A/H5N8 vaccine were well-tolerated. Immunogenicity improved with receipt of two doses of adjuvanted vaccine and higher antigen content. (Funded by the National Institute of Allergy and Infectious Diseases
- Published
- 2022
23. The Operational Feasibility of Vaccination Programs Targeting Influenza Risk Groups in the World Health Organization (WHO) African and South-East Asian Regions
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Samba O. Sow, Justin R. Ortiz, Stephen Yu, Kathleen M. Neuzil, Amanda J. Driscoll, Jui-Shan Hsu, Wilbur H. Chen, Sonali Kochhar, Sarah R. Williams, Joanie Robertson, and Robin Biellik
- Subjects
Microbiology (medical) ,Vaccination schedule ,Influenza vaccine ,Population ,Cold storage ,immunization ,World Health Organization ,Risk groups ,Pregnancy ,Environmental health ,Influenza, Human ,Health care ,Humans ,Medicine ,education ,education.field_of_study ,Immunization Programs ,business.industry ,Vaccination ,Major Articles and Commentaries ,South-East Asia ,AcademicSubjects/MED00290 ,Infectious Diseases ,Immunization ,Influenza Vaccines ,Africa ,Feasibility Studies ,Female ,Seasons ,influenza vaccine ,influenza ,business - Abstract
Background Influenza vaccination is uncommon in low-resource settings. We evaluated aspects of operational feasibility of influenza vaccination programs targeting risk groups in the World Health Organization (WHO) African (AFR) and South-East Asian (SEAR) Regions. Methods We estimated routine immunization and influenza vaccination campaign doses, doses per vaccinator, and cold storage requirements for 1 simulated country in each region using evidence-based population distribution, vaccination schedule, and vaccine volumes. Influenza vaccination targeted persons, We investigated the operational feasibility of preseasonal influenza vaccination campaigns in countries in World Health Organization (WHO) African and South-East Asian Regions. Influenza vaccination campaigns targeting most risk groups substantially increase doses and doses per vaccinator over routine immunization baselines.
- Published
- 2021
24. Acute respiratory distress syndrome (ARDS) as an adverse event following immunization: Case definition & guidelines for data collection, analysis, and presentation of immunization safety data
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Sarah R. Williams, Patricia Bastero, Shreemanta K. Parida, Bassey Edem, Maja Subelj, Manoj Kumar Das, Anand Kawade, Justin R. Ortiz, Nathan A. Serazin, Flor M. Munoz, T. Anh Wartel, and Kathryn M. Edwards
- Subjects
Adverse event ,Adult ,ARDS ,COVID-19 Vaccines ,Case definition ,media_common.quotation_subject ,030231 tropical medicine ,Context (language use) ,Review ,Acute respiratory distress ,Guidelines ,03 medical and health sciences ,Presentation ,0302 clinical medicine ,Humans ,Medicine ,030212 general & internal medicine ,Adverse effect ,media_common ,Pediatric ,Respiratory Distress Syndrome ,Data collection ,Acute respiratory distress syndrome ,General Veterinary ,General Immunology and Microbiology ,SARS-CoV-2 ,business.industry ,Data Collection ,Public Health, Environmental and Occupational Health ,COVID-19 ,medicine.disease ,Infectious Diseases ,Immunization ,Preparedness ,Molecular Medicine ,Medical emergency ,business - Abstract
This is a Brighton Collaboration Case Definition of the term "Acute Respiratory Distress Syndrome - ARDS" to be utilized in the evaluation of adverse events following immunization. The Case Definition was developed by a group of experts convened by the Coalition for Epidemic Preparedness Innovations (CEPI) in the context of active development of vaccines for SARS-CoV-2 vaccines and other emerging pathogens. The case definition format of the Brighton Collaboration was followed to develop a consensus definition and defined levels of certainty, after an exhaustive review of the literature and expert consultation. The document underwent peer review by the Brighton Collaboration Network and by selected Expert Reviewers prior to submission. The comments of the reviewers were taken into consideration and edits incorporated in this final manuscript.
- Published
- 2021
25. The value of vaccine programme impact monitoring during the COVID-19 pandemic
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Kathleen M. Neuzil and Justin R. Ortiz
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Vaccines ,2019-20 coronavirus outbreak ,Coronavirus disease 2019 (COVID-19) ,Immunization Programs ,SARS-CoV-2 ,business.industry ,Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) ,MEDLINE ,COVID-19 ,Articles ,General Medicine ,Impact monitoring ,Environmental health ,Pandemic ,Humans ,Medicine ,business ,Pandemics ,Value (mathematics) - Abstract
Background In the USA, COVID-19 vaccines became available in mid-December, 2020, with adults aged 65 years and older among the first groups prioritised for vaccination. We estimated the national-level impact of the initial phases of the US COVID-19 vaccination programme on COVID-19 cases, emergency department visits, hospital admissions, and deaths among adults aged 65 years and older. Methods We analysed population-based data reported to US federal agencies on COVID-19 cases, emergency department visits, hospital admissions, and deaths among adults aged 50 years and older during the period Nov 1, 2020, to April 10, 2021. We calculated the relative change in incidence among older age groups compared with a younger reference group for pre-vaccination and post-vaccination periods, defined by the week when vaccination coverage in a given age group first exceeded coverage in the reference age group by at least 1%; time lags for immune response and time to outcome were incorporated. We assessed whether the ratio of these relative changes differed when comparing the pre-vaccination and post-vaccination periods. Findings The ratio of relative changes comparing the change in the COVID-19 case incidence ratio over the post-vaccine versus pre-vaccine periods showed relative decreases of 53% (95% CI 50 to 55) and 62% (59 to 64) among adults aged 65 to 74 years and 75 years and older, respectively, compared with those aged 50 to 64 years. We found similar results for emergency department visits with relative decreases of 61% (52 to 68) for adults aged 65 to 74 years and 77% (71 to 78) for those aged 75 years and older compared with adults aged 50 to 64 years. Hospital admissions declined by 39% (29 to 48) among those aged 60 to 69 years, 60% (54 to 66) among those aged 70 to 79 years, and 68% (62 to 73), among those aged 80 years and older, compared with adults aged 50 to 59 years. COVID-19 deaths also declined (by 41%, 95% CI –14 to 69 among adults aged 65–74 years and by 30%, –47 to 66 among those aged ≥75 years, compared with adults aged 50 to 64 years), but the magnitude of the impact of vaccination roll-out on deaths was unclear. Interpretation The initial roll-out of the US COVID-19 vaccination programme was associated with reductions in COVID-19 cases, emergency department visits, and hospital admissions among older adults. Funding None.
- Published
- 2022
26. Global, regional and national estimates of influenza-attributable ischemic heart disease mortality
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Sandra S. Chaves, Joshua Nealon, Katrin G. Burkart, Daniel Modin, Tor Biering-Sørensen, Justin R. Ortiz, Victor M. Vilchis-Tella, Lindsey E. Wallace, Gregory Roth, Cedric Mahe, and Michael Brauer
- Subjects
Ischemic heart disease ,Global disease burden ,General Medicine ,Mortality ,Cardiovascular ,Influenza - Abstract
Background: Influenza virus infection is associated with incident ischemic heart disease (IHD) events. Here, we estimate the global, regional, and national IHD mortality burden attributable to influenza. Methods: We used vital registration data from deaths in adults ≥50 years (13.2 million IHD deaths as underlying cause) to assess the relationship between influenza activity and IHD mortality in a non-linear meta-regression framework from 2010 to 2019. This derived relationship was then used to estimate the global influenza attributable IHD mortality. We estimated the population attributable fraction (PAF) of influenza for IHD deaths based on the relative risk associated with a given level of weekly influenza test positivity rate and multiplied PAFs by IHD mortality from the Global Burden of Disease study. Findings: Influenza activity was associated with increased risk of IHD mortality across all countries analyzed. The mean PAF of influenza for IHD mortality was 3.9% (95% uncertainty interval [UI] 2.5–5.3%), ranging from
- Published
- 2022
27. Relative Effectiveness of Cell-based Versus Egg-based Quadrivalent Influenza Vaccines in Children and Adolescents in the United States During the 2019-2020 Influenza Season
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Mahrukh Imran, Justin R. Ortiz, Huong Q McLean, Lauren Fisher, Dan O’Brien, Machaon Bonafede, James A. Mansi, and Constantina Boikos
- Subjects
Microbiology (medical) ,Mammals ,Adolescent ,Vaccination ,United States ,Infectious Diseases ,Vaccines, Inactivated ,Influenza Vaccines ,Pediatrics, Perinatology and Child Health ,Influenza, Human ,Animals ,Humans ,Seasons ,Vaccines, Combined ,Child ,Retrospective Studies - Abstract
Egg-based influenza vaccine production can lead to the accumulation of mutations that affect antigenicity. The mammalian cell-based inactivated quadrivalent influenza vaccine (IIV4c) may improve effectiveness compared with egg-based vaccines. This study estimated the relative vaccine effectiveness (rVE) of IIV4c versus egg-based inactivated quadrivalent influenza vaccine (IIV4e) in preventing influenza-related medical encounters (IRME) among children and adolescents during the 2019-2020 US influenza season.This retrospective cohort study used a dataset linking primary and specialty care electronic medical records with medical and pharmacy claims data from US residents 4 through 17 years of age vaccinated with IIV4c or IIV4e during the 2019-2020 influenza season. Odds ratios (ORs) were derived from a doubly robust inverse probability of treatment-weighted approach adjusting for age, sex, race, ethnicity, region, index week, health status and two proxy variables for healthcare accessibility and use. Adjusted rVE was estimated by (1-OR adjusted )*100, and an exploratory analysis evaluated IRMEs separately for outpatient and inpatient settings.The final study cohort included 60,480 (IIV4c) and 1,240,990 (IIV4e) vaccine recipients. Fewer IRMEs were reported in subjects vaccinated with IIV4c than IIV4e. The rVE for IIV4c versus IIV4e was 12.2% [95% confidence interval (CI): 7.5-16.6] for any IRME and 14.3% (9.3-19.0) for outpatient IRMEs. Inpatient IRMEs were much less frequent, and effectiveness estimates were around the null.Fewer IRMEs occurred in pediatric subjects vaccinated with IIV4c versus IIV4e. These results support the greater effectiveness of IIV4c over IIV4e in this population during the 2019-2020 US influenza season.
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- 2022
28. Relative Effectiveness of Cell-Based Versus Egg-Based Quadrivalent Influenza Vaccines in Adults During the 2019-2020 Influenza Season in the United States
- Author
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Mahrukh Imran, Justin R Ortiz, Huong Q McLean, Lauren Fisher, Dan O’Brien, Machaon Bonafede, James A Mansi, and Constantina Boikos
- Subjects
Infectious Diseases ,Oncology - Abstract
Background Mutations occurring during egg-based influenza vaccine production may affect vaccine effectiveness. The mammalian cell-based quadrivalent inactivated influenza vaccine (IIV4c) demonstrated improved protection relative to egg-based vaccines in prior seasons. This study estimated the relative vaccine effectiveness (rVE) of IIV4c versus standard-dose egg-based quadrivalent inactivated influenza vaccine (IIV4e) in preventing influenza-related medical encounters (IRMEs) in the 2019–2020 US influenza season. Methods This retrospective cohort study was conducted using a dataset linking electronic medical records with medical and pharmacy claims data among individuals ≥18 years vaccinated with IIV4c or IIV4e during 2019–2020. A doubly robust inverse probability of treatment weighting model was used to obtain odds ratios (ORs) adjusted for age, sex, race, ethnicity, region, vaccination week, health status, frailty, and baseline healthcare resource utilization. rVE was calculated by (1 – OR) × 100. An exploratory analysis evaluated IRMEs in inpatient and outpatient settings separately. Results The final study cohort included 1 499 215 IIV4c and 4 126 263 IIV4e recipients ≥18 years of age. Fewer IRMEs were reported in individuals with recorded IIV4c versus IIV4e. The rVE for IIV4c versus IIIV4e for any IRME was 9.5% (95% confidence interval [CI], 7.9%–11.1%). Inpatient and outpatient rVEs were 5.7% (95% CI, 2.1%–9.2%) and 11.4% (95% CI, 9.5%–13.3%), respectively. In age subgroup analyses, rVEs favored IIV4c except in adults aged ≥65 years. Conclusions Adults vaccinated with IIV4c had a lower risk of IRMEs versus IIV4e recipients in the 2019–2020 US influenza season. These results support IIV4c as a potentially more effective public health measure against influenza than egg-based vaccines.
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- 2022
29. Optimizing next-generation RSV prevention in Mali: a cost-effectiveness analysis of pediatric vaccination, maternal vaccination, and extended half-life monoclonal antibody immunoprophylaxis
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Rachel S. Laufer, Ranju Baral, Andrea G. Buchwald, James D. Campbell, Flanon Coulibaly, Fatoumata Diallo, Moussa Doumbia, Amanda J. Driscoll, Alison P. Galvani, Adama M. Keita, Kathleen M. Neuzil, Samba Sow, Clint Pecenka, Justin R. Ortiz, and Meagan C. Fitzpatrick
- Abstract
BackgroundRespiratory syncytial virus (RSV) is the most common cause of early childhood lower respiratory tract infection (LRTI) in low- and middle-income countries (LMICs). Maternal vaccines, birth-dose extended half-life monoclonal antibodies (mAbs), and pediatric vaccines are under development for prevention of respiratory syncytial virus (RSV) lower respiratory tract infection (LRTI) in young children.MethodsWe conducted an analysis of both health and economic impacts of RSV interventions used alone or in combinations in Mali. We modeled age-specific and season-specific risks of RSV LRTI in children through three years of life, using WHO Preferred Product Characteristics and data generated in Mali. Health outcomes included RSV LRTI cases, hospitalizations, deaths, and disability-adjusted life-years (DALYs). We identified the optimal combination of products across a range of scenarios.FindingWe found that mAb delivered at birth could avert 878 DALYs per birth cohort at an incremental cost-effectiveness ratio (ICER) of $597 per DALY averted compared to no intervention if the product were available at $1 per dose. Combining mAb with pediatric vaccine administered at 10/14 weeks, 1947 DALYs would be prevented. The ICER of this combination strategy is $1514 per DALY averted compared to mAb alone. In an optimization analysis incorporating parameter uncertainty, mAb alone is likely to be optimal from the societal perspective at efficacy against RSV LRTI above 66%. The optimal strategy was sensitive to economic considerations, including product prices and willingness-to-pay for DALYs. For example, the combination of mAb and pediatric vaccine would be optimal from the government perspective at a willingness-to-pay above $775 per DALY. Maternal vaccine alone or in combination with other interventions was never the optimal strategy, even for high vaccine efficacy. The same was true for pediatric vaccine administered at 6/7 months.InterpretationAt prices comparable to existing vaccine products, public health programs using extended half-life RSV mAbs alone or in combination with pediatric RSV vaccines would be impactful and efficient components of prevention strategies in LMICs such as Mali.
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- 2022
30. Cost-effectiveness of infant respiratory syncytial virus preventive interventions in Mali: A modeling study to inform policy and investment decisions
- Author
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Justin R. Ortiz, Samba O. Sow, Rachel S. Laufer, Andrea G. Buchwald, Alison P. Galvani, Clint Pecenka, Fadima Cheick Haidara, Lauren A.V. Orenstein, Flanon Coulibaly, Ranju Baral, Amanda J. Driscoll, James D. Campbell, Milagritos D. Tapia, Moussa Doumbia, Kathleen M. Neuzil, Karen L. Kotloff, Evan W. Orenstein, Adama Mamby Keita, Fatoumata Diallo, and Meagan C. Fitzpatrick
- Subjects
Pediatrics ,medicine.medical_specialty ,Cost effectiveness ,medicine.drug_class ,Cost-Benefit Analysis ,Respiratory Syncytial Virus Infections ,Monoclonal antibody ,Global Health ,Mali ,Virus ,Article ,medicine ,Global health ,Humans ,health care economics and organizations ,Pediatric ,General Veterinary ,General Immunology and Microbiology ,Respiratory tract infections ,business.industry ,Prevention ,fungi ,Public Health, Environmental and Occupational Health ,food and beverages ,Infant ,Pneumonia ,medicine.disease ,Clinical trial ,Infectious Diseases ,Policy ,Respiratory Syncytial Virus, Human ,Molecular Medicine ,Respiratory Syncytial Virus ,business ,Vaccine ,Cohort study - Abstract
Highlights • New RSV prevention products can substantially reduce disease burden. • Longer-acting monoclonal antibodies, priced affordably, are likely cost-effective. • Maternal vaccines meeting preferred product characteristics would be cost-effective. • RSV prevention products can provide good value in low-income countries., Importance Low- and middle-income countries have a high burden of respiratory syncytial virus lower respiratory tract infections. A monoclonal antibody administered monthly is licensed to prevent these infections, but it is cost-prohibitive for most low- and middle-income countries. Long-acting monoclonal antibodies and maternal vaccines against respiratory syncytial virus are under development. Objective We estimated the likelihood of respiratory syncytial virus preventive interventions (current monoclonal antibody, long-acting monoclonal antibody, and maternal vaccine) being cost-effective in Mali. Design We modeled age-specific and season-specific risks of respiratory syncytial virus lower respiratory tract infections within monthly cohorts of infants from birth to six months. We parameterized with respiratory syncytial virus data from Malian cohort studies, as well as product efficacy from clinical trials. Integrating parameter uncertainty, we simulated health and economic outcomes for status quo without prevention, intra-seasonal monthly administration of licensed monoclonal antibody, pre-seasonal birth dose administration of a long-acting monoclonal antibody, and maternal vaccination. We then calculated the incremental cost-effectiveness ratio of each intervention compared to status quo from the perspectives of the government, donor, and society. Results At a price of $3 per dose and from the societal perspective, current monoclonal antibody, long-acting monoclonal antibody, and maternal vaccine would have incremental cost-effectiveness ratios of $4280 (95% CI $1892 to $122,434), $1656 (95% CI $734 to $9091), and $8020 (95% CI $3501 to $47,047) per disability-adjusted life-year averted, respectively. Conclusions and Relevance In Mali, long-acting monoclonal antibody is likely to be cost-effective from both the government and donor perspectives at $3 per dose. Maternal vaccine would need higher efficacy over that measured by a recent trial in order to be considered cost-effective.
- Published
- 2021
31. Immunogenicity of seasonal inactivated influenza and inactivated polio vaccines among children in Senegal: Results from a cluster-randomized trial
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Meagan E. Deming, Justin R. Ortiz, Mbayame Ndiaye Niang, Aldiouma Diallo, Ousmane M. Diop, Doudou Diop, Déborah Goudiaby, Kathryn E. Lafond, John C. Victor, Kristen D.C. Lewis, Ndongo Dia, Marc-Alain Widdowson, and Kathleen M. Neuzil
- Subjects
medicine.medical_specialty ,Influenza vaccine ,030231 tropical medicine ,Antibodies, Viral ,Article ,03 medical and health sciences ,Influenza A Virus, H1N1 Subtype ,0302 clinical medicine ,Internal medicine ,Influenza, Human ,medicine ,Humans ,030212 general & internal medicine ,Seroconversion ,Child ,Hemagglutination assay ,General Veterinary ,General Immunology and Microbiology ,business.industry ,Influenza A Virus, H3N2 Subtype ,Immunogenicity ,Public Health, Environmental and Occupational Health ,Antibody titer ,Infant ,virus diseases ,Hemagglutination Inhibition Tests ,medicine.disease ,Senegal ,Poliomyelitis ,Vaccination ,Titer ,Infectious Diseases ,Vaccines, Inactivated ,Influenza Vaccines ,Child, Preschool ,Molecular Medicine ,Seasons ,business - Abstract
Data on influenza vaccine immunogenicity in children are limited from tropical developing countries. We recently reported significant, moderate effectiveness of a trivalent inactivated influenza vaccine (IIV) in a controlled, cluster-randomized trial in children in rural Senegal during 2009, a year of H3N2 vaccine mismatch (NCT00893906). We report immunogenicity of IIV3 and inactivated polio vaccine (IPV) from that trial. We evaluated hemagglutination inhibition (HAI) and polio antibody titers in response to vaccination of three age groups (6 through 35 months, 3 through 5 years, and 6 through 8 years). As all children were IIV naive, each received two vaccine doses, although titers were assessed after only the first dose for subjects aged 6 through 8 years. Seroconversion rates (4-fold titer rise or increase from
- Published
- 2020
32. Relative Effectiveness of MF59 Adjuvanted Trivalent Influenza Vaccine vs Nonadjuvanted Vaccines During the 2019–2020 Influenza Season
- Author
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Mahrukh Imran, Joan Puig-Barbera, Justin R Ortiz, Lauren Fischer, Dan O’Brien, Machaon Bonafede, James A Mansi, and Constantina Boikos
- Subjects
Infectious Diseases ,Oncology - Abstract
Background Age-related immunosenescence may impair the immune response to vaccination in older adults. Adjuvanted influenza vaccines are designed to overcome immune senescence in older adults. This study estimated the relative vaccine effectiveness (rVE) of MF59-adjuvanted trivalent inactivated influenza vaccine (aIIV3) vs egg-derived quadrivalent inactivated influenza vaccine (IIV4e) and high-dose trivalent inactivated influenza vaccine (HD-IIV3) in preventing influenza-related medical encounters in the 2019–2020 US season. Methods This retrospective cohort study used electronic medical records linked to pharmacy and medical claims data. The study population included adults age ≥65 years with a record of aIIV3, IIV4e, or HD-IIV3 vaccination. A doubly robust inverse probability of treatment weighting model was used to derive adjusted odds ratios (ORs). rVE was calculated by (1 – ORadjusted)*100 and was determined overall and separately for age subgroups. An exploratory analysis evaluated the outcome separately in inpatient and outpatient settings. Results Subjects received aIIV3 (n = 936 508), IIV3e (n = 651 034), and HD-IIV3 (n = 1 813 819), and influenza-related medical encounters were recorded in 0.5%, 0.9%, and 0.7% of each cohort, respectively. Overall, the rVE of aIIV3 was 27.5% (95% CI, 24.4% to 30.5%) vs IIV4e and 13.9% (95% CI, 10.7% to 17.0%) vs HD-IIV3. aIIV3 had a more favorable rVE in inpatient and outpatient settings. Findings remained consistent across age subgroups and during alternative seasonal dates. Conclusions Adults age ≥65 years vaccinated with aIIV3 had fewer influenza-related medical encounters compared with IIV4e or HD-IIV3 during the 2019–2020 US influenza season.
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- 2022
33. Assessing the strength of evidence for a causal effect of respiratory syncytial virus lower respiratory tract infections on subsequent wheezing illness: a systematic review and meta-analysis
- Author
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Daniel R. Feikin, Louis Bont, Tebeb Gebretsadik, Justin R. Ortiz, Patrick G. Holt, Pingsheng Wu, Heather J. Zar, David A. Savitz, Amanda J. Driscoll, Niranjan Bhat, Steven M. Brunwasser, Deshayne B. Fell, Brittney M. Snyder, Becky Skidmore, William D. Dupont, and Tina V Hartert
- Subjects
Pulmonary and Respiratory Medicine ,Pediatrics ,medicine.medical_specialty ,Respiratory tract infections ,medicine.diagnostic_test ,business.industry ,Confounding ,Odds ratio ,medicine.disease ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,030228 respiratory system ,Randomized controlled trial ,law ,Meta-analysis ,medicine ,Observational study ,030212 general & internal medicine ,Respiratory sounds ,business ,Asthma - Abstract
Summary Background Although a positive association has been established, it is unclear whether lower respiratory tract infections (LRTIs) with respiratory syncytial virus (RSV) cause chronic wheezing illnesses. If RSV-LRTI were causal, we would expect RSV-LRTI prevention to reduce the incidence of chronic wheezing illnesses in addition to reducing acute disease. We aimed to evaluate the strength of evidence for a causal effect of RSV-LRTI on subsequent chronic wheezing illness to inform public health expectations for RSV vaccines. Methods We did a systematic review and meta-analysis of observational studies evaluating the association between RSV-LRTI and subsequent wheezing illness (exposure studies) and studies evaluating the association between RSV immunoprophylaxis and subsequent wheezing illness (immunoprophylaxis studies). Exposure studies were included if the exposure group members had an LRTI with laboratory-confirmed RSV and if the exposure ascertainment period began before 2 years of age and ended before 5 years of age. We required a wash-out period of more than 30 days between the index RSV-LRTI and the outcome measurement to allow for resolution of the acute illness. Comparisons between RSV-LRTI and non-RSV-LRTI were not included. Immunoprophylaxis studies were included if they measured the association with subsequent wheezing illness relative to a control group, either in a randomised controlled trial (RCT) or an observational design. For the immunoprophylaxis drugs in question, we required evidence of efficacy in targeting RSV-LRTI from at least one RCT to ensure biological plausibility. All variations of wheezing illness were combined into a single outcome that refers broadly to asthma or any other respiratory illness with wheezing symptoms. Ovid MEDLINE and Embase databases were searched from inception up to Aug 28, 2018. We evaluated whether data from exposure studies could provide evidence against the most viable non-causal theory that RSV-LRTI is a marker of respiratory illness susceptibility rather than a causal factor. Additionally, we tested whether RSV immunoprophylaxis reduces the odds of subsequent wheezing illnesses. We used a random-effects modelling framework and, to accommodate studies providing multiple correlated estimates, robust variance estimation meta-regressions. Meta-regression coefficients (b) quantify differences between exposure and comparator groups on the loge odds ratio (loge OR) scale. Findings From 14 235 records we identified 57 eligible articles that described 42 studies and provided 153 effect estimates. 35 studies estimated the direct effect of RSV-LRTI on wheezing illnesses (exposure studies) and eight evaluated the effect of RSV immunoprophylaxis (immunoprophylaxis studies). Exposure studies that adjusted for genetic influences yielded a smaller mean adjusted OR estimate (aOR+ 2·45, 95% CI 1·23–4·88) compared with those that did not (4·17, 2·36–7·37), a significant difference (b 0·53, 95% CI 0·04–1·02). Infants who were not protected with RSV immunoprophylaxis tended to have higher odds of subsequent wheezing illness, as we would expect if RSV-LRTI were causal, but the effect was not significant (OR+ 1·21, 95% CI 0·73–1·99). There was generally a high threat of confounding bias in the observational studies. Additionally, in both the observational studies and immunoprophylaxis RCTs, there was high risk of bias due to missing outcome data. Interpretation Our findings, limited to exposure and immunoprophylaxis studies, do not support basing policy decisions on an assumption that prevention of RSV-LRTI will reduce recurrent chronic wheezing illnesses. Funding Bill & Melinda Gates Foundation.
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- 2020
34. Efficacy, duration of protection, birth outcomes, and infant growth associated with influenza vaccination in pregnancy: a pooled analysis of three randomised controlled trials
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Saad B Omer, Dayna R Clark, Shabir A Madhi, Milagritos D Tapia, Marta C Nunes, Clare L Cutland, Eric A F Simões, Anushka R Aqil, Joanne Katz, James M Tielsch, Mark C Steinhoff, Niteen Wairagkar, William Blackwelder, Joseph Bresee, Flanon Coulibaly, Boubacar Diallo, Fatoumata Diallo, Wilbur Chen, Moussa Doumbia, Fadima Cheick Haidara, Adama Mamby Keita, Alexander Klimov, Mamoudou Kodio, Karen Kotloff, Myron M. Levine, Vladimir Mishcherkin, Uma Onwuchekwa, Sandra Panchalingam, Marcela Pasetti, Doh Sanogo, Samba Sow, Milagritos Tapia, Boubou Tamboura, Ibrahim Teguete, Sharon Tennant, Awa Traore, John Treanor, Janet A. Englund, Subarna K. Khatry, Jane Kuypers, Steven C. LeClerq, Luke C. Mullany, Laxman Shrestha, Mark C. Steinhoff, James M. Tielsch, Peter V. Adrian, Clare L. Cutland, Andrea Hugo, Stephanie Jones, Locadiah Kuwanda, Keith P. Klugman, Shabir A. Madhi, Kathleen M. Neuzil, Nadia van Niekerk, Marta C. Nunes, Justin R. Ortiz, Eric A.F. Simões, Florette Treurnicht, Marietjie Venter, Avy Violari, and Adriana Weinberg
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Pulmonary and Respiratory Medicine ,Pediatrics ,medicine.medical_specialty ,Time Factors ,Influenza vaccine ,Gestational Age ,Mali ,Article ,law.invention ,South Africa ,Child Development ,Nepal ,Randomized controlled trial ,Pregnancy ,law ,Influenza, Human ,medicine ,Humans ,Pregnancy Complications, Infectious ,business.industry ,Vaccination ,Pregnancy Outcome ,Infant ,Gestational age ,medicine.disease ,Vaccine efficacy ,Treatment Outcome ,Influenza Vaccines ,Small for gestational age ,Female ,Immunization ,Underweight ,medicine.symptom ,business - Abstract
Summary Background Maternal influenza immunisation can reduce morbidity and mortality associated with influenza infection in pregnant women and young infants. We aimed to determine the vaccine efficacy of maternal influenza immunisation against maternal and infant PCR-confirmed influenza, duration of protection, and the effect of gestational age at vaccination on vaccine efficacy, birth outcomes, and infant growth up to 6 months of age. Methods We did a pooled analysis of three randomised controlled trials done in Nepal (2011–2014), Mali (2011–2014), and South Africa (2011–2013). Pregnant women, gestational age 17–34 weeks in Nepal, 28 weeks or more in Mali, and 20–36 weeks in South Africa, were enrolled. Women were randomly assigned 1:1 to a study group, in which they received trivalent inactivated influenza vaccine (IIV) in all three trials, or a control group, in which they received saline placebo in Nepal and South Africa or quadrivalent meningococcal conjugate vaccine in Mali. Enrolment at all sites was complete by April 24, 2013. Infants and women were assessed for respiratory illness, and samples from those that met the case definition were tested for influenza by PCR testing. Growth measurements, including length and weight, were obtained at birth at all sites, at 24 weeks in South Africa, and at 6 months in Nepal and Mali. The three trials are registered with ClinicalTrials.gov , numbers NCT01430689 , NCT01034254 , and NCT02465190 . Findings 10 002 women and 9800 liveborn infants were included. Pooled efficacy of maternal vaccination to prevent infant PCR-confirmed influenza up to 6 months of age was 35% (95% CI 19 to 47). The pooled estimate was 56% (28 to 73) within the first 2 months of life, 39% (11 to 58) between 2 and 4 months, and 19% (–9 to 40) between 4 and 6 months. In women, from enrolment during pregnancy to the end of follow-up at 6 months postpartum, the vaccine was 50% (95% CI 32–63) efficacious against PCR-confirmed influenza. Efficacy was 42% (12 to 61) during pregnancy and 60% (36 to 75) postpartum. In women vaccinated before 29 weeks gestational age, the estimated efficacy was 30% (–2 to 52), and in women vaccinated at or after 29 weeks, efficacy was 71% (50 to 83). Efficacy was similar in infants born to mothers vaccinated before or after 29 weeks gestation (34% [95% CI 12 to 51] vs 35% [11 to 52]). There was no overall association between maternal vaccination and low birthweight, stillbirth, preterm birth, and small for gestational age. At 6 months of age, the intervention and control groups were similar in terms of underweight (weight-for-age), stunted (length-for-age), and wasted (weight-for-length). Median centile change from birth to 6 months of age was similar between the intervention and the control groups for both weight and length. Interpretation The assessment of efficacy for women vaccinated before 29 weeks gestational age might have been underpowered, because the point estimate suggests that there might be efficacy despite wide CIs. Estimates of efficacy against PCR-confirmed influenza and safety in terms of adverse birth outcomes should be incorporated into any further consideration of maternal influenza immunisation recommendations. Funding Bill & Melinda Gates Foundation.
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- 2020
35. Effects of Air Pollution and Other Environmental Exposures on Estimates of Severe Influenza Illness, Washington, USA
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Justin R. Ortiz, Jeffrey S. Duchin, Ranjani Somayaji, Michael L. Jackson, Adam A. Szpiro, Christopher H. Goss, Kathryn H. Lofy, Moni B. Neradilek, and Kathleen M. Neuzil
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Washington ,Microbiology (medical) ,medicine.medical_specialty ,Fine particulate ,respiratory syncytial virus ,air pollution ,Air pollution ,lcsh:Medicine ,Respiratory Syncytial Virus Infections ,medicine.disease_cause ,Severe influenza ,Environmental data ,lcsh:Infectious and parasitic diseases ,respiratory infections ,Environmental health ,Influenza, Human ,Epidemiology ,medicine ,Humans ,lcsh:RC109-216 ,business.industry ,Research ,Incidence (epidemiology) ,lcsh:R ,RSV ,Effects of Air Pollution and Other Environmental Exposures on Estimates of Severe Influenza Illness, Washington, USA ,Environmental Exposure ,United States ,Infectious Diseases ,epidemiology ,business ,influenza ,hospitalization - Abstract
Ecologic models of influenza burden may be confounded by other exposures that share winter seasonality. We evaluated the effects of air pollution and other environmental exposures in ecologic models estimating influenza-associated hospitalizations. We linked hospitalization data, viral surveillance, and environmental data, including temperature, relative humidity, dew point, and fine particulate matter for 3 counties in Washington, USA, for 2001-2012. We used negative binomial regression models to estimate the incidence of influenza-associated respiratory and circulatory (RC) hospitalizations and to assess the effect of adjusting for environmental exposures on RC hospitalization estimates. The modeled overall incidence rate of influenza-associated RC hospitalizations was 31/100,000 person-years. The environmental parameters were statistically associated with RC hospitalizations but did not appreciably affect the event rate estimates. Modeled influenza-associated RC hospitalization rates were similar to published estimates, and inclusion of environmental covariates in the model did not have a clinically important effect on severe influenza estimates.
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- 2020
36. Quantifying risks and interventions that have affected the burden of lower respiratory infections among children younger than 5 years
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Tesfaye Dessale Kassa, Félix Carvalho, Luke D. Knibbs, Sonia Lewycka, Sonali Kochhar, Aaron Cohen, Luca Ronfani, Ebrahim M Yimer, Srinivas Murthy, Ejaz Ahmad Khan, Josip Car, Rodrigo Sarmiento-Suarez, Babak Moazen, Mostafa Qorbani, Javad Nazari, Nancy Fullman, Niranjan Kissoon, Keyghobad Ghadiri, Marissa B Reitsma, Benn Sartorius, Ashish Awasthi, Aman Yesuf Endries, Christopher Troeger, Evanson Z. Sambala, Nelson Alvis-Guzman, Alessandra C. Goulart, Erlyn Rachelle King Macarayan, Ahmad Daryani, Fakher Rahim, Fiseha Wadilo Wada, Yuming Guo, Sonia Saxena, Justin R. Ortiz, Monika Sawhney, Eyal Oren, Alaa Badawi, Tomislav Mestrovic, Sezer Kisa, Cheru Tesema Leshargie, Ai Koyanagi, Long Hoang Nguyen, Alireza Rafiei, Aziz Rezapour, Huong Lan Thi Nguyen, Abdallah M. Samy, Catrin E. Moore, André Karch, Seyyed Meysam Mousavi, Chi Linh Hoang, Katie R Nielsen, Eleonora Dubljanin, Giuseppe Gorini, Charles Shey Wiysonge, Bach Xuan Tran, Christopher J L Murray, Khanh Bao Tran, Maarten J. Postma, Mohammad Sadegh Rezai, Bartosz Miazgowski, Hagos Tasew Atalay, Aziz Sheikh, Reginald Quansah, Kirsten E. Wiens, Mika Shigematsu, Devasahayam J. Christopher, Hamid Yimam Hassen, Yasir Waheed, Robert Reiner, Smita Pakhale, Joseph Adel Mattar Banoub, Fares Alahdab, Vafa Rahimi-Movaghar, Mahesh P A, Ruth W Kimokoti, Feleke Mekonnen Demeke, Mohamad-Hani Temsah, Zakir Hussain, Naohiro Yonemoto, Noore Alam, Mu'awiyyah Babale Sufiyan, Lidia Morawska, Adane Teshome Kefale, Ali H. Mokdad, Rachel L Updike, Amir Kasaeian, Yousef Veisani, Rajesh Kumar Rai, Jeffrey D. Stanaway, Mina Anjomshoa, Corey B. Bills, Puja C Rao, Euripide Frinel G Arthur Avokpaho, Lorenzo Monasta, Zoubida Zaidi, Yousef Khader, Heather J. Zar, Ali Bijani, Tommi Vasankari, Kefyalew Addis Alene, Young-Ho Khang, Afewerki Gebremeskel Tsadik, Joseph Frostad, Ghulam Mustafa, Jalal Arabloo, Rajaa Al-Raddadi, Shanshan Li, David L. Smith, Maria Jesus Rios-Blancas, Carlos A Castañeda-Orjuela, Syed Mohamed Aljunid, Andrew T Olagunju, Suleman Atique, Abdullah T Khoja, Ibrahim A Khalil, William M. Gardner, Zikria Saleem, Addisu Melese, Stephen S Lim, Eyasu Ejeta Duken, Erkin M. Mirrakhimov, Gessessew Bugssa Hailu, Hmwe H Kyu, Seyedmojtaba Seyedmousavi, Aleksandra Barac, Spencer L. James, Salvatore Rubino, Lalit Dandona, Arya Haj-Mirzaian, Kate Causey, Nicholas J Kassebaum, Simon I. Hay, Ravi Prakash Jha, Karzan Abdulmuhsin Mohammad, Son Hoang Nguyen, Belay Tessema, Muhammad Imran Nisar, Barthelemy Kuate Defo, Alireza Ahmadi, Theo Vos, Krittika Bhattacharyya, Irfan Ullah, Molly H Biehl, Kalpana Balakrishnan, Tinuke O Olagunju, Florian Fischer, Olatunde Aremu, Brigette F. Blacker, Derrick A Bennett, Vahid Alipour, Carl Abelardo T. Antonio, Manisha Dubey, Tuomo J. Meretoja, G Anil Kumar, Varshil Mehta, Molly R Nixon, Eduarda Fernandes, Chandrashekhar T Sreeramareddy, Anselm Okoro, Zulfiqar A Bhutta, Maysaa El Sayed Zaki, Shafiu Mohammed, Nuruzzaman Khan, Jost B. Jonas, Samah Awad, Miloje Savic, Soewarta Kosen, Quique Bassat, Amha Admasie, Cuong Tat Nguyen, Chalachew Genet Akal, Milena M Santric Milicevic, Adnan Kisa, Arvin Haj-Mirzaian, Jonathan F. Mosser, Stephanie R M Zimsen, Dharmesh Kumar Lal, Birhanu Geta, Nobuyuki Horita, Gulfaraz Khan, Saeed Amini, Ziad A. Memish, Rakhi Dandona, Alyssa N. Sbarra, Dietrich Rothenbacher, Samer Hamidi, Felix Akpojene Ogbo, Helena Manguerra, Shirin Djalalinia, Degu Abate, Rakesh Lodha, Samuel B. Albertson, Seyed Sina Naghibi Irvani, Abdullah Al Mamun, Neeraj Bedi, Parvaiz A Koul, Desalegn Tadese Mengistu, Katie Welgan, Masood Ali Shaikh, Marek Majdan, Mihaela Hostiuc, Mohamed Lemine Cheikh brahim Ahmed, Public Health, GBD Lower Resp Infect, Microbes in Health and Disease (MHD), Real World Studies in PharmacoEpidemiology, -Genetics, -Economics and -Therapy (PEGET), Value, Affordability and Sustainability (VALUE), Collaborators, GBD 2017 Lower Respiratory Infections, Clinicum, Institute for Molecular Medicine Finland, HUS Comprehensive Cancer Center, Staff Services, University of Helsinki, II kirurgian klinikka, and Department of Oncology
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Male ,Psychological intervention ,Global Health ,Global Burden of Disease ,0302 clinical medicine ,Risk Factors ,Case fatality rate ,Medicine ,030212 general & internal medicine ,Respiratory Tract Infections ,INFLUENZAE TYPE-B ,education.field_of_study ,NUTRITION TRANSITION ,CHALLENGES ,Trastornos respiratorios ,Incidence (epidemiology) ,Mortality rate ,Incidence ,Enfermedades en niños ,CHILDHOOD PNEUMONIA ,Children younger than 5 years ,3. Good health ,Infectious Diseases ,Child, Preschool ,Child Mortality ,Female ,TERRITORIES ,CONJUGATE VACCINE ,030231 tropical medicine ,Population ,195 COUNTRIES ,Infections ,Article ,CHINA ,03 medical and health sciences ,Age Distribution ,Nutrition transition ,SYSTEMATIC ANALYSIS ,Humans ,Risk factor ,education ,Lower respiratory ,Models, Statistical ,business.industry ,AIR-POLLUTION ,Verbal autopsy ,Enfermedades respiratorias ,Socioeconomic Factors ,3121 General medicine, internal medicine and other clinical medicine ,Human medicine ,business ,Demography - Abstract
Background Despite large reductions in under-5 lower respiratory infection (LRI) mortality in many locations, the pace of progress for LRIs has generally lagged behind that of other childhood infectious diseases. To better inform programmes and policies focused on preventing and treating LRIs, we assessed the contributions and patterns of risk factor attribution, intervention coverage, and sociodemographic development in 195 countries and territories by drawing from the Global Burden of Diseases, Injuries, and Risk Factors Study 2017 (GBD 2017) LRI estimates. Methods We used four strategies to model LRI burden: the mortality due to LRIs was modelled using vital registration data, demographic surveillance data, and verbal autopsy data in a predictive ensemble modelling tool; the incidence of LRIs was modelled using population representative surveys, health-care utilisation data, and scientific literature in a compartmental meta-regression tool; the attribution of risk factors for LRI mortality was modelled in a counterfactual framework; and trends in LRI mortality were analysed applying changes in exposure to risk factors over time. In GBD, infectious disease mortality, including that due to LRI, is among HIV-negative individuals. We categorised locations based on their burden in 1990 to make comparisons in the changing burden between 1990 and 2017 and evaluate the relative percent change in mortality rate, incidence, and risk factor exposure to explain differences in the health loss associated with LRIs among children younger than 5 years. Findings In 2017, LRIs caused 808 920 deaths (95% uncertainty interval 747 286–873 591) in children younger than 5 years. Since 1990, there has been a substantial decrease in the number of deaths (from 2 337 538 to 808 920 deaths; 65·4% decrease, 61·5–68·5) and in mortality rate (from 362·7 deaths [330·1–392·0] per 100 000 children to 118·9 deaths [109·8–128·3] per 100 000 children; 67·2% decrease, 63·5–70·1). LRI incidence declined globally (32·4% decrease, 27·2–37·5). The percent change in under-5 mortality rate and incidence has varied across locations. Among the risk factors assessed in this study, those responsible for the greatest decrease in under-5 LRI mortality between 1990 and 2017 were increased coverage of vaccination against Haemophilus influenza type b (11·4% decrease, 0·0–24·5), increased pneumococcal vaccine coverage (6·3% decrease, 6·1–6·3), and reductions in household air pollution (8·4%, 6·8–9·2). Interpretation Our findings show that there have been substantial but uneven declines in LRI mortality among countries between 1990 and 2017. Although improvements in indicators of sociodemographic development could explain some of these trends, changes in exposure to modifiable risk factors are related to the rates of decline in LRI mortality. No single intervention would universally accelerate reductions in health loss associated with LRIs in all settings, but emphasising the most dominant risk factors, particularly in countries with high case fatality, can contribute to the reduction of preventable deaths. Funding Bill & Melinda Gates Foundation.
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- 2020
37. Immunogenicity and safety of different dosing schedules of trivalent inactivated influenza vaccine in pregnant women with HIV: a randomised controlled trial
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Y Abdoola, Justin R. Ortiz, Kathleen M. Neuzil, Andrea Hugo, Stephanie Jones, Keith P. Klugman, Shabir A. Madhi, L-A Stoltenkamp, Eric A. F. Simões, Marta C. Nunes, P Sithole, Adriana Weinberg, Clare L. Cutland, Andrew Moultrie, Florette K. Treurnicht, and N. van Niekerk
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0301 basic medicine ,Adult ,medicine.medical_specialty ,Adolescent ,Epidemiology ,Influenza vaccine ,Immunology ,Population ,HIV Infections ,Article ,law.invention ,03 medical and health sciences ,South Africa ,Young Adult ,0302 clinical medicine ,Immunogenicity, Vaccine ,Randomized controlled trial ,Double-Blind Method ,law ,Pregnancy ,Virology ,Internal medicine ,Influenza, Human ,Medicine ,Humans ,030212 general & internal medicine ,Dosing ,Young adult ,Seroconversion ,Pregnancy Complications, Infectious ,education ,Immunization Schedule ,education.field_of_study ,business.industry ,Immunogenicity ,Infant, Newborn ,Infant ,030112 virology ,Antibodies, Bacterial ,Regimen ,Infectious Diseases ,Influenza Vaccines ,Immunization ,Female ,Pregnant Women ,business - Abstract
Summary Background Standard-dose, seasonal, trivalent, inactivated influenza vaccine induces moderate-to-low haemagglutination-inhibition antibody responses in people living with HIV. This study assessed the immunogenicity and safety of different dosing schedules of inactivated influenza vaccine in pregnant women living with HIV in South Africa. Methods In this double-blind, randomised, controlled trial, we recruited pregnant women with HIV from seven antenatal clinics in Soweto, South Africa. Pregnant women were eligible if they were aged 18–38 years, infected with HIV, and had an estimated gestational age of 12–36 weeks. Women were randomly assigned (1:1:1), using a computer-generated randomisation list, to receive inactivated influenza vaccine containing 15 μg of each of the three seasonal influenza strains for that year, as a single dose, a double dose, or two single doses 1 month apart. Participants and study personnel were masked to group allocation. Haemagglutination-inhibition antibody responses were measured for all groups in the mothers at enrolment and at 1 month after each vaccine dose, and in the single-dose and double-dose groups within 7 days of birth in the neonates. Immunogenicity analyses only included women with visits 28–35 days apart and infants who were born at least 28 days after maternal immunisation. The primary was seroconversion rate to each of the vaccine strains in the mothers 1 month after completion of the dosing schedule, and the primary safety outcomes were frequency of local and systemic reactions. Safety was assessed in mothers and infants until 24 weeks post partum and analysed in all participants who received at least one dose of vaccine. This study is registered with ClinicalTrials.gov , NCT01527825 , and is closed to accrual. Findings Between Feb 11, and June 6, 2013, 800 pregnant women living with HIV were enrolled and randomly assigned to the single-dose (n=266), double-dose (n=265), or two-single-doses (n=269) group. In the analysable population, seroconversion rates in mothers 1 month after the final vaccine dose were significantly higher in the double-dose group (n=230; ranging from 29% to 65% for the three vaccine strains) than in the single-dose group (n=230; ranging from 18% to 49%; p≤0·019 for the three vaccine strains), but were similar between the two-single-doses group (n=220; ranging from 23% to 52%) and the single-dose group (p≥0·20 for the three vaccine strains). Safety outcomes were similar in the three groups, except for more injection-site reactions in recipients in the double-dose group. Interpretation A regimen of double-dose inactivated influenza vaccine gave slightly greater immunogenicity than did a single-dose regimen in pregnant women living with HIV. However, immunogenicity in the double-dose group was still lower than historical data from the same setting in pregnant women without HIV. More immunogenic vaccines are needed for pregnant women living with HIV to enhance transplacental transfer of vaccine-induced protective antibodies to their newborn infants. Funding Bill & Melinda Gates Foundation.
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- 2020
38. Clinical endpoints to inform vaccine policy: A systematic review of outcome measures from pediatric influenza vaccine efficacy trials
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Jordan B. Braunfeld, Heather N. Carson, Sarah R. Williams, Lauren M. Schwartz, Kathleen M. Neuzil, and Justin R. Ortiz
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Infectious Diseases ,Policy ,General Veterinary ,General Immunology and Microbiology ,Influenza Vaccines ,Influenza, Human ,Outcome Assessment, Health Care ,Public Health, Environmental and Occupational Health ,Molecular Medicine ,Humans ,Vaccine Efficacy ,Child ,Randomized Controlled Trials as Topic - Abstract
We conducted a systematic review of pediatric influenza vaccine efficacy trials to assess clinical outcome measures and whether the trials defined important public health endpoints.We systematically identified phase 3 or 4 influenza vaccine randomized controlled trials among children ≤18 years of age with laboratory-confirmed influenza outcomes since 1980. We recorded countries, age groups, vaccine formulations, specimen collection criteria, laboratory diagnostics, primary and secondary outcome measures, and funders, and we determined income category for study countries. We used descriptive statistics to summarize study characteristics. We analyzed the studies overall and a subset of studies conducted in at least one low- and middle-income country (LMIC).From 6455 potentially relevant articles, we identified 41 eligible studies. Twenty-one studies (51%) were conducted in at least one LMIC, while the remaining studies (49%) were conducted in high-income countries only. Thirty-one studies (76%) included children younger than six years. We found 40 different primary outcome measures among the 41 eligible studies. Thirty-three studies (80%) reported standardized symptoms or findings which defined a primary outcome or triggered specimen collection. One study defined a primary outcome which captured more severe illness; however, cases were mostly due to high body temperature without other severity criteria. Of the 21 studies from at least one LMIC, 15 (71%) were published since 2010 and 17 (81%) enrolled children younger than six years. Eighteen (86%) studies from at least one LMIC reported standardized symptoms or findings which defined a primary outcome or triggered specimen collection.Among pediatric influenza vaccine efficacy trials, primary outcome measures and clinical specimen collection criteria were highly variable and, with one exception, focused on capturing any influenza illness. As most LMICs do not have influenza vaccination programs, our study highlights a potential data limitation affecting policy and implementation decisions in these settings.
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- 2021
39. Estimates of Inactivated Influenza Vaccine Effectiveness Among Children in Senegal: Results From 2 Consecutive Cluster-Randomized Controlled Trials in 2010 and 2011
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Marc-Alain Widdowson, Kathryn E. Lafond, Justin R. Ortiz, Mbayame Nd Niang, Jonathan D. Sugimoto, Kathleen M. Neuzil, M. Elizabeth Halloran, Kristen D.C. Lewis, Aldiouma Diallo, John C. Victor, Bou Diarra, Vecteurs - Infections tropicales et méditerranéennes (VITROME), Institut de Recherche pour le Développement (IRD)-Aix Marseille Université (AMU)-Institut de Recherche Biomédicale des Armées (IRBA), Centers for Disease Control and Prevention [Atlanta] (CDC), Centers for Disease Control and Prevention, and Institut de Recherche pour le Développement (IRD)-Aix Marseille Université (AMU)-Institut de Recherche Biomédicale des Armées [Brétigny-sur-Orge] (IRBA)
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Microbiology (medical) ,medicine.medical_specialty ,Influenza vaccine ,Population ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Randomized controlled trial ,[SDV.MHEP.CSC]Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system ,law ,[SDV.MHEP.MI]Life Sciences [q-bio]/Human health and pathology/Infectious diseases ,Internal medicine ,Influenza, Human ,medicine ,Humans ,Cumulative incidence ,[SDV.MP.PAR]Life Sciences [q-bio]/Microbiology and Parasitology/Parasitology ,030212 general & internal medicine ,Cluster randomised controlled trial ,education ,Child ,Online Only Articles ,2. Zero hunger ,0303 health sciences ,education.field_of_study ,[SDV.MHEP.ME]Life Sciences [q-bio]/Human health and pathology/Emerging diseases ,030306 microbiology ,business.industry ,Influenza A Virus, H3N2 Subtype ,[SDV.MP.BAC]Life Sciences [q-bio]/Microbiology and Parasitology/Bacteriology ,Confidence interval ,Senegal ,3. Good health ,Vaccination ,Infectious Diseases ,Vaccines, Inactivated ,Influenza Vaccines ,[SDV.MP.VIR]Life Sciences [q-bio]/Microbiology and Parasitology/Virology ,Inactivated Poliovirus Vaccine ,business - Abstract
BackgroundWe report results of years 2 and 3 of consecutive cluster-randomized controlled trials of trivalent inactivated influenza vaccine (IIV3) in Senegal.MethodsWe cluster-randomized (1:1) 20 villages to annual vaccination with IIV3 or inactivated poliovirus vaccine (IPV) of age-eligible residents (6 months–10 years). The primary outcome was total vaccine effectiveness against laboratory-confirmed influenza illness (LCI) among age-eligible children (modified intention-to-treat population [mITT]). Secondary outcomes were indirect (herd protection) and population (overall community) vaccine effectiveness.ResultsWe vaccinated 74% of 12 408 age-eligible children in year 2 (June 2010–April 11) and 74% of 11 988 age-eligible children in year 3 (April 2011–December 2011) with study vaccines. Annual cumulative incidence of LCI was 4.7 (year 2) and 4.2 (year 3) per 100 mITT child vaccinees of IPV villages. In year 2, IIV3 matched circulating influenza strains. The total effectiveness was 52.8% (95% confidence interval [CI], 32.3–67.0), and the population effectiveness was 36.0% (95% CI, 10.2–54.4) against LCI caused by any influenza strain. The indirect effectiveness against LCI by A/H3N2 was 56.4% (95% CI, 39.0–68.9). In year 3, 74% of influenza detections were vaccine-mismatched to circulating B/Yamagata and 24% were vaccine-matched to circulating A/H3N2. The year 3 total effectiveness against LCI was −14.5% (95% CI, −81.2–27.6). Vaccine effectiveness varied by type/subtype of influenza in both years.ConclusionsIIV3 was variably effective against influenza illness in Senegalese children, with total and indirect vaccine effectiveness present during the year when all circulating strains matched the IIV3 formulation.Clinical Trials RegistrationNCT00893906.
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- 2021
40. Evaluation of post-introduction COVID-19 Vaccine Effectiveness: Summary of interim guidance of the World Health Organization
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Pete Smith, Claudio F. Lanata, Siddhivinayak Hirve, Walter A. Orenstein, Natasha S. Crowcroft, Francisco Nogareda, Stephanie J. Schrag, Marta Valenciano, Isabel Bergeri, Daniel R. Feikin, Maïna L'Azou Jackson, Benjamin J. Cowling, Minal K. Patel, Mark A. Katz, Sudhir Joshi, Kamal Fahmy, Annelies Wilder-Smith, Gagandeep Kang, Joseph S. Bresee, Marc Lipsitch, Jennifer R. Verani, Justin R. Ortiz, Richard Pebody, Jason M. Mwenda, Lorenzo Subissi, D. W. Vaughn, and Padmini Srikantiah
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medicine.medical_specialty ,Emergency Use Authorization ,030231 tropical medicine ,Disease ,03 medical and health sciences ,0302 clinical medicine ,Interim ,Pandemic ,medicine ,030212 general & internal medicine ,Intensive care medicine ,General Veterinary ,General Immunology and Microbiology ,vaccine effectiveness ,business.industry ,Clinical study design ,Public Health, Environmental and Occupational Health ,COVID-19 ,Conference Report ,Vaccine efficacy ,vaccination ,Clinical trial ,Vaccination ,Infectious Diseases ,Molecular Medicine ,business - Abstract
Phase 3 randomized-controlled trials have provided promising results of COVID-19 vaccine efficacy, ranging from 50 to 95% against symptomatic disease as the primary endpoints, resulting in emergency use authorization/listing for several vaccines. However, given the short duration of follow-up during the clinical trials, strict eligibility criteria, emerging variants of concern, and the changing epidemiology of the pandemic, many questions still remain unanswered regarding vaccine performance. Post-introduction vaccine effectiveness evaluations can help us to understand the vaccine's effect on reducing infection and disease when used in real-world conditions. They can also address important questions that were either not studied or were incompletely studied in the trials and that will inform evolving vaccine policy, including assessment of the duration of effectiveness; effectiveness in key subpopulations, such as the very old or immunocompromised; against severe disease and death due to COVID-19; against emerging SARS-CoV-2 variants of concern; and with different vaccination schedules, such as number of doses and varying dosing intervals. WHO convened an expert panel to develop interim best practice guidance for COVID-19 vaccine effectiveness evaluations. We present a summary of the interim guidance, including discussion of different study designs, priority outcomes to evaluate, potential biases, existing surveillance platforms that can be used, and recommendations for reporting results.
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- 2021
41. Recalibrating public health expectations of respiratory syncytial virus lower respiratory tract illness prevention on chronic respiratory disease
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Amanda J. Driscoll, Corinne A. Riddell, Justin R. Ortiz, and Tina V. Hartert
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medicine.medical_specialty ,Motivation ,General Veterinary ,General Immunology and Microbiology ,business.industry ,Public health ,Respiratory disease ,Public Health, Environmental and Occupational Health ,Bronchi ,Respiratory Syncytial Virus Infections ,medicine.disease ,Virus ,Article ,Respiratory Syncytial Viruses ,Infectious Diseases ,medicine.anatomical_structure ,Molecular Medicine ,Medicine ,Humans ,Public Health ,Respiratory system ,business ,Intensive care medicine ,Illness prevention ,Respiratory tract - Published
- 2021
42. Trivalent influenza vaccination randomized control trial of pregnant women and adverse fetal outcomes
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Richard Madimabe, Eric A. F. Simões, MatFlu Team, Marta C. Nunes, Kathleen M. Neuzil, Shabir A. Madhi, Clare L. Cutland, Phyllis Carosone-Link, Keith P. Klugman, and Justin R. Ortiz
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Adult ,medicine.medical_specialty ,Adolescent ,Influenza vaccine ,030231 tropical medicine ,Gestational Age ,Article ,Young Adult ,03 medical and health sciences ,0302 clinical medicine ,Double-Blind Method ,Pregnancy ,Influenza, Human ,Humans ,Medicine ,030212 general & internal medicine ,Pregnancy Complications, Infectious ,Fetus ,General Veterinary ,General Immunology and Microbiology ,business.industry ,Obstetrics ,Pregnancy Outcome ,Public Health, Environmental and Occupational Health ,Gestational age ,Small for gestational age ,Vaccine efficacy ,medicine.disease ,3. Good health ,Vaccination ,Low birth weight ,Infectious Diseases ,Randomized controlled trial ,Influenza Vaccines ,Infant, Small for Gestational Age ,Molecular Medicine ,Female ,medicine.symptom ,Prematurity ,business - Abstract
Highlights • A two-year randomized controlled trial of seasonal IIV3. • Over 2000 mothers in South Africa, from March 2011 until post 2012 influenza season. • Birth outcomes investigated were fetal death, SGA, birth weight and prematurity. • Vaccine demonstrated no appreciable impact of maternal IIV3 immunization., Introduction The purpose of this study was to evaluate the association of influenza vaccine during pregnancy and adverse fetal outcomes. Preventing fetal death, low birth weight, small for gestational age birth and preterm birth are important potential effects of antenatal maternal influenza immunization for which there are conflicting data. Materials and methods A double-blind, randomized, placebo-controlled clinical trial of trivalent inactivated influenza vaccine was conducted in South Africa from March 2011 until after the 2012 influenza season when the infants born had reached the age of 24 weeks. Mothers were administered the vaccine or placebo during pregnancy at a gestation of 20 to 36 weeks. A comparison of rates of fetal death, low birth weight, small for gestational age birth, and preterm birth, between vaccinated and placebo groups was made. Fetal outcome differences between the groups were measured using Student’s t-tests, vaccine efficacy with 95% confidence intervals, and Poisson regression for incidence rates. All analyses except fetal death excluded mothers who were administered vaccine or placebo after 34 weeks gestational age. Results There were 2116 HIV-uninfected pregnant women age 18 to 38 years in the trial; 2005 infants were born to mothers where vaccine or placebo had been administered ≥ 14 days prior to delivery, and there were 6 miscarriages and 23 stillbirths. There was no significant vaccine efficacy (with [95% confidence interval]) on fetal death (−21.2% [−150.8, 41.4]), low birth weight (−11.1% [−42.3, 12.5]), small for gestational age birth (−9.9% [−35.6, 11.0]), or preterm birth (−21.3% [−60.5, 8.3]). Neither was vaccine efficacy demonstrated when the analysis was restricted to infants of mothers who were exposed to an influenza season (1832 outcomes available). Conclusion We did not find a beneficial effect of trivalent inactivated influenza vaccine during pregnancy on adverse fetal outcomes.
- Published
- 2019
43. Influenza vaccine programs for children in low- and middle-income countries: current status and way forward
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Justin R. Ortiz and Kathleen M. Neuzil
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0301 basic medicine ,Economic growth ,Influenza vaccine ,Immunology ,03 medical and health sciences ,0302 clinical medicine ,Influenza, Human ,Drug Discovery ,Humans ,030212 general & internal medicine ,Child ,Developing Countries ,Disease burden ,Pharmacology ,Immunization Programs ,Value proposition ,Vaccination ,Economic benefits ,Vaccine introduction ,030104 developmental biology ,Immunization ,Influenza Vaccines ,Low and middle income countries ,Molecular Medicine ,Business - Abstract
Introduction: Influenza vaccines are safe and effective, yet they are infrequently used in low- and middle-income countries (LMICs). Areas covered: We examine influenza vaccine programs for children from within a framework of new vaccine adoption in LMICs. We review the available evidence on disease burden and vaccine introduction, the current global and financing policies, and the current status of vaccine availability, and country readiness for implementation. Expert commentary: Access to appropriate formulations of influenza vaccines and existing immunization infrastructures must be strengthened if influenza vaccine programs are to be expanded in LMICs. While WHO recommends that implementation of influenza vaccine programs should be a country decision based on national goals, capacities, and data review, vaccine decision makers from many LMICs will likely need more evidence to inform the value proposition of program investment for pediatric vaccination, particularly related to alternative immunization strategies that align with current vaccine delivery platforms, anticipated program impact on severe illness endpoints, and program costs and economic benefits. Targeted research and development to address the specific needs of LMICs may be needed to demonstrate the value proposition of influenza vaccines and to expand influenza vaccine programs in these settings.
- Published
- 2019
44. Maternal immunization in Malawi: A mixed methods study of community perceptions, programmatic considerations, and recommendations for future planning
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Monica Jamili-Phiri, Jessica A. Fleming, Kathleen M. Neuzil, Alister Munthali, Philipp Lambach, Bagrey Ngwira, Justin R. Ortiz, Niranjan Bhat, Maria Stepanchak, John Kadzandira, and Joachim Hombach
- Subjects
Adult ,Malawi ,medicine.medical_specialty ,Adolescent ,Influenza vaccine ,Health Personnel ,030231 tropical medicine ,Disease ,Operational research ,Article ,Young Adult ,03 medical and health sciences ,0302 clinical medicine ,Pregnancy ,Environmental health ,Humans ,Medicine ,030212 general & internal medicine ,Pregnancy Complications, Infectious ,Maternal tetanus toxoid and maternal influenza vaccine ,Vaccines ,General Veterinary ,General Immunology and Microbiology ,business.industry ,Tetanus ,Public health ,Vaccination ,Public Health, Environmental and Occupational Health ,Middle Aged ,Patient Acceptance of Health Care ,medicine.disease ,Focus group ,Infectious Diseases ,Immunization ,Tetanus vaccine ,Maternal immunization ,Molecular Medicine ,Female ,Pregnant Women ,business ,medicine.drug - Abstract
Highlights • Health workers and community members expressed high acceptance of maternal vaccines. • Malawi’s strong tetanus vaccine delivery system may benefit new maternal vaccines. • Community members and policy makers have low awareness of influenza disease burden., Background Safe, effective vaccines are given to pregnant women to protect their infants and/or themselves against certain infectious agents; however, apart from tetanus vaccination, maternal immunization in low- and middle-income countries (LMICs) remains low. Tetanus toxoid vaccine is integrated into antenatal care services in Malawi with high coverage and provides an opportunity to identify factors that facilitate successful immunization delivery to pregnant women in LMICs. Methods PATH and the University of Malawi’s Centre for Social Research conducted a mixed-methods study in 2015 to document community perceptions of maternal immunization, using tetanus vaccine as an example, and to identify factors perceived to be important to successfully introducing other maternal vaccines, such as influenza vaccine, in Malawi. We conducted 18 focus group discussions with pregnant and recently pregnant women and their family members and 76 semi-structured interviews with pregnant and recently pregnant women, community leaders, health workers, public health program managers, non-governmental partners, and policy makers. Results We identified factors perceived to support the introduction of new maternal vaccines, including strong maternal vaccine acceptance in the community, an existing strategy for maternal tetanus vaccine delivery, and positive health workers’ views about the introduction of additional maternal vaccines. Potential challenges to adoption and acceptance included identifying and tracking the target population and monitoring adverse events, and the need to ensure operational capacity of the health system to support the introduction and wide-scale use of an additional vaccine. For influenza vaccine specifically, additional challenges included limited awareness of influenza disease and its low prioritization among health needs. Conclusions Lessons from the successful delivery of maternal tetanus immunization in Malawi may be informative for similar countries considering new vaccines for pregnant women or striving to optimize the delivery of those currently provided.
- Published
- 2019
45. Introduction of new vaccines for immunization in pregnancy - Programmatic, regulatory, safety and ethical considerations
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Sonali Kochhar, Pedro L. Moro, Kathryn M. Edwards, Justin R. Ortiz, Alba Maria Ropero Alvarez, and Public Health
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Maternal-Child Health Services ,Policy making ,Health Personnel ,MEDLINE ,Healthcare providers ,Antenatal care ,Communicable Diseases ,Article ,Health policies ,03 medical and health sciences ,Pharmacovigilance ,0302 clinical medicine ,Nursing ,Global policies ,SDG 3 - Good Health and Well-being ,Pregnancy ,030225 pediatrics ,Health care ,medicine ,Humans ,030212 general & internal medicine ,Vaccine hesitancy ,Developing Countries ,Vaccination coverage ,Licensure ,Vaccines ,Introduction ,Program ,General Veterinary ,General Immunology and Microbiology ,business.industry ,Immunization Programs ,Vaccination ,Public Health, Environmental and Occupational Health ,medicine.disease ,Regulatory ,Maternal Immunization ,Country-level policy making ,Product (business) ,Infectious Diseases ,Immunisation ,Immunization ,Molecular Medicine ,Female ,Business ,Pregnant Women ,Safety - Abstract
Immunizing pregnant women is a promising strategy to reduce infectious disease-related morbidity and mortality in pregnant women and their infants. Important pre-requisites for the successful introduction of new vaccines for immunization in pregnancy include political commitment and adequate financial resources: trained, committed and sufficient numbers of healthcare workers to deliver the vaccines; close integration of immunization programs with antenatal care and Maternal and Child Health services; adequate access to antenatal care by pregnant women in the country (especially in low and middle-income countries (LMIC)); and a high proportion of births occurring in health facilities (to ensure maternal and neonatal follow-up can be done). The framework needed to advance a vaccine program from product licensure to successful country-level implementation includes establishing and organizing evidence for anticipated vaccine program impact, developing supportive policies, and translating policies into local action. International and national coordination efforts, proactive planning from conception to implementation of the programs (including country-level policy making, planning, and implementation, regulatory guidance, pharmacovigilance) and country-specific and cultural factors must be taken into account during the vaccines introduction.
- Published
- 2019
46. Association of Maternal Influenza Vaccination During Pregnancy With Early Childhood Health Outcomes
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Azar Mehrabadi, Linda Dodds, Noni E. MacDonald, Karina A. Top, Eric I. Benchimol, Jeffrey C. Kwong, Justin R. Ortiz, Ann E. Sprague, Laura K. Walsh, Kumanan Wilson, and Deshayne B. Fell
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Obstetrics and Gynecology ,General Medicine - Published
- 2021
47. Immunogenicity and Viral Shedding of Russian-Backbone, Seasonal, Trivalent, Live, Attenuated Influenza Vaccine in a Phase II, Randomized, Placebo-Controlled Trial Among Preschool-Aged Children in Urban Bangladesh
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Kathleen M. Neuzil, Alicia M. Fry, Justin R. Ortiz, Min Z. Levine, Len Dally, Kristen D.C. Lewis, Irina Isakova-Sivak, Stephen Lindstrom, W. Abdullah Brooks, Larisa Rudenko, Mohammed Ziaur Rahman, Natalia A. Ilyushina, Mustafizur Rahman, Joseph S. Bresee, Victoria Matyushenko, Jacqueline M. Katz, and Peter F. Wright
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0301 basic medicine ,Microbiology (medical) ,Immunoglobulin A ,Influenza vaccine ,030106 microbiology ,Vaccines, Attenuated ,Russia ,03 medical and health sciences ,Immune System Phenomena ,0302 clinical medicine ,children ,Influenza, Human ,Live attenuated influenza vaccine ,Medicine ,Humans ,030212 general & internal medicine ,Viral shedding ,Child ,Articles and Commentaries ,clinical trials ,Bangladesh ,Hemagglutination assay ,biology ,business.industry ,Immunogenicity ,virus diseases ,Vaccination ,Titer ,Infectious Diseases ,Influenza Vaccines ,Immunology ,biology.protein ,influenza vaccine ,business - Abstract
Background We evaluated a Russian-backbone, live, attenuated influenza vaccine (LAIV) for immunogenicity and viral shedding in a randomized, placebo-controlled trial among Bangladeshi children. Methods Healthy children received a single, intranasal dose of LAIV containing the 2011–2012 recommended formulation or placebo. Nasopharyngeal wash (NPW) specimens were collected on days 0, 2, 4, and 7. Reverse transcription polymerase chain reactions and sequencing identified the influenza virus (vaccine or wild-type). On days 0 and 21, blood specimens were collected to assess immunogenicity using hemagglutination inhibition, microneutralization, and immunoglobulin A (IgA) and G enzyme-linked immunosorbent assays (ELISAs); NPW specimens were also collected to assess mucosal immunogenicity using kinetic IgA ELISA. Results We enrolled 300 children aged 24 through 59 months in the immunogenicity and viral shedding analyses. Among children receiving LAIV, 45% and 67% shed A/H3N2 and B vaccine strains, respectively. No child shed A/H1N1 vaccine strain. There were significantly higher day 21 geometric mean titers (GMTs) for the LAIV, as compared to the placebo groups, in all immunoassays for A/H3N2 and B (log10 titer P < .0001; GMT Ratio >2.0). Among immunoassays for A/H1N1, only the mucosal IgA GMT was significantly higher than placebo at day 21 (log10 titer P = .0465). Conclusions Children vaccinated with LAIV had serum and mucosal antibody responses to A/H3N2 and B, but only a mucosal IgA response to A/H1N1. Many children shed A/H3N2 and B vaccine strains, but none shed A/H1N1. More research is needed to determine the reason for decreased LAIV A/H1N1 immunogenicity and virus shedding. Clinical Trials Registration NCT01625689., In this Phase II trial of live, attenuated influenza vaccine in Bangladeshi children, we detected post-vaccination antibody responses to A/H3N2 and B viruses and viral shedding. However, we detected a reduced post-vaccination antibody response to A/H1N1 and no viral shedding.
- Published
- 2018
48. The potential effects of deploying SARS-Cov-2 vaccines on cold storage capacity and immunization workload in countries of the WHO African Region
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Amanda J. Driscoll, Robin Biellik, Stephen Yu, Meagan C. Fitzpatrick, Sarah R. Williams, Joanie Robertson, Samba O. Sow, Justin R. Ortiz, Kathleen M. Neuzil, Jui-Shan Hsu, and Wilbur H. Chen
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Adult ,COVID-19 ,Delivery ,Immunization ,Implementation ,Africa ,SARS-CoV-2 ,COVID-19 Vaccines ,Adolescent ,Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) ,030231 tropical medicine ,Population ,Cold storage ,Workload ,World Health Organization ,Article ,Young Adult ,03 medical and health sciences ,0302 clinical medicine ,Refrigeration ,Environmental health ,Pandemic ,Humans ,Medicine ,030212 general & internal medicine ,Child ,education ,Aged ,education.field_of_study ,General Veterinary ,General Immunology and Microbiology ,Immunization Programs ,business.industry ,Vaccination ,Public Health, Environmental and Occupational Health ,Middle Aged ,biochemical phenomena, metabolism, and nutrition ,Infectious Diseases ,Child, Preschool ,Absenteeism ,Molecular Medicine ,business - Abstract
BACKGROUND: SARS-CoV-2 vaccines will be deployed to countries with limited immunization systems. METHODS: We assessed the effect of deploying SARS-Cov-2 vaccines on cold storage capacity and immunization workload in a simulated WHO African Region country using region-specific data on immunization, population, healthcare workers (HCWs), cold storage capacity (quartile values for national and subnational levels), and characteristics of an approved SARS-CoV-2 vaccine. We calculated monthly increases in vaccine doses, doses per vaccinator, and cold storage volumes for four-month SARS-CoV-2 vaccination campaigns targeting risk groups compared to routine immunization baselines. RESULTS: Administering SARS-CoV-2 vaccines to risk groups would increase total monthly doses by 27.0% for ≥ 65 years, 91.7% for chronic diseases patients, and 1.1% for HCWs. Assuming median nurse density estimates adjusted for absenteeism and proportion providing immunization services, SARS-CoV-2 vaccination campaigns would increase total monthly doses per vaccinator by 29.3% for ≥ 65 years, 99.6% for chronic diseases patients, and 1.2% for HCWs. When we applied quartiles of actual African Region country vaccine storage capacity, routine immunization vaccine volumes exceeded national-level storage capacity for at least 75% of countries, but subnational levels had sufficient storage capacity for SARS-CoV-2 vaccines for at least 75% of countries. CONCLUSIONS: In the WHO African Region, SARS-CoV-2 vaccination campaigns would substantially increase doses per vaccinator and cold storage capacity requirements over routine immunization baselines. Pandemic vaccination campaigns would increase storage requirements of national-level stores already at their limits, but sufficient capacity exists at subnational levels. Immediate attention to strengthening immunization systems is essential to support pandemic responses.
- Published
- 2021
49. National routine adult immunisation programmes among World Health Organization Member States: an assessment of health systems to deploy COVID-19 vaccines
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Hanna M. LeBuhn, Justin R. Ortiz, Kathleen M. Neuzil, Wilbur H. Chen, Sarah R. Williams, and Amanda J. Driscoll
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Adult ,medicine.medical_specialty ,COVID-19 Vaccines ,Coronavirus disease 2019 (COVID-19) ,Epidemiology ,Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) ,030231 tropical medicine ,World Health Organization ,World health ,03 medical and health sciences ,0302 clinical medicine ,Virology ,Environmental health ,Pandemic ,medicine ,Humans ,030212 general & internal medicine ,Child ,Pandemics ,Vaccines ,adult immunisation ,business.industry ,SARS-CoV-2 ,Immunization Programs ,Public health ,Member states ,Research ,public health ,Vaccination ,Public Health, Environmental and Occupational Health ,COVID-19 ,Odds ratio ,Hepatitis B ,medicine.disease ,joint reporting form ,Europe ,Africa ,business ,policy - Abstract
Introduction As SARS-CoV-2 disproportionately affects adults, the COVID-19 pandemic vaccine response will rely on adult immunisation infrastructures. Aim To assess adult immunisation programmes in World Health Organization (WHO) Member States. Methods We evaluated country reports from 2018 on adult immunisation programmes sent to WHO and UNICEF. We described existing programmes and used multivariable regression to identify independent factors associated with having them. Results Of 194 WHO Member States, 120 (62%) reported having at least one adult immunisation programme. The Americas and Europe had the highest proportions of adult immunisation programmes, most commonly for hepatitis B and influenza vaccines (> 47% and > 91% of countries, respectively), while Africa and South-East Asia had the lowest proportions, with Discussion Worldwide, 38% of countries lack adult immunisation programmes. COVID-19 vaccine deployment will require national systems for vaccine storage and handling, delivery and waste management to target adult risk groups. There is a need to strengthen immunisation systems to reach adults with COVID-19 vaccines.
- Published
- 2021
50. National Routine Adult Immunization Programs among World Health Organization Member States: An Assessment of Health Systems to Deploy Future SARS-CoV-2 Vaccines
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Amanda J. Driscoll, Justin R Ortiz, Sarah R. Williams, Kathleen M. Neuzil, Hanna M. LeBuhn, and Wilbur H. Chen
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Adult Immunization ,2019-20 coronavirus outbreak ,business.industry ,Vaccine response ,Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) ,Environmental health ,Member states ,Pandemic ,Medicine ,business ,World health ,Healthcare system - Abstract
IntroductionAs the SARS-CoV-2 pandemic disproportionately affects older adults, future pandemic vaccine response will rely on existing adult immunization infrastructures.MethodsWe evaluated the 2018 WHO/UNICEF Joint Reporting Form on Immunization for country reports on adult immunization programs. We described countries with programs and used multivariable regression to identify independent factors associated with having them.ResultsOf 194 WHO Member States, 120 (62%) reported having any adult vaccination program. The Americas and Europe had the most adult immunization programs, most commonly Hepatitis B and influenza vaccines (>45% and >90% of countries). Africa and South-East Asia had the fewest adult immunization programs, with DiscussionThat 38% of countries lack functional platforms for adult immunization has major implications for future SARS-CoV-2 vaccine deployment. Systems for vaccine storage and handling, delivery, and waste management for adult immunization do not exist in much of the world. Developing countries should strengthen immunization programs to reach adults with SARS-CoV-2 vaccines when they become available.
- Published
- 2020
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