Last data update: May 06, 2024. (Total: 46732 publications since 2009)
Records 1-8 (of 8 Records) |
Query Trace: Ema S[original query] |
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Establishing vaccine pregnancy registries and active surveillance studies in low-and middle-income countries: Experience from an observational cohort surveillance project in The Gambia
Kochhar S , Okomo U , Nkereuwem O , Shaum A , Gidudu JF , Bittaye M , Fofana S , Marena M , Kaira MJ , Kampmann B , Longley AT . Vaccine 2023 41 (44) 6453-6455 Despite significant advances in child survival, infectious diseases continue to be among the leading causes of neonatal deaths [1]. Maternal immunization is a well-recognized public health intervention to reduce vaccine-preventable disease-related morbidity and mortality in the pregnant woman, her foetus, and infant from tetanus, pertussis, seasonal influenza, and COVID-19 [2]. The development of new maternal vaccines against respiratory syncytial virus (RSV) and group B streptococcus (GBS) may significantly decrease the morbidity and mortality from these diseases in neonates and infants [2], with the U.S. Food and Drug Administration (FDA) approval for licensure of an RSV vaccine to be administered in pregnancy occurring in August 2023 [3]. | | Ongoing safety assessment of novel vaccines administered during pregnancy requires well-functioning passive and active surveillance systems to collect and assess adverse maternal and neonatal outcomes [4]. In high-income countries (HICs), regulatory authorities, such as the European Medicines Agency (EMA) and the U.S. FDA, require extensive post-authorization safety monitoring activities for products used during pregnancy, including active surveillance for safety-related events through pregnancy registries and observational cohort studies [4], [5], [6]. However, safety surveillance for vaccines used in pregnancy in many low- and middle-income countries (LMICs) currently relies on passive surveillance systems whose output cannot be interpreted appropriately due to lack of information on background rates of adverse events in pregnancy in general and lack of data on the number of pregnant women vaccinated as the relevant specific comparator [4], [5], [6]. |
Tackling a global epidemic threat: Nipah surveillance in Bangladesh, 2006-2021
Satter SM , Aquib WR , Sultana S , Sharif AR , Nazneen A , Alam MR , Siddika A , Akther Ema F , Chowdhury KIA , Alam AN , Rahman M , Klena JD , Rahman MZ , Banu S , Shirin T , Montgomery JM . PLoS Negl Trop Dis 2023 17 (9) e0011617 Human Nipah virus (NiV) infection is an epidemic-prone disease and since the first recognized outbreak in Bangladesh in 2001, human infections have been detected almost every year. Due to its high case fatality rate and public health importance, a hospital-based Nipah sentinel surveillance was established in Bangladesh to promptly detect Nipah cases and respond to outbreaks at the earliest. The surveillance has been ongoing till present. The hospital-based sentinel surveillance was conducted at ten strategically chosen tertiary care hospitals distributed throughout Bangladesh. The surveillance staff ensured that routine screening, enrollment, data, and specimen collection from suspected Nipah cases were conducted daily. The specimens were then processed and transported to the reference laboratory of Institute of Epidemiology, Disease Control and Research (IEDCR) and icddr,b for confirmation of diagnosis through serology and molecular detection. From 2006 to 2021, through this hospital-based surveillance platform, 7,150 individuals were enrolled and tested for Nipah virus. Since 2001, 322 Nipah infections were identified in Bangladesh, 75% of whom were laboratory confirmed cases. Half of the reported cases were primary cases (162/322) having an established history of consuming raw date palm sap (DPS) or tari (fermented date palm sap) and 29% were infected through person-to-person transmission. Since the initiation of surveillance, 68% (218/322) of Nipah cases from Bangladesh have been identified from various parts of the country. Fever, vomiting, headache, fatigue, and increased salivation were the most common symptoms among enrolled Nipah patients. Till 2021, the overall case fatality rate of NiV infection in Bangladesh was 71%. This article emphasizes that the overall epidemiology of Nipah virus infection in Bangladesh has remained consistent throughout the years. This is the only systematic surveillance to detect human NiV infection globally. The findings from this surveillance have contributed to early detection of NiV cases in hospital settings, understanding of Nipah disease epidemiology, and have enabled timely public health interventions for prevention and containment of NiV infection. Although we still have much to learn regarding the transmission dynamics and risk factors of human NiV infection, surveillance has played a significant role in advancing our knowledge in this regard. |
Protocol for a sequential, prospective meta-analysis to describe coronavirus disease 2019 (COVID-19) in the pregnancy and postpartum periods (preprint)
Smith ER , Oakley E , He S , Zavala R , Ferguson K , Miller L , Grandner GW , Abejirinde IO , Afshar Y , Ahmadzia H , Aldrovandi G , Akelo V , Tippett Barr BA , Bevilacqua E , Brandt JS , Broutet N , Fernández Buhigas I , Carrillo J , Clifton R , Conry J , Cosmi E , Delgado-López C , Divakar H , Driscoll AJ , Favre G , Flaherman V , Gale C , Gil MM , Godwin C , Gottlieb S , Hernandez Bellolio O , Kara E , Khagayi S , Kim CR , Knight M , Kotloff K , Lanzone A , Le Doare K , Lees C , Litman E , Lokken EM , Laurita Longo V , Magee LA , Martinez-Portilla RJ , McClure E , Metz TD , Money D , Mullins E , Nachega JB , Panchaud A , Playle R , Poon LC , Raiten D , Regan L , Rukundo G , Sanin-Blair J , Temmerman M , Thorson A , Thwin S , Tolosa JE , Townson J , Valencia-Prado M , Visentin S , von Dadelszen P , Adams Waldorf K , Whitehead C , Yang H , Thorlund K , Tielsch JM . medRxiv 2022 2020.11.08.20228056 We urgently need answers to basic epidemiological questions regarding SARS-CoV-2 infection in pregnant and postpartum women and its effect on their newborns. While many national registries, health facilities, and research groups are collecting relevant data, we need a collaborative and methodologically rigorous approach to better combine these data and address knowledge gaps, especially those related to rare outcomes. We propose that using a sequential, prospective meta-analysis (PMA) is the best approach to generate data for policy- and practice-oriented guidelines. As the pandemic evolves, additional studies identified retrospectively by the steering committee or through living systematic reviews will be invited to participate in this PMA. Investigators can contribute to the PMA by either submitting individual patient data or running standardized code to generate aggregate data estimates. For the primary analysis, we will pool data using two-stage meta-analysis methods. The meta-analyses will be updated as additional data accrue in each contributing study and as additional studies meet study-specific time or data accrual thresholds for sharing. At the time of publication, investigators of 25 studies, including more than 76,000 pregnancies, in 41 countries had agreed to share data for this analysis. Among the included studies, 12 have a contemporaneous comparison group of pregnancies without COVID-19, and four studies include a comparison group of non-pregnant women of reproductive age with COVID-19. Protocols and updates will be maintained publicly. Results will be shared with key stakeholders, including the World Health Organization (WHO) Maternal, Newborn, Child, and Adolescent Health (MNCAH) Research Working Group. Data contributors will share results with local stakeholders. Scientific publications will be published in open-access journals on an ongoing basis.Competing Interest StatementClare Whitehead declares a a relationship with the following entities, Ferring Pharmaceuticals COVID19 Investigational, Grant, NHMRC Fellowship (salary support). Alice Panchaud declares the following research grants to institution: H2020-Grant (Consortium member of Innovative medicine initiative call 13 topic 9) (ConcePTION), Efficacy and safety studies on Medicines EMA/2017/09/PE/11, Lot 4, WP 2 lead (CONSIGN: Study on impact of COVID-19 infection and medicines in pregnancy), Safety monitoring of COVID-19 vaccines in the EU Reopening of competition no. 20 under a framework contract following procurement procedure EMA/2017/09/PE (Lot 3) 4. Federal Office of Public Health (207000 CHF). (The COVI-Preg registry). Edward Mullins declares a relationship with the following entities National Institute for Health Research (Project grant for PAN COVID study) Deborah Money declares a relationship with the following entities, Canadian Institutes of Health Research (payments to my institution only), Public Health Agency of Canada (payments to my institution only), BC Womens Foundation (payments to my institution only) and is a Member of the COVID-19 Immunity Task Force sponsored by the Canadian government. Torri D. Metz declares a relationship with the following entities, Pfizer (site Principal Investigator for SARS-CoV-2 vaccination in pregnancy study, money paid to institution and member of Medical Advisory Board for SARS-CoV-2 vaccination in pregnancy study, money paid to me), NICHD (subcommittee Chair for the NICHD Maternal-Fetal Medicine Units Network Gestational Research Assessments of COVID-19 (GRAVID) study), and Society for Maternal-Fetal Medicine (board member). Erica Lokken declares a relationship with the following entity, US NIH (paid institution). Karen L. Kotloff declares a relationship with the following entity, Bill and Melinda Gates Foundation. Siran He declares a relationship with the following entity, Bill and Melinda Gates Foundtion (payments made to my institution). Valerie Flaherman declares a relationship with the following entities, Bill and Melinda Gates Foundation (payments to my institution), Yellow Chair Foundati n (payments to my institution), Robert Woods Johnson Foundation (payments to my institution), CDC Foundation, California Health Care Foundation (payments to my institution), Tara Health Foundation (payments to my institution), UCSF Womens Health Center of Excellence (payments to my institution) and California Department of Health Care Services (payments made to my institution). Jose Sanin-Blair declares a relationship with the following entity, Ferring Pharmaceuticals which give a grant ($10,000) for the expenses of RECOGEST trial and is a part of the Columbian Federation of Perinatology Yalda Afshar declares a relationship with the following entities, Bill and Melinda Gates Foundation (payments made to my institution), CDC Foundation (payments made to my institution), Robert Woods Johnson Foundation (payments made to my institution), and UCLA Deans Office COVID-19 research (payments made to my institution). Rebecca Cliffton declares a relationship with the following entity, NIH HD36801 (MFMU Network DCC).Clinical TrialPROSPERO ID: 188955Funding StatementFunded by the Bill & Melinda Gates Foundation grant to Emily Smith (INV-022057) at George Washington University and a grant to Emily Smith via a grant from the Bill & Melinda Gates Foundation to Stephanie Gaw (INV-017035) at University of California San Francisco.Author DeclarationsI confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.YesThe details of the IRB/oversight body that provided approval or exemption for the research described are given below:This is a protocol paper and thus exempt from ethical approval. Ultimately, the meta-analysis study is exempt from human research ethics approval as the study authors will be synthesizing de-identified or aggregate data.I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.YesI understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).YesI have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.YesThis is a protocol paper and there is no related data to share. |
Understanding thrombosis with thrombocytopenia syndrome after COVID-19 vaccination.
Buoninfante A , Andeweg A , Baker AT , Borad M , Crawford N , Dogné JM , Garcia-Azorin D , Greinacher A , Helfand R , Hviid A , Kochanek S , López-Fauqued M , Nazy I , Padmanabhan A , Pavord S , Prieto-Alhambra D , Tran H , Wandel Liminga U , Cavaleri M . NPJ Vaccines 2022 7 (1) 141 Safety and efficacy of vaccines against the SARS-CoV-2 coronavirus has been demonstrated in clinical trials and next by their real world use through the course of the ongoing COVID-19 pandemic. However, very rare adverse events have been detected post-authorization in certain parts of the world. This meeting report summarizes an EMA workshop's discussion on the epidemiology, clinical presentation and biology of thrombosis with thrombocytopenia syndrome after adenovirus vector COVID-19 vaccination. General agreement was reached by international regulators, scientists and developers on the steps needed to fill the gaps in the characterization of this new syndrome. In particular, actions should be taken to improve the post-vaccination surveillance activities in low and middle income countries and investigate potential genetic predisposition factors. |
Receipt and timeliness of newborn hearing screening and diagnostic services among babies born in 2017 in 9 states
Deng X , Ema S , Mason C , Nash A , Carbone E , Gaffney M . J Public Health Manag Pract 2020 28 (1) E100-E108 CONTEXT: By providing timely services at all steps along the continuum of the early hearing detection and intervention (EHDI) process, providers may be able to lessen potential adverse effects of late identification of hearing loss on children's language development. OBJECTIVE: To examine the timeliness of key events in the EHDI process from birth through diagnosis of hearing loss among different populations. DESIGN: Retrospective, cross-sectional. SETTING: Data pooled from 9 states' EHDI information systems were used to determine the extent to which timely screening and diagnosis were achieved by 754 613 infants born in calendar year 2017. Enrollment into early intervention for children diagnosed is not examined here due to incomplete data. PARTICIPANTS: Nine state EHDI programs were selected to participate in this study for their successful experience in using EHDI-IS to collect detailed child-level data. MAIN OUTCOME MEASURES: Age of service, rate of service receipt. RESULTS: Median age of newborn hearing screening was 1 day, and median age of hearing loss diagnosis was 68 days. Early completion of newborn hearing screening was associated with maternal education, maternal race/ethnicity, and admission into a neonatal intensive care unit (NICU). Receiving and completing follow-up diagnostic services were associated with maternal education, maternal race/ethnicity, age of screening, and enrollment into the Women, Infants, and Children program. CONCLUSIONS: Timely completion of the newborn hearing screening is achieved by most of the population among the participating states. Increased efforts may be considered by state EHDI programs to provide additional follow-up and education to underrepresented racial/ethnic groups, mothers with less education, and NICU infants and their families as these groups appear to be at an increased risk for delayed diagnostic testing for hearing loss. |
Implementation of a three-tiered approach to identify and characterize anti-drug antibodies raised against HIV-specific broadly neutralizing antibodies
Bharadwaj P , Riekofski C , Lin S , Seaman MS , Garber DA , Montefiori D , Sarzotti-Kelsoe M , Ackerman ME , Weiner JA . J Immunol Methods 2020 479 112764 The ability to detect, quantify, and interrogate the properties of immune responses raised against biological therapeutics is not only important to our understanding of these molecules, but also to their success in the clinic. A tiered assay approach to identify the presence, specificity, and titer of anti-drug antibody (ADA) responses has been adopted as a gold standard by industry leaders, the FDA, and the EMA. In order to support pre-clinical and clinical trials, these assays must be standardized, and their performance sufficiently characterized to ensure the accuracy and reproducibility of results under relevant testing conditions. Here we present implementation of electrochemiluminiscence assays that fit into the tiered paradigm of ADA testing for five HIV broadly neutralizing antibodies (3NC117, 3BNC117-LS, 10-1074, PGT121, and PGDM1400) in compliance with Good Clinical Laboratory practices. Assay sensitivities and matrix effects were evaluated and used to inform the development of positivity cut points. Once cut points were established, assay precision, specificity, free-drug tolerance, and robustness were defined. In all cases, assay characteristics met or surpassed recommendations set forth by the FDA. To further evaluate the performance of these assays and the tiered approach, samples from non-human primates that had received a subset of the five therapeutics were evaluated. In sum, this study reports qualification of a set of ADA assays available to the scientific community as pre-clinical and clinical trials of broadly HIV-neutralizing antibodies proceed, and a framework that is easily adapted as new drug products are advanced in the clinic. |
Public health emergency risk communication and social media reactions to an errant warning of a ballistic missile threat - Hawaii, January 2018
Murthy BP , Krishna N , Jones T , Wolkin A , Avchen RN , Vagi SJ . MMWR Morb Mortal Wkly Rep 2019 68 (7) 174-176 On January 13, 2018, at 8:07 a.m. Hawaii Standard Time, an errant emergency alert was sent to persons in Hawaii. An employee at the Hawaii Emergency Management Agency (EMA) sent the errant alert via the Wireless Emergency Alert (WEA) system and the Emergency Alert System (EAS) during a ballistic missile preparedness drill, advising persons to seek shelter from an incoming ballistic missile. WEA delivers location-based warnings to wireless carrier systems, and EAS sends alerts via television and radio (1). After 38 minutes, at 8:45 a.m., Hawaii EMA retracted the alert via WEA and EAS (2). To understand the impact of the alert, social media responses to the errant message were analyzed. Data were extracted from Twitter* using a Boolean search for tweets (Twitter postings) posted on January 13 regarding the false alert. Tweets were analyzed during two 38-minute periods: 1) early (8:07-8:45 a.m.), the elapsed time the errant alert circulated until the correction was issued and 2) late (8:46-9:24 a.m.), the same amount of elapsed time after issuance of the correction. A total of 5,880 tweets during the early period and 8,650 tweets during the late period met the search criteria. Four themes emerged during the early period: information processing, information sharing, authentication, and emotional reaction. During the late period, information sharing and emotional reaction themes persisted; denunciation, insufficient knowledge to act, and mistrust of authority also emerged as themes. Understanding public interpretation, sharing, and reaction to social media messages related to emergencies can inform development and dissemination of accurate public health messages to save lives during a crisis. |
Determination of crystalline silica in respirable dust upon occupational exposure for Egyptian workers
Mohamed SH , El-Ansary AL , El-Aziz EMA . Ind Health 2018 56 (3) 255-263 Crystalline free silica is considered as a lung carcinogen and the occupational exposure to its dust is a health hazard to workers employed in industries that involve ores of mineral dust. In Egypt, thousands of people work under conditions of silica dust exposure exceeding the occupational exposure limit, as a result the monitoring of this occupational exposure to crystalline silica dust is required by government legislation. The assessment of the later is a multi-phase process, depend on workplace measurements, quantitative analyses of samples, and comparison of results with the permissible limits. This study aims to investigate occupational exposure to crystalline silica dust at 22 factories in Egypt with different industrial activities like stone cutting, glass making, ceramic, and sand blasting. Dust samples were collected from work sites at the breathing zone using a personal sampling pump and a size-selective cyclone and analyzed using FTIR. The sampling period was 60-120 min. The results show that the exposure at each of the industrial sectors is very much higher than the current national and international limits, and that lead to a great risk of lung cancer and mortality to workers. |
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