27 research outputs found

    Hypersensitivity to the Moderna COVID-19 vaccine caused by tromethamine: PEG is not always the culprit excipient

    Get PDF
    Vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are considered the cornerstone of the solution to the current global pandemic. The first vaccines to receive authorization for emergency use in humans were the BNT162b2 Pfizer-BioNTech and the mRNA-1273 Moderna vaccines. Both contain synthetic mRNA that codes for the SARS-CoV-2 spike (S) protein, which is encased in a lipid nanoparticle envelope. Anaphylaxis and immediate hypersensitivity reactions were noted in only 1 case during phase III trials for BNT162b2, while no immediate hypersensitivity reactions were noted for the mRNA-1273 vaccine. However, a history of hypersensitivity to any component of the vaccines was an exclusion criterion. Nonetheless, cases of anaphylaxis were reported shortly after initiation of the vaccination campaign

    Evaluation of the impact of the voucher and accreditation approach on improving reproductive behaviors and RH status: Bangladesh

    Get PDF
    <p>Abstract</p> <p>Background</p> <p>Cost of delivering reproductive health services to low-income populations will always require total or partial subsidization by the government and/or development partners. Broadly termed "Demand-Side Financing" or "Output-Based Aid", includes a range of interventions that channel government or donor subsidies to the service user rather than the service provider. Initial findings from the few assessments of reproductive health voucher-and-accreditation programs suggest that, if implemented well, these programs have great potential for achieving the policy objectives of increasing access and use, reducing inequities and enhancing program efficiency and service quality. At this point in time, however, there is a paucity of evidence describing how the various voucher programs function in different settings, for various reproductive health services.</p> <p>Methods/Design</p> <p>Population Council-Nairobi, funded by the Bill and Melinda Gates Foundation, intends to address the lack of evidence around the pros and cons of 'voucher and accreditation' approaches to improving the reproductive health of low income women in five developing countries. In Bangladesh, the activities will be conducted in 11 accredited health facilities where Demand Side Financing program is being implemented and compared with populations drawn from areas served by similar non-accredited facilities. Facility inventories, client exit interviews and service provider interviews will be used to collect comparable data across each facility for assessing readiness and quality of care. In-depth interviews with key stakeholders will be conducted to gain a deeper understanding about the program. A population-based survey will also be carried out in two types of locations: areas where vouchers are distributed and similar locations where vouchers are not distributed.</p> <p>Discussion</p> <p>This is a quasi-experimental study which will investigate the impact of the voucher approach on improving maternal health behaviors and status and reducing inequities at the population level. We expect a significant increase in the utilization of maternal health care services by the accredited health facilities in the experimental areas compared to the control areas as a direct result of the interventions. If the voucher scheme in Bangladesh is found effective, it may help other countries to adopt this approach for improving utilization of maternity care services for reducing maternal mortality.</p

    Evaluation of the impact of the voucher and accreditation approach on improving reproductive behaviors and status in Cambodia

    Get PDF
    Background: Cost of delivering reproductive health services to low-income populations will always require total or partial subsidization by government and/or development partners. Broadly termed “demand-side financing” or “output-based aid,” these strategies include a range of interventions that channel government or donor subsidies to the user rather than the service provider. Initial pilot assessments of reproductive health voucher programs suggest that they can increase access, reduce inequities, and enhance program efficiency and service quality. However, there is a paucity of evidence describing how these programs function in different settings for various reproductive health services. Methods/Design: Population Council, funded by the Bill and Melinda Gates Foundation, intends to generate evidence around the “voucher and accreditation” approaches to improving the reproductive health of low-income women in Cambodia. The study comprises four populations: facilities, providers, women of reproductive age using facilities, and women and men who have been pregnant and/or used family planning within the previous 12 months. The study will be carried out in a sample of 20 health facilities that are accredited to provide maternal and newborn health and family planning services to women holding vouchers from operational districts in three provinces: Kampong Thom, Kampot, and Prey Veng and a matched sample of non-accredited facilities in three other provinces. Health facility assessments will be conducted at baseline and endline to track temporal changes in quality of care, client out-of-pocket costs, and utilization. Facility inventories, structured observations, and client exit interviews will be used to collect comparable data across facilities. Health providers will also be interviewed and observed providing care. A population survey of about 3,000 respondents will also be conducted in areas where vouchers are distributed and similar non-voucher locations. Discussion: A quasi-experimental study will investigate the impact of the voucher approach on improving reproductive health behaviors, reproductive health status, and reducing inequities at the population level and assess effects on access, equity, and quality of care at the facility level. If the voucher scheme in Cambodia is found effective, it may help other countries adopt this approach for improving utilization and access to reproductive health and family planning services

    Factors influencing gastrointestinal tract and microbiota immune interaction in preterm infants

    Get PDF
    The role of microbial colonization is indispensable for keeping a balanced immune response in life. However, the events that regulate the establishment of the microbiota, their timing, and the way in which they interact with the host are not yet fully understood. Factors such as gestational age, mode of delivery, environment, hygienic measures, and diet influence the establishment of microbiota in the perinatal period. Environmental microbes constitute the most important group of exogenous stimuli in this critical time frame. However, the settlement of a stable gut microbiota in preterm infants is delayed compared to term infants. Preterm infants have an immature gastrointestinal tract and immune system which predisposes to infectious morbidity. Neonatal microbial dynamics and alterations in early gut microbiota may precede and/or predispose to diseases such as necrotizing enterocolitis (NEC), late-onset sepsis or others. During this critical period, nutrition is the principal contributor for immunological and metabolic development, and microbiological programming. Breast milk is a known source of molecules that act synergistically to protect the gut barrier and enhance the maturation of the gut-related immune response. Host-microbe interactions in preterm infants and the protective role of diet focused on breast milk impact are beginning to be unveiled.M.C. acknowledges a “Rio Hortega” Research Fellowship Grant (CM13/0017) and M.V. acknowledges grants PI11/0313 and RD12/0026/0012 (Red SAMID) from the Instituto Carlos III (Spanish Ministry of Economy and Competitivity). M.C.C. and G.P-M. were supported by the grant AGL2013-47420-R from the Spanish Ministry of Science and Innovation.Peer reviewe

    A global point prevalence survey of antimicrobial use in neonatal intensive care units: The no-more-antibiotics and resistance (NO-MAS-R) study

    Get PDF
    Background: Global assessment of antimicrobial agents prescribed to infants in the neonatal intensive care unit (NICU) may inform antimicrobial stewardship efforts. Methods: We conducted a one-day global point prevalence study of all antimicrobials provided to NICU infants. Demographic, clinical, and microbiologic data were obtained including NICU level, census, birth weight, gestational/chronologic age, diagnoses, antimicrobial therapy (reason for use; length of therapy), antimicrobial stewardship program (ASP), and 30-day in-hospital mortality. Findings: On July 1, 2019, 26 of infants (580/2,265; range, 0�100; median gestational age, 33 weeks; median birth weight, 1800 g) in 84 NICUs (51, high-income; 33, low-to-middle income) from 29 countries (14, high-income; 15, low-to-middle income) in five continents received �1 antimicrobial agent (92, antibacterial; 19, antifungal; 4, antiviral). The most common reasons for antibiotic therapy were �rule-out� sepsis (32) and �culture-negative� sepsis (16) with ampicillin (40), gentamicin (35), amikacin (19), vancomycin (15), and meropenem (9) used most frequently. For definitive treatment of presumed/confirmed infection, vancomycin (26), amikacin (20), and meropenem (16) were the most prescribed agents. Length of therapy for culture-positive and �culture-negative� infections was 12 days (median; IQR, 8�14) and 7 days (median; IQR, 5�10), respectively. Mortality was 6 (42, infection-related). An NICU ASP was associated with lower rate of antibiotic utilization (p = 0·02). Interpretation: Global NICU antibiotic use was frequent and prolonged regardless of culture results. NICU-specific ASPs were associated with lower antibiotic utilization rates, suggesting the need for their implementation worldwide. Funding: Merck & Co.; The Ohio State University College of Medicine Barnes Medical Student Research Scholarship © 2021 The Author
    corecore