Drugs, Diagnostics, Vaccines, Preventive Technologies, Research toward a cure, and immune-based and gene therapies in development
The objective of the 2022 Compendium is to compile and highlight emerging innovative health technologies for low-resource settings. It presents a snapshot of technologies that are solutions to an unmet medical/health technology need or are likely to improve health outcomes and the quality of life. H...ealth technologies in the Compendium underwent WHO evidence-based assessments focused on the life cycle of health technology innovations for low-resource settings.
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Prepared as an outcome of ICMR Expert Group on Immunophenotyping of Hematolymphoid Neoplasms | Coordinated by Division of Non Communicable Diseases | This document addresses on various issue related to good quality practices in laboratory work up of flow cytometric immunophenotyping and will be of u...se to pathologists, cytometrists, hematologists, technologists and scientists working in this field.
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This document is an output of a WHO cross-programme initiative aiming to improve the prevention, diagnosis and management of anaemia and thereby accelerate reduction in its prevalence. It comes at an important time, midway through the era of the Sustainable Development Goals, when progress in reduci...ng anaemia has stagnated. This framework is based on the core principles of primary health care: meeting people’s health needs through comprehensive promotive, protective, curative, and rehabilitative care along the life course; systematically addressing the broader determinants of health; and empowering individuals, families, and communities to optimize their health
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These guidelines provide a framework for effective action to facilitate access to safe and ethical
testing services for different population groups. The implementation of the a comprehensive
approach, known as HIV Testing Services (HTS) is cardinal as an effective package of services
that diminis...hes the impact of the HIV epidemic in our country. All forms of HTS adhere to
the 5Cs: Confidentiality, Counselling, Consent, Correct results and Connection, or linkage
to care, with all based within a human right context. In addition to the 5Cs, however, the
MOHCDGEC emphasizes the use of a variety of approaches to HTS that will reduce the
number of missed opportunities. These include Provider-Initiated Testing and Counselling
testing, Couple counselling and testing, Index testing, and infant and children counselling and
testing in alignment to the revised WHO guidelines. Furthermore, these guidelines accentuate
on the continual provision of integrated HTS service at all levels of the public and private
health service delivery system.
The HTS Providers, managers and other stakeholders
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The report aims to capture lessons from the COVID-19 pandemic and to highlight the opportunity for more ambitious global action: expanding sustainable access to vaccines for all towards the Immunization Agenda 2030 and pandemic prevention, preparedness and response efforts. The report is organized i...n two sections: the first section provides WHO insights on global vaccine market dynamics, drawing from data provided by Member States, which are, in turn, analysed and displayed in the second section.
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The guidelines are to be used to guide the management of adults with lower respiratory tract infection (LRTI). As will be seen in the following text, this diagnosis, and the other clinical syndromes within this grouping, can be difficult to make accurately. In the absence of agreed definitions of th...ese syndromes these guidelines are to be used when, in the opinion of a clinician, an LRTI syndrome is present. The following are put forward as def-initions to guide the clinician, but it will be seen in the ensuingtext that some of these labels will always be inaccurate. These definitions are pragmatic and based on a synthesis of available studies. They are primarily meant to be simple to apply in clinical practice, and this might be at the expense of scientific accuracy. These definitions are not mutually exclusive, with lower respiratory tract infection being an umbrella term that includes all others, which can also be used for cases that cannot be classified into one of the other groups. No new evidence has been identified that would lead to a change in the clinical definitions,which are therefore unchanged from the 2005 publication.
Clin Microbiol Infect 2011;17(Suppl. 6): 1–24 The full version of these guidelines can be found on Wiley Online Library.
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This is the 42nd situation report for the multi-country outbreak of mpox, which provides an update on the epidemiological situation of mpox in Africa (including countries in the WHO African Region and some countries in the WHO Eastern Mediterranean Region), with data as of 3 November 2024.
Full Perscribing information on Fexinidazole Tablet for oral use
INDICATIONS AND USAGE
Fexinidazole Tablets are indicated for the treatment of both the first-stage (hemolymphatic) and second-stage (meningoencephalitic) human African trypanosomiasis (HAT) due to Trypanosoma brucei gambiense in pati...ents 6 years of age and older and weighing at least 20 kg.
Limitations of Use
Due to the decreased efficacy observed in patients with severe second stage HAT (cerebrospinal fluid white blood cell count (CSF-WBC) >100 cells/μL) due to T. brucei gambiense disease, Fexinidazole Tablets should only be used in these patients if there are no other available treatment options [see Warnings and Precautions (5.1)]
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Interim Assessement Report
The EMA review was started by the Agency’s Committee for Medicinal Products for Human Use (CHMP) to support decision-making by health authorities. This first interim report includes information on seven experimental medicines intended for the treatment of people infecte...d with the Ebola virus:
BCX4430 (Biocryst);
Brincidofovir (Chimerix);
Favipiravir (Fujifilm Corporation/Toyama);
TKM-100802 (Tekmira);
AVI-7537 (Sarepta);
ZMapp (Leafbio Inc.);
Anti-Ebola F(ab’)2 (Fab’entech).
The amount of information available for the seven treatments is highly variable. For some compounds there is no data from use in human subjects available. A small number of treatments have been administered to patients in the current Ebola outbreak as compassionate use. Finally, there are also medicines included in this review that have already been studied in humans, albeit for the treatment of other viral diseases.
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The guidelines reiterate that the general principles of ethics for biomedical research involving human participants shall also be applicable. In addition, the guidelines specify unique provisions for stem cells, because of their inherent property for unlimited proliferation, differentiation to cells... of the germ layers, oncogenic potential, unrecognised toxicities and possible involvement in pre-implantation stages of human development. The guideline therefore focuses on: 1. Monitoring mechanism and regulatory pathway for basic, clinical research and product development based on categories of research and level of manipulation. 2. Procurement of gametes, embryos and somatic cells for derivation and propagation of any stem cell lines, their banking and distribution. 3. Other important areas like international collaboration, exchange of cell/lines and education for stakeholders and advertisement.
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Modern healthcare has given rise to extremely complex and multifaceted ethical dilemmas. All too often physicians are unprepared to manage these competently. This publication is specifically structured to reinforce and strengthen the ethical mindset and prac...tice of physicians and provide tools to find ethical solutions to these dilemmas. It is not a list of “rights and wrongs” but an attempt to sensitise the conscience of the physician, which is the basis for all sound and ethical decision-making. To this end, you will find several case studies in the book, which are intended to foster individual ethical reflection as well as discussion within team settings.
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TNew data from the World Health Organization reveal that the COVID-19 pandemic has disrupted malaria services, leading to a marked increase in cases and deaths.
According to WHO’s latest World malaria report, there were an estimated 241 million malaria cases and 627 000 malaria deaths worldwide i...n 2020. This represents about 14 million more cases in 2020 compared to 2019, and 69 000 more deaths. Approximately two-thirds of these additional deaths (47 000) were linked to disruptions in the provision of malaria prevention, diagnosis and treatment during the pandemic.
As in past years, the report provides an up-to-date assessment of the burden of malaria at global, regional and country levels. It tracks investments in malaria programmes and research as well as progress across all intervention areas. This latest report draws on data from 87 countries and territories with ongoing malaria transmission.
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Über SARS-CoV-2-Testsysteme informieren das Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) und das Paul-Ehrlich-Institut. Die Informationen ergänzen sich, den rechtlichen Rahmen bietet u.a. die Coronavirus-Testverordnung-TestV.
Das BfArM bietet eine Liste von Antigen-Tests zum dir...ekten Erregernachweis des Coronavirus SARS-CoV-2 an. In dieser Liste befinden sich diejenigen Tests, die sich laut Herstellerangaben gemäß den Vorgaben des Medizinproduktegesetzes (MPG) rechtmäßig in Europa bzw. Deutschland in Verkehr befinden und alle vom Paul-Ehrlich-Institut in Abstimmung mit dem Robert Koch-Institut (RKI) festgelegten Mindestkriterien für Antigen-Tests erfüllen.
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Trypanosoma cruzi is the etiological agent of Chagas disease (CD), considered one of the most important parasitic infections in Latin America. Between 25 and 90 million humans are at infection risk via at least one of multiple infection mechanisms. Under natural conditions, the principal transmissio...n modes are transplacental or via one of more than 140 hematophagous triatomine bugs (Reduviidae: Triatominae). Triatomines acquire the parasite from mammal reservoirs due to their obligate blood-feeding (albeit triatomines can also feed on non-reservoir vertebrates such as birds and reptiles). The disease burden for CD in the Latin America and Caribbean region, based on disability-adjusted life-years (DALYs), is at least five times greater than that of malaria, and is approximately one-fifth that of HIV/AIDS. In recent decades, CD has extended to other continents outside natural reservoir or vector distributions due to human migration, with a minimum estimated 10 million individuals infected worldwide.
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WHO has updated its guidelines for COVID-19 therapeutics, with revised recommendations for patients with non-severe COVID-19. This is the 13th update to these guidelines.
Updated risk rates for hospital admission in patients with non-severe COVID-19
The guidance includes updated risk rates for... hospital admission in patients with non-severe COVID-19.
The current COVID-19 virus variants tend to cause less severe disease while immunity levels are higher due to vaccination, leading to lower risks of severe illness and death for most patients.
This update includes new baseline risk estimates for hospital admission in patients with non-severe COVID-19. The new ‘moderate risk’ category now includes people previously considered to be high risk including older people and/or those with chronic conditions, disabilities, and comorbidities of chronic disease. The updated risk estimates will assist healthcare professionals to identify individuals at high, moderate or low risk of hospital admission, and to tailor treatment according to WHO guidelines:
**High: **People who are immunosuppressed remain at higher risk if they contract COVID-19, with an estimated hospitalization rate of 6%.
**Moderate: **People over 65 years old, those with conditions like obesity, diabetes and/or chronic conditions including chronic obstructive pulmonary disease, kidney or liver disease, cancer, people with disabilities and those with comorbidities of chronic disease are at moderate risk, with an estimated hospitalization rate of 3%.
Low: Those who are not in the high or moderate risk categories are at low risk of hospitalization (0.5%). Most people are low risk.
Review of COVID-19 treatments for people with non-severe COVID-19
WHO continues to strongly recommend nirmatrelvir-ritonavir (also known by its brand name ‘Paxlovid’) for people at high-risk and moderate risk of hospitalization. The recommendations state that nirmatrelvir-ritonavir is considered the best choice for most eligible patients, given its therapeutic benefits, ease of administration and fewer concerns about potential harms. Nirmatrelvir-ritonavir was first recommended by WHO in April 2022.
If nirmatrelvir-ritonavir is not available to patients at high-risk of hospitalization, WHO suggests the use of molnupiravir or remdesivir instead.
WHO suggests against the use of molnupiravir and remdesivir for patients at moderate risk, judging the potential harms to outweigh the limited benefits in patients at moderate risk of hospital admission.
For people at low risk of hospitalization, WHO does not recommend any antiviral therapy. Symptoms like fever and pain can continue to be managed with analgesics like paracetamol.
WHO also recommends against use of a new antiviral (VV116) for patients, except in clinical trials.
The update also includes a strong recommendation against the use of ivermectin for patients with non-severe COVID-19. WHO continues to advise that in patients with severe or critical COVID-19, ivermectin should only be used in clinical trials.
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HIV-1 drug resistance (HIVDR) genotyping is an essential component of the WHO global HIVDR surveillance strategy. Plasma “gold standard” specimen type for HIVDR genotyping, but its use may not be feasible in rural, remote areas in low- and middle-income countries, since preparing and storing it ...require personnel and laboratory infrastructure that are often lacking. An alternative specimen type is dried blood spots (DBS), which can be made without special laboratory processing. DBS are more easily transported than plasma because they can be shipped at ambient temperature as non-hazardous materials using regular mail or courier services.
3rd edition
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GDF is the largest global provider of quality-assured tuberculosis (TB)
medicines, diagnostics, and laboratory supplies to the public sector.
Since 2001, GDF has facilitated access to high-quality TB care in over 130
countries, providing treatments to over 30 million people with TB and procuring
...
and delivering more than $200 million worth of diagnostic equipment
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HIV testing programmes need to ensure that all clients who test for HIV are provided with correct diagnoses. The accuracy of HIV testing is critical to prevent misdiagnosis, as the consequences of giving an incorrect test result can be serious for clients, HIV testing services, HIV programmes and pu...blic health.
With the evolution of global HIV epidemiology, HIV testing approaches must also evolve to maintain accuracy and efficiency in population-level diagnosis. Reports suggest that misdiagnosis of HIV status may occur when suboptimal testing algorithms and out-of-date testing strategies are used. As a result of changing epidemiology and declining HIV positivity in testing, WHO recommends all countries use a standard three-test strategy to ensure a PPV of at least 99%, minimizing false-positive misdiagnosis. The WHO-recommended HIV testing strategy, along with quality assurance measures such as retesting to verify a positive diagnosis prior to initiation of HIV treatment, is cost-effective as it prevents misdiagnosis and unnecessary initiation of costly lifelong treatment.
This implementation guide provides practical advice on switching to a three-test strategy and instituting other measures that can help national HIV programmes deliver high-quality, accurate HIV testing services and ensure that misdiagnosis is minimized.
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This global guidance provided the framework for over 100 countries to develop their NDVPs. This updated (second) version supersedes the previous version published in 16 November 2020. New information has been added on the following areas:
the COVID-19 Partners Platform;
the use of COVID...-19 simulation exercises to test deployment strategies;
the indemnity agreement and no-fault compensation programme for vaccines secured through the COVAX Facility in the Advance Market Commitment (AMC) eligible economies;
the availability and use of the WHO-UNICEF COVID-19 Vaccine Introduction and deployment Costing (CVIC) tool;
the COVAX Facility’s humanitarian buffer that enables allocation of vaccine to cover high-risk populations in humanitarian settings;
recommendations for vaccination of pregnant and lactating women;
supplementary information on infection prevention and control (IPC) measures to be used to deliver COVID-19 vaccines safely;
the WHO licensed COVID-19 vaccines product-specific information;
use of geospatial data and digital micro plans for equitable access and delivery of COVID-19 vaccines;
lessons learned from the development of NDVPs and early experiences in COVID-19 vaccine deployment in countries; and
updated additional resources at the end of each chapter.
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