The latest update (28 January 2021) includes the following addition and revision:
biosafety aspects for working with antigen-detecting rapid diagnostic test;
handling new variants of SARS-CoV-2 in the laboratory;
updated assay decontamination before disposal;
personal protectiv...e equipment (PPE) for specimen collection;
addressing chemical hazards and their safe disposal; and
the fourth edition of the WHO Laboratory Biosafety Manual (LBM4) is now available and the terminology in this guidance was aligned with the LBM4.
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Основные аспекты обеспечения биологической безопасности в лабораторных условиях в связи с распространением вируса SARS-CoV
Many critical questions remain about the effectiveness of COVID-19 vaccines in real-world settings. These questions can only be answered in post-introduction vaccine effectiveness studies.This guidance document outlines an approach to leverage existing surveillance systems for Severe Acute Respirato...ry Infection (SARI) to estimate COVID-19 vaccine effectiveness (VE) in preventing SARI associated with laboratory-confirmed SARS-CoV-2 using existing SARI surveillance systems. The approach uses the test-negative design to evaluate VE; cases are SARI patients who tested positive for SARS-CoV-2, and controls are SARI patients who tested negative for SARS-CoV-2.
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Pharmaceutical regulators are at the forefront of ensuring that only safe and effective medicines are authorized and available in the market. This document builds on the recommendations in the above publication and has been prepared to specifically assist national medicines regulatory authorities to... understand the nature and extent of oxytocin quality issues and to provide key technical information and quality requirements for oxytocin products in dossier assessments. Furthermore, this document also presents recommendations on other regulatory actions needed to ensure that only quality-assured oxytocin products are authorized and made available to women.
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The frequency of infectious disease epidemics is increasing, and the role of the health sector in the management of epidemics is crucial in terms of response. In the context of infectious disease epidemics, the use of climate-informed early warning systems (EWS) has the potential to increase the eff...ectiveness of disease control by intervening before or at the beginning of the epidemic curve, instead of during the downward slope.
Currently, the initiation of interventions is heavily reliant on routine disease surveillance systems – data that often arrive too late for preventative response. However, forecasting of disease outbreaks using surveillance and weather information shows promising potential – there also remains further scope to examine seasonal climate forecasts. By combining these elements in new EWS based on computational models, it will be possible to improve both the timeliness and impact of disease control. The World Health Organization (WHO) is strengthening existing surveillance systems for infectious diseases to enable the development of more robust and timely EWS, which has resulted in the rapid development and innovation of EWS for disease outbreaks.
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This report presents an analysis of antibacterial agents in preclinical (third annual review) and clinical (fifth annual review) development. The analysis covers traditional (direct-acting small molecules) and non-traditional antibacterial agents in development worldwide. It evaluates to what extent... the present pipeline addresses infections caused by WHO Priority Pathogens, Mycobacterium tuberculosis and Clostridioides difficile. The report also provides an assessment of the traditional agents with respect to whether they meet a set of predefined criteria for innovation, namely absence of known cross-resistance, new target, mode of action and/or class. It also includes an overview of the agents that obtained authorization since 1 July 2017.
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The WHO Ebola Virus Disease (EVD) Clinical management: living guidance contains the Organization’s most up-to-date recommendations for the clinical management of people with EVD. Providing guidance that is comprehensive and holistic for the optimal care of patients with EVD throughout their il...lness is important.
The living guidance is available in both pdf format (via the ‘Download’ button) and via an online platform in both French and English, and is updated regularly as new evidence emerges.
This first version of the Clinical management for EVD living guidance contains four new recommendations regarding use of therapeutics for EVD, this includes two strong recommendations for the use of monoclonal antibody therapies. This new living guideline is written to accompany the optimized supportive care (oSoC) for EVD standard operating procedures (5, 6). The living guideline aims to summarize high quality evidence for EVD therapeutics and make recommendations for their use.
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Les Lignes directrices de l'OMS sur le paludisme rassemblent les recommandations les plus récentes de l'Organisation pour le paludisme dans une plateforme en ligne conviviale et facile à naviguer.
Les Lignes directrices de l'OMS sur le paludisme remplacent 2 publications précédentes de l'OMS: l...es Lignes directrices pour le traitement du paludisme, troisième édition et les Lignes directrices pour la lutte contre les vecteurs du paludisme. Les recommandations sur le paludisme continueront d'être examinées et, le cas échéant, mises à jour sur la base des dernières données disponibles. Toutes les recommandations mises à jour afficheront toujours la date de la révision la plus récente dans la plate-forme MAGICapp. À chaque mise à jour, une nouvelle version PDF des lignes directrices unifiées sera également disponible en téléchargement sur le site Web de l'O
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Trachoma is the leading infectious cause of blindness (2). It is characterized by repeated
conjunctival infection with particular strains of Chlamydia trachomatis. This scars the conjunctivae and,
in some cases, leads to trichiasis with or without entropion. The abrasive action of eyelashes can
d...amage the cornea. In 2018, trachoma affected the poorest residents of the poorest communities of 43
countries
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The development of this target product profile (TPP) was led by the WHO Department of Control of Neglected Tropical Diseases (NTD) following standard WHO guidance for TPP development. In order to identify and prioritize diagnostic needs, a WHO NTD Diagnostics Technical Advisory Group (DTAG) was form...ed, and different subgroups were created to advise on specific NTDs, including a subgroup working on the human African trypanosomiasis (HAT) diagnostic innovation needs. This group of independent experts included leading scientists, public health officials and endemic-country end-user representatives. Standard WHO Declaration of Interest procedures were followed. A landscape analysis of the available products and of the development pipeline was conducted, and the salient areas with unmet needs were identified.
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The WHO Pharmaceuticals Newsletter provides you with the latest information on the safety of medicinal products and regulatory actions taken by authorities around the world.
In addition, this edition includes summary and recommendations from the virtual meeting of the members of the WHO Programme f...or International Drug Monitoring (PIDM) and other partners, which was held on 20 October 2022.
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The Fifty-first World Health Assembly adopted resolution WHA51.11 in 1998, which targets the
global elimination of trachoma as a public health problem by 2020 (1). The strategy recommended
to achieve that goal is encapsulated by the acronym “SAFE”, which represents: Surgery for
individuals wi...th trachomatous trichiasis (TT; the late blinding stage of trachoma); and Antibiotics,
Facial cleanliness and Environmental improvement (2). The A, F and E interventions are delivered to
entire districts in which active (inflammatory) trachoma is common in order to treat ocular infection
with Chlamydia trachomatis, the causative organism of trachoma, and sustainably reduce its
transmission.
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En 1998, la Cinquante-et-Unième Assemblée mondiale de la Santé a adopté la résolution
WHA51.11 qui vise l’élimination mondiale du trachome en tant que problème de santé publique
à l’horizon 2020 (1). La stratégie recommandée pour atteindre cet objectif est récapitulée dans
le sig...le « CHANCE » qui signifie CHirurgie pour les personnes atteintes de trichiasis
trachomateux (TT – le dernier stade cécitant du trachome) ; Antibiothérapie, Nettoyage du
visage et Changements Environnementaux (2). Les interventions relatives aux volets A, N et CE
sont menées dans des districts entiers dans lesquels les cas de trachome évolutif
(inflammatoire) sont courants, dans le but de traiter les infections oculaires dues à Chlamydia
trachomatis, l’agent pathogène à l’origine du trachome, et de réduire durablement sa
transmission.
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Six months after its launch on 24 April, the Access to COVID-19 Tools (ACT) Accelerator has already delivered concrete results in speeding up the development of new therapeutics, diagnostics, and vaccines. Now mid-way through the scale-up phase, the tools we need to fundamentally change the course o...f this pandemic are within reach. But to deliver the full impact of the ACT-Accelerator – and ultimately an exit to this global crisis – these tools need to be available everywhere. On behalf of the ACT-Accelerator Pillar lead agencies – CEPI, Gavi, the Global Fund, FIND, Unitaid, Wellcome Trust, the World Bank, and the World Health Organization, as well as the Bill & Melinda Gates Foundation – I am pleased to share this document setting out the near-term priorities, deliverables and financing requirements of the ACT-Accelerator Pillars and Health Systems Connector. Urgent action to address these financing requirements will boost the impact of the ACTAccelerator achievements to date, fast-track the development and deployment of additional game-changing tools, and mitigate the risk of a widening gap in access to COVID-19 tools between low- and high-income countries. Delivering on this promise requires strong political leadership, financial investment, and incountry capacity building. COVID-19 cannot be beaten by any one country acting alone. We must ACT now, and ACT together to end the COVID-19 crisis.
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WHO has published the first-ever guidance on the clinical management of diphtheria. The only previously available guidance was an operational protocol. The new guidance followed the rigorous process for developing guidance at WHO.
It addresses the use of Diphtheria Antitoxin (DAT) in the treatmen...t of diphtheria. There is a worldwide shortage of DAT and evidence based recommendations on the use of DAT were requested by many Member States.
The guidance also includes new recommendations on antibiotics. In patients with suspected or confirmed diphtheria, WHO recommends using macrolide antibiotics (azithromycin, erythromycin) rather than penicillin antibiotics.
This clinical practice guideline has been rapidly developed recognizing the global increase in diphtheria outbreaks. Outbreaks of diphtheria in Nigeria, Guinea and neighbouring countries in 2023 have highlighted the urgent need for evidence-based clinical practice guidelines for the treatment of diphtheria. Given the sporadic nature of outbreaks, many clinicians in the affected regions have never managed acute diphtheria and its related complications. Diphtheria remains a neglected disease and vaccination is the top priority. At the same time, for patients with diphtheria, access to antibiotics, DAT and supportive care can be lifesaving.
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This document outlines the evaluation process that WHO undertakes to assess novel tools and strategies targeted at VBDs. Its aim is to articulate the linkage between the generation of evidence that demonstrates public health impact of novel interventions, and the development of policy recommendation...s based on the generated data. The document defines standards for the evaluation process, as well as the steps that an applicant needs to undertake, along with some guiding principles that aim to support applicants in the development of submissions with WHO.
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