Report of the 23rd WHO Expert Committee on the selection and use of essential medicines
This executive summary reports the recommendations made by the Expert Committee for the 2021 update of the WHO Model List of Essential Medicines (EML) and the Model List of Essential Medicine for Children (EMLc)....
The 23rd meeting of the WHO Expert Committee on Selection and Use of Essential Medicines was coordinated from Geneva, Switzerland, and held virtually from 21 June to 2 July 2021. The Committee considered 88 applications proposing additions, changes and deletions of medicines, medicine classes and formulation on the Model Lists of Essential Medicines. The Committee evaluated the scientific evidence for comparative effectiveness, safety and cost-effectiveness of the medicines in question. The Committee also considered a review of the therapeutic alternatives for medicines on the Model Lists, and update to the AWaRe classification of antibiotics, and reviews and reports relevant to the selection and use of essential medicines.
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The 23rd meeting of the WHO Expert Committee on Selection and Use of Essential Medicines was coordinated from Geneva, Switzerland, and held virtually from 21 June to 2 July 2021. The Committee considered 88 applications proposing additions, changes and deletions of medicines, medicine classes and fo...rmulations on the Model Lists of Essential Medicines. The Committee evaluated the scientific evidence for comparative effectiveness, safety and cost-effectiveness of the medicines in question. The Committee also considered a review of the therapeutic alternatives for medicines on the Model Lists, and update to the AWaRe classification of antibiotics, and reviews and reports relevant to the selection and use of essential medicines.
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This document updates the earlier version published in April 2020. In recent weeks, information on the potential use of chloroquine or hydroxychloroquine for the treatment of people with COVID-19 has been disseminated in academic journals and public media. Although there are now ongoing clinical tri...als testing the efficacy and safety of several medicines for COVID-19, as of the date of this document, there is a lack of quality evidence to demonstrate chloroquine and/or hydroxychloroquine are effective in the treatment of COVID-19. Evidence is recently emerging via small studies with sub-optimal methodologies that are conflicting.
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The COVID-19 vaccine tracker and landscape compiles detailed information of each COVID-19 vaccine candidate in development by closely monitoring their progress through the pipeline.
The COVID-19 vaccine tracker:
Provides summary tables of COVID-19 vaccine candidates in both clinical and pre-...clinical development;
Provides analysis and visualization for several COVID-19 vaccine candidate categories;
Tracks the progress of each vaccine from pre-clinical, Phase 1, Phase 2 through to Phase 3 efficacy studies and including Phase 4 registered as interventional studies;
Provides links to published reports on safety, immunogenicity and efficacy data of the vaccine candidates;
Includes information on key attributes of each vaccine candidate and
Allows users to search for COVID-19 vaccines through various criteria such as vaccine platform, schedule of vaccination, route of administration, developer, trial phase and clinical endpoints.
The database is updated regularly - twice a week (Tuesday and Friday, 17:00 CET).
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The purpose of this document is to present and promote the minimum requirements for IPC programmes at the national and health care facility level, identified by expert consensus according to available evidence and in the context of the WHO core components.
The minimum requirements are defined as: I...PC standards that should be in place at the national and facility level to provide minimum protection and safety to patients, HCWs and visitors, based on the WHO core components for IPC programmes.
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15 January 2021
This Aide Memoire is for policy makers, immunization programme managers, infection prevention and control (IPC) focal points at national, sub-national, and facility level, as well as for health workers involved in COVID-19 vaccination delivery. This document summarizes the key IPC p...rinciples to consider and the precautions to take for safely delivering COVID-19 vaccines. The principles and recommendations provided in this document derive from World Health Organization (WHO) IPC and immunization standards and other guidance in the context of COVID-19. WHO will update these recommendations as new information becomes available. All technical guidance for COVID-19 is available online.
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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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People-centered approaches that help communities maintain protective behaviours and follow guidelines set out by public health and government agencies are more important than ever. The evidence is clear, communities play a role in preventing and controlling epidemics and they are best able to take a...ction and slow or stop the spread of disease when properly engaged and empowered. This toolbox in 2 parts offers best practice approaches to community engagement with families. Promoting individual and joint responsibilities for the safety of the family, this toolbox aims to bring families and households together to manage shared risks and agree to safe behaviours critical for their safety and the safety of their community.
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When situations occur in which unwanted events are rightly or wrongly connected with vaccination, they may erode confidence in vaccines and the authorities delivering them. This document presents the scientific evidence behind WHO’s recommendations on building and restoring confidence in vaccines ...and vaccination, both in ongoing work and during crises. The evidence draws on a vast reserve of laboratory research and fieldwork within psychology and communication. It examines how people make decisions about vaccination; why some people are hesitant about vaccination; and the factors that drive a crisis, covering how building trust, listening to and understanding people, building relations, communicating risk and shaping messages to the audiences may mitigate crises. This document provides a knowledge base for stakeholders who develop communication strategies or facilitate workshops on communication and trust-building activities in relation to vaccines and immunization, such as immunization programme units, ministries of health, public relations and health promotion units, vaccine safety communication trainers and immunization advisory bodies.
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Tackling COVID-19 misinformation. Ensuring communities have access to lifesaving public health information from trusted sources and are not misled by misinformation is essential to ending the COVID-19 pandemic.
In an effort to empower doctors and nurses – some of the most effective and trusted... messengers of public health information – to actively address COVID-19 misinformation and build vaccine confidence globally, the WHO welcomes this social media toolkit for healthcare practitioners, developed by the Government of the United Kingdom.
This toolkit aims to provide healthcare workers with the tools, skills and content needed to effectively share authentic and reliable information online. Centered around three core vaccine confidence messages, Vaccine Safety, Vaccine Development and Vaccine Reducing Risk of Sickness; this toolkit sets out three approaches: creating your own posts, posting the images and videos provided in the toolkit, or resharing vaccine information from trusted sources.
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This chronology of facts has challenged public health systems worldwide and regulatory bodies are no exception. Regulatory authorities with mechanisms in place to authorize the use of investigational products had to development guidelines and procedures, create task forces and alliances to maximize ...the efficiency of assessment, review and authorizations of medical products. Vaccines are undoubtedly the most complex medical products to develop, from concept to a stage where sufficient evidence of quality, safety and efficacy are collected to provide an assurance that their use will provide more benefits than risks when used in the context of a public health emergency.
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Development of one or more vaccines for Neisseria gonorrhoeae is an important objective for sexual and reproductive health worldwide, and for the fight against antimicrobial resistance.
WHO preferred product characteristics (PPCs) provide strategic guidance as to WHO’s preferences for new vacci...nes in priority disease areas. PPCs are intended to encourage innovation and development of vaccines for use in settings most relevant to the global unmet public health need.
Gonococcal vaccine PPCs describe global public health goals for gonococcal vaccines and preferred parameters pertaining to vaccine indications and target populations, safety and efficacy considerations, and immunization strategies.
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The roadmap describes the actions needed to
achieve the three development goals for TB
vaccines set by the WHO:
1. A safe, effective and affordable TB vaccine
for adolescents and adults.
2. An affordable TB vaccine for neonates and
infants with improved safety and efficacy.
3. A therapeutic v...accine to improve TB
treatment outcomes
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Welcome to Global Pharmacovigilance. This is an open-access collaborative forum for sharing experiences, knowledge and tools relating to pharmacovigilance and other patient/research participant safety-related issues.
On 15–16 December 2020, WHO and the Medicines for Malaria Venture co-convened a technical consultation to consider the preferred product characteristics (PPCs) for drugs used in malaria chemoprevention. The main goal of the technical consultation was to agree on the most important PPCs for drugs t...o protect populations from malaria (chemoprevention), while considering relevant measures of efficacy and the safety data needed to support WHO policy recommendations.
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Dengue is the fastest spreading, mosquito-borne viral infectious disease worldwide, with remarkable morbidity and mortality. In the past decades, profound contributions have been made towards understanding its epidemiology, including disease burden and distributions, risk factors, and control and pr...evention practices. Dengue continues to disseminate to new areas, including high latitude regions, and a new serotype (dengue virus serotype 5) has been identified. Vaccine research has made new progress, in which the licensed yellow fever and dengue virus quadrivalent chimeric vaccine is now under further safety assessment. In disease surveillance, because of its operational simplicity, rapidity, capability, and utility as an indicator of disease severity, dengue virus NS1 antigen detection has great promotion and application value among primary health care institutions. Vector control progress has driven new breakthroughs in biotechnology, including Wolbachia-infected Aedes and genetically modified Aedes. Both Aedes variants have been used to block transmission of the dengue virus through population replacement and suppression. In the future, vector control should still be pursued as a key measure to prevent transmission, along with anti-viral drug and vaccine research.
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A sanitary inspection is a simple, on-site evaluation (traditionally using a checklist) to help identify and support the management of priority risk factors that may lead to contamination of a drinking-water supply. Sanitary inspections are a well-established and widely-applied practice. They can su...pport water safety planning, and in some contexts, may be a simplified alternative to water safety plans.
This publication presents the World Health Organization’s (WHO’s) sanitary inspection packages. These packages update the sanitary inspection forms in WHO’s 1997 Guidelines for drinking-water quality. Volume 3: surveillance and control of community supplies. With more than 25 years of practical experience with the application of sanitary inspections, these packages have been developed from a comprehensive evidence review and established good practices.
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The document, "Sustainable Management of Radiotherapy Facilities and Equipment," by WHO and IAEA, provides guidelines for managing radiotherapy equipment and facilities to ensure effective and safe cancer treatment. It covers essential aspects like preventive and corrective maintenance, funding, inf...rastructure, and staffing requirements for sustainable operation. The document aims to support radiotherapy departments, especially in low-resource settings, by outlining strategies for equipment procurement, maintenance, and replacement, emphasizing safety, quality assurance, and optimal patient care.
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About one fourth of the world’s population is estimated to have been infected with the tuberculosis (TB) bacilli, and about 5–10% of those infected develop TB disease in their lifetime. The risk for TB disease after infection depends on several factors, the most important being the person’s im...munological status. TB preventive treatment (TPT) given to people at highest risk of progressing from TB infection to disease remains a critical element to achieve the global targets of the End TB Strategy, as reiterated by the second UN High Level Meeting on TB in 2023. Delivering TPT effectively and safely necessitates a programmatic approach to implement a comprehensive package of interventions along a cascade of care: identifying individuals at highest risk, screening for TB and ruling out TB disease, testing for TB infection, and choosing the preventive treatment option that is best suited to an individual, managing adverse events, supporting medication adherence and monitoring programmatic performance.
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About one fourth of the world’s population is estimated to have been infected with the tuberculosis (TB) bacilli, and about 5–10% of those infected develop TB disease in their lifetime. The risk for TB disease after infection depends on several factors, the most important being the person’s im...munological status. TB preventive treatment (TPT) given to people at highest risk of progressing from TB infection to disease remains a critical element to achieve the global targets of the End TB Strategy, as reiterated by the second UN High Level Meeting on TB in 2023. Delivering TPT effectively and safely necessitates a programmatic approach to implement a comprehensive package of interventions along a cascade of care: identifying individuals at highest risk, screening for TB and ruling out TB disease, testing for TB infection, and choosing the preventive treatment option that is best suited to an individual, managing adverse events, supporting medication adherence and monitoring programmatic performance
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