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11 May 2022
What are WHO's recommendations for COVID-19 vaccines and children? And what does the evidence say so far about the safety of these vaccines in children? And if you live in a country where this vaccination is not available for your kids,
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how can you keep them safe? WHO’s Dr Soumya Swaminathan explains in Science in 5.
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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.
Laboratory testing for the monkeypox virus
recommended
Any individual that meets the suspected case definition of monkeypox should be offered testing in appropriately equipped laboratories by staff trained in the relevant technical and safety procedures. Confirmation of monkeypox virus infection is base
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d on nucleic acid amplification testing (NAAT), using real-time or conventional polymerase chain reaction (PCR), for detection of unique sequences of viral DNA. PCR can be used alone, or in combination with sequencing. The recommended specimen type for laboratory confirmation of monkeypox is skin lesion material, including swabs of lesion surface and/or exudate, roofs from more than one lesion, or lesion crusts.
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This technical report summarizes the discussions on the status of programmatic transition to tenofovir, lamivudine and dolutegravir (TLD) in low– and middle- income countries, addressing the best practices and major challenges faced by HIV programmes.
The latest data on
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safety and efficacy of dolutegravir (DTG) containing regimens were also reviewed. The document identified the remaining gaps in knowledge, research, monitoring, and surveillance on DTG and TLD transition and listed the future priorities.
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The Ethiopian Food and Drug Administration (EFDA) is mandated, in the proclamation 661/2009, to ensure the safety, quality and efficacy of medicines. To achieve this, the authority has been working on different regulatory activities. The medicine ma
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rket authorization system is one of the top priority areas that have been implemented. In addition to the dedicated assessors, the authority uses a national drug advisory committee for the assessment and registration of medicines.
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These guidelines deal specifically with water, sanitation and hygiene, and are designed to be used in schools in low-cost settings in low- and medium-resource countries to:
• assess prevailing situations and plan for required improvements;
• develop and reach essential
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safety standards as a first goal; and
• support the development and application of national policies.
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The number of people facing acute food insecurity1 is growing at an alarming rate in the European Union (EU) Member States of Central Eastern Europe. COVID-19 and the resulting disruption to global markets, trade, and food supply chains have negatively affected food security since 2020; now, this ha
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s been compounded by the Russian invasion of Ukraine. Women and girls who have been displaced from Ukraine into Hungary are facing tremendous obstacles to their safety and wellbeing, particularly given the link between food insecurity and gender-based violence (GBV). Urgent policy responses and concrete actions are needed to support low-income households and vulnerable communities, particularly women and their families displaced from Ukraine, to stem this growing crisis.
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As climate change increasingly contributes to migration and displacement in many parts of the world, there is a pressing need for measures that build resilience and prevent displacement as well as those that help climate-affected people move to safety
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and support receiving communities. Multilateral development banks (MDBs) are critical, if sometimes overlooked, players because of their ability to invest in large-scale projects that contribute to sustainable development, primarily in low- and middle-income countries.
This report explores the unique role of MDBs in the climate finance landscape and highlights opportunities for migration, humanitarian, and other key actors to partner with them on projects that effectively target climate-related migration and displacement. After reviewing the evidence on the complex linkages between climate and mobility, the report examines MDBs’ climate-related work to date, challenges they face to scaling up these efforts, and strategies to begin to address hurdles. These recommendations include learning from past MDB investments that have touched on climate migration, funding data collection or sharing to strengthen understanding of climate migration trends, and developing partnerships to support policy and project development, financing, and implementation.
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NFPA continues to work with partners to respond to the Ukraine emergency. Highlights from the month of January include:
- The #TrainOfHope launched between Kyiv and Chisinau is a lifeline, providing refugees, including many women with children, both a route to
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safety and a way back home.
- When the Government of Ukraine lost control of Kherson city, social workers at a shelter for survivors of domestic violence continued to work so that women and girls could receive essential assistance.
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The new WHO recommendations for rabies immunization supersede the 2010 WHO position
on pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP) for rabies. These updated
recommendations are based on new evidence and directed by public health needs that are cost-,
dose- and time-sparing
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, while assuring safety and clinical effectiveness. In addition, new guidance on
prudent use of rabies immunoglobulins (RIG) is provided.
The following sections summarize the main points of the updated WHO position as endorsed by the
Strategic Advisory Group of Experts on immunization (SAGE) at its meeting in October 20171. The full
version of the WHO position on rabies vaccines and immunoglobulins will be published in the Weekly
Epidemiological Record2 in April 2018.
Rabies prevention involves two main strategies: (i) dog vaccination to interrupt virus transmission to
humans; and (ii) human vaccination as a series of vaccine administrations before or after an exposure.
Currently, rabies vaccines made from inactivated cell cultures are extremely well tolerated and have no
contraindications.
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Operational guide: use of referral laboratories for the analysis of foodborne hazards in the Pacific
The Operational guide: use of referral laboratories for the analysis of foodborne hazards in the Pacific aims to strengthen the food analysis capacity of Pacific Island countries and areas by identifying national and reference laboratories capable of testing for priority foodborne hazards. The Pacif
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ic Island countries and areas are often vulnerable to food safety incidents and emergencies due to their geographical distribution and dependence on food imports. The guide outlines key considerations for selecting referral laboratories and submitting samples to them, enabling continuous improvement of food safety systems and providing safe food for all. The target audiences are health and food safety authorities.
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This guideline provides evidence-informed guidance on the use of non-sugar sweeteners to reduce the risk of unhealthy weight gain and diet-related noncommunicable diseases in adults and children. The guidance in this guideline is not based on toxicological assessments of the
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safety of individual non-sugar sweeteners and is therefore not intended to update or replace guidance on safe or maximal levels of intake established by the Joint Food and Agriculture Organization of the United Nations (FAO)/WHO Expert Committee on Food Additives (JECFA) or other authoritative bodies.
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Fully functioning water, sanitation, hygiene (WASH) and health care waste management services are a critical aspect of infection prevention and control (IPC) practices, and ensuring patient safety and quality of care. Such services are also essentia
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l for creating an environment that supports the dignity and human rights of all care seekers, especially mothers, newborns, children and care providers.
WASH and waste services are also critical for preventing and effectively responding to disease outbreaks. The COVID-19 pandemic has exposed gaps in these basic services (Box 1). These gaps threaten the safety of patients and caregivers, and have environmental consequences, especially as a result of large increases in plastic health care waste. In short, WASH is a critical foundation for improving quality across the health system (1).
Many facilities lack plans and budgets for WASH, which has impacts on IPC. This lack of services, and of systems to improve them, compromises the ability to provide safe and quality care, and places health care providers and those seeking care at substantial risk of infection and loss of dignity. Unhygienic health care facilities without drinking water or functional toilets are also a disincentive to seeking care and undermine staff morale – these factors can have a critical impact on controlling infectious disease outbreaks.
Climate change and its impacts on WASH and health services, gender-specific needs, and equity in service provision and management all require rigorous attention, adaptable tools and regular monitoring.
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Many vaccines and drugs hold the promise of reducing mortality and morbidity among pregnant women and infants living in low- and middle-income countries (LMICs). However, sufficient information on the safety of drugs and vaccines in pregnant women i
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s rarely available at the time of product licensure or approval. To account for this, active safety surveillance efforts are needed during the post-licensure and post-approval
phase to assess the safety of drugs and vaccines in pregnant women and their offspring. Pregnancy exposure registries (PER) are used to monitor the safety of vaccines and drugs. PERs are observational studies that systematically collect health information on exposure to medical products such as drugs and vaccines during pregnancy. This review demonstrates that a number of resources presently exist in LMICs that perform active safety surveillance in pregnant populations. These results indicate such systems employ a wide variety of approaches, each with their own set of strengths and challenges, as summarized in the final section of the report.
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When explosive weapons are used in populated areas, they have direct and indirect impacts
on the provision of services, community cohesion, humanitarian access, regular support for
basic needs, physical safety, mental health and psychological well
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-being, as well as other
social and economic impacts. The challenges and human impacts in hard-to-reach areas –
such as in Kharkiv, Mykolaiv and Kherson Oblasts – exemplify the specific and systematic
pattern of harm caused by explosive weapons during and after armed conflicts.
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To survive and thrive, children and adolescents need good health, adequate nutrition, security, safety and a supportive clean environment, opportunities for early learning and education, responsive relationships and connectedness, and opportunities
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for personal autonomy and self-realization. To promote their health and wellbeing, children and adolescents need support from parents, families, communities, surrounding institutions, and an enabling environment. Scheduled well care visits provide a critical opportunity for support of individual children, adolescents, parents, caregivers and families promote health and wellbeing. This guidance on scheduled child and adolescent well-care visits is the first in a series of publications to support the operationalization of the comprehensive agenda for child and adolescent health and wellbeing. It provides guidance on what is required to strengthen health systems and services to ensure healthy growth and development of all children and adolescents, and to support their parents and caregivers.
The guidance focuses on scheduled routine contacts with providers to support children and adolescents in their growth and developmental trajectory, as well as their primary caregivers and families. It outlines the rationale and objectives of well care visits and proposes a minimum 17 scheduled visits; describes the expected tasks during a contact; provides age-specific content to be address during each contact; and proposes actions to build on and maximize existing opportunities and resources.
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Animicrobial resistance (AMR) was declared by the World Health Organization (WHO) as one of the
top 10 health threats facing humanity. The effects of AMR are far-reaching as it cuts across sectors and affects food safety,
nutrition security, livel
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ihoods, environment and, consequently, attainment of several sustainable development goals (SDGs)
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A technical guide for sputum smear microscopy, initiated by the International Union against Tuberculosis, is designed to be an easy to use reference standard for the collection, storage and transport of sputum specimens and for the examination of sputum smears by direct microscopy. This edition incl
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udes updates addressing bio-safety and quality assurance aspects of sputum smear microscopy.
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Laboratory biosafety manual
recommended
4th edition
The WHO Laboratory Biosafety Manual (LBM) has been in broad use at all levels of clinical and public health laboratories, and other biomedical sectors globally, serving as a de facto global standard that presents best practices and sets trends in biosafety.
LBM encouraged countries t
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o accept and implement basic concepts in biological safety and to develop national codes of practice for the safe handling of biological agents in laboratories within their geographical borders.
This fourth edition of the manual builds on the risk assessment framework introduced in the third edition. A thorough, evidence-based and transparent assessment of the risks allows safety measures to be balanced with the actual risk of working with biological agents on a case-by-case basis.
This novel evidence- and risk-based approach will allow optimised resource use and sustainable laboratory biosafety and biosecurity policies and practices that are relevant to their individual circumstances and priorities, enabling equitable access to clinical and public health laboratory tests and biomedical research opportunities without compromising safety.
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Ethical considerations for use of unregistered interventions for Ebola viral disease
World Health Organization
(2014)
West Africa is experiencing the largest, most severe, most complex outbreak of Ebola virus disease in history. On 11 August 2014, WHO convened a consultation where the participants concluded that in the particular context of the current Ebola outbreak in West Africa, it is ethically acceptable to of
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fer unproven interventions that have shown promising results in the laboratory and in animal models but have not yet been evaluat-
ed for safety and efficacy in humans as potential treatment or prevention
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