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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This guidance addresses rationale, risk-based scenarios, practical considerations prior to adoption of the self-testing products, quality assurance, safety and ethical considerations, and data management considerations for COVID-19 self-testing. The Africa CDC recommends the use of rapid antigen sel...f-testing within two key scenarios. The first includes testing for case identification within scenarios with a high risk of infection, including symptomatic cases and contacts of a confirmed case. The second scenario involves general screening within scenarios of low or unknown risk exposure allowing for self-care such as before gatherings with at-risk individuals and prior to participation in events involving members of different households. Within these scenarios, a positive test result indicates likelihood of current infection, while a negative test result indicates a lower risk of active infection, though it does not rule out infection altogether. All positive cases should be managed following the national COVID-19 management protocol of Member States.ssur
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Good Manufacturing Practice (GMP) describes a set of principles and procedures that, when followed, ensure that medicines and related substances are of high quality, safety and efficacy. SAHPRA is a
participating authority of the Pharmaceutical Inspection Cooperation Scheme (jointly known as PIC/S).... PIC/S aims to develop international standards between countries and pharmaceutical inspection
authorities, to provide harmonised and constructive co-operation in the field of GMP. PIC/S affiliation is subject to initial and periodic assessment of the participating authority to ensure that it has equivalent legislation, regulatory and enforcement procedures and inspection capacity.
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Antimicrobial resistance (AMR) is a multifaceted, international public health problem, which poses a direct threat to the safety of the population of South Africa. A national response is required to complement the development of a global plan, as articulated in the WHO’s draft resolution EB134/37 ...“Combating antimicrobial resistance including antibiotic resistance”, adopted by theWorld Health Assembly in May 2014. The overuse of antimicrobials is driving resistance. A return to appropriate, targeted antimicrobial use in humans, animals and the environment is critical if we are to conserve the antimicrobial armamentarium. Various interventions have been put in place to address antimicrobial resistance in South Africa. However, these are insufficient to effectively tackle the threat faced by the country. The strengths of the current system are outweighed by its weaknesses.
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Communication to Healthcare Professionals Mar-2020
This guideline is intended to assist healthcare professionals in the participation of very important process of continuous surveillance of safety and efficacy of the health products which are used in their clinical practice. Continuous evaluation o...f medicines’ benefit and harm help to achieve the ultimate goal of safe and effective treatments available to patients.
The guideline is intended to assist healthcare professionals in the reporting of suspected adverse drug reactions (ADRs) associated with the use of all registered health products, including medicines, old medicines, medical devices and in-vitro diagnostics (IVDs).
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Current evidence that the climate is changing is overwhelming. Impacts of climate change and variability are being observed: more intense heat-waves, fires and floods; and increased prevalence of food- water- and vector-borne diseases. Climate change will put pressure on environmental and health det...erminants, such as food safety, air pollution and water quantity and quality. A climate-resilient future depends fundamentally on reducing greenhouse gas emissions. Limiting warming to below 2 °C requires transformational technological, institutional, political and behavioural changes: the foundations for this are laid out in the Paris Agreement of December 2015. The health sector can lead by example, shifting to environmentally friendly practices and minimizing its carbon emissions. A climate-resilient future will increasingly depend on managing and reducing climate change risks to protect health. In the near term, this can be enhanced by including climate change in national health programming and creating climate-resilient health systems.
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May 9, 2022.Since the onset of the COVID-19 pandemic, a large number of clinical trials have been planned and developed to assess the effectiveness and safety of various interventions that could prevent hospitalizations and progression to severe disease in people infected with SARS-CoV-2. Currently,... the WHO and the PAHO recommend the use of corticosteroids, tocilizumab, baricitinib, and casirivimab e imdevimab (the latter in seronegative COVID-19 patients) and propose the use of sotrovimab, casirivimab/imdevimab, and molnupiravir in patients with non-severe illness who are at high risk for complications
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These guidelines are based on the 3rd Edition of the WHO Guidelines (Published 2015) World Health Organization’s Guidelines for the treatment of malaria. Additional literature surveys have been undertaken. Factors that were considered in the choice of therapeutic options included effectiveness, sa...fety, and impact on malaria transmission and on the emergence and spread of antimalarial drug resistance. On-going surveillance is critical given the spread of artemisinin resistance in Southeast Asia, although not yet confirmed anywhere in Africa. The guidelines on the treatment of malaria in South Africa aim to facilitate effective, appropriate and timeous treatment of malaria, thereby reducing the burden of this disease in our communities. This is essential to further reduce the malaria case fatality rates currently recorded in South Africa, to decrease malaria transmission and to limit resistance to antimalarial drugs.
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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, how can you keep them safe? WHO’s Dr Soumya Swa...minathan 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.
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 based on nucleic acid amplification testing (NAAT), usi...ng 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 safety and efficacy of do...lutegravir (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 market authorization system is one of the top priorit...y 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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Adapting community-led approaches . Three out of 10 people in urban areas do not use improved sanitation facilities, and one out of 10 people are forced to practise open defecation. Still higher proportions do not have access to safely managed sanitation facilities, where the fecal sludge
is contai...ned and either left in situ or safely emptied, transported, and delivered to a treatment plant.
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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 safety standards as a f...irst 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...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 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 safety and a way back home.
- When t...he 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..., 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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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...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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