Malaria vaccines: preferred product characteristics and clinical development considerations

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Author :
Publisher : World Health Organization
ISBN 13 : 9240057463
Total Pages : 77 pages
Book Rating : 4.2/5 (4 download)

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Book Synopsis Malaria vaccines: preferred product characteristics and clinical development considerations by : World Health Organization

Download or read book Malaria vaccines: preferred product characteristics and clinical development considerations written by World Health Organization and published by World Health Organization. This book was released on 2022-09-30 with total page 77 pages. Available in PDF, EPUB and Kindle. Book excerpt: Preferred product characteristics” (PPCs) are key tools to incentivize and guide the development of urgently needed health products. The PPCs published here aim to articulate the public health need, preferred characteristics, and clinical development considerations for new malaria vaccines. WHO PPCs were initially conceived in 2012-2013 as a class of research-oriented normative guidance documents. The first edition of the WHO PPCs for malaria vaccines (WHO/IVB/14.09), published in 2014, was the first-in-class of these documents. The document published here is an update to the 2014 edition. Since the first malaria vaccine PPCs were published in 2014, major milestones in malaria vaccine R&D have been achieved. In 2021, RTS,S/AS01 became the first malaria vaccine to be recommended by WHO for use in moderate- to high-transmission settings in sub-Saharan Africa. However, a healthy market of vaccines will be needed to meet the global demand. A continued focus on developing new and improved vaccines will be vital in our efforts to reduce global malaria burden and to achieve elimination and eradication. This includes malaria vaccines to prevent blood-stage infection, reduce morbidity and mortality, and/or reduce community-level transmission.

Monoclonal antibodies for malaria prevention: preferred product characteristics and clinical development considerations

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Author :
Publisher : World Health Organization
ISBN 13 : 9240070982
Total Pages : 36 pages
Book Rating : 4.2/5 (4 download)

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Book Synopsis Monoclonal antibodies for malaria prevention: preferred product characteristics and clinical development considerations by : World Health Organization

Download or read book Monoclonal antibodies for malaria prevention: preferred product characteristics and clinical development considerations written by World Health Organization and published by World Health Organization. This book was released on 2023-04-20 with total page 36 pages. Available in PDF, EPUB and Kindle. Book excerpt: Preferred product characteristics (PPCs) are key tools to incentivize and guide the development of urgently needed health products. The PPCs published here aim to articulate the public health need, preferred characteristics, and clinical development considerations for monoclonal antibodies (mAbs) for malaria prevention. Alongside the development of new malaria vaccines and chemoprevention drugs, there have been recent R&D advances in the development of mAbs for malaria prevention. Passive immunization with mAbs through direct administration of functional antibodies could potentially overcome some of the limitations of vaccines by providing immediate protection. Furthermore, mAbs with simplified dose regimens could potentially circumvent some of the coverage and adherence issues faced by malaria chemoprevention. To support this quickly developing R&D area, WHO convened a scientific development group to consider the PPCs for mAbs to be used for malaria prevention, with a focus on the reduction of morbidity and mortality in infants and children due to Plasmodium falciparum.

Malaria vaccine advisory committee (MALVAC) meeting on preferred product characteristics for malaria vaccines

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Author :
Publisher : World Health Organization
ISBN 13 : 9240042202
Total Pages : 12 pages
Book Rating : 4.2/5 (4 download)

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Book Synopsis Malaria vaccine advisory committee (MALVAC) meeting on preferred product characteristics for malaria vaccines by :

Download or read book Malaria vaccine advisory committee (MALVAC) meeting on preferred product characteristics for malaria vaccines written by and published by World Health Organization. This book was released on 2022-02-10 with total page 12 pages. Available in PDF, EPUB and Kindle. Book excerpt: On 27–28 October 2020, the WHO Initiative for Vaccine Research and Global Malaria Programme convened a meeting of the Malaria Vaccine Advisory Committee (MALVAC) to review priority issues in product development in malaria vaccine research and development (R&D). Experts reviewed major use case scenarios for malaria vaccines, including the reduction of morbidity and mortality, and the reduction of malaria transmission. Other potential use case scenarios were also discussed, including seasonal vaccination, vaccination to prevent malaria in pregnancy, and vaccines targeting non-Plasmodium falciparum species such as P. vivax. MALVAC members discussed how best to update and build on the previously developed malaria vaccine Preferred Product Characteristics (PPCs), bearing in mind advances in the field and lessons learned from the development and evaluation of the RTS,S/AS01E vaccine.

Malaria chemoprevention: preferred product characteristics

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Publisher : World Health Organization
ISBN 13 : 9240070966
Total Pages : 38 pages
Book Rating : 4.2/5 (4 download)

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Book Synopsis Malaria chemoprevention: preferred product characteristics by : World Health Organization

Download or read book Malaria chemoprevention: preferred product characteristics written by World Health Organization and published by World Health Organization. This book was released on 2023-04-20 with total page 38 pages. Available in PDF, EPUB and Kindle. Book excerpt: Preferred product characteristics” (PPCs) are key tools to incentivize and guide the development of urgently needed health products. The PPCs published here aim to articulate the public health need, preferred characteristics, and clinical development considerations for drugs for malaria chemoprevention. WHO recommends several chemoprevention strategies for malaria control, including seasonal malaria chemoprevention, perennial malaria chemoprevention, intermittent preventive treatment of malaria in pregnancy, and mass drug administration. These strategies face a number of challenges such as suboptimal adherence and coverage and the emergence and spread of drug resistance. This document presents PPCs for the development of drugs for malaria chemoprevention in children, in pregnancy and in non-immune travellers, and outlines potential clinical development approaches, including the repurposing of approved malaria treatments for use as chemoprevention, recombining approved individual drugs into new combinations for malaria prevention, and the development of new drug combinations specifically for chemoprevention.

WHO working group on late-stage development for malaria vaccines to reduce disease burden

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Publisher : World Health Organization
ISBN 13 : 9240048278
Total Pages : 20 pages
Book Rating : 4.2/5 (4 download)

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Book Synopsis WHO working group on late-stage development for malaria vaccines to reduce disease burden by :

Download or read book WHO working group on late-stage development for malaria vaccines to reduce disease burden written by and published by World Health Organization. This book was released on 2022-05-17 with total page 20 pages. Available in PDF, EPUB and Kindle. Book excerpt:

WHO meeting on preferred product characteristics for monoclonal antibodies for malaria prevention

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Author :
Publisher : World Health Organization
ISBN 13 : 9240060405
Total Pages : 16 pages
Book Rating : 4.2/5 (4 download)

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Book Synopsis WHO meeting on preferred product characteristics for monoclonal antibodies for malaria prevention by : World Health Organization

Download or read book WHO meeting on preferred product characteristics for monoclonal antibodies for malaria prevention written by World Health Organization and published by World Health Organization. This book was released on 2022-10-21 with total page 16 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Practical Considerations on Malaria Vaccines and Clinical Trials

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Publisher :
ISBN 13 :
Total Pages : 666 pages
Book Rating : 4.:/5 (994 download)

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Book Synopsis Practical Considerations on Malaria Vaccines and Clinical Trials by :

Download or read book Practical Considerations on Malaria Vaccines and Clinical Trials written by and published by . This book was released on 1986 with total page 666 pages. Available in PDF, EPUB and Kindle. Book excerpt:

World malaria report 2022

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Publisher : World Health Organization
ISBN 13 : 9240064893
Total Pages : 372 pages
Book Rating : 4.2/5 (4 download)

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Book Synopsis World malaria report 2022 by : World Health Organization

Download or read book World malaria report 2022 written by World Health Organization and published by World Health Organization. This book was released on 2022-12-08 with total page 372 pages. Available in PDF, EPUB and Kindle. Book excerpt: Each year, WHO’s World malaria report offers in-depth information on the latest trends in malaria control and elimination at global, regional and country levels. The report highlights progress towards global targets and describes opportunities and challenges for curbing and eliminating the disease. This year’s report includes three new sections on: (1) global and regional initiatives launched in 2021 and 2022; (2) global malaria surveillance and country-level case studies on surveillance systems assessments; and (3) research and development. The report also includes an expanded section on threats to malaria control, with a focus on the declining effectiveness of insecticide-treated mosquito nets.

Evidence generation for development of health products

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Publisher : World Health Organization
ISBN 13 : 9240084290
Total Pages : 40 pages
Book Rating : 4.2/5 (4 download)

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Book Synopsis Evidence generation for development of health products by : World Health Organization

Download or read book Evidence generation for development of health products written by World Health Organization and published by World Health Organization. This book was released on 2023-12-15 with total page 40 pages. Available in PDF, EPUB and Kindle. Book excerpt: This document describes the main elements that World Health Organization (WHO) technical departments should elaborate on when providing guidance on evidence generation to research and development (R&D) specialists who are developing health products to address critical unmet needs in public health. While WHO’s TPPs, preferred product characteristics (PPCs) and target regimen profiles (TRPs) provide high-level information on the desired characteristics of the product, the target population, and the key endpoints for safety and efficacy evaluation, more detailed guidance is needed to enable the development of suitable trial/study designs aimed at producing relevant evidence for WHO’s normative products such as guidelines. The objective of the Guidance for evidence generation (GEG) process is to produce a guidance document on how best to perform studies for the development of novel products (diagnostics, drugs, vaccines, vector control) and thus how to enable the generation of robust data and evidence to inform a WHO evidence review process.

Malaria Control and Elimination

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Publisher : Methods in Molecular Biology
ISBN 13 : 9781493995523
Total Pages : 341 pages
Book Rating : 4.9/5 (955 download)

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Book Synopsis Malaria Control and Elimination by : Frédéric Ariey

Download or read book Malaria Control and Elimination written by Frédéric Ariey and published by Methods in Molecular Biology. This book was released on 2020-07-17 with total page 341 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Battling Malaria

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Publisher : National Academies Press
ISBN 13 : 0309180430
Total Pages : 144 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Battling Malaria by : Institute of Medicine

Download or read book Battling Malaria written by Institute of Medicine and published by National Academies Press. This book was released on 2006-07-26 with total page 144 pages. Available in PDF, EPUB and Kindle. Book excerpt: Malaria is an infectious disease common to several parts of the world, including Africa, northern South America, and Asia. During their service in the military, U.S. active members may be sent to any part of the world, including parts of the world where Malaria is an issue. In Liberia in 2003, for example, there was a 28 percent attack rate in Marines who spent a short time ashore, and half of the 80 Marines affected needed to be evacuated to Germany. This was not only costly to the U.S. military but dangerous as well. To fight against this disease, there exists a Malaria Vaccine program in the U.S. military. However, there exists a variety of potential vaccine targets for the most severe and important form of malaria; malaria from the species Plasmodium falciparum. Issues also arise with the fact that there are three possible stages to create vaccines against-preerythrocytic, blood, or transmission. The Department of Defense (DoD), through the commanding general of the U.S. Army Medical Research and Materiel Command (USAMRMC), requested that the Institute of Medicine (IOM) conduct a programmatic review of the military Plasmodium falciparum malaria vaccine research and development program. There was to be a focus on vaccine against the preerythrocytic and blood stages. The IOM formed a committee of 11 experts with collective expertise in malaria vaccine research, parasite immunology, malarial biology, clinical trials and regulatory affairs, industrial and public-sector vaccine development, biologic products research and development (vaccinology), military research and development programs, tropical medicine, and public health. The committee focused different tasks including determining whether the DoD malaria vaccine research and development program is scientifically sound and able to achieve the vaccine program objectives within specified timelines, recommending how to overcome significant, identified barriers, and identifying major strategic goals and timelines based on the material received and presentations made by the DoD's program representatives. Battling Malaria: Strengthening the U.S. Military Malaria Vaccine Program presents the committee's findings, current malaria vaccines, and recommendations for the development of the U.S. Military vaccine research.

Saving Lives, Buying Time

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Publisher : National Academies Press
ISBN 13 : 0309165938
Total Pages : 384 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Saving Lives, Buying Time by : Institute of Medicine

Download or read book Saving Lives, Buying Time written by Institute of Medicine and published by National Academies Press. This book was released on 2004-09-09 with total page 384 pages. Available in PDF, EPUB and Kindle. Book excerpt: For more than 50 years, low-cost antimalarial drugs silently saved millions of lives and cured billions of debilitating infections. Today, however, these drugs no longer work against the deadliest form of malaria that exists throughout the world. Malaria deaths in sub-Saharan Africaâ€"currently just over one million per yearâ€"are rising because of increased resistance to the old, inexpensive drugs. Although effective new drugs called "artemisinins" are available, they are unaffordable for the majority of the affected population, even at a cost of one dollar per course. Saving Lives, Buying Time: Economics of Malaria Drugs in an Age of Resistance examines the history of malaria treatments, provides an overview of the current drug crisis, and offers recommendations on maximizing access to and effectiveness of antimalarial drugs. The book finds that most people in endemic countries will not have access to currently effective combination treatments, which should include an artemisinin, without financing from the global community. Without funding for effective treatment, malaria mortality could double over the next 10 to 20 years and transmission will intensify.

Vaccines for the 21st Century

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Publisher : National Academies Press
ISBN 13 : 0309174988
Total Pages : 472 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Vaccines for the 21st Century by : Institute of Medicine

Download or read book Vaccines for the 21st Century written by Institute of Medicine and published by National Academies Press. This book was released on 2001-02-21 with total page 472 pages. Available in PDF, EPUB and Kindle. Book excerpt: Vaccines have made it possible to eradicate the scourge of smallpox, promise the same for polio, and have profoundly reduced the threat posed by other diseases such as whooping cough, measles, and meningitis. What is next? There are many pathogens, autoimmune diseases, and cancers that may be promising targets for vaccine research and development. This volume provides an analytic framework and quantitative model for evaluating disease conditions that can be applied by those setting priorities for vaccine development over the coming decades. The committee describes an approach for comparing potential new vaccines based on their impact on morbidity and mortality and on the costs of both health care and vaccine development. The book examines: Lessons to be learned from the polio experience. Scientific advances that set the stage for new vaccines. Factors that affect how vaccines are used in the population. Value judgments and ethical questions raised by comparison of health needs and benefits. The committee provides a way to compare different forms of illness and set vaccine priorities without assigning a monetary value to lives. Their recommendations will be important to anyone involved in science policy and public health planning: policymakers, regulators, health care providers, vaccine manufacturers, and researchers.

Disease Control Priorities, Third Edition (Volume 6)

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Publisher : World Bank Publications
ISBN 13 : 1464805253
Total Pages : 1027 pages
Book Rating : 4.4/5 (648 download)

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Book Synopsis Disease Control Priorities, Third Edition (Volume 6) by : King K. Holmes

Download or read book Disease Control Priorities, Third Edition (Volume 6) written by King K. Holmes and published by World Bank Publications. This book was released on 2017-11-06 with total page 1027 pages. Available in PDF, EPUB and Kindle. Book excerpt: Infectious diseases are the leading cause of death globally, particularly among children and young adults. The spread of new pathogens and the threat of antimicrobial resistance pose particular challenges in combating these diseases. Major Infectious Diseases identifies feasible, cost-effective packages of interventions and strategies across delivery platforms to prevent and treat HIV/AIDS, other sexually transmitted infections, tuberculosis, malaria, adult febrile illness, viral hepatitis, and neglected tropical diseases. The volume emphasizes the need to effectively address emerging antimicrobial resistance, strengthen health systems, and increase access to care. The attainable goals are to reduce incidence, develop innovative approaches, and optimize existing tools in resource-constrained settings.

WHO Recommendations for Prevention and Treatment of Maternal Peripartum Infections

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Publisher : World Health Organization
ISBN 13 : 924154936X
Total Pages : 80 pages
Book Rating : 4.2/5 (415 download)

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Book Synopsis WHO Recommendations for Prevention and Treatment of Maternal Peripartum Infections by : World Health Organization

Download or read book WHO Recommendations for Prevention and Treatment of Maternal Peripartum Infections written by World Health Organization and published by World Health Organization. This book was released on 2016-02-12 with total page 80 pages. Available in PDF, EPUB and Kindle. Book excerpt: The goal of the present guideline is to consolidate guidance for effective interventions that are needed to reduce the global burden of maternal infections and its complications around the time of childbirth. This forms part of WHO's efforts towards improving the quality of care for leading causes of maternal death especially those clustered around the time of childbirth in the post-MDG era. Specifically it presents evidence-based recommendations on interventions for preventing and treating genital tract infections during labour childbirth or puerperium with the aim of improving outcomes for both mothers and newborns. The primary audience for this guideline is health professionals who are responsible for developing national and local health protocols and policies as well as managers of maternal and child health programmes and policy-makers in all settings. The guideline will also be useful to those directly providing care to pregnant women including obstetricians midwives nurses and general practitioners. The information in this guideline will be useful for developing job aids and tools for both pre- and inservice training of health workers to enhance their delivery of care to prevent and treat maternal peripartum infections.

Assessment of Long-Term Health Effects of Antimalarial Drugs When Used for Prophylaxis

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Publisher : National Academies Press
ISBN 13 : 0309672104
Total Pages : 427 pages
Book Rating : 4.3/5 (96 download)

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Book Synopsis Assessment of Long-Term Health Effects of Antimalarial Drugs When Used for Prophylaxis by : National Academies of Sciences, Engineering, and Medicine

Download or read book Assessment of Long-Term Health Effects of Antimalarial Drugs When Used for Prophylaxis written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2020-04-24 with total page 427 pages. Available in PDF, EPUB and Kindle. Book excerpt: Among the many who serve in the United States Armed Forces and who are deployed to distant locations around the world, myriad health threats are encountered. In addition to those associated with the disruption of their home life and potential for combat, they may face distinctive disease threats that are specific to the locations to which they are deployed. U.S. forces have been deployed many times over the years to areas in which malaria is endemic, including in parts of Afghanistan and Iraq. Department of Defense (DoD) policy requires that antimalarial drugs be issued and regimens adhered to for deployments to malaria-endemic areas. Policies directing which should be used as first and as second-line agents have evolved over time based on new data regarding adverse events or precautions for specific underlying health conditions, areas of deployment, and other operational factors At the request of the Veterans Administration, Assessment of Long-Term Health Effects of Antimalarial Drugs When Used for Prophylaxis assesses the scientific evidence regarding the potential for long-term health effects resulting from the use of antimalarial drugs that were approved by FDA or used by U.S. service members for malaria prophylaxis, with a focus on mefloquine, tafenoquine, and other antimalarial drugs that have been used by DoD in the past 25 years. This report offers conclusions based on available evidence regarding associations of persistent or latent adverse events.

Immunization in Practice

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Publisher : World Health Organization
ISBN 13 : 9241549092
Total Pages : 292 pages
Book Rating : 4.2/5 (415 download)

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Book Synopsis Immunization in Practice by :

Download or read book Immunization in Practice written by and published by World Health Organization. This book was released on 2015 with total page 292 pages. Available in PDF, EPUB and Kindle. Book excerpt: This practical guide contains seven modules targeted at district and health facility staff. It intends to meet the demands to improve immunization services so as to reach more infants in a sustainable way, building upon the experiences of polio eradication. It includes materials adapted from polio on planning, monitoring and use of data to improve the service, that can be used at any level. Revising the manual has been a team exercise. There are contributions from a large number of experts, organizations and institutions. This new edition has seven modules. Several new vaccines that have become more readily available and used in recent years have been added. Also the section on integration with other health interventions has been expanded as exciting opportunities and experiences have become evident in the years following the previous edition. Module 1: Target diseases and vaccines Module 2: The vaccine cold chain Module 3: Ensuring safe injections Module 4: Microplanning for reaching every community Module 5: Managing an immunization session Module 6: Monitoring and surveillance Module 7: Partnering with communities.