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

Author: World Health Organization

Publisher: World Health Organization

Published: 2023-04-20

Total Pages: 36

ISBN-13: 9240070982

DOWNLOAD EBOOK

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 chemoprevention: preferred product characteristics
Malaria chemoprevention: preferred product characteristics

Author: World Health Organization

Publisher: World Health Organization

Published: 2023-04-20

Total Pages: 38

ISBN-13: 9240070966

DOWNLOAD EBOOK

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 Malaria Policy Advisory Group (MPAG) meeting report, 18–20 April 2023
WHO Malaria Policy Advisory Group (MPAG) meeting report, 18–20 April 2023

Author: World Health Organization

Publisher: World Health Organization

Published: 2023-06-01

Total Pages: 29

ISBN-13: 9240074384

DOWNLOAD EBOOK

On 18–20 April 2023, the WHO Malaria Policy Advisory Group (MPAG) convened to review updates and progress, and to provide guidance on thematic areas of work by the Global Malaria Programme. The meeting focused on the following topics: 1) the RBM Partnership to End Malaria evaluation of the “High burden to high impact” (HBHI) approach; 2) updates on the vector control, treatment and diagnostic recommendations in the WHO guidelines for malaria; 3) revisiting comparative effectiveness in the context of the arrival of new vector control products; 4) an update on certification of malaria elimination and the E-2025 Global Forum; 5) an update on the RTS,S/AS01 Malaria Vaccine Implementation Programme and WHO evidence review for the R21/Matrix-M vaccine; 6) an update on the work areas of the Strategic Information for Response Unit; 7) a report from the technical consultation on the effectiveness of rectal artesunate (RAS) and field implementation manual; 8) a report from the technical consultation on community-based delivery of intermittent preventive treatment of malaria in pregnancy (IPTp); 9) an update on the WHO/TDR field implementation manual for seasonal malaria chemoprevention (SMC); 10) an update on the Anopheles stephensi regional strategy; 11) an update on histidine-rich protein 2 (HRP2) gene deletions and global response plan; and 12) an update on antimalarial drug resistance in Africa.

Malaria Policy Advisory Group (MPAG) meeting, October 2021
Malaria Policy Advisory Group (MPAG) meeting, October 2021

Author:

Publisher: World Health Organization

Published: 2021-11-08

Total Pages: 17

ISBN-13: 9240038620

DOWNLOAD EBOOK

On 4–7 October 2021, the WHO Malaria Policy Advisory Group (MPAG) convened virtually to review updates and progress, and to provide guidance on thematic areas of work by the Global Malaria Programme. The meeting focused on 8 topics in 5 open sessions: 1) “Rethinking Malaria”; 2) update on the technical consultation on non-inferiority evaluations of vector control tools; 3) a discussion on malaria re-bound; 4) an update on antimalarial drug resistance in Africa; 5) an update on rectal artesunate (RAS) and quality of care; 6) a review of the relationship between chemoprevention and drug resistance; 7) an update on the WHO guidelines for malaria; and 8) a joint session with the Strategic Advisory Group of Experts on Immunization (SAGE) to review the evidence and consider a recommendation for broader use of the malaria vaccine.

WHO Expert Committee on Biological Standardization
WHO Expert Committee on Biological Standardization

Author: WHO Expert Committee on Biological Standardization. Meeting

Publisher: World Health Organization

Published: 2013

Total Pages: 241

ISBN-13: 9241209771

DOWNLOAD EBOOK

This report presents the recommendations of a WHO Expert Committee commissioned to coordinate activities leading to the adoption of international recommendations for the production and control of vaccines and other biologicals and the establishment of international biological reference materials. The report starts with a discussion of general issues brought to the attention of the Committee and provides information on the status and development of reference materials for various antibodies, antigens, blood products and related substances, cytokines, growth factors, endocrinological substances and in vitro diagnostic devices. The second part of the report, of particular relevance to manufacturers and national regulatory authorities, contains revised WHO recommendations for production and control of live attenuated influenza vaccines and for production and control of pneumococcal conjugate vaccines. New WHO guidelines on the regulatory evaluation of similar biotherapeutic medicines are also provided. Also included are a list of recommendations, guidelines and other documents for biological substances used in medicine, and of international standards and reference reagent for biological substances.

Malaria
Malaria

Author: Institute of Medicine

Publisher: National Academies Press

Published: 1991-02-01

Total Pages: 312

ISBN-13: 9780309045278

DOWNLOAD EBOOK

Malaria is making a dramatic comeback in the world. The disease is the foremost health challenge in Africa south of the Sahara, and people traveling to malarious areas are at increased risk of malaria-related sickness and death. This book examines the prospects for bringing malaria under control, with specific recommendations for U.S. policy, directions for research and program funding, and appropriate roles for federal and international agencies and the medical and public health communities. The volume reports on the current status of malaria research, prevention, and control efforts worldwide. The authors present study results and commentary on the: Nature, clinical manifestations, diagnosis, and epidemiology of malaria. Biology of the malaria parasite and its vector. Prospects for developing malaria vaccines and improved treatments. Economic, social, and behavioral factors in malaria control.