Consultants – Monkeypox Vaccine R&D at World Health Organization

Purpose of consultancy

To establish a roster of consultants to provide technical expertise to the R&D Blueprint during the Monkeypox outbreak.

Background  

Since early May 2022, cases of monkeypox have been reported from countries where the disease is not endemic, and continue to be reported in several endemic countries. This is the first time that many monkeypox cases and clusters have been reported concurrently in non-endemic and endemic countries in widely disparate geographical areas.

In response, a Monkeypox Strategic Preparedness and Response Plan (SPRP) has been developed. It sets out the strategic objectives to support preparedness, prevention, readiness and response for monkeypox, and describes the key actions across five areas by which those objectives will be achieved: emergency coordination; collective intelligence; engaging and protecting communities; clinical care and infection prevention and control; and countermeasures and research.

The R&D Blueprint is responsible for generating the science on diseases that have epidemic and pandemic potential, and for which there are insufficient medical countermeasures. As part of the SPRP for Monkeypox, the R&D Blueprint is responsible for:

• Developing Target Product Profiles for vaccines to guide developers on their preferred and minimally acceptable characteristics.
• Landscaping all vaccines candidates in pre-clinical and clinical development and tracking their progress through the development pipeline.
• Mapping all registered clinical trials for vaccine and undertaking systematic reviews of trial results.
• Establishing an independent process to prioritize the most promising and high impact candidate vaccines for further research and clinical evaluation.
• Developing standardized core clinical trial protocols and standard operating procedures according to good clinical practice.
• Supporting large, international, randomized controlled clinical trials designed to rapidly evaluate of the benefits and risks of prioritized candidate vaccines.

Deliverables

• Deliverable 1:  Develop Target Product Profiles (TPP) for Monkeypox Vaccines. The TPP documents would aim to inform product developers, regulatory agencies, procurement agencies and funders on R&D and public health priorities. They would describe the preferred and the minimally acceptable profiles for Monkeypox vaccines and provide information for funders and developers on the performance and operational characteristics expected of products if they are to meet WHO’s needs.
• Deliverable 2: Conduct a landscape analysis of Monkeypox Vaccine candidates. The landscape analyses would compile detailed information of every known vaccine candidate pre-clinical and clinical development by closely monitoring their progress through the development pipeline. The landscape would include additional information and published reports on safety, immunogenicity and efficacy. 
• Deliverable 3: Vaccine Prioritization. Based on the landscaping of candidate vaccines, an independent process is needed to help WHO prioritize research efforts on the more promising candidates that may have the highest impact. Independent group of experts would need to be constituted and managed to advise WHO on the prioritization of candidates. 
• Deliverable 4: Develop Core Protocols for Monkeypox Vaccine Clinical Trials. WHO recommends researchers around the world to systemically evaluate candidate vaccines in randomized control trials as the gold standard. For this WHO develops standardized and simplified core clinical trial protocols that can be implemented with similar methodology, primary and secondary outcomes that are comparable. 
• Deliverable 5: Provide technical expertise to randomized controlled clinical trials in various countries. WHO will not be sponsoring any Monkeypox clinical trials for vaccines but will support existing trials. Areas of support will include clinical trial data management, surveillance, pharmacovigilance and/or statistical and modelling analyses, trial operationalization in countries and clinical sites (incl. research site planning/preparations, local research team constitution and support, support for regulatory and ethics approvals of core protocol), Global Clinical Practice (GCP) training, Laboratory support, and Supply, logistics and cold chain support.

Qualifications, experience, skills and languages

Educational Qualifications:

Essential:

• An advanced university degree in medicine, public health, or epidemiology in infectious diseases relevant to the tasks of the consultancy.

Desirable:

• A PhD in one of the above-mentioned fields.

Experience

Essential:

• Band level B:  5 to 10 years relevant experience in research and development of key high impact epidemic diseases, including experience providing senior level advice and guidance to decision makers, as well as experience in the area of developing and establishing policies and strategies.
• Band level C:  Over 10 years relevant experience in research and development of key high impact epidemic diseases, including experience providing senior level advice and guidance to decision makers, as well as experience in the area of developing and establishing policies and strategies
• Demonstrated experience at the international level.

Skills/Knowledge:

• Globally-respected level of technical expertise and knowledge of therapeutics for epidemic and pandemic prone diseases.
• Proven understanding of the management of acute and complex public health responses, including infectious disease outbreaks in humanitarian emergencies.
• Strong skills in the area of developing and establishing polices and strategies.
• Ability to engage, build consensus and communicate effectively and diplomatically. Commitment to collaborate effectively with key partners.

Closing Date: Sep 28, 2022