The World Health Organization (WHO) is seeking experts to serve as members one of the Technical Advisory Group on Measles and Rubella Microarray Patches (MR-MAPs). This “Call for experts” provides information about the advisory group in question, the expert profiles being sought, the process to express interest, and the process of selection.
Background
MAPs are promising single-dose devices for the delivery of vaccines directly to the dermis or epidermis. Unlike traditional vaccination methods, MAPs eliminate the need for reconstitution and administration by needles and syringes, making them easy to prepare and deliver. These patches offer several advantages, including minimal pain upon application and the potential for increased thermostability over the existing vaccines, which could simplify cold chain requirements and allow lesser trained personnel to deliver vaccines. Encouragingly, a candidate MAP for the measles and rubella vaccine has successfully completed its phase 2 trial in infants in Gambia. The trial demonstrated that the safety and immunogenicity of the MR-MAP were similar to the conventional sub-cutaneous delivery route with needle and syringe. Another MR-MAP candidate will soon enter a phase 2 trial in infants, also in Gambia. Building on this success, investment is expected to establish a pilot manufacturing line for the production of materials required for a phase 3 trial and early commercial use. The ongoing work is focused on planning a robust phase 3 trial that adheres to regulatory standards, ensuring fast approval and WHO prequalification. The design of the phase 3 trial will inform an assessment of Evidence Considerations for Vaccine Policy (ECVP) which facilitates identifying evidence that could inform a future policy recommendation by Strategic Advisory Group of Experts on Immunization (SAGE). In addition, several questions around the implementation and use of microarray patches remain. These must be identified and answered through research in the anticipated delivery setting. The ultimate goal is to facilitate the swift introduction, widespread adoption, and positive impact of measles and rubella MAPs in countries worldwide.
As such, the primary focus of this TAG is to contribute to the planning and preparation of the phase 3 trial for MR-MAPs, the regulatory approval and WHO prequalification, the policy decision, and subsequent product implementation.
Functions of the Technical Advisory Group on Measles and Rubella Microarray Patches (MR-MAPs)
In its capacity as an advisory body to WHO, the AG shall have the following functions:
- To provide independent evaluation of the scientific, technical, regulatory and strategic aspects related to MR-MAPs, including but not limited to safety, efficacy, immunogenicity, manufacturing processes, resulting in recommendations on data requirements, study designs, clinical trial protocols and regulatory strategies.
- To advise WHO on evidence to support policy formulation, optimal programmatic strategies and pre-approval implementation research to accelerate the recommendation, introduction and use of MR-MAPs, ensuring alignment with global health objectives and immunization goals.
- To recommend research priorities to the WHO and/or relevant WHO technical units regarding the development, evaluation, regulatory approval and implementation of MR-MAPs for measles and rubella vaccines.
Operations of the Technical Advisory Group on Measles and Rubella Microarray Patches (MR-MAPs)
The Advisory Group (AG) typically meets once annually, with the potential for additional meetings convened by WHO, either in-person or virtually. Meetings can be in open or closed sessions, with open sessions allowing for the exchange of non-confidential information and participation by invited observers. A two-thirds quorum is required for AG meetings. WHO can invite external individuals as observers, who might present their views but won't partake in decision-making. The AG can form smaller working groups without quorum requirements. Members must attend meetings, with potential removal after missing two consecutive sessions. Meeting reports and recommendations are submitted to WHO, with all final decisions resting with WHO. Recommendations are usually consensus-based, but minority views are documented if consensus isn't reached. AG members are expected to actively participate, review materials, and provide inputs, while communication modes are determined by WHO. Members can't represent the AG or WHO externally. The AG may be disbanded once its objectives are met or at WHO's discretion.
Who can express interest?
The Technical Advisory Group on Measles and Rubella Microarray Patches (MR-MAPs) will be multidisciplinary, with members who have a range of technical knowledge, skills and experience relevant to challenges related to implementation of measles and rubella vaccine, experience in the design of phase III trials and preparing a product for a regulatory decision and a WHO policy consideration, and microarray patches. Approximately up to 15 members may be selected.
WHO welcomes expressions of interest from experts with expertise in:
- Clinical Trials Expertise: Individuals with deep understanding and experience in designing, conducting, and evaluating phase 3 clinical trials, especially for vaccines.
- Regulatory and Compliance Knowledge: Professionals experienced in navigating regulatory pathways, ensuring adherence to standards for fast approval, and achieving WHO prequalification.
- Vaccinology and Immunology: Experts in the field of vaccine development, with a particular focus on dermal or epidermal delivery systems, who can understand and assess the vaccine's immunogenicity.
- Microarray Patch Technology: Specialists with a background in the development, manufacture, or evaluation of microarray patches, especially in a medical or pharmaceutical context.
- Policy Development: Individuals familiar with the process of turning clinical and scientific findings into actionable health policy, especially in the context of global health and immunization.
- Implementation Science and Delivery: Experts who can guide the introduction and scaling up of new health interventions in real-world settings, ensuring that they achieve maximum impact.
- Health Economics: Professionals who can evaluate the cost-effectiveness of introducing MR-MAPs compared to traditional vaccination methods.
- Epidemiology: Experts who can understand and predict the potential impact of MR-MAPs on measles and rubella incidence and prevalence in target populations.
- Cultural and Societal Considerations: Individuals who can anticipate and address cultural or societal barriers to the adoption of MR-MAPs in various regions.
Submitting your expression of interest
To register your interest in being considered for the Technical Advisory Group on Measles and Rubella Microarray Patches (MR-MAPs), please submit the following documents by 1st of December 24:00h (midnight) Geneva time to Dr Mateusz Hasso-Agopsowicz (vaccines@who.int) using the subject line “Expression of interest for the Technical Advisory Group on Measles and Rubella Microarray Patches (MR-MAPs):
- A cover letter, indicating your motivation to apply and how you satisfy the selection criteria. Please note that, if selected, membership will be in a personal capacity. Therefore do not use the letterhead or other identification of your employer);
- Your curriculum vitae; and
- A signed and completed Declaration of Interests (DOI) form for WHO Experts, available at https://www.who.int/about/ethics/declarations-of-interest.
Deadline for submissions: 1st December 2023.
After submission, your expression of interest will be reviewed by WHO. Due to an expected high volume of interest, only selected individuals will be informed.
Important information about the selection processes and conditions of appointment
Members of WHO advisory groups (AGs) must be free of any real, potential or apparent conflicts of interest. To this end, applicants are required to complete the WHO Declaration of Interests for WHO Experts, and the selection as a member of a AG is, amongst other things, dependent on WHO determining that there is no conflict of interest or that any identified conflicts could be appropriately managed (in addition to WHO’s evaluation of an applicant’s experience, expertise and motivation and other criteria).
All AG members will serve in their individual expert capacity and shall not represent any governments, any commercial industries or entities, any research, academic or civil society organizations, or any other bodies, entities, institutions or organizations. They are expected to fully comply with the Code of Conduct for WHO Experts (https://www.who.int/about/ethics/declarations-of-interest). AG members will be expected to sign and return a completed confidentiality undertaking prior to the beginning of the first meeting.
At any point during the selection process, telephone interviews may be scheduled between an applicant and the WHO Secretariat to enable WHO to ask questions relating to the applicant’s experience and expertise and/or to assess whether the applicant meets the criteria for membership in the relevant AG.
The selection of members of the AGs will be made by WHO in its sole discretion, taking into account the following (non-exclusive) criteria: relevant technical expertise; experience in international and country policy work; communication skills; and ability to work constructively with people from different cultural backgrounds and orientations .The selection of AG members will also take account of the need for diverse perspectives from different regions, especially from low and middle-income countries, and for gender balance.
If selected by WHO, proposed members will be sent an invitation letter and a Memorandum of Agreement. Appointment as a member of a AG will be subject to the proposed member returning to WHO the countersigned copy of these two documents.
WHO reserves the right to accept or reject any expression of interest , to annul the open call process and reject all expressions of interest at any time without incurring any liability to the affected applicant or applicants and without any obligation to inform the affected applicant or applicants of the grounds for WHO's action. WHO may also decide, at any time, not to proceed with the establishment of the AG, disband an existing TAG or modify the work of the AG.
WHO shall not in any way be obliged to reveal, or discuss with any applicant, how an expression of interest was assessed, or to provide any other information relating to the evaluation/selection process or to state the reasons for not choosing a member.
WHO may publish the names and a short biography of the selected individuals on the WHO internet.
AG members will not be remunerated for their services in relation to the AG or otherwise. Travel and accommodation expenses of AG members to participate in AG meetings will be covered by WHO in accordance with its applicable policies, rules and procedures.
The appointment will be limited in time as indicated in the letter of appointment.
If you have any questions about this “Call for experts”, please write to Dr Mateusz Hasso-Agopsowicz (vaccines@who.int) well before the applicable deadline.