Terms of Reference: Build Capacity for mRNA Vaccine Production

Nigeria faces a significant burden from both communicable and non-communicable diseases, which strains the healthcare system and hinders economic development. Despite ongoing efforts to address these challenges, the country remains heavily reliant on imports for essential health commodities. This dependency leads to high costs, supply chain vulnerabilities, and inconsistent availability of critical healthcare products. Strengthening local capacity and optimizing supply chain management is essential to improving the accessibility, affordability, and sustainability of healthcare products. This is key to advancing public health.

Market shaping strategies have proven successful in other health sectors by leveraging economies of scale, improving quality control, and enhancing distribution efficiency. Adopting this model for manufacturing and distributing essential health commodities could reduce costs, improve product consistency, and ensure more reliable supply chains. However, transitioning from an import-dependent system to one with a robust local production capacity and an efficient pooled procurement system is a complex process. It requires a comprehensive, multi-faceted approach that addresses manufacturing capabilities, quality assurance mechanisms, supply chain optimization, workforce capacity building, and supportive policy frameworks.

The Presidential Initiative for Unlocking Healthcare Value Chain (PVAC) and the National Malaria Elimination Programme (NMEP), with the support of the World Bank IMPACT, embarked on a project called "Enhancing Local Manufacturing and Supply Chain Management for Health Commodities and Supplies in Nigeria." This project addresses these challenges through a phased approach that balances short-term and long-term objectives. The strategies for addressing these challenges include developing and laying the groundwork for local manufacturing of malaria commodities (including ACTs, RDTs, APIs, and LLINs), enhancing production capacity, ensuring compliance with international quality standards, and fostering workforce development. At the same time, the project will focus on optimizing the pooled procurement of imported malaria commodities to improve cost-effectiveness and distribution efficiency. Over the medium to long term, these interventions will strengthen the entire health commodities value chain, create opportunities for economic growth, and support Nigeria's self-sufficiency in critical healthcare products. This comprehensive approach seeks to improve Nigeria's healthcare supply systems' efficiency and resilience while unlocking new economic opportunities within the country's health sector.

This consultancy aims to provide technical and strategic support for strengthening Nigeria’s capacity for local vaccine production using mRNA technology and clinical research, focusing on malaria mRNA vaccines following the success recorded with the current mRNA vaccine being imported for malaria prevention following the success achieved during the COVID-19 epidemic where mRNA-a newer and more adaptable technology that proved extremely useful in halting the COVID-19 epidemic proved to be an excellent platform for vaccine development. This consultancy will help to identify key gaps and capabilities that support vaccine development and deployment for improved prevention efforts and preparedness.

The consultant/consulting firm is expected to:

1. Develop a training plan and packages, including course outlines, for vaccine production by different vaccine types, such as LAVmRNA, especially for malaria mRNA vaccines.

2. Conduct a pre-training knowledge and capacity assessment of the selected institutions and agencies participating in the training.

3. Conduct capacity building for the selected institutions and agencies needed for the local formulation and production of mRNA products. This will include, among other things:

   • Biomanufacturing processes and applications
   • Good Manufacturing Practices, including aseptic techniques.
   • Quality management systems, including risk management processes related to vaccine production.

4. Conduct a post-training assessment to measure the knowledge the participants acquired.

5. Develop a comprehensive report on the training provided and other relevant activities undertaken to build the capacity and skills of institutions and agencies to produce vaccines.

Local vaccine production strengthens health security, enhances accessibility, fosters innovation, and supports malaria elimination efforts through sustainable supply and clinical research. Recognizing this critical need, PVAC is seeking the expertise of a qualified consultant for this initiative. The consultant will provide training and mentorship support to selected institutions and agencies for mRNA vaccine production in Nigeria.

The methodology for this project should outline how the consultant or consulting firm will approach capacity building for regulatory agencies on quality control.

1. Preliminary activities

   • Develop training plans and slide decks for training the identified institutions and agencies for mRNA vaccine production.
   • For the training, procure the required tools, equipment, and vaccine platforms (e.g., mRNA, live-attenuated).

2. Training Implementation

   • Conduct a pre-training knowledge and skills assessment
   • Train and build the capacity of local institutions and agencies to produce mRNA vaccines.
   • Conduct a post-training assessment to measure the improvement in trainees' capabilities, knowledge, and skills.

3. Reporting

   • Develop a comprehensive report on the training provided and other relevant activities undertaken to build the capacity and skills of the identified institutions and agencies to produce mRNA vaccines.

The expected outcomes include:

1. Training report including the list of institutions and agencies (including their pre- and post-training scores)

2. Institutions and agencies with required mRNA technology skills can cascade the skills to other organizations to enhance sustainable skill transfer and local mRNA vaccine development capabilities.

The selection process will follow a Limited Consultant Qualification-Based Method (LCQBM). Under this approach, interested consultants/consulting firms will submit proposals in response to the Terms of Reference (TOR) issued by PVAC. As part of the evaluation, consultants/consulting firms must demonstrate their relevant experience and qualifications in managing similar projects. Only the most qualified consultants or firms with proven expertise in project management, monitoring & evaluation, and health supply chain optimization will be shortlisted and considered for final selection.

The required expertise for this scope of work includes:

• Experience in developing and managing mRNA vaccine development programmes.
• Experience developing training modules for institutions, agencies, and organizations in mRNA technology and integrating digital tools into the production processes.
• Experience in training and capacity-building services in mRNA vaccine development in Africa (and internationally).
• Experience working with state agencies to design and implement vaccine development platforms and systems
• Familiarity with the mRNA vaccine production training needs in Nigeria, especially regarding technology and regulatory requirements.
• Demonstrate proficiency in conducting regulatory compliance assessments and implementing risk mitigation strategies specific to vaccine production and clinical research.

8 months -- May to December, 2025

Interested organizations are expected to submit the following documents:

1. Technical Proposal: The technical proposal should include:

• A clear methodology that demonstrates expertise in managing this project.
• A track record and experience in implementing similar projects
• At least 3 references from similar projects

2. A valid CAC certificate (or equivalent)

3. Financial Proposal -- including clear budget narratives.

All required documents should be sent to [email protected] on or before May 19^th, 2025. Proposals sent after this date will not be considered.