Olaoluwa Olatunde and Aderonke Poopla (Lead writers)
Nigeria continues to bear a high burden of infectious diseases, including Lassa fever, malaria, and tuberculosis. However, clinical trials capacity for therapeutics and vaccines in the country remains limited, emphasising the urgent need to strengthen local trial infrastructure and building technical expertise to ensure equitable access the vaccines targeting global threats. Developing the necessary expertise also includes improving regulatory readiness.
This challenge reflects a wider continental gap. Africa accounts for 25% of the global disease burden, however, the continent has only hosted 845 of the 76,331 clinical trials conducted worldwide in 2023, representing just 1.1%. In addition, only 43% of all clinical trials analysed in the 2024 Index were conducted in any low- and- middle-income countries (LMICs), despite these countries being home to nearly 80% of the global population. According to the World Health Organization’s International Clinical Trials Registry Platform (WHO-ICTRP), only 1,185 clinical trials were registered in Nigeria in the past 25 years.
This stark underrepresentation continues to limit Africa’s ability to generate context-specific data for its populations, constraining progress in vaccine development, manufacturing readiness, and policy translation needed to ensure timely and equitable access to innovations.
Building Africa’s End-to-End Vaccine Ecosystem
As highlighted in a joint assessment by the Africa Centre for Disease Control and Prevention (Africa CDC), this gap has contributed to the continent’s continued reliance on external sources for life-saving vaccines. Only about 1% of vaccines used in Africa are produced locally, while 99% are imported. Such an imbalance in research and manufacturing capacity perpetuates inequitable access to essential vaccines and widens health disparities between Africa and the rest of the world. Building end-to-end capabilities from research and development to production and delivery has become very critical to reducing dependency and ensuring sustainable access.
In order to strengthen vaccine preparedness and readiness, the Coalition for Epidemic Preparedness Innovations (CEPI) has taken an integrated approach to strengthening the broader vaccine ecosystem. With the mission to accelerate the development of vaccines against emerging infectious diseases, CEPI’s model aims to build a connected and resilient ecosystem, linking clinical evidence and manufacturing readiness. This would ensure that vaccines developed for global threats are also designed, tested and produced with and for Africa.
In collaboration with the Nigeria Lassa Fever Vaccine Task Force, the West African Health Organization (WAHO), and with support from CEPI, a Lassa Fever Vaccine End-to-End (E2E) Access Deep Dive Workshop was convened. The task force, led by the Nigeria Centre for Disease Control and Prevention (NCDC) and the National Agency for Food and Drug Administration and Control (NAFDAC), brought together a broad coalition of national stakeholders including representatives from government ministries and agencies, regulators, research institutions, policymakers, finance specialists, civil society organisations, and Coalition Secretariat Partners (CSP) members to align on Nigeria’s needs, risks, and priority actions. The discussions were aimed at informing the development of a Nigeria-specific Lassa E2E Access Roadmap to guide coordinated national efforts.
The workshop represented an important step in bringing stakeholders together to agree on Nigeria’s priorities for ensuring fair and timely access to future Lassa vaccines. It focused on identifying the country’s specific needs, potential risks, and the critical interventions required to enable vaccine readiness and delivery. As one of the facilitators from a global vaccine research and development partnership emphasised during the discussions, “the end-to-end vaccine pathway spans the entire journey from early research through sustainable supply. It is not just about developing products, but about building sustainable systems”.
Insights from the discussions will shape the development of a Nigeria-specific Lassa E2E Access Roadmap, designed to guide coordinated national action across research, regulation, and access planning. In the words of a representative from a national public health agency, “As a leading endemic country, Nigeria recognises that equitable and timely access to safe and effective vaccines is critical to reducing the disease burden and fulfilling national healthcare obligations. While vaccine development is vital, ensuring availability”.
The session gathered a broad coalition of stakeholders, including representatives from government ministries and agencies, vaccine introduction experts, implementation partners, regulators, research institutions, policymakers, finance specialists, civil society organisations, and Coalition Secretariat Partners (CSP) members.
The multi-sectoral engagement reflected the collaborative approach needed to operationalise CEPI’s end-to-end roadmap, linking evidence generation with policy, regulation, and setting a model for how national ecosystems can be strengthened to accelerate vaccine access and potential of countries in Africa to strengthen clinical trial capacity.
Reflecting on the discussions, a representative global health organisation noted: “There is a need for regional vaccine manufacturing capacity to ensure a sustainable supply. This includes establishing vaccine manufacturing hubs within West Africa especially in Nigeria, given its high disease burden and facilitating technology transfer from established facilities to Nigerian and regional manufacturers”
The End-to-End Model in Action
Deepening the commitment to vaccine equity, CEPI is currently funding the Phase 2a Lassa fever vaccine trial alongside the end-to-end (E2E) workshop in Nigeria. By linking research to policy, regulation, production, financing, and access, CEPI’s model provides a practical example for how collaborative investment can transform Africa from a passive recipient of innovation into an active contributor to global health security.
Unlike conventional donor-funded trials that focus narrowly on product evaluation, accelerating vaccine development and delivery readiness will ensure that there is comprehensive support across the entire vaccine value chain, from strengthening local systems and regulatory capacity to strengthening manufacturing linkages, and research networks. This integrated model represents an important change toward sustainable scientific autonomy for the region, while reflecting Nigeria’s scientific leadership and growing role in supporting the strengthening Africa’s research and innovation landscape. The strong performance of national institutions such as the NCDC, NAFDAC, and NPHCDA continues to demonstrate the country’s readiness to lead in end-to-end vaccine development.
While the workshop and ongoing vaccine trials demonstrate Nigeria’s role in efforts to develop a Lassa fever vaccine, they also raise a crucial question, “will the country leverage this catalytic moment to move beyond donor-driven initiatives toward systemic reform?” Recent analyses suggests that clinical trials globally could soon be run faster and reach twice as many patients, highlighting the urgency for Nigeria to strengthen its own trial capacity and coordination.
This represents a strategic opportunity for Nigeria to build a resilient health innovation ecosystem, one that integrates research, regulation and manufacturing into a connected value chain. These efforts to strengthen clinical trial expertise should therefore be seen as essential investments in Africa’s health sovereignty and long-term self-reliance.
Advancing Vaccine Development in Nigeria
As the epicentre of Lassa fever, hosting clinical trials alone will not be enough. Nigeria has a strategic opportunity to lead vaccine innovation and distribution across West Africa. With Lassa fever cases in over 20 states, the country’s proximity to the burden of infection provides an opportunity to strengthen leadership and clinical trials capacity for regional vaccine research and delivery.
A next step for Nigeria, therefore, lies in using its participation in clinical trials as a foundation to build in-country capabilities and strengthen the supporting systems, from research governance to regulatory oversight. As highlighted by the Access to Medicine Foundation, Africa has the potential to host high-quality, well-regulated clinical trials that meet global standards. For Nigeria, aligning CEPI’s catalytic investments with existing national frameworks such as the Nigeria Vaccine Policy, and the Biovaccines Nigeria Limited (BVNL) partnership would help translate this potential into sustained institutional capacity and public health impact.
As Nigeria takes part in clinical trials, the discussions must now move beyond access and coordination to focus on how the country can translate this momentum for enduring national capacity. Clinical trials are integral to strengthening governance and data systems in order to sustain vaccine development. When integrated into national health and research structures, clinical research can improve regulatory maturity and scientific capacity, and domestic pathways to local manufacturing and equitable vaccine access.
For Nigeria, institutions such as the National Health Research Ethics Committee (NHREC) and NAFDAC are important for this transformation to take place, serving as enablers not just regulators of national capacity. Without reinforcing these systems, countries like Nigeria risk remaining data providers rather than beneficiaries, as evidence and innovation flow outward instead of strengthening domestic capability. Experiences from Rwanda’s biotechnology partnerships and South Africa’s expanding clinical trial capacity, demonstrated by trials of its first domestically manufactured oral cholera vaccine show how integrating research within national innovation systems drives technology transfer, skills growth, and industrial development.
Why now?
The convergence of factors, the recently concluded 2nd ECOWAS Lassa Fever International Conference, the pledge by West African leaders to advance the Lassa vaccine and the encouraging results from IAVI’s Phase 1 clinical trials of their Lassa vaccine candidate has created increased momentum around Lassa vaccine development.
With Nigeria’s expanding regulatory maturity and demonstrated coordination among national health institutions, the Lassa vaccine trial provides a blueprint for building comprehensive clinical trial ecosystems that strengthen national health security.
To ensure this vital momentum is not lost, Nigeria must implement several key structural changes:
· Institutionalise the E2E Model: The multi-stakeholder End-to-End model must be formally adopted as the standard operating procedure for all large-scale, public health research projects.
· Develop Long-Term Funding Mechanisms: Creative and sustainable long-term funding mechanisms for domestic health research must be secured, reducing reliance on short-term grants.
Seizing this moment requires investment in research infrastructure and skilled professionals, that link individual vaccine trial to broader national and regional goals. Nigeria’s must transition from being merely a host for global trials to becoming a regional leader in innovation, manufacturing, and equitable access. By doing so, the country will not only protect its citizens from Lassa fever but also lay the groundwork for scientific sovereignty and sustainable health security across West Africa.
Nigeria’s participation in Lassa vaccine development creates and opportunity to strengthen local innovation and regulatory systems, ensuring that this translates into access for the country and the wider West African region. By embedding these efforts within long-term national strategies, Nigeria can help build the foundation for scientific self-reliance and sustainable health security. To support regional preparedness, the end-to-end workshops will take place in other Lassa-endemic West African countries to encourage shared learnings.