We Are Developing Lassa Fever, HIV, Ebola Vaccines In Nigeria – Dr Simon Agwale

Dr Simon Agwale is the Chief Executive of Innovative Biotech Nigeria and Innovative Biotech USA. He also serves as Chairman of the Technology Working Group and Vice Chairman of the Board of the African Vaccine Manufacturing Initiative (AVMI). In this interview with Chinedu AROH, he speaks on his long-standing vision and efforts toward establishing an indigenous, end-to-end vaccine manufacturing company in Nigeria.

What informed your quest to establish an indigenous vaccine manufacturing company in Nigeria?

This initiative began almost two decades ago, and it has been a very challenging journey, particularly in terms of raising the required funding. Our strategy has always been to establish a truly end-to-end vaccine manufacturing facility. What most facilities in Africa currently do is import active pharmaceutical ingredients (APIs) and only carry out formulation or packaging locally. Our approach is fundamentally different. We aim to conduct research and development, produce active ingredients, and carry out fill-and-finish operations for vaccines that are critically needed in Nigeria, as well as vaccines targeting emerging and re-emerging diseases

We currently have several vaccine candidates in development, including Lassa fever, HIV, and Ebola vaccines. In addition, we license already commercialised vaccines so that we can locally formulate and fill them. These include vaccines used in Nigeria’s routine childhood immunisation programme, as well as vaccines for diseases such as typhoid, for which we have a typhoid conjugate vaccine, and outbreak-prone diseases like meningitis.

How tough has the journey been?

Establishing an end-to-end vaccine manufacturing facility requires an investment of over USD 100 million. Recently, however, we received support from the African Export–Import Bank (Afreximbank) to complete comprehensive feasibility studies. These include technical feasibility, conceptual process design, and financial feasibility, covering capital expenditure, operational expenditure, cash-flow projections, equity and investment structures, as well as an Environmental Impact Assessment (EIA) for our proposed site at the Abuja Technology Village.

The EIA has been completed, and we are currently awaiting certification from the Federal Ministry of Environment. Once that is obtained, we will commence the establishment of the research and development component. The manufacturing plant itself will be a modular facility constructed in Europe and shipped to Nigeria for on-site assembly.

How soon will this vision materialise?

We are currently working with an international development finance institution, and as expected, there are several processes involved. The first phase is the feasibility study, which will be submitted for review. Upon approval, the project proceeds to the implementation phase. If funding were immediately available, the factory could be completed within 18 months, followed by an additional four months for qualification, validation, and regulatory testing before production begins. However, because the duration of the next approval phase with Afreximbank is uncertain, it is difficult to give an exact timeline. That said, we are targeting the first quarter of next year to initiate implementation.

What does Nigeria stand to gain from this initiative?

The benefits are substantial. First, it will create high-technology jobs, as we are undertaking full end-to-end vaccine manufacturing. It will also significantly enhance national health security, enabling Nigeria to respond rapidly to pandemics—unlike during COVID-19, when we depended on global goodwill for vaccine access.

The project will generate both direct and indirect employment, and a large proportion of the products will be exported, contributing to foreign exchange earnings. Vaccines will be sold in US dollars to other African countries and global markets, depending on the product. We envision replicating what Dangote has achieved in the oil sector—ensuring Nigeria no longer imports vaccines but instead produces all those required for national use, thereby conserving foreign exchange.

Beyond manufacturing, we will create a training and innovation platform for Nigerian students and researchers. Students will gain hands-on experience in vaccine manufacturing, good laboratory practices, and regulatory science. Graduate students will have opportunities for advanced research and development. We will also produce rapid diagnostic test kits, particularly for the vaccines we manufacture, enabling real-time monitoring of vaccine effectiveness. Ultimately, this platform will help build the next generation of Nigerian scientists and stimulate the growth of related component industries, many of which will initially rely on imports but can later be domesticated.

How much support are you receiving from the federal government?

The presidential initiative for unlocking the healthcare value chain (PVAC) has been supportive and open to assisting us. We already have funding support from Afreximbank and are in discussions with them regarding a possible equity component. We are also engaging the National Primary Health Care Development Agency (NPHCDA) on a potential off-take commitment, which is a key requirement for securing financing, as governments are the largest purchasers of vaccines.

Once we move to the next phase, NAFDAC will be involved from the early stages and will work closely with us throughout the process to ensure smooth regulatory approval. While we have enjoyed strong regulatory support, we have not yet received direct funding from the government.

Are there similar facilities in Africa?

Most vaccine manufacturing facilities in Africa—particularly in South Africa and Morocco—focus on fill-and-finish operations. The Institut Pasteur de Dakar (IPD) in Senegal is a notable exception, as it produces the yellow fever vaccine end-to-end and is expanding into other vaccines. In Egypt, most facilities currently do fill-and-finish but are planning to move into active ingredient production. What makes our project unique is that we own intellectual property for some of the vaccines and are not only manufacturing APIs but also actively conducting vaccine discovery and development.

What is a vaccine, and why is it important?

Globally, many pathogens—including those causing malaria, typhoid, and sexually transmitted infections—are becoming increasingly resistant to antibiotics. This poses a serious future threat. Vaccines remain the most cost-effective health intervention known to humanity because they prevent infection before they occur. Vaccines have eradicated diseases such as smallpox, drastically reduced polio, and eliminated measles and hepatitis B in many parts of the world. Africa continues to suffer disproportionately because of late vaccine introduction and low uptake. Local vaccine production builds trust and confidence, which increases acceptance and coverage.

How safe are vaccines?

Vaccines are among the safest medical products ever developed. Their development is governed by extremely stringent regulations. Vaccine candidates undergo extensive animal studies, including toxicity and biodistribution testing in at least two animal models, before progressing to human trials.

Human trials are conducted in three phases, each requiring regulatory approval based on safety and efficacy data. Even after approval, vaccines are continuously monitored through pharmacovigilance. Unlike drugs given to sick individuals, vaccines are administered to healthy people, which is why safety standards are exceptionally high. If vaccines were unsafe, humanity would not have survived their widespread use. Vaccines are safe, effective, and essential for public health.

How will this initiative impact researchers and students?

Currently, no Nigerian university adequately prepares students for careers in vaccine manufacturing. As part of this project, we are already sending staff for specialised training across the world. Initially, experienced international experts will lead critical units while simultaneously mentoring Nigerian professionals.

Our facility will partner with universities to provide hands-on training in vaccine research, bio-manufacturing, good laboratory practices, and clinical research. Our laboratory in Keffi has already trained many Nigerian students, and we will expand this effort significantly. This initiative is our contribution to ensuring Nigerian graduates are industry-ready and capable of driving innovation in biotechnology and vaccine manufacturing.