By Iroyin Yoruba Television
Nigeria's National Agency for Food and Drug Administration and Control has called on international development partners to support the establishment of local vaccine manufacturing facilities, warning that the country's dependence on imported vaccines remains a major gap in its quest for stronger health security.
NAFDAC Director-General Professor Mojisola Adeyeye made the appeal in Lagos during the 8th Nigeria Pharma Manufacturers' Expo, where pharmaceutical manufacturers, regulators, investors and development partners discussed the future of medicine production in Nigeria.
Adeyeye said Nigeria needs to restore domestic vaccine manufacturing capacity, particularly through the establishment of a fill-and-finish modular facility that could help the country meet the remaining requirement for the World Health Organisation's highest regulatory maturity level for medicines and vaccines.
The NAFDAC chief said the agency has already met eight of the nine functions and requirements needed to achieve WHO Maturity Level 4 for vaccine lot release.
The remaining requirement is the country's capacity to conduct vaccine lot release within a functioning domestic manufacturing environment.
Vaccine lot release is an important regulatory process.
Before vaccines can be distributed for use, regulators must be able to assess and authorise individual batches according to established quality and safety requirements.
The process provides an additional safeguard by ensuring that vaccines entering the national immunisation system meet required standards.
Nigeria's inability to manufacture vaccines locally therefore has implications not only for industrial development but also for regulatory capacity.
Adeyeye said Nigeria had previously manufactured vaccines and argued that the country needs to return to local production.
Her appeal comes as Nigeria continues to depend heavily on international suppliers for vaccines used in routine immunisation and public-health campaigns.
Imported vaccines have helped protect millions of Nigerians, but reliance on external supply chains can create vulnerabilities.
International disruptions, manufacturing shortages, transportation problems, currency fluctuations and global competition for vaccines can all affect availability.
A domestic manufacturing capacity could give Nigeria greater control over at least part of its vaccine supply chain.
It could also reduce the time and logistical complexity associated with importing certain products.
However, establishing vaccine manufacturing is considerably more complicated than producing conventional pharmaceutical products.
Vaccines require highly controlled manufacturing environments, specialised technology, stringent quality systems and extensive regulatory oversight.
Manufacturers must demonstrate that their facilities, processes and products meet international standards.
This is one reason why NAFDAC's regulatory maturity is important.
Achieving WHO Maturity Level 4 would demonstrate a high level of regulatory capability in medicines and vaccine oversight.
Adeyeye said NAFDAC had already made significant progress toward that objective.
The agency has previously achieved WHO Maturity Level 3 following an assessment of its regulatory systems.
The remaining step requires Nigeria to demonstrate the capacity necessary for vaccine lot release.
The proposed fill-and-finish modular plant could provide a practical pathway toward addressing that gap.
A fill-and-finish facility generally receives vaccine material that has already undergone earlier manufacturing stages and completes the final processes required before distribution.
Those processes can include filling the product into appropriate containers, sealing, labelling and packaging under controlled conditions.
Although it is not the same as producing a vaccine's active biological components from the beginning, a functioning fill-and-finish facility can represent an important step toward domestic manufacturing capacity.
It can also provide Nigerian regulators and manufacturers with experience in handling vaccine products under local conditions.
The development could eventually support a broader vaccine-manufacturing ecosystem.
That ecosystem would require manufacturers, regulatory laboratories, research institutions, skilled personnel, quality-control specialists, supply-chain companies and specialised equipment providers.
Building those capabilities would take sustained investment.
Adeyeye therefore appealed to international development partners that have supported Nigeria's health-sector development over the years.
She argued that their assistance could help Nigeria establish the infrastructure needed to complete the remaining requirements for WHO Level 4.
International support has played an important role in Nigeria's public-health system.
Development partners have supported vaccination programmes, disease surveillance, laboratory systems, pharmaceutical regulation and other health initiatives.
The NAFDAC appeal seeks to move some of that partnership toward domestic manufacturing capacity.
The objective is not simply to secure donations of vaccines.
It is to help Nigeria develop the ability to manufacture and regulate vaccines within the country.
That distinction is important for long-term health security.
When countries rely almost entirely on external suppliers, their access to essential medical products can be affected by events outside their control.
During global health emergencies, countries with domestic manufacturing capabilities may have greater flexibility in securing supplies.
The COVID-19 pandemic demonstrated the vulnerability of international medical supply chains.
Countries around the world competed for vaccines, medicines, protective equipment and other essential health products.
The experience encouraged governments to reconsider their dependence on foreign supply chains.
Nigeria has since placed greater emphasis on pharmaceutical sovereignty and domestic production.
The vaccine manufacturing proposal fits into that wider strategy.
NAFDAC's latest appeal also comes as Nigeria's pharmaceutical manufacturing sector seeks a more predictable policy environment.
The Pharmaceutical Manufacturing Group of the Manufacturers Association of Nigeria has called for the extension of the Presidential Executive Order on pharmaceutical manufacturing after its scheduled expiration in March 2027.
Industry representatives argue that medicine security cannot be achieved through short-term interventions.
They want consistent policies, investment incentives, infrastructure development and stronger support for local manufacturers.
A stable policy environment can encourage companies to make long-term investments in manufacturing facilities.
Pharmaceutical production requires significant capital.
Companies need specialised buildings, production equipment, quality-control laboratories, skilled workers and reliable utilities.
Investors are less likely to commit large amounts of capital if policies change frequently or if operating conditions remain unpredictable.
The vaccine sector presents an even higher level of complexity.
Manufacturers need to comply with strict quality requirements and demonstrate that their products are safe and effective.
Regulatory agencies therefore play a critical role.
NAFDAC must ensure that local manufacturing does not compromise vaccine quality.
The goal is not simply to produce vaccines domestically.
The vaccines must meet the same rigorous standards expected of internationally manufactured products.
This is why WHO regulatory maturity matters.
A strong regulatory system gives patients, healthcare providers and international partners greater confidence in the quality of medicines and vaccines manufactured or released in the country.
NAFDAC has invested in strengthening its regulatory infrastructure.
The agency's Yaba laboratory achieved WHO prequalification in September 2023, an important milestone for Nigeria's pharmaceutical regulatory system.
Adeyeye also said NAFDAC has conducted inspections of more than 165 pharmaceutical companies under its Good Manufacturing Practice compliance programme.
Good Manufacturing Practice standards are designed to ensure that medicines are consistently produced and controlled according to quality requirements.
They cover areas such as facilities, equipment, personnel, documentation, production processes and quality assurance.
For vaccine manufacturing, these controls are particularly important because vaccines are biological products and can be sensitive to manufacturing conditions.
The proposed domestic manufacturing initiative will therefore require close cooperation between regulators and manufacturers.
Manufacturers need to understand regulatory requirements from the earliest stages of facility design.
Regulators also need sufficient technical expertise and laboratory capacity to assess complex vaccine products.
That relationship can help reduce delays while maintaining safety.
Nigeria's pharmaceutical industry has already demonstrated some progress in reducing dependence on imported medicines.
According to data cited by NAFDAC, imports of products affected by the agency's "5 Plus 5" policy and Ceiling Initiative declined by 70 per cent between 2021 and 2025 as local manufacturers increased production.
The figure indicates that domestic manufacturing policies can influence the structure of the pharmaceutical market.
The challenge is extending that progress to more technologically complex products such as vaccines.
Local vaccine production could also create opportunities for Nigerian scientists and pharmaceutical professionals.
The industry would require specialists in microbiology, biotechnology, quality assurance, regulatory affairs, engineering, laboratory science and supply-chain management.
Universities and research institutions could potentially benefit from stronger links with manufacturers.
Research and development capacity could also grow as local institutions gain experience with vaccine technologies.
Over time, Nigeria could potentially develop capabilities beyond fill-and-finish operations.
The country could work toward more comprehensive vaccine production and eventually participate in regional supply chains.
That would have implications for Africa's broader health-security ambitions.
Many African countries rely heavily on vaccines manufactured outside the continent.
Developing manufacturing capacity in several African countries could reduce dependence on distant suppliers and improve the continent's ability to respond to outbreaks.
Nigeria's large population and pharmaceutical market make it a potentially important part of that effort.
The country's manufacturing capacity could eventually serve both domestic needs and selected regional markets, provided international quality standards are met.
However, achieving that objective requires sustained investment.
The first priority is establishing a viable facility.
The second is ensuring that the facility operates efficiently and consistently.
The third is creating a market capable of supporting production.
Domestic manufacturers need predictable demand to justify investment.
Government procurement and immunisation programmes can provide part of that demand.
Long-term procurement agreements can also help manufacturers plan production and investment.
Public-health authorities will nevertheless need to balance domestic procurement with cost, quality and supply considerations.
Local production should not automatically mean purchasing products at any price.
Manufacturers must become competitive while maintaining quality.
This is where policy incentives may be important during the early stages.
Government could potentially use targeted incentives to reduce the cost of establishing manufacturing facilities while requiring manufacturers to meet clear performance and quality standards.
The industry also needs reliable electricity.
Pharmaceutical manufacturing facilities require stable power because temperature-controlled systems, laboratory equipment and production processes can be sensitive to interruptions.
Reliable water supply and specialised waste-management systems are also essential.
Transport infrastructure matters because vaccines require controlled handling and distribution.
The cold chain is particularly important.
Many vaccines must be stored and transported within specified temperature ranges.
A manufacturing facility is therefore only one part of the supply system.
Nigeria would also need strong distribution infrastructure capable of maintaining product quality from the factory to vaccination centres.
This makes vaccine manufacturing a national infrastructure project rather than a single-company initiative.
It requires coordination between regulators, manufacturers, government agencies, development partners, logistics providers and healthcare institutions.
The proposed modular approach could make the first stage more achievable.
Instead of attempting to establish a massive end-to-end vaccine manufacturing complex immediately, Nigeria could begin with a strategically designed facility capable of completing specific manufacturing stages.
That could allow the country to build technical capacity while planning more ambitious production in the future.
NAFDAC's call for international support is therefore focused on a practical starting point.
The agency believes Nigeria already possesses much of the regulatory foundation needed to move forward.
The remaining challenge is building the manufacturing capacity required to support vaccine lot release.
For Nigerian families, the importance of the project is ultimately measured in access to safe and reliable vaccines.
Vaccination remains one of the most effective tools for preventing serious infectious diseases.
Nigeria continues to face outbreaks of vaccine-preventable diseases in some communities, making reliable access to quality vaccines an important public-health priority.
Domestic production would not eliminate the need for international cooperation.
Nigeria would continue to benefit from international research, technology partnerships and global health programmes.
But local manufacturing could give the country greater resilience when international supply chains are disrupted.
It could also strengthen national expertise.
The development of local manufacturing capabilities can create knowledge that remains within the country.
Scientists, engineers and regulators gain experience that can be applied to future health challenges.
That experience becomes particularly valuable during emergencies when rapid decision-making is required.
The COVID-19 pandemic demonstrated that countries with stronger domestic manufacturing capabilities have more options during global crises.
Nigeria's current push is therefore part of a broader effort to strengthen preparedness for future emergencies.
The country's vaccine manufacturing ambitions are also linked to its broader pharmaceutical sovereignty strategy.
Reducing dependence on imported medicines can improve national resilience, but it requires more than government declarations.
It requires factories, skilled personnel, capital, reliable infrastructure, effective regulation and predictable demand.
NAFDAC is now calling for the partnerships needed to move that process forward.
The agency's appeal places international development partners in a position to support infrastructure development while allowing Nigeria to assume greater responsibility for production.
The proposed fill-and-finish facility could become a starting point for that transition.
The next steps will require detailed financing, technical planning, facility development and regulatory preparation.
Manufacturers will also need to determine which vaccine products could initially be produced or completed domestically.
Regulators will need to assess the facility and its processes.
The WHO requirements for vaccine lot release will remain an important benchmark.
Achieving Maturity Level 4 would represent a significant milestone for NAFDAC and Nigeria's health system.
It would demonstrate that the country has developed a regulatory framework capable of supporting sophisticated vaccine oversight.
For Nigeria, however, the significance goes beyond an international ranking.
The real benefit would be a stronger system capable of ensuring that vaccines reaching Nigerian patients meet rigorous standards while reducing vulnerability to external supply disruptions.
That is why Adeyeye has described the return to vaccine manufacturing as a priority.
Nigeria once had domestic vaccine production capability.
Rebuilding that capacity will not be easy, but the current pharmaceutical environment may provide a stronger foundation than existed in previous decades.
The country's pharmaceutical industry is larger, its regulatory system has developed significantly and demand for medical products continues to increase.
Those factors could support a renewed manufacturing effort.
The challenge is converting that potential into sustainable production.
Government, industry and international partners will need to work together.
Investment decisions must be backed by long-term policies.
Regulatory systems must remain strong.
Manufacturers must meet international quality requirements.
And health authorities must ensure that domestic production contributes meaningfully to public-health needs.
If those conditions are met, Nigeria could gradually reduce its dependence on imported vaccines while strengthening its pharmaceutical sector.
The benefits could extend to employment, technology transfer, scientific research and regional health security.
The immediate goal, however, is clear.
NAFDAC wants Nigeria to establish the capacity necessary for vaccine lot release and move toward WHO Maturity Level 4.
Achieving that goal would mark an important step in the country's effort to build a more self-reliant health system.
For millions of Nigerians who depend on vaccines to prevent serious diseases, stronger domestic manufacturing could ultimately provide greater security.
The project therefore represents more than an industrial ambition.
It is a public-health investment aimed at ensuring that Nigeria has greater control over essential medical products when the country needs them most.