Vaccine Manufacturing Gap Stalls Nigeria’s Bid for WHO Maturity Level 4 Certification, Says NAFDAC

 The National Agency for Food and Drug Administration and Control (NAFDAC) has revealed that Nigeria’s current lack of local vaccine manufacturing capacity remains the primary hurdle preventing the agency from attaining World Health Organization (WHO) Maturity Level 4 status.

Speaking through a statement issued on Sunday by NAFDAC’s Resident Media Consultant, Sayo Akintola, the Director-General of the agency, Prof. Mojisola Adeyeye, explained that while Nigeria has successfully met eight of the nine regulatory functions required for WHO’s highest benchmark, the final function Vaccine Lot Release cannot be operationalized without domestic production facilities.

The Last Mile to Maturity Level 4

WHO Maturity Level 4 (ML4) represents the highest global regulatory standard, operating at an advanced level of performance with continuous improvement. Achieving ML4 status for NAFDAC would allow regulatory decisions and approvals made in Nigeria to be recognized globally, enabling local pharmaceutical companies to export vaccines and medicines seamlessly across international borders.

NAFDAC achieved WHO Maturity Level 3 in 2022, certifying the agency as a stable, well-functioning regulatory body for medicines and imported vaccines. However, progressing to ML4 requires the active capability to conduct "Lot Release"—a stringent quality-control process where every single batch of locally produced vaccine is independently tested, evaluated, and authorized before public distribution.

"To get Lot Release Maturity Level 4, we have figured it out in a way we have estimated. It's not going to cost too much. We will share that with you, because we cannot afford to go back to where we used to be," Adeyeye said.

Adeyeye emphasized that Nigeria historically possessed local vaccine production capacity and declared that returning to domestic manufacturing is critical for national health security.

"It's high time we went back to vaccine manufacturing," she noted, linking local production directly to strengthening Nigeria's broader pharmaceutical base and reducing dangerous dependence on imported biological products.

Call for International Support and "Fill-and-Finish" Facilities

To bridge the gap, NAFDAC has issued an urgent appeal to global development partners and international donor organizations. The agency called on technical partners to assist in funding and establishing modular "fill-and-finish" vaccine facilities plants that import formulated active pharmaceutical ingredients in bulk and handle the final formulation, vial filling, packaging, and quality testing locally.

"We want to call on our international partners who have been of tremendous help. Without them, we wouldn't have been here," Adeyeye stated. "I want to challenge them to contribute to modular fill-and-finish vaccine manufacturing so that we can get our vaccine lot released."

Such modular facilities are seen as a pragmatic, fast-track solution to initiate local batch production without waiting for the lengthy capital construction of full end-to-end biological synthesis plants.

Broader Gains in Local Manufacturing Capacity

Despite the delay in vaccine lot release, NAFDAC highlighted significant strides made across Nigeria’s pharmaceutical sector through deliberate regulatory policies.

The agency reported that over 165 local pharmaceutical companies have been inspected and evaluated under its Good Manufacturing Practice (GMP) compliance framework. Furthermore, data tracking from 2021 through 2025 demonstrates that imports of products restricted under NAFDAC’s "5 Plus 5" policy and Ceiling Initiative declined by 70 per cent as local production scaled up to fill supply gaps.

The announcements were made following a major pharmaceutical exposition that convened 132 participating companies from Nigeria and international delegations including the United States, China, India, Egypt, France, Germany, the UAE, Austria, Argentina, Rwanda, and Indonesia.

Manufacturers Demand Policy Stability

Stakeholders in the local manufacturing industry underscored that industrial capability requires long-term policy backing. Speaking at the event, Oluwatosin Jolayemi, Chairman of the Pharmaceutical Manufacturers Group of the Manufacturers Association of Nigeria (PMG-MAN) and CEO of Daily Need Limited, urged the Federal Government to extend the Presidential Executive Order on pharmaceutical manufacturing.

The executive order, aimed at waiving tariffs on raw materials and equipment to lower local production costs, is currently scheduled to expire in March 2027. Jolayemi advocated for an immediate two-year extension to provide investors with a predictable operating environment.

"Medicine security and pharmaceutical sovereignty require sustained government policies and investment in local production," Jolayemi stated, calling for policy consistency, capability development, and predictable access to foreign exchange for machinery.

As NAFDAC targets the final hurdle for WHO Level 4 certification, public health experts maintain that securing local vaccine manufacturing will not only unlock full international accreditation for the regulatory agency but also protect West Africa's most populous country against future pandemic disruptions.