NAFDAC Chief Urges Foreign Partners to Back Local Vaccine Manufacturing

LAGOS, NIGERIA — Stressing the critical connection between regulatory excellence and domestic production, the Director-General of NAFDAC, Prof. Mojisola Adeyeye, has called on international partners to invest directly in local vaccine manufacturing infrastructure across Nigeria. Speaking at the 8th Nigeria Pharma Manufacturers’ Expo in Lagos, she emphasized that establishing modular fill-and-finish plants is essential for expanding national drug security.

The strategic push directly ties into NAFDAC’s ambition to achieve Maturity Level 4 (ML4)—the highest regulatory classification awarded by the World Health Organization (WHO). While NAFDAC reached WHO Maturity Level 3 in March 2022, attaining Level 4 requires establishing independent “vaccine lot release” capabilities, a regulatory function that cannot be validated without active domestic production facilities.

Regulatory Framework and Local Vaccine Manufacturing

Evaluating NAFDAC’s progress under WHO assessment parameters highlights key operational benchmarks as Nigeria pursues expanded local vaccine manufacturing capabilities:

Regulatory Benchmark & Operational Indicator	Current Status & Regulatory Baseline	Strategic Objective & Target
WHO Maturity Level	Maturity Level 3 (Achieved March 2022)	Target: Maturity Level 4 (Highest WHO Rating)
WHO Regulatory Functions	Benchmarked in 8 out of 9 functions	Outstanding Function: Vaccine Lot Release
Domestic Product Imports	70% reduction (2021–2025 period)	Driven by “5 plus 5” & ceilings policies
8th Pharma Manufacturers’ Expo	132 participating companies	Drawn from 12 countries to drive domestic investment

Fill-and-Finish Infrastructure and Import Policy Reform

During her address, Adeyeye noted that NAFDAC has calculated the estimated costs for achieving vaccine lot release certification, emphasizing that initial steps focus on modular fill-and-finish plants—where bulk vaccine is filled into vials, sealed, and packaged. Establishing these facilities will revive Nigeria’s historical footprint in local vaccine manufacturing.

“Without them we wouldn’t have been here. I want to challenge them to contribute to fill and finish modular vaccine manufacturing so that we can get our vaccine lot release,” she stated, urging international stakeholders to support the initiative.

Adeyeye credited policy support—specifically President Bola Tinubu’s 2024 Executive Order—for boosting pharmaceutical production. Audits conducted under NAFDAC’s Good Manufacturing Practice (GMP) roadmap, supported by USAID and the United States Pharmacopeia (USP), helped reduce finished product imports by 70 percent between 2021 and 2025.

Policy Consistency and Continental Health Security

Industry leaders echoed calls for sustained legislative support to ensure that investments in local vaccine manufacturing remain viable over the long term:

• Executive Order Extension: Oluwatosin Jolayemi, Chairman of the Pharmaceutical Manufacturers Group of the Manufacturers Association of Nigeria (PMG-MAN), urged the Federal Government to extend the 2024 Executive Order beyond its March 2027 expiration date to preserve policy stability.

• Continental Self-Reliance: Relying on imported vaccines leaves African nations vulnerable during global health crises, as seen during the COVID-19 pandemic. Securing WHO ML4 status for NAFDAC would allow Nigerian-manufactured vaccines to be procured internationally by agencies like UNICEF and Gavi.

• Staffing Constraints: While regulatory oversight expands, capacity remains bottlenecked; NAFDAC operates with approximately 2,000 personnel against an estimated operational requirement of 12,000 staff.

Why It Matters: Without domestic vaccine production, NAFDAC cannot achieve WHO Maturity Level 4 certification, preventing Nigerian pharmaceutical manufacturers from participating in international vaccine supply chains.

Source: ThisDay Report,  October 2026.