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Lack Of Local Vaccine Production Delays Nigeria’s WHO Level 4 Status

Nigeria’s inability to manufacture vaccines locally is delaying the National Agency for Food and Drug Administration and Control’s (NAFDAC) attainment of World Health Organisation (WHO) Maturity Level 4 for vaccine lot release.

NAFDAC Director-General, Prof. Mojisola Adeyeye, disclosed this on Saturday at the 8th Nigeria Pharma Manufacturers’ Expo in Lagos, organised by the Pharmaceutical Manufacturing Group of the Manufacturers Association of Nigeria (PMG-MAN) and PGE Expo PVT Limited.

Adeyeye said the agency had met eight of the nine functions and requirements needed to become fully benchmarked for medicines and vaccines, with vaccine lot release remaining the only outstanding requirement.

She called for support from international development partners to establish vaccine manufacturing facilities in Nigeria, particularly a fill-and-finish modular vaccine manufacturing plant.

“We want to call on our international partners that have been of tremendous help. 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 said.

According to her, Nigeria has virtually all the requirements needed to attain WHO Maturity Level 4, except for local vaccine manufacturing capacity.

“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.

In a statement on Sunday by the agency’s Resident Media Consultant, Sayo Akintola, Adeyeye said Nigeria had previously manufactured vaccines and needed to resume local production.

“It’s high time we went back to vaccine manufacturing,” she said.

Adeyeye said support from international development partners had contributed to NAFDAC’s progress towards WHO Maturity Level 3 and would also be needed to complete the remaining requirement for Level 4.

She said efforts to improve pharmaceutical manufacturing standards had also contributed to the agency’s progress, including inspections of more than 165 pharmaceutical companies under its Good Manufacturing Practice (GMP) compliance programme.

According to her, data from 2021 to 2025 showed that imports of products affected by NAFDAC’s “5 Plus 5” policy and Ceiling Initiative declined by 70 per cent as local manufacturers increased production.

Meanwhile, the Chairman of PMG-MAN, Oluwatosin Jolayemi, called for the extension of the presidential executive order on pharmaceutical manufacturing by another two years when it expires in March 2027.

Jolayemi, who is also the Managing Director/CEO of Daily Need Limited, said medicine security and pharmaceutical sovereignty required sustained government policies and investment in local production.

He called for policy consistency, investment, capability development and a predictable operating environment to sustain local pharmaceutical manufacturing.