…Agency ready for human vaccine production
By Chioma Obinna
The Director General of the National Agency for Food and Drug Administration and Control, NAFDAC, Prof. Mojisola Adeyeye, has challenged pharmaceutical manufacturers in Nigeria to make bold investment decisions that will make the local production of human vaccines a reality.
She warned that Nigeria must not wait for another pandemic before getting prepared, recalling the country’s dependence on international donors during the COVID-19 crisis.
“When COVID-19 struck, we were at the mercy of other countries because we depended entirely on foreign supplies for vaccines. That experience should never repeat itself,” she said.
According to her, NAFDAC has strengthened its regulatory system through a major restructuring process in line with World Health Organisation, WHO, global benchmarking standards to pave the way for vaccine manufacturing in Nigeria.
“When I came to NAFDAC, the registration of all regulated products—food, drugs, cosmetics, vaccines, medical devices, herbal medicines, pesticides, and others—was under one directorate. That made the system inefficient and prone to corruption,” she explained.
“To achieve good governance, we had to create governable units. One director cannot effectively oversee seven different regulated areas. That was why we separated vaccines and medical devices from the Drug Registration and Regulatory Affairs Directorate.”
Adeyeye disclosed that the agency achieved WHO Maturity Level 3, ML3, in 2022 for medicines and imported vaccines, a global recognition that qualifies it as a functional regulatory authority.
She said that in November 2024, NAFDAC established a new Directorate of Vaccines, Biologics, and Medical Devices, following approval by the Head of Service of the Federation, to align with international best practices and ensure effective oversight.
“For NAFDAC to be benchmarked for vaccines and biologics, we needed a dedicated directorate,” she said. “We are now operating at the same level as advanced countries.”
Expressing optimism that Nigeria will soon begin manufacturing its own vaccines, Adeyeye said:
“It will be exciting news for me if, before I leave office, Nigeria begins vaccine production. We’ve been producing veterinary vaccines since 1924, yet we still depend on foreign countries for human vaccines. That must change.”
The NAFDAC boss emphasised that any country seeking WHO prequalification for vaccines must have a regulatory system with at least ML3 status.
She noted that Nigeria fulfilled nine WHO Global Benchmarking Tool modules, with NAFDAC responsible for eight of them, and has achieved ML3 for seven—except for locally manufactured vaccines, which are yet to begin.
“We are working towards ML3 for locally manufactured vaccines. WHO has verified our vaccine Lot Release indicators; what remains is local vaccine production, which will allow us to carry out facility inspections,” she added.
Adeyeye also revealed that NAFDAC is the only National Regulatory Agency, NRA, in sub-Saharan Africa with an in-house laboratory for vaccines, biologics, and medical devices.
“The South African Health Products Regulatory Authority has a vaccines lab, but it’s outsourced. Ours is fully in-house,” she said.
Speaking further, she urged manufacturers to seize the moment, noting that President Bola Ahmed Tinubu’s Renewed Hope Agenda encourages local manufacturing across sectors.
“We have capable scientists and a strengthened regulatory framework. We can start with the ‘Fill and Finish’ stage while developing full-scale manufacturing. Now is the time to get it done,” she asserted.
Corroborating the NAFDAC DG’s position, Mrs. Khadijah Ade-Abolade, Director of Vaccines, Biologics, and Medical Devices Registration and Regulatory Affairs, said the federal government is already playing a strategic role to ensure that vaccine production takes off in Nigeria.
“The regulatory framework is already established and functional for imported vaccines, and it will be applied to locally produced ones once manufacturing begins,” she explained.
She added that NAFDAC’s regulatory system already covers market authorisation, inspection, clinical trial oversight, post-market surveillance, and pharmacovigilance—all crucial for vaccine safety and efficacy monitoring.
“We are ready. What remains is for the manufacturers to begin operations,” she said.
With its strengthened regulatory framework and WHO recognition, stakeholders agree that Nigeria is now closer than ever to producing its own human vaccines—a move that could end decades of dependency and safeguard public health.
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