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 towards producing human vaccines locally.
This was contained in a statement signed by Mr. Sayo Akintola, Resident Media Consultant, and made available to newsmen in Lagos.
The statement reads partly: “Nigeria should not wait for another pandemic before it gets prepared. We must avoid being caught unawares, as we were during COVID-19, when the country depended heavily on international donors to survive the scourge.
“When I came to NAFDAC, we had the Registration and Regulatory Affairs Directorate in charge of all NAFDAC-regulated products food, drugs, cosmetics, medical devices, herbal medicines, vaccines, veterinary products, pesticides, and other finished chemicals under one Director. That structure made the system ineffective and susceptible to corruption.
“If you want good governance and leadership, you must have governable units. One Director overseeing seven regulated products will not achieve efficiency. That was why we separated vaccines and medical devices from the Drug Registration and Regulatory Affairs Directorate.
“NAFDAC became Maturity Level 3 (ML3) in 2022 for medicines and imported vaccines, and to be benchmarked for vaccines, biologics, and medical devices, we had to create a separate directorate headed by a director, aligning with international best practices and operating at the same level as advanced countries.”
Prof. Adeyeye explained that the restructuring led to the creation of a Directorate of Vaccines, Biologics, and Medical Devices in November 2024, following approval and assessment by the Head of the Civil Service of the Federation.
The move, she said, was part of NAFDAC’s strategic effort to strengthen Nigeria’s regulatory system and prepare the nation for future epidemics.
She expressed hope that Nigeria would begin vaccine production before the end of her tenure, stressing that local manufacturing remained a crucial step toward national health sovereignty.
Prof. Adeyeye noted that although Nigeria had produced veterinary vaccines since 1924, the absence of human vaccine manufacturing continued to expose the country to global supply risks.
She said NAFDAC had already developed guidelines for emergency preparedness and urged the government and private sector to act swiftly to translate regulatory readiness into production.
According to her, any country aspiring to manufacture vaccines prequalified by the World Health Organisation (WHO) must possess at least Maturity Level 3 regulatory status. Nigeria, she explained, already attained ML3 for medicines and imported vaccines in 2022 and was now working towards achieving the same for locally manufactured vaccines.
She revealed that NAFDAC remains the only National Regulatory Authority (NRA) in sub-Saharan Africa with an in-house laboratory for vaccines, biologics, and medical devices. While the South African Health Products Regulatory Authority (SAHPRA) outsourced its laboratory functions, NAFDAC’s in-house system has enabled continuous Lot Release testing for imported vaccines.
Speaking further, the Director of Vaccines, Biologics, and Medical Devices Registration and Regulatory Affairs, Mrs. Khadijah Ade-Abolade, said the federal government was already providing policy support and infrastructure to fast-track local vaccine manufacturing.
She explained that all the regulatory functions necessary for vaccine oversight from market authorisation and clinical trial supervision to post-market surveillance and pharmacovigilance were fully established under NAFDAC’s operational structure.
Prof. Adeyeye emphasised that Nigeria had the scientific expertise to begin with “Fill and Finish” vaccine production while developing full-scale greenfield facilities. She commended President Bola Ahmed Tinubu, GCFR, for prioritising local manufacturing under the Renewed Hope Agenda, describing it as the right time for Nigeria to assert self-reliance in vaccine production.