The Director-General of the National Agency for Food and Drug Administration and Control (NAFDAC), Prof. Mojisola Adeyeye, has affirmed that Nigeria is now capable of producing its own vaccines, following significant regulatory reforms within the agency.
Adeyeye made the announcement in a statement released on Sunday by NAFDAC’s Resident Media Consultant, Sayo Akintola.
She urged pharmaceutical companies in the country to take swift investment decisions that would bring local vaccine production to fruition.
Highlighting the urgency of self-sufficiency, Adeyeye emphasized that Nigeria cannot wait for another pandemic to be fully prepared, recalling the country’s dependence on international donors during the COVID-19 crisis.
“We must decide as a country that we will not be too dependent on others. We will manufacture our own,” she said.
Adeyeye explained that NAFDAC has strengthened its regulatory framework for vaccines, biologics, and medical devices through a restructuring initiative aligned with global best practices.
The agency achieved Maturity Level 3 (ML3) in 2022 for medicines and imported vaccines, a designation from the World Health Organization (WHO) that validates a country’s regulatory competence.
“When I came to NAFDAC, we had the Registration and Regulatory Affairs Directorate, which was in charge of all regulated products. One director overseeing seven regulated products will not achieve the necessary efficiency,” she said.
To boost efficiency, the agency established a dedicated Directorate of Vaccines, Biologics, and Medical Devices in November 2024, following approval from the Head of Service of the Federation.
Adeyeye added that NAFDAC aims to reach Maturity Level 3 for locally manufactured vaccines, noting that WHO has already assessed the agency’s readiness for vaccine lot release and regulatory oversight.
“We are working towards getting our ML3 for locally manufactured vaccines. We already have ML3 for medicines and imported vaccines since 2022. WHO came last year; they saw everything that we have as a regulatory agency on indicators for vaccine lot release; we have almost satisfied everything, except that the country must manufacture vaccines, because it’s when we manufacture vaccines that we can do local facility inspections,” she said.
The NAFDAC DG highlighted that the agency has developed robust guidelines for epidemic and pandemic preparedness, stressing that local vaccine production is critical to national security.
She expressed confidence that Nigeria could initiate vaccine production in phases, beginning with “fill and finish” operations before moving to full-scale manufacturing.
“We have the capability to manufacture vaccines. The country can start with ‘fill and finish’ while planning on the greenfield. We have sound scientists. We have our President, Bola Ahmed Tinubu, GCFR, who is encouraging local manufacturing as part of the Renewed Hope Agenda. Now is the time to get it done,” she said.
Mrs. Khadijah Ade-Abolade, Director of Vaccines, Biologics, and Medical Devices, also noted that the Federal Government has provided policies and support to ensure local vaccine production begins soon.
She added that all necessary regulatory systems are in place, covering market authorization, clinical trial oversight, inspections, post-market surveillance, and pharmacovigilance.
“The regulatory system for local vaccine manufacture is already well established in the country. We are just waiting for the manufacturing operations to start by the manufacturers,” she said.
Adeyeye further highlighted that NAFDAC remains the only national regulatory agency in sub-Saharan Africa with an in-house laboratory for vaccines, biologics, and medical devices.
“The South African Health Products Regulatory Authority has a laboratory for vaccines but contracted it out to private operators,” she noted.
She concluded that NAFDAC’s restructuring and continuous improvements have positioned Nigeria among countries capable of producing their own human vaccines.
