The Director-General of the National Agency for Food and Drug Administration and Control (NAFDAC), Prof. Mojisola Adeyeye, has advised manufacturers of pharmaceutical products in the country to take the necessary investment decisions that will facilitate the production of human vaccines in Nigeria.
She warned that Nigeria should not wait for another pandemic before it gets prepared and avoid being caught unawares, as witnessed during COVID-19, when the country depended on international donors to survive the scourge.
The Director-General recalled: “When I came to NAFDAC, we had the Registration and Regulatory Affairs Directorate, which was in charge of registration of all NAFDAC-regulated products, meaning the registration of food, drugs, cosmetics, medical devices, herbal medicines, vaccines, veterinary products, pesticides, and other finished chemicals was under one Director, which made the system susceptible to ineffectiveness and corruption.
“I first carved out the Food Registration and Regulatory Affairs Directorate, and what was left over was still huge. If you want good governance and leadership, you must have governable units, governable groups. One Director overseeing seven regulated products will not achieve the necessary efficiency. That was why we knew that we had to separate vaccines and medical devices from the Drug Registration and Regulatory Affairs Directorate.
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“NAFDAC became Maturity Level 3 in 2022 for medicines and imported vaccines. For NAFDAC to be benchmarked for vaccines, biologics and medical devices, she explained that we had to have a separate Directorate headed by a director to ensure that we align with international best practices, and we are operating at the same level as advanced countries of the world”, the renowned pharmacist added.
Adeyeye disclosed that the agency had to separate Vaccines, Biologics, and Medical Devices in November 2024 to form one directorate, following the Head of Service of the Federation’s assessment, evaluation, and sanction, to ensure that it would be a viable Directorate with operating units.
The Director-General, who expressed optimism that Nigeria would manufacture vaccines before the end of her tenure office, said: “It will be exciting news for me, because during the pandemic we were too dependent on foreign countries. We couldn’t get any vaccines unless from outside the country. That was when the preparedness for epidemics became a reality for us.”
She confirmed that the agency now had guidelines for emergency preparedness for epidemics and pandemics but cautioned that “if there is another pandemic now and Nigeria is not yet manufacturing human vaccines, despite having manufactured veterinary vaccines since 1924, the country will again be at the mercy of other countries.
“During the pandemic, we ran up and down to see whether we could start manufacturing vaccines, but things did not work out. We must decide as a country that we will not be too dependent on others. We will manufacture our own.”
According to her, there has been a movement to do that, but this has not come to reality and that is why she is hopeful that before her tenure is over, Nigeria will be manufacturing vaccines.
According to her, any country that wants to manufacture vaccines that will be pre-qualified by the WHO must have a regulatory system with at least Maturity Level 3 status.
Adeyeye maintained that the fact that Nigeria now have ML3 for medicines and imported vaccines in 2022 necessitated the discussion on manufacturing vaccines.
She explained that as a country, Nigeria had to fulfil the requirements of nine modules in the WHO Global Benchmarking Tool, one of which is Licensing Establishments for the Pharmacy Council of Nigeria (PCN), and NAFDAC had the remaining eight.
She pointed out that the ML3 the agency achieved was for seven of the eight, emphasizing that Nigeria hasnot been benchmarked for locally manufactured vaccines.
While noting that NAFDAC is the only National Regulatory Agency (NRA) in sub-Saharan Africa that has an in-house laboratory for vaccines, biologics, and medical devices, the Director-General disclosed the South African Health Products Regulatory Authority (SAHPRA) had a laboratory for vaccines but contracted it out to private operators.
She further clarified: “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 NAFDAC had also been conducting Lot Release testing on imported vaccines in her lab for years, but that the WHO wanted to know that the country can also effectively monitor locally manufactured ones.
Adeyeye said: “This is where we are as a country, and I pray that within a short time, we will be able to manufacture our own vaccines.”
Also speaking, Director of Vaccines, Biologics, and Medical Devices Registration and Regulatory Affairs, Mrs. Khadijah Ade-Abolade, said that the Federal Government was playing a strategic role to ensure that local vaccine manufacturing takes off in the country.
She explained that the policy had been established, and that support was being provided to ensure that vaccine manufacturing takes off in Nigeria.
According to her, the important thing is the regulatory framework, which is already established by NAFDAC and is well-functioning for imported vaccines, and which will also be applied to local vaccines when manufacturing starts in the country.
The Director said: ‘All the required regulatory functions for the regulation of vaccines are already available. We have our market authorisation, which is the registration that we do; the Inspectorate arm of the Agency conducts regulatory inspections. We have Clinical trial oversight, which is crucial for vaccine regulation, as well as Post-Market Surveillance and Pharmacovigilance, because we need to monitor the safety and efficacy of our vaccines.
Ade–Abolade maintained that the regulatory system for local vaccine manufacture was already well established in the country, stressing that the agency is just waiting for the manufacturing operations to start by the manufacturers.
She further emphasized that Nigeria had the capability to manufacture vaccines and that country can start with “Fill and Finish” while planning on the greenfield based on the soundness of the nation’s scientists.
