NAFDAC Boss, Adeyeye Pushes for Local Vaccine Manufacturing Before Leaving Office
Onyebuchi Ezigbo in Abuja
The Director General of the National Agency for Food and Drug Administration and Control, NAFDAC, Prof. Mojisola Adeyeye, has expressed the hope that the nation would manufacture vaccines before she leaves office.
She said the regulatory agency is currently working on the final stage towards securing Maturity Level 3 status (ML3) for locally manufactured vaccines.
She said that Nigeria has already gotten ML3 for medicines and imported vaccines since 2022.
According to her, the regulatory system for local vaccine manufacture is already well established in the country, but the agency is waiting local manufacture of vaccine to begin before activating it.
Adeyeye challenged manufacturers of pharmaceutical products in the country to take the necessary investment decisions that will facilitate the production of human vaccines in Nigeria.
In a statement signed by NAFDAC’s Resident Media Consultant, Sayo Akintola, the DG said the agency has been conducting Lot Release testing on imported vaccines in her laboratory for years, adding that, “the WHO wants to know that we can also effectively monitor locally manufactured ones.
“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.
“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.
Adeyeye 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.
For NAFDAC to be benchmarked for vaccines, biologics and medical devices, Adeyeye said it had to have a separate Directorate headed by a director to ensure that it aligned with international best practices.
Presently, the DG said Nigeria is operating at the same level as advanced countries of the world.
She said 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.
Adeyeye who will be three years into her second tenure in office expressed the hope that the nation would manufacture vaccines before she leaves office.
She 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 stated the Agency now has guidelines for emergency preparedness for epidemics and pandemics.
Her words: “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.’ NAFDAC became Maturity Level 3 in 2022 for medicines and imported vaccines”.
According to Adeyeye, 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.
She added the fact that Nigeria now have ML3 for medicines and imported vaccines in 2022 brought us to the discussion of manufacturing vaccines.
She explained that as a country we 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.
With attainment of ML3, Adeyeye said the agency has achieved seven of the eight requirements, but has not been benchmarked for locally manufactured vaccines.
She noted 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 statement also quoted the Director of Vaccines, Biologics, and Medical Devices Registration and Regulatory Affairs, Mrs. Khadijah Ade-Abolade, as saying that NAFDAC has put in place the regulatory frameworks for imported vaccines, and which will also be applied to local vaccines when manufacturing starts in the country.
She said: “All the required regulatory functions for the regulation of vaccines are already available. We have in place 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.”
