By Hassan Zaggi
The plan by Nigeria to manufacture its vaccines locally within the country is gradually coming to fruition.
This is even as the National Agency for Food and Drug Administration and Control (NAFDAC) has disclosed that it is targeting the second quarter of 2024 to attain Maturity Level (ML) 4, a standard set by the World Health Organisation (WHO).
It would be recalled that NAFDAC was certified ML3 by the WHO in March 2022.
Even though the mandate of NAFDAC does not include the production of vaccine, but “the Agency’s mandate is to ensure that any vaccines manufactured have the quality, safety, and efficacy based on international standards.”
Responding to questions exclusively from THE AUTHORITY, on Nigeria’s effort towards local vaccine production, the Director General of NAFDAC, Prof. Mojisola Adeyeye, disclosed that the production of local vaccine that can be eligible for WHO Prequalification is dependent on the attainment of Maturity Level 3 (for medicines and imported vaccines) only, which she revealed, NAFDAC achieved in March 2022.
NAFDAC, according to her, has targeted 2024 for the attainment of ML4 for medicines and imported vaccines.
“However, attainment of Maturity Level 4 Lot Release specifically (for vaccine producing countries), is dependent on existence of local vaccine manufacturing facility.
“The Agency has set her goals and developed the roadmap with timelines to effectively address all the requirements to reach ML4 for Lot release by first quarter of 2024.
“This date is also dependent on the readiness of the local manufacturing industry for human vaccine production and the WHO schedule to conduct the benchmarking mission,” she said.
The NAFDAC Director General, however, explained that for the country to begin local manufacturing of the vaccine, there are several components and segments of the country’s system that have an input into preparation for vaccine production in the country.
She explained that there is the policy direction from government, research and development input to ensure sustainability and meeting country-specific vaccine needs, manufacturing industry contribution to ensure availability of vaccines for use, regulatory component to ensure quality safety and efficacy of the vaccines.
Other components, she said, include the availability of manufacturing talent and workforce, financing mechanisms, intellectual property protection issues, distribution and supply chain infrastructure etc.
“From the regulatory perspective, NAFDAC is putting in tremendous efforts to fulfil the requirements of the WHO Global Benchmarking of National Regulatory Authorities (NRAs) to reach ML4 for all regulatory functions including Vaccine Lot release function by first quarter of 2024.
“For example, the Gazetting of the Lot Release Regulation for human vaccine to give legal backing to release of lots of manufactured vaccines, conduct of internal benchmarking of the regulatory system to identify gaps to enable closure before the actual benchmarking by WHO and implementation of other regulatory tools have reached an advance stage.
“The Agency has also embarked on rigorous human capacity building in the areas of vaccine Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), vaccine quality control, lot release and supply chain traceability to appropriately position the Agency for effective regulation of locally manufactured vaccines.”
She further explained that from the industrial perspective, strategic efforts and concerted steps are being deployed in engaging potential vaccine manufacturers to enable the production of vaccines in Nigeria.
Responding to a question on how prepared are the laboratories in NAFDAC at the moment, she said: “It should be noted that NAFDAC is the only regulatory authority in sub-Saharan Africa that has an in-house National Control Laboratory for Vaccines and Biologics (NCLVB).
“NAFDAC has been conducting laboratory testing and lot release of imported vaccines since establishment of the NCLVB in 1999.
“The Agency is currently building a state-of-the-art Vaccine Control Laboratory in Oshodi, Lagos to increase our capacity and provide vaccine QC and lot release services, serve as a reference laboratory for other regulatory authorities among other functions.
“The Laboratory is over 70% completed as civil works have been concluded and installation of facilities are ongoing.”
While calling on stakeholders to join forces together to ensure that vaccines are manufactured locally due to its security importance, Prof. Adeyeye said: “It is imperative for all stakeholders to know that vaccine self-sufficiency, just like medicines self-sufficiency is a matter of national security and should be given the priority it deserves.
“We are all aware of the challenges the country faced during the COVID-19 pandemic in getting vaccines and other medical products for our use because we are dependent on products manufactured in other countries.
“It is not unexpected that those countries will want to secure the well-being of their citizens first before considering other countries like Nigeria.
“Therefore, we do not have any option other than to ensure we put in place systems to enable us to cater for our health needs in-country.
“A lot of work is ongoing from the government Public Private Partnership with May and Baker Nigeria PLC, and few other private manufacturers for local manufacturing of vaccine.”
She, however, advised that “the country needs to speed up the pace of these activities and translate ongoing plans into action.
“For instance, the national strategic plan for local vaccine production is being developed and this needs to be propelled into action at the earliest as nobody knows when the next epidemic/pandemic will be.”
On his part, the Director General of the National Institute for Pharmarceutical Research and Development (NIPRD), Dr. Obi Adigwe, disclosed that vaccine and biotech Research and Development (R&D) does not begin by putting a plant down
He made the assertion while addressing a delegation from some Non Governmental Organisations (NGOs) that paid him a courtesy visit in his office, recently.
“It starts from advocacy. It starts from theories and policies. There is the very famous case of an ABI plant that was established in Ghana and because there was no appropriate policy environment it died.”
It would be recalled that Nigeria’s effort to manufacture vaccines locally started many years ago.
In the 1990s, Nigeria produced much of the vaccines needed in the country and other nations in Africa. Those vaccines were produced at the Federal Vaccine Production Laboratory, Yaba in Lagos State – the first vaccine institute established in the country.
The Laboratory was created from the Rockefeller Yellow Fever Laboratory that had been in existence in Yaba, Lagos, since 1925.
However, in the 1930s, it started to produce vaccines against smallpox, then rabies, yellow fever, for not only Nigeria but also neighbouring countries like Cameroon, Central Africa, and others on the continent.
This laboratory was said to have contributed tremendously to the elimination of smallpox from West Africa. Smallpox is the only human infectious disease to have been eradicated. Its eradication is a major historical triumph of global healthcare.
But it was unfortunately, shut down in 1991 by the government, which said it wanted to reactivate and upgrade the facility, which is yet to commence vaccine production three decades later.
