Unlike the rest of the world, especially developed countries, it has been a long walk for Nigeria to get the nod of the World Health Organization (WHO) to produce vaccines, including COVID-19 vaccine.
Attaining this is no mere feat for Nigeria, considering the humongous amount of efforts the Federal Government, alongside its development partners have put in to make this a reality. The National Agency for Food and Drug Administration and Control (NAFDAC) actually started the business rolling, while Bio-Vaccine Nigeria Limited (BVNL) got involved in the completion of the documentation and the interviews. The Federal Ministry of Health officials then went on diplomatic shuttles to seal the deal – the winning team!
Many African countries competed to be listed for vaccine production, however only six countries emerged victorious – including Nigeria. The fact that Nigeria was selected clearly shows it has a lot of competence in that regard.
Information gathered by The Nation showed that the country seems to have met the sundry criteria put in place by the WHO before any country can be deemed fit to produce vaccines. One of such conditions is the attainment of maturity level three (3) in terms of laboratory testing. This can only be achieved when a country has successfully fulfilled the 868 recommendations by the global health body.
As of October 15, 2021, the country had met all 868 recommendations by the WHO, according to the Director General of the National Agency for Food and Drug Administration and Control (NAFDAC), Prof Mojisola Adeyeye, in November last year.
The NAFDAC boss disclosed that Nigeria is now leading globally, and is being recognised internationally for the monitoring of vaccines in the supply chain. In fact, Oxford University recognises what NAFDAC is doing and they called it “Abuja Principles.”
Prof Adeyeye said: “This global benchmarking audit wouldn’t have been possible if we did not adopt a change in culture and the way we think of customers. We started using ISO 9001 in January of 2018. We did this in parallel to the WHO auditing.
“Part of the global benchmarking is laboratory testing. They told us that we had to expand our laboratories in order to be able to get to maturity level three. Part of that expansion includes the drug laboratory in Yaba and the vaccine laboratory. The government came to our aid about this as part of improving the health sector. The vaccine laboratory is being built now in Oshodi, and we should be seeing the completion towards the middle of 2022.
“For a regulatory agency to be deemed strong, you have to make sure that the supply chain, which NAFDAC is supposed to be overseeing in terms of distribution, should be strong. We adopted DS1-driven traceability which the Honourable Minister launched in 2020 or late 2019.
“The monitoring of our commodities, including vaccines that we are using as pilot, is to ensure there is no infiltration of substandard and falsified vaccines in the supply chain.”
Implications of the WHO listing
February 18, 2022, will remain a momentous day in the historical annals of the country, as it was the day the World Health Organization named Nigeria, alongside five other countries – Egypt, Kenya, Senegal, South Africa and Tunisia, as the first countries on the African continent that would receive the technology needed to produce the Messenger RNA (mRNA) vaccines, in order to protect their citizens against the deadly COVID-19. The announcement was made at the European Union (EU) – African Union (AU) Summit in Brussels.
In short, Messenger RNA (mRNA) vaccines teach the body cells how to make a protein that will trigger an immune response inside our bodies. Like all vaccines, mRNA vaccines benefit people who get vaccinated by giving them protection against diseases like COVID-19 without risking the potentially serious consequences of getting sick. The Pfizer-BioNTech and Moderna COVID-19 vaccines are mRNA vaccines.
According to the latest global updates on COVID-19 from the WHO, as of February 24, 2022, there have been 428,511,601 confirmed cases of COVID-19, including 5,911,081 deaths. Also, as of February 21, 2022, a total of 10,407,359,583 vaccine doses have been administered.
In Nigeria, data from the Nigeria Centre for Disease Control (NCDC), showed that as of February 24, 2022, the country has recorded a total of 254,428 confirmed cases, with 248,850 discharges, and sadly, 3,142 deaths.
Also, in terms of COVID-19 vaccination, latest data from the National Primary Health Care Development Agency (NPHCDA), showed that as of February 24, 2022, 17,494,069 of total eligible persons targeted for COVID-19 vaccination were reached with first dose while 7,936,257 were reached with second dose (fully vaccinated).
Although the African continent has been the least affected with 8,308,215 confirmed cases, it has vaccinated the least eligible populations due to unavailability and inaccessibility of the vaccines. This is largely due to the vaccine nationalism by richer countries, which the WHO has vehemently condemned.
The WHO stresses that no one is safe until everyone is safe; by this, it means that the hoarding of vaccines by rich countries to cater for only their citizens will only frustrate the collective drive to stop the spread of the COVID-19 virus.
During the announcement of the countries to be provided with technology, technical assistance etc., to produce vaccines, the Director General of the WHO, Dr Tedros Ghebreyesus, said: “No other event like the COVID-19 pandemic has shown that reliance on a few companies to supply global public goods is limiting and dangerous.
“In the mid to long-term, the best way to address health emergencies and reach universal health coverage (UHC) is to significantly increase the capacity of all regions to manufacture the health products they need, with equitable access as their primary endpoint.”
The global mRNA technology transfer hub was established in South Africa in 2021 to support low and middle-income countries in manufacturing their own mRNA vaccines – with the required operating procedures and know-how to meet international standards.
The WHO notes that although the primary aim of setting up the hub is to address the COVID-19 emergency, it however has the potential to expand its capacity to manufacture other vaccines. This puts countries in the driver seat when it comes to the kinds of vaccines needed to address their health priorities.
After three decades of inactivity, is Nigeria getting it right with BVNL?
A little over four years ago, the Federal Government got together with the big pharmaceutical company – May and Baker, to set up a private company called Bio-Vaccine Nigeria Limited (BVNL) for local vaccine production. The government’s share in terms of assets in the partnership is valued to be about N1.3 billion. As it stands today, the Federal Government is a 49 per cent shareholder in the company. The remaining 51 per cent is the ownership share of May and Baker.
The purpose of the joint venture between the Government and the pharmaceutical company was to bring to life, the Federal Vaccine Production Laboratory in Yaba, Lagos State.
The laboratory, which is now moribund for over three decades now was the darling and pride of the country because it was a foremost vaccine production facility in Africa, which operated between 1940 to 1991 when it was shut down.
The facility produced large quantities of vaccines against yellow fever, smallpox, and rabies for the country. In fact, it also produced vaccines for neighbouring African countries like Cameroon.
Another opportunity for redemption has come with the WHO listing of Nigeria to produce vaccines. Nigeria cannot afford to fail, else it risks being the laughing stock of the global community.
The Minister of Health, Dr Osagie Ehanire and other stakeholders in the health sector have continued to advocate that Nigeria needs to begin to invest heavily in vaccine production, as lessons from COVID-19 have shown that the country cannot continue to rely on other countries for the protection of its people.
The Federal Government in October 2021, launched a new vaccine policy meant to enhance access and use of vaccines for protection of citizens from infectious diseases. Dr Ehanire explained that the vaccine policy would create a supportive environment for access and use of vaccines to protect citizens.
BVNL is expected to use appropriate technologies in modern vaccines production to boost local production of vaccines in Nigeria, and make vaccines available to Nigerians, and probably the entire West Africa.
Reacting to the WHO’s announcement, Nigeria’s foremost virologist and Chairman of the Ministerial Expert Advisory Committee on COVID-19, Prof Oyewale Tomori, in a chat with The Nation, said: “This is a matter of national importance requiring urgent action. Bio-Vaccine Nigeria Limited (BVNL) is already in place to work on and implement required action for success. Because of the national relevance and global importance of the project, we should set up an advisory committee of relevant stakeholders from private industry, public enterprises, research and development experts and civil society to work with BVNL.
“We have read positive comments from the government on this matter. Government should move beyond comments and upgrade to commitment – financial, moral, accountable and transparent commitment. This issue requires immediate and sustainable commitment, no matter the outcome of the 2023 elections.
“BVNL has already identified available skill sets and gaps. This will be fine-tuned as soon as details of future activities are available. BVNL will be working with WHO and partners to address these issues. We will complement our skill needs in the areas of research and development, technology transfer, vaccine discovery development and production. BVNL will work with NAFDAC on regulatory issues, and sourcing finance from development banks and agencies, locally and internationally.
“This selection is a catalyst to accelerate national plans through BVNL for local vaccine production. It is also a unique opportunity, through research and development, to improve on existing vaccines, as well as develop and design vaccines targeted to control specific diseases unique to our environment, which do not attract global interest.”
The Registrar and Secretary-General of the West African Postgraduate College of Medical Laboratory Science, Dr Godswill Okara, while speaking with The Nation, stressed that vaccine production is not rocket science, as the country has the required skillset and competences to get it done.
“Concerning the production of COVID-19 vaccines and other vaccines, it should be a wakeup call for Africa and Nigeria. The earlier we realise that our destiny is in our hands, the better for us. We have the resources because the production of vaccines is not rocket science. They are things that we have done before. As we speak, up to 18 different animal vaccines are being produced in Nigeria. It is the same procedure and principle. We produced millions of doses of smallpox and yellow fever vaccines in Nigeria. Yes, we used analogue procedures; you don’t abandon what you know best to do just because you are waiting to update your procedure and acquire new technology.
“Medical laboratory scientists are trained and skilled in the production of vaccines – that is part of our training. It is only a matter of providing the enabling environment. The human vaccine production laboratory in Yaba has gone into dilapidation for decades now. We make production of vaccines look like it is rocket science. It is not.
“For Nigeria to go cap in hand begging for vaccine donation and allocation is ridiculous. The people that produced smallpox, yellow fever vaccines in Yaba, many of them are still alive. If the government makes available the things that are needed, and brings together the people whose training and professional practice is all about vaccine production, we can produce vaccines,” he said.
Professor of Public Health Parasitology and Director of McCarthy Study Centre of National Open University Nigeria, Mba Okoronkwo, added: “Although vaccines are not the actual cause of the immunity that Nigerians have developed, however, I think it is a welcome idea. If the WHO and other health organisations believe that COVID-19 vaccines are efficacious, and that citizens need to be vaccinated to get protected, then that is very welcomed.”
Speaking about the listing of Nigeria among countries to be supported to produce COVID-19 vaccines, during the GAVI Alliance high level mission delegates’ visit to the National Strategic Cold Store, the Executive Director and Chief Executive Officer of the National Primary Health Care Development Agency (NPHCDA), Dr Faisal Shuaib, said: “It is exciting news coming to Nigeria and it will be a very strong platform for us to develop local vaccine production capacity. Of course, the federal government in the last few years had heightened the collaborations that needed us to get to this stage. This was not an overnight success. This has come from several months and years of the Honourable Minister of Health engaging with our networks of donors and developing partners.
“For us at the NPHCDA, there is no better news than the opportunity for us to be able to vaccinate our citizens, using vaccines that are locally produced. That will increase the confidence that people have in the vaccines that are being administered – both routine immunisation vaccines and COVID-19 vaccines.”
Nigeria needs between about $60 million for a vaccine production facility
Stakeholders in the health sector have urged the Federal Government to rally the private sector to begin the process of the sourcing of domestic funding for the production of vaccines.
They noted that the Central Bank of Nigeria (CBN) can work with the Coalition Against COVID-19 (CACOVID) to develop some platform/initiative to kick-start the process. The Nation gathers that Nigeria needs about $60 million to achieve the vaccine production plant.
Recall that last year, the Minister of Health, Dr Osagie Ehanire stated that the Government had earmarked N10 billion for the production of vaccines.
“In our own home, believing that it is possible to easily find a partner to import the technology to produce our own vaccines here, the National Assembly earmarked N10 billion for the production of vaccines. I will assure you that not one penny has been taken out of it. It Has not been too easy to import that technology to start producing COVID-19 vaccines.
“Therefore, the aspiration to produce vaccines has not been fulfilled. It is not that it is abandoned; we are working on it and I have spoken with one of the members of the board of management of the bio-vaccine and we are working on getting that technology to both produce routine vaccines and also covid-19 vaccines under license and importation of the technology and partnership for it,” he said.