Efforts to restart local manufacture of vaccines suffer setbacks

Controversy shrouds initiative to begin local manufacture of vaccines

Five years after, Nigeria’s quest to get its first set of locally manufactured vaccines is still a mirage.

The Guardian investigation revealed that the firm floated to achieve this target, Biovaccines Nigeria Limited, has yet to complete building the state-of-the-art pharmaceutical manufacturing facility needed for the vaccines.

Also, the facility, when completed, would have to be prequalified by the World Health Organisation (WHO) before it starts producing vaccines.

It was also gathered that the N10 billion released by the Federal Government for the flag-off of the project is yet to get to the management of Biovaccines.

The Federal Government had in 2017 inaugurated an initiative to begin local production of essential vaccines. May and Baker Plc., an indigenous pharmaceutical industry had signed a Memorandum of Understanding (MoU) with the Federal Government, which was vetted by the Federal Executive Council (FEC) to immediately begin local production of vaccines.

According to the MoU, the project, handled through Biovaccines Nigeria Limited (BVNL), will build local capacity in vaccine production as well as develop a centre of excellence for research and development of vaccine technology and other biologics.

Nigeria was expected to roll out her first locally produced vaccines in July 2019 after a long while, beginning with the jabs against yellow fever, tetanus toxoid and hepatitis B after resuscitating a manufacturing line at the defunct National Vaccine Production Laboratory (NVPL) in Yaba, Lagos, which was acquired by BVNL.

Stakeholders said the project would help Nigeria to better respond to emergencies like Cerebro Spinal Meningitis (CSM), yellow fever, COVID-19 among others, generate internal revenue and increase the Gross Domestic Product (GDP) of the country.

What a paradox. Nigeria was not only producing vaccines for smallpox, yellow fever, and anti-rabies vaccines, between 1940 and 1991, but also exported to Cameroon, Central African Republic and a few other countries.

However, in 1991 the NVPL in Yaba, Lagos, stopped production because the government claimed it wanted to reactivate and upgrade the facility, which did not take place until today.

Unfortunately, Nigeria spends over N7 billion yearly importing vaccines, with about 80 percent cost of vaccines being subsided by Global vaccine initiative (GAVI).

A virologist and Chairman of Governing Board, Biovaccines, Prof. Oyewale Tomori, raised the alarm that some people are trying to scuttle plans to manufacture vaccines in Nigeria.

The WHO had chosen Biovaccines as the company for its plan to make Nigeria a vaccine-manufacturing hub. But Tomori told The Guardian: “I am sending this to you to confirm that it is Biovaccines that WHO chose. But we have the ministers of health and agriculture fishing for another location in Vom, Jos, to use veterinary facility meant for producing vaccines for animals to produce COVID-19 vaccines. It is a dead on arrival proposal creating confusion and doubt in the mind of external partners. Nigeria keeps surprising me.”

The WHO and the Medicines Patent Pool (MPP) had announced the names of the 15 manufacturers including Biovaccines that will receive support from the mRNA technology transfer programme. The programme is based around a technology transfer “hub” Afrigen, which is located in South Africa.

On whether Biovaccines is going to benefit from WHO’s plan to support African countries on local manufacture of vaccines, Chief Operating Officer at Biovaccines Nigeria Limited, Mr. Everest Okeakpu, told The Guardian: “Yes, following the introduction by the Director General (DG) of National Agency for Food and Drug Administration and Control (NAFDAC) and the submission of the required Expression of Interest by Biovaccines Nigeria Limited (BVNL), Nigeria was announced by the WHO DG, at the recently concluded 7th EABF 2022, in Brussels, Belgium, on February 18, 2022, as one of the six countries to serve as spokes to produce mRNA vaccines in Africa.

“Already, BVNL has had series of meetings with Afrigen Biologics, the Hub in South Africa, and other partners, on an integrated work plan that will guide our national plan for obtaining and adapting the mRNA technology for pandemic preparedness and to support Universal Health Coverage in Nigeria.”

On which vaccines are the country’s priorities, Tomori said the focus is on vaccines used for routine immunisation and there is also the plan to adapt the mRNA technology for developing novel vaccines for other vaccine preventable diseases (VPD’s) example, Lassa fever.

Recalling the challenges, Tomori said the major challenge has been that of ensuring that Nigeria is focused and pulls in one direction to achieve this most important national objective. He said the Minister of Health, Dr. Osagie Ehanire, has been working very hard on this.

On if the counterpart funding for Biovaccines was captured in the Federal Ministry of Science, Technology and Innovation (FMST&I) budget, Tomori said: “The Federal Government of Nigeria is presently represented in Biovaccines through the Federal Ministry of Health, and not FMST&I. Indeed, the equity contribution of government in the BVNL joint venture, are the old vaccines manufacturing facilities in Yaba, Lagos. So, really, no counterpart funding, that is, actual cash has ever been released to BVNL.”

On what has become of the N10 billion released for the project few years ago, Tomori said: “For the avoidance of doubt, no (cash) has been released to BVNL. Federal government equity is purely the landed properties at Yaba and the old buildings, which have not been put to use since vaccine production was stopped in the 1990s. Specifically on the much publicised N10 billion funding, BVNL is yet to access that fund. However, efforts are being made by all stakeholders to ensure that money is released to BVNL through the Central Bank of Nigeria (CBN).”

On what must be done to urgently produce vaccines locally, Tomori said: “We must focus, concentrate and collaborate on current BVNL efforts, by all stakeholders. Nigeria must see the successful completion of the BVNL initiative as crucial and necessary to end our dependence on foreign sources for our vaccine needs, the enhancement of our national development and upholding of our national pride.”

To urgently produce vaccines locally, Tomori recommended that the title documents of the FGN equity contribution to BVNL be released without further delay; urgently move forward with and complete the processes on activating the market access (conditional for technology transfer) MoU between Federal Ministry of Health (FMoH) and BVNL; and release the N10 billion appropriated for local production of vaccines to BVNL on mutually agreed terms.

He told journalists that the infusion of N10 billion is a “needed spanner to repair the wheel of vaccines production” in the country, but regretted that the 15-month delay in the release of the fund has become a “spanner thrown into the wheel of progress.”

He added that the N10 billion should be released and in full.

“Nigeria being able to manufacture her own vaccines will make her better prepared to respond more effectively and adequately to future pandemics and to the COVID-19 pandemic that has continued to evolve,” he added.

A virologist and vaccinologist and Chief Executive Officer (CEO) of Innovative Biotech Limited, based in Keffi, Nasarawa State and the United States (U.S.), Dr. Simon Agwale said the Innovative recently signed a deal with the German biotech firm for local production of vaccines in Nigeria. He said the end-to-end vaccine development and manufacturing capacity when built will enable Nigeria to handle the current pandemic, and future epidemics/pandemics.

Agwale, who was elected to lead the COVID-19 vaccine task team of the African Vaccine Manufacturing Initiative (AVMI), said the initiative will support the response to disease outbreaks and scale up the deployment of experts in the country, and also train scientists on vaccine development and other vaccine related activities. This strategy will bring the needed knowledge-based economy to the country.

He said Africa has around 16 per cent of the world’s population and carries 25 per cent of the world’s global disease burden. “Over 50 per cent of the world’s infectious diseases burden (HIV, Ebola, Lassa fever, etc.) is borne by Africa. Less than one per cent of the vaccines required by Africans are produced in Africa, creating a significant health security risk. Innovative Biotech will help reduce Africa’s dependency on imports for critical vaccines,” Agwale said.

Agwale said Innovative Biotech will manufacture vaccines in Nigeria, and the vaccines will be sold on the continent for local consumption. “Thus, Innovative Biotech will be key player in reducing Africa’s reliance on vaccine imports, and therefore contribute to strengthening Africa’s Health security,” he said.

He, however, said the COVID-19 vaccine work is currently ongoing in the US in collaboration with industry partners. “The initial production will be done in the US until our factory is up and running in Nigeria. We target a second generation COVID-19 vaccine with more durable immunity,” Agwale said.

Meanwhile, experts are excited that Nigeria was chosen by WHO as one of the six African countries to serve as hubs for manufacture of COVID-19 vaccines.

President, National Association of Resident Doctors (NARD), Dr. Dare Ishaya, told The Guardian: “Definitely, it will. If Nigeria is chosen, it will be a huge plus for our health sector.”

Ishaya said the vaccines of priority are those against childhood illnesses. He said the national immunisation programmes cover killer diseases such as tuberculosis, pertussis, whooping cough, yellow fever, measles, hepatitis B, polio and the likes. “We could look to add a few more to them. These should be our priority,” he said.

Ishaya said the challenges towards local manufacture of vaccines are like those in every sector. “The challenge of transparency and accountability is a huge issue in this country. Peculiar to the manufacturing of vaccines will be the challenge of power, especially to maintain the cold chain and ensure that the vaccines are still potent when they reach end-users,” he said.

On the N10 billion promised for Biovaccines by the Federal Government, Ishaya said: “I’m not sure about that. The last I heard was that the project was going to cost about $30 million.

“I’m not sure about that either but the project could cost a lot more, which means there’s a need for more funding.”

To revamp local vaccine production, he said: “There’s a need for a stable power supply, increased access to loans with low-interest rates, and taxation on such industries should be friendly enough to allow them to grow. Also, there is need to develop policies that will encourage local production and protect the country from being a dumping ground for substandard or even fake vaccines.”

Also, Director General, National Agency for Food and Drug Administration and Control (NAFDAC), Prof. Christianah Adeyeye, told journalists that all is set for Nigeria to begin local production of vaccines by the end of this year.

Adeyeye, at a media parley in Lagos, claimed: “We are working day and night to make sure that by the end of the year, we start manufacturing of vaccines. That doesn’t mean that we will produce completely developed vaccine.”

On the Biovaccine initiative, she said: The Federal Government also has a Public Private Partnership (PPP) arrangement with Biovaccines or with May and Baker rather to form Biovaccines. The government has 49 per cent and May and Baker has 51 per cent. The goal is to be able to manufacture vaccines and this arrangement started long time ago. So, it not just because of COVID-19 pandemic,” she added.

Adeyeye, who is also a pharmacist, said Nigeria is upbeat about manufacturing of local vaccines because NAFDAC had achieved Maturity Level 3.

It explained that the two new entrants’ medical products regulatory agencies had achieved Maturity Level 3, the NAFDAC DG said.

Maturity Level 3 means that these national bodies have been found to function well and could be eligible for inclusion into the transitional WHO Listed Authorities, a list that comprises the world’s regulators of reference – that is regulatory authorities – that should be globally recognised as meeting international standards.

WHO said Nigeria attained Maturity Level 3 for medicines and imported vaccines, even as several other regulators on the continent are undergoing assessment.

Regarding the production of the vaccines, Adeyeye said: “Yes, we are working on local manufacture of vaccines. NAFDAC is part and parcel of it, and we are looking forward to a very bright future in terms of starting manufacturing. Whether we are using modular laboratory to begin with, which is Good Manufacturing Practice (GMP). It is like a mobile home that is already fitted to be able to start quickly. Whether we are using that or the traditional type that will take longer time, but I am thinking that very likely, we will start with the modular vaccine laboratory.”

She explained that WHO’s assessment of regulatory authorities is based on the ‘Global Benchmarking Tool’ – an evaluation tool that checks regulatory functions against a set of more than 260 indicators – covering core regulatory functions such as product authorisation, testing of products, market surveillance and ability to detect adverse events to establish their level of maturity and functionality.

Chairman, Pharmaceutical Manufacturers Group of Manufacturers Association of Nigeria (PMG-MAN), Dr. Fidelis Ayebae, had told The Guardian: “Overall, we are very far from vaccine production because we have not yet made the investment needed as a country. Firstly, the facility is not available. Secondly, the partnerships with those with the technology are yet to be cultivated. Thirdly, our in-licensing/patent laws need to be worked on such that Nigeria, in collaboration with owners of a patent, can roll out products under licence when there are national emergencies. Still a lot to accomplish in this direction but no one is working on it because of inconsistency in our policy implementation. No one will invest in something which gestation will be short-lived because someone in government made tragic pronouncements without consulting with the organised private sector as they often do.”

A consultant pharmacist and former President, Pharmaceutical Association of Nigeria (PSN), Olumide Akintayo, had said the partnership between M & B and the FG had little or no bearing with availability of vaccines from the stables of Pfizer and any other multinational pharmaceutical company.

“Typically, it is the company that owns a patent that manufactures a drug product or vaccine. In pandemics or emergencies, there may be exemptions to allow production of generic equivalent of the patent rights before the expiration of the mandatory and exclusive 10-year window for post marketing surveillance.

“This is usually brokered by global bodies like World Health Organisation (WHO). Except such procedures are approved, it will be a mirage to expect local production of COVID19 vaccines in Nigeria.”

Meanwhile, President Muhammadu Buhari has directed the Minister of Health, Dr. Osagie Ehanire, to submit a progress report by the end of May 2022 on the indigenous production of vaccines in the country.

The President gave the directive while receiving the leadership of the Nigeria Integrated Biopharmaceuticals Industries Consortium (NIBI), led by Mr. Vilarugel Cuyas, Chairman/Chief Executive Officer of Fredlab.

The President commended the NIBI consortium made up of European biotechnology companies Merck, Unizima, Rommelag, and Fredlab, who are collaborating with the Nigerian start-up PIA BioPharma to establish a world-class Bio-Pharma Industrial Complex for the manufacture of vaccines and essential therapeutics in Nigeria.

Stressing that this administration considers food and medicine sufficiency as national security issues, the President asked the health minister and his team to work closely with the consortium regarding Federal Government’s support for the actualisation of the NIBI project within the next few months.

‘‘While the Ministry of Health continues to drive collaboration with investors for vaccines, pharmaceuticals, and medical devices, in a move towards self-sufficiency, I welcome the NIBI consortium’s desire to partner with the Federal Government in support of our agenda and look forward to the implementation of the NIBI project as it takes shape,’’ the President said.

Recounting the impact of COVID-19 pandemic on Nigeria’s economy and health systems and how some nations with comparative advantages in being centres of bio-pharmaceutical productions adopted a “me-first” attitude towards securing their citizens, President Buhari said:

‘‘I want Nigeria to make a bold statement in this field not just for reasons mentioned earlier, but because of its knock-on effects on our economy at large.’’

The President told his audience that Nigeria has learnt key lessons from the pandemic, including that countries must look inward for sustenance in food and medical supplies.

‘‘Having witnessed the impact of the COVID-19 pandemic on our health system, our communal life and national economy, from which we are yet to fully recover, we are reminded that the wealth of a nation is dependent on the health and wellbeing of its citizens,” he said.