LCA Policy Briefs

June 2021 Version
vaccine- can we produce again

CAN WE PRODUCE AGAIN?

Reviving Vaccine Production in Nigeria

Executive Summary

The uncertainty around access to vaccines by poor countries underscores the need to re-open conversations around the state of Nigeria’s preparedness for vaccine distribution and more importantly, subsequent production. This policy brief x-rays Nigeria’s strides and unfortunate decline as a vaccine producer in Africa decades ago. In light of COVID-19 driven ‘Vaccine Nationalism’ and how countries are acting in the best interest of their citizens, it considers policy-based actions while spotlighting the modern role for governments in vaccine production and distribution.

Vaccine Nationalism – that is one of the newest phrases in the global lexicon since the development of vaccines to curb Covid-19. It defines the action of rich countries scrambling to secure substantial vaccine doses for their domestic population to the detriment of poorer countries.

In 2009, with the H1N1 pandemic raging, rich countries acquired most of the available vaccines leaving little for the rest of the world that could not afford it. This pattern was also noticeable in the early days of inoculations against smallpox and polio – vaccines were only available in developing countries after rich countries had had more than their fair share. The World Economic Forum speculates that such limitations might have spurred some countries like India and China to develop local capabilities. [1] Recently, with the tsunami of infections tearing through India, over 150million doses of vaccine meant to come into Africa and by extension Nigeria is threatened. The reason is simple, India needs to cater to its population first.

Nigeria, a developing country is negatively affected by trends such as this. However, it has the pedigree to be on the ascendancy as a vaccine manufacturer like India and China. Perhaps the lessons of the Ebola epidemic were what roused the government in 2017 to attempt to revive the Federal Vaccine Production Laboratory, Yaba, Lagos through a joint venture company with May and Baker. The new company, BioVaccines Nigeria Limited (BVNL), has however not started operation. Nigeria is now totally dependent on the subsidized prices from GAVI to immunize its infant population as well as vital vaccines like antivenoms. By 2022, the country will no longer be eligible for GAVI prices. There is no better time than now for Nigeria to reactivate its vaccine-production capabilities for the local population, export and job creation.

A Tale of Promise, Retrogression and New Opportunities

In 2016, Nigeria was ranked 142 among 195 countries in terms of global healthcare access and quality by the Lancet [2]. Before understanding how we got to such a dismal rating and where we currently are especially with the COVID-19 pandemic, it is important to look back to understand where we used to be particularly in terms of vaccine production.

Between 1947 and 1991, Nigeria produced vaccines through the Federal Vaccine Production Laboratories. The lab was responsible for different vaccines for smallpox, rabies and yellow fever. For instance, the lab produced 142,340 doses of Yellow Fever Vaccine in 1976 to over 500,000 by 1987 [3]. By 1995, the estimated production capacity of the lab to produce Yellow Fever Vaccines was estimated at five million doses per annum [4].  Due to the presence of a functioning vaccine production lab among other factors, vaccination in Nigeria had soared to 80% by 1990 [5]. More interesting was that these vaccines not only addressed local needs but also met the needs of countries like Cameroon, Central Africa Republic and other countries on the continent.

Unfortunately, by 1991 the successes gained began to decline. By 1995, there were only 2 cold stores functioning, one in Lagos and the other in Kano. There were also challenges in terms of funding, vaccine supply & demand planning, supply chain management, manpower shortages and poor coordination between the different public health agencies among others.

Production was halted at the laboratories based on expansion plans which are yet to materialize to date. Despite different feasibility studies and attempts, the production of human vaccines has not been achieved in Nigeria. Over 30 years later, with a pandemic surging across the globe, Nigeria does not have enough freezers to store the Pfizer/BioNtech vaccines which require a storage temperature of -70 degrees. Luckily, the country received the Astrazeneca vaccines which is relatively easier to store. Despite this, the government has had to partner with private bodies for dry ice during transportation.

A discourse such as this would be incomplete without the mention of National Veterinary Research Institute, (formerly the Federal Department of Veterinary Research) Vom, Plateau State. NVRI is a success story by Nigerian standards. Established in 1924, the institute has continued to function silently and achieved some stability as well. The institute currently produces at least 6 to 8 different vaccines for animals. A proper understanding of the workings of the institute would provide key insights to help in the establishment of a general vaccine production company or institute.

Major reasons for the demise of the FVPL and related infrastructure was excessive government control, malfeasance and poor funding. In the modern world, the government’s role should be like that obtainable in the telecommunications industry, which is strictly regulatory. It is plausible that realizations such as this led the government to partner with a private sector player in floating BioVaccines Nigeria Ltd (BVNL), designed as a public private partnership (PPP) entity with a 51% – 49% private-public ownership ratio. However, despite the huge opportunity available to the country in this regard, no concrete result has been achieved till date.

Re-defining the role of government in the Vaccine Value Chain

The government of Nigeria is the overarching body responsible for the assessment, safety, efficacy, licensure, monitoring and regulation of vaccines and their production to protect public health within the country. The National Agency for Food and Drug Administration and Control (NAFDAC) through the National Vaccine Quality Control Laboratory (NVQCL) is responsible for testing the efficacy of vaccines and eventually licensing them for use. While the Nigerian Government has recorded successes with the NVRI, it is becoming apparent that for vaccine production to be locally sustainable in Nigeria, private organisations must see its profitability and suitability within Nigeria. This implies that the Nigerian state must demystify the route for private establishments to set up vaccine production factories within Nigeria.

When COVID-19 hit, many countries that spent billions of dollars on research and development still turned to the Serum Institute of India to manufacture their vaccines for them. In March 2021, India placed a temporary hold on AstraZeneca vaccine exportation to enable the country to vaccinate more Indians due to spiking coronavirus levels. This hold will affect vaccination levels in an estimated 190 countries that India supplies vaccines to. India, with a population of over 1 billion, is a 3rd world country like Nigeria. It is also plagued with unstable electricity supply and shares some of the poorer health indices that Nigeria has. So the question to ask is how has India secured itself as the world’s largest producer of vaccines and what role can the government play?

For one, the government took its hands off the wheel and set itself firmly as a quality control mechanism. Serum Institute of India (the world’s largest vaccine manufacturer), and Biological E (producers of the Jannesen Vaccine) are all privately owned for-profit ventures. The same is true of Aspen Pharmacare in South Africa which has made inroads into the global pharmaceutical trade and is considered the largest drug company in Africa. May & Baker, Fidson, and Emzor, are some of the Nigerian pharma companies that can do well in the production of vaccines with the right support. In 2020, Serum Institute took a risk that paid off. They procured over 40 million empty glass vials while vaccines were still in development and testing, thus meaning that as soon as vaccines were ready, they were ready to produce [6]. Making such decisions in a government-led facility bogged down by bureaucracy would be almost impossible. This readiness was proof of concept for the government of India to negotiate and facilitate the quad funding from Australia, Japan and the United States of America for COVID vaccines [7].

Vaccine production is expensive; the startup costs are huge and while they pay off in the long term, the numerous processes and testing required to show the vaccines are still comparable in the new production site are rigorous [8]. Manufacturing facilities can cost between $50–$500 million per antigen in the United States. This could depend on complexity of design, automation, segregation, utilities, and contamination controls. The US Department of Defense estimates that it takes about 7 years to design, build, validate, and commence commercial manufacturing. It is anticipated that these costs (including labour and material) would be much lower in developing countries [9]. While start-up and manufacturing costs will be recouped over the years, it is still important in the first few years of development that private vaccine makers receive financial stimulus to begin the manufacturing process. The government of Nigeria can make financial and monetary contributions such as tax cuts, loan facilities and direct funding available to investors geared at incentivizing them.

Such public-private funding should be targeted not only at medical research but also in storage and distribution logistics for reagents, viral and bacterial seedstocks and power supply among other requirements. The 253-million-naira grant given to researchers by the Central Bank of Nigeria is a good move but consistent investment is the key. Private investment would also generate interest in the study of genomics, virology, biochemistry, clinical research and other allied fields that would create the manpower for this industry. For instance, Nigeria currently has a vaccine candidate led by Professor Christian Happi and the team at the African Centre of Excellence for Genomics of Infectious Diseases (ACEGID), Redeemer’s University, Ede, Osun State, Nigeria. Such efforts like this needs more support.

Another approach worth considering is to court pharmaceuticals and research agencies to gain access to the licenses and standards required to manufacture generic versions of vaccines in Nigeria. This means that national agencies in the country can show that they can be effective regulators and that when Nigerian manufacturers commence manufacturing, the agencies will have the standard operating procedures required for quality monitoring and regulation of vaccines. Consequently, instilling confidence in people regarding the quality of the vaccines. In October 2020, the governments of India and South Africa, who already had proof of concept of vaccine manufacturing, sent a petition to the World Trade Organization (WTO). The petition requested a temporary waiver of intellectual property protections for vaccines related to the COVID-19 pandemic [10]. The idea is to lift 20-year patents and allow companies like the Serum Institute to manufacture generic versions of the COVID vaccines quickly and cheaply. Current feelers from the WTO show that the organisation leans towards a licensing structure as a way of resolving the petition. WTO appears to believe that licensing manufacturing to countries so that they can have adequate supplies is the way to go. All this while still making sure that intellectual property protections are still in place. Whilst this scenario is in place with Serum Institute’s partnership with AstraZeneca, it limits the amount of different types of vaccines that can be produced.

It is also important to note that the African Centre for Disease Control has an agreement with African Union (AU) countries to set up 5 vaccine research centres that can manufacture vaccines over the next 10 – 15 years [11]. The government of Nigeria will need to act fast not only to ratify the terms of this agreement but also to play a big role in the entire scheme so citizens can benefit from having a research centre within the country. The economic benefits are also immense.

Ensuring biosecurity through regulations

Vaccine production is not just serious business; it is one that cannot be trifled with. In most advanced jurisdictions where it is chiefly a private business, governments have stringent regulatory protocols to ensure public safety. Covid-19 is controversial partly for its unclear origins. Though recent investigations conclude that it most likely came from an animal, conspiracies abound about the virus being developed in a laboratory. China took and is still receiving backlash for being the source of this strange and deadly ailment. While we recommend full private operations of the vaccine industry in Nigeria, there must be commensurate and uncompromising regulation of the players to ensure continuous biosafety not just for Nigeria but for the world.  NAFDAC which is analogous to the FDA in America and the EMA in Europe must upgrade its processes, technology, personnel and its ethics to achieve this. With the spate of rising insecurity within the country, vaccine production labs are prime assets that must be adequately protected.

Conclusion 

COVID-19 and the scramble for vaccines has once again revealed the underbelly of Nigeria’s precarious health system. It is also apparent that vaccine production capacity provides any country with such capabilities significant leverage in the global health community. Despite the failings of previous administrations to act, the federal government must immediately take steps towards ensuring Nigeria gets back to winning ways in vaccine production. The war on COVID-19 would definitely be won but as history has shown, another epidemic (possibly more deadly than COVID-19) would emerge within this decade or the next. For history not to repeat itself, the time to act is now. 

Yet to sign up to receive free digital copies of the brief? 

Edited By

Gbenga Rufai

References

  1. Mwai, P. (May 10, 2021). Covid-19 Africa: What is happening with vaccines? BBC Reality Check. https://www.bbc.com/news/56100076
  2. GBD, HAC. (2018). Measuring performance on the Healthcare Access and Quality Index for 195 countries and territories and selected subnational locations: a systematic analysis from the Global Burden of Disease Study 2016.  The Lancet. 391(10136), 2236-2271. https://doi.org/10.1016/S0140-6736(18)30994-2
  3. Akira, H. (1987). Report on technical consultancy at Federal Vaccine Production Laboratories/Yellow Fever Vaccine Production, Yaba. Lagos Nigeria (Report No. IDL-47493).International Development Research Centre. https://idl-bnc-idrc.dspacedirect.org/handle/10625/47493
  4. Children’s Vaccine Initiative. (1997). An assessment of vaccine supply in Nigeria. World Health Organization.  https://apps.who.int/iris/handle/10665/63311
  5. Akira, H. (1987). Report on technical consultancy at Federal Vaccine Production Laboratories/Yellow Fever Vaccine Production, Yaba. Lagos Nigeria (Report No. IDL-47493).International Development Research Centre. https://idl-bnc-idrc.dspacedirect.org/handle/10625/47493
  6. Pathak, S. & Nayar, V. (2021, March 18). The World’s Largest Vaccine Maker Took A Multimillion Dollar Pandemic Gamble. https://www.npr.org/sections/goatsandsoda/2021/03/18/978065736/indias-role-in-covid-19-vaccine-production-is-getting-even-bigger
  7. The White House. (2021). Fact Sheet: Quad Summit [Fact Sheet]. https://www.whitehouse.gov/briefing-room/statements-releases/2021/03/12/fact-sheet-quad-summit/
  8. Plotkin, S., Robinson, J. M., Cunningham, G., Iqbal, R., & Larsen, S. (2017). The complexity and cost of vaccine manufacturing – An overview. Vaccine, 35(33), 4064–4071. https://doi.org/10.1016/j.vaccine.2017.06.003
  9. Plotkin, S., Robinson, J. M., Cunningham, G., Iqbal, R., & Larsen, S. (2017). The complexity and cost of vaccine manufacturing – An overview. Vaccine, 35(33), 4064–4071. https://doi.org/10.1016/j.vaccine.2017.06.003
  10. World Trade Organization. (2020, October 2). Waiver from certain provisions of the TRIPS agreement for the prevention, containment and treatment of Covid-19 [Press release]. https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=q:/IP/C/W669.pdf&Open=True
  11. Agyarko, R. (2021, April 14). A new era of vaccine sovereignty in Africa. Mail & Guardian. https://mg.co.za/africa/2021-04-14-a-new-era-of-vaccine-sovereignty-in-africa-beckons/

Don’t miss another edition of the policy brief.

If you haven’t done so already, sign up now to receive free digital copies.