COVID-19 Vaccine Manufacturing: Options and Opportunities for Nigeria

By Olumide Okunola

It goes without saying that the country will have to cough out a substantial amount of its hard-earnedforeign exchange to procure COVID-19 vaccines. It is estimated that for Nigeria to cover about 70% of itspopulation before herd immunity arrives it will need to spend close to N400B (One billion USD) to procure the highly valued COVID 19 vaccine.

For a country in recession this forex requirements could have been better spent. Only if the country had invested in its health systems and established vaccine manufacturing capabilities.

In fact, individuals like Mr. Bill Gates argues that Nigeria should divert resources budgeted for approved COVID-19 vaccines into the development of the country’s weak health care system and wait for the COVAX arrangements to kick in.

Countries are currently sourcing their COVID-19 vaccine availability through the following five routes – COVAX initiative (co-led by Gavi, the Coalition for Epidemic Preparedness Innovations (CEPI) and the WHO), bilateral agreements between governments and manufacturers/countries, pre-positioning through pre-orders, off the shelf commercial contracts and leveraging vaccine manufacturing capabilities in-country.

This article explores the last route arguing that Nigeria needs to fast track its vaccine manufacturing potential as part of the overall pandemic preparedness and as a health security priority.

The ongoing pandemic will not be the last one it is therefore imperative that ahead of future outbreaks Nigeria needs to invest in vaccine manufacturing capacity rather than relying on reserved doses through the COVAX arrangements or exploring country to country contracts as is been explored with Russia and China.

Vaccine nationalism implies that western countries have already pre-ordered the bulk of potential vaccines even though they do not have the bulk of the world’s population. With half of our population classified as poor the possibility of commercial purchase for the vaccine is far-fetched.

Countries with manufacturing capacity have been able to jump the queue. Johnson and Johnson will be utilizing the plants of ASPEN in South Africa for fill and finish. Argentina and Mexico will produce the AstraZeneca COVID-19 vaccine for most of Latin America.

In India the world’s largest vaccine manufacturer the Serum Institute of India (SII) has been contracted to produce large amounts of the AstraZeneca and Novavax vaccines — with half of it promised to the Indian government.

Whilst acknowledging the complexity of vaccine production and the difficulties inherent in scaling up production Nigeria ought to be one of the countries with not just greater vaccine manufacturing capacity it should have been able to use that capacity as leverage like the aforementioned countries.

It ought to be clear that a decision to invest in vaccine manufacturing capacity should now not be guided by just financial returns but undoubtedly national interest.

Africa represents 14% of the world’s population but has only an infinitesimal capability (less than 0.1%) of the world’s vaccine production! Beyond the lack of technological expertise and high research and development costs associated with the early phases of vaccine development there are also concerns associated with the cost of production in small to medium plants who cannot compete with large manufacturers.

Furthermore, small sized plants might not be feasible as subsidies from GAVI makes the prospects of such local production non-viable. For comparison Serum Institute of India (SII) produces 100 million vaccine doses per month whilst ASPEN of South Africa produces 300 million doses per annum.

However, COVID-19 pandemic requires a serious rethink of previous efforts for local production of vaccine in Africa and this should be led by Nigeria. This requires a number of policy actions on the part of the Government of Nigeria (GoN).

The sweet spot for early starters in vaccine manufacturing like Nigeria is the last and final stage where vaccines are filled into vials and packaged for delivery and is often called “fill and finish”. Fill and finish technology transfers offer a relatively high value proposition and are more common than technology transfers including bulk antigen production. This article highlights some of the policies fulfilling necessary conditions for Nigeria to become a vaccine manufacturing country for “fill and finish”.

Scale is a key consideration in vaccine manufacturing which will require a plant securing public vaccine production capacity to grow to a more modest size to be a strategic asset. Nigeria vaccine requirements for childhood vaccine supplies assures the kind of scale required for profitable vaccine manufacturing. The new AfCFTA trade agreement further guarantees the kind of scale required to make investment decisions quickly and urgently.

The technology transfer associated with fill and finish provides an essential learning curve which gives a country the opportunity, technical capacity and experience useful for bulk antigen production (the phase before fill and finish). However, the ability to produce a vaccine is heavily reliant on finding a suitable technology transfer partner from amongst the other vaccine manufacturers, who are also competitors.

The establishment of a vaccine manufacturing plant will require capital. However, such a project is deemed investment worthy where packaging locally for carefully selected high and medium viability products can generate substantial revenues.

The business case will have to use modest assumptions by estimating prices below what is procured by UNICEF. But there are other considerations beyond financial viability – the availability of the fill and finish lines can be retooled in the case of a pandemic to produce the kind of vaccine we now require. There are jobs opportunities too. For emphasis all countries that have now jumped to the front of the line leveraged available manufacturing capabilities in-country to do so.

Lastly, all the factors discussed above needs to be backed by political commitment in government. The GoN needs to support this kind of endeavor with tax concessions, financing, policy coherence enshrined in advance market commitments and guarantees. The influence of government is also essential in obtaining the necessary partnerships with friendly countries for technology transfer and deploying provisions of AfCFTA for the scale necessary for such an investment.

All the ingredients listed above are found in the BIOVACCINES Nigeria PPP (BVNL). This is a publicprivate partnership (PPP) between the GoN and May & Baker Nigeria. May & Baker Nigeria Plc, which is quoted on the Nigerian Stock Exchange (NSE), holds the majority 51 per cent equity stake in BVNL. A Memorandum of Understanding (MOU) for market access with the Federal Ministry of Health, enables it to fill and finish approved vaccines of her international technical partners to the Nigerian market.

The BVNL PPP is proposing to deliver its plant in 2024 or thereabout to enable it to put in place – faculty construction and equipment procurement; facility and equipment commissioning and qualification; process optimization and media fill validation; facility certification; process validation and product registration. The fast-paced research and development associated with COVID has shattered widely held views about vaccine R&D – a process that takes about five years was achieved in less than a year. Rapid developments in testing capabilities allowing for testing at scale was achieved with similar timelines.

The BVNL PPP must by necessity become a national priority project in healthcare for Nigeria. The GoNshould facilitate immediate engagement with the CBN, NEPZA, NIPC, NSIA, NIPRD, NAFDAC and other identified stakeholders to fast track the immediate delivery of the BVNL PPP. If we set our minds and heart to this task the facility can be delivered within a shorter timeline.

The United states invoked the Defence Production Act in response to the COVID pandemic allowing it to impose a certain degree of control over the private sector in order to ensure the production and distribution of goods that are considered necessary for public health, including critical medical and protective equipment.

Vaccine nationalism as exhibited by countries in the global north has shown that if Africa led by Nigeria does not make use of this crisis to establish local production for vaccines aimed at accelerating human capital development, providing employment, enhancing technology transfer and saving hard earned forex then this crisis would have essentially been wasted.

… Okunola, a Senior health specialist with World Bank, Nigeria wrote in via

ookunola@ifc.org