As governments begin to issue the first emergency use authorizations to deploy a COVID-19 vaccine, the world is facing the stark reality that the need for these vaccines far outstrips global production capacity.
An estimated 14 billion doses of vaccine would be needed to stop the pandemic. Governments of high- and middle-income countries have already made deals with the leading vaccine manufacturers to reserve at least 6.8 billion doses, leading to a situation where lower-income countries may be waiting until 2023 or 2024 before gaining widespread access to COVID-19 vaccines.
Funding to purchase COVID-19 vaccines in low- and middle-income countries is beginning to amass through the COVAX Facility and other mechanisms. More will be needed. However, even if the money materializes, there are insufficient vaccine doses available for purchase and significant infrastructure and logistical challenges.
Access to poor-quality vaccines is worse than no access. The goal of local manufacturing must be to ensure quality, protect patients, and foster trust in vaccine safety.—
To compound matters, without a stable supply, opportunities for substandard and falsified vaccines to enter the supply-chain may increase, diminishing trust in vaccines and health systems.
In the face of this global shortfall, calls to scale up vaccine production capacity in Africa are growing louder. While not a panacea for filling the COVID-19 vaccine production gap in the immediate term, bolstering capacity in Africa to conduct key aspects of the manufacturing process, namely, formulation, filling, and packaging for COVID-19 vaccines will help facilitate access.
Developing the fledgling industry will also help countries prepare for greater self-sufficiency in meeting their growing vaccine needs and prevent future vaccine access crises when the next pandemic hits.
The role of regional manufacturing in Africa
In recent years, a concerted effort to build up local pharmaceutical manufacturing capacity in Africa has begun to pay dividends, paving the way for the nascent vaccine industry. Manufacturers in Nigeria, Ethiopia, South Africa, Egypt, and elsewhere are becoming major producers of priority medicines for their countries and regions.
A concerted, decades-long effort by USP, the United States Agency for International Development, and others to bolster the quality assurance systems of pharmaceutical manufacturers in LMICs toward achieving international quality standards has made many products more competitive.
Although 70%-90% of pharmaceuticals used in Africa are still imported, local manufacturing sectors are poised with latent capacity, and bolstering local production is being urgently prioritized in the face of COVID-19 related shortages.
On the other hand, vaccine production in Africa has largely failed to launch. African vaccine manufacturers currently produce less than 1% of the vaccines that are used across the continent. Many manufacturers ceased production over the last 25 years due to inability to compete with imported vaccines.
As of 2017, there were eight vaccine manufacturers in Africa, only two of which were performing all aspects of the vaccine manufacturing process from active ingredient production through packaging.
COVID-19 as a stimulus for expansion
The COVID-19 pandemic has the potential to tip the scales in favor of accelerating local vaccine production in Africa. Major barriers — including a fragmented vaccine market, high cost and complexity of manufacturing, and absence of political will to invest — are no longer insurmountable with the pooled procurement mechanisms, capital investments, and urgent political mandate brought on by the pandemic.
Building on current vaccine production capacity for the last steps of vaccine manufacturing — including fill and finish in countries like Senegal, Egypt, Tunisia, Ethiopia, and South Africa — may provide an opportunity for stepwise integration of vaccine production capacity on the continent.
Recent technology transfers by major vaccine developers are providing a stepping stone to address current and future threats like COVID-19. For example, Biovac of South Africa has begun producing the six-in-one vaccine Hexaxim — given to children to prevent diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, and Haemophilus influenzae type b — for the South African market and will begin production of Pneumovax — which prevents pneumococcal disease — as soon as next year.
In addition, the Africa Centres for Disease Control has identified and is working with eight companies in Africa that may be able to help manufacture COVID-19 vaccines, particularly if booster shots are needed on an ongoing basis. These companies could serve as sites for future vaccine production across Africa.
Ingredients for success
Beyond the complexity of the vaccine manufacturing process itself, the prerequisite supplies, equipment, facilities, and highly specialized scientific expertise needed to make quality-assured vaccines is beyond the purview of any one company. For example, sourcing inactive ingredients, vials, and stoppers can be limiting factors.
Simultaneously, like any other business, vaccine manufacturers in Africa must be able to make a return on investment while competing with established manufacturers in countries like India, China, Indonesia, and Pakistan. Important factors include sufficient demand in the country or region, government investment policies and incentives, cost of labor and capital, availability of raw materials, and physical infrastructure.
Each of these individual barriers can be overcome, but taken as a whole, expanding vaccine manufacturing capacity in Africa requires cohesive national and regional strategies that align with national pharmaceutical and industrial policies while addressing areas of weakness and laying out incentives to attract investment.
For instance, a regional strategy for manufacturing active pharmaceutical ingredients could help support this nascent industry while avoiding fragmentation and redundancies. In addition, international procurement agencies could support sustainable access to vaccines and other health products in Africa by carving out a portion of global procurements for African manufacturers producing quality-assured health commodities.
Investing now in strengthening vaccine production capacity on the continent will set countries up for success as they prepare to graduate from receiving foreign assistance.
Quality is paramount
Access to poor-quality vaccines is worse than no access. The goal of local manufacturing must be to ensure quality, protect patients, and foster trust in vaccine safety.
Therefore, quality assurance is an essential ingredient to make vaccine production sustainable. Very few national regulatory authorities in Africa have achieved the level of maturity required to enable the production of quality-assured vaccines in their countries. However, there are feasible steps regulators can take to expedite access to COVID-19 vaccines.
Additionally, efforts to pool expertise and streamline regulatory oversight of vaccines on the continent are moving forward through the African Vaccine Regulatory Forum. For their part, local vaccine manufacturers should work with partners — like Africa CDC, the Developing Countries Vaccine Manufacturers Network, the African Vaccine Manufacturing Initiative, the Federation of African Pharmaceutical Manufacturers Associations, and USP — to strengthen their quality management systems toward attaining international standards.
Boosting pandemic preparedness
Gavi CEO Seth Berkley projected that COVID-19 vaccines “will be the single largest and most rapid global vaccine deployment we have ever seen.”
By harnessing the strong political will and investment behind COVID-19 vaccines to advance regional vaccine manufacturing in Africa, we have the opportunity to facilitate greater access in the immediate term and prepare for future vaccine needs for both routine immunization programs and unexpected health emergencies.