Sustainable Vaccines Manufacturing in Africa
A business case simulation for Fill & Finish Contract Manufacturing in Africa
David Honba & Benoit Gregoire (Unizima)
Published by Deutsche Gesellschaft für Internationale Zusammenarbeit (GIZ) GmbH
The African Union’s Partnership for African Vaccine Manufacturing aims to locally produce 60% of vaccines used on the continent by 2040. Transferring Fill/Finish (F/F) operations of established commercial vaccines to contract manufacturing organizations (CMO’s) in Africa is a realistic first step to localize manufacturing. Based on a costing simulation, this study, commissioned by GIZ programme BACKUP Health, assesses the financial viability of such a business and compares the cost of manufacturing in Africa versus importing the products.
- Africa’s demand of 2.1 billion doses of vaccines in 2040 represents 280 million containers of different vials and blow-fill-seal (BFS) tubes. A network of at least 5 factories would be required to leverage economy of scale and limit risks due to complexity. A standard factory in our model would have 2 liquid vial filling lines, one freeze-drying line and one BFS tube line.
- Setting up one model factory would require a capital investment of 89 mio EUR and an associated project expense of 35 mio EUR. The time to first commercial production is estimated at 5 to 6 years.
- The model shows that the investment can be competitive and profitable with adequate product mix, high-capacity utilization, and smooth and timely execution of the project. Profitability is strongly influenced by capacity utilization, raw materials cost (mainly filling raw materials such as vials and stoppers) and the local salary and energy costs.
- Taking into account savings from replacing the shipment of finished products by the shipment of vaccine bulk concentrates, the price per dose of local Fill/Finish can compete with India for selected products.
- The development of alternative containers can provide substantial benefits. The replacement of multi-dose glass vials for injectable vaccines by multi-dose blow-fill-seal (BFS) containers would reduce the Fill/Finish cost by 45%.
- Multiple challenges would need to be overcome to achieve fully functioning and sustainable contract manufacturing of vaccines in Africa. A CMO must demonstrate high quality standards and reliability, ideally certified through WHO prequalification. This reliability can only be achieved with strong and continuous political willingness and ability to provide support, develop the required infrastructure and capability. Incentives such as advance purchase agreements will be required to compensate for any financial disadvantages.
The underlying costing model is accessible on request to firstname.lastname@example.org