Upscaling vaccine manufacturing capacity - key bottlenecks and lessons learned.

ABSTRACT

The COVID-19 pandemic put enormous pressure on the vaccine production chain as billions of vaccines had to be produced in the shortest timeframe possible. Vaccine production chains struggled to keep up with demand, resulting in disruptions and production delays. This study aimed to make an inventory of challenges and opportunities that occurred in the production chain of the COVID-19 vaccine. Insights derived through approximately 80 interviews and roundtable discussions were combined with findings from a scoping literature review. Data were analysed through an inductive process where barriers and opportunities were linked to specific facets of the production chain. Key bottlenecks identified include a lack of manufacturing facilities, a lack of tech-transfer personnel, inefficient arrangement of production stakeholders, critical shortages in raw materials, and restricting protectionist measures. A need for a central governing body to map out shortages and to coordinate allocation of available resource became evident. Other suggested solutions were to repurpose existing facilities and to build in more flexibility in the production process by making materials interchangeable. Also, simplification of the production chain could be achieved through geographical reengagement of processes. Three overarching themes were identified, impacting overall functioning of the vaccine production chain regulatory and visibility, collaboration and communication, and funding and policy. The results in this study showed a multitude of interdependent processes underlying the vaccine production chain, executed by diverse stakeholders with differing objectives. It characterizes the global complexity of the pharmaceutical production chain and highlights its extreme vulnerability to disruptions. More resilience and robustness must be integrated into the vaccine production chain, and low-middle income countries should be empowered to manufacture vaccines themselves. In conclusion, there's a need to rethink the production system for vaccines and other essential medicines in order to become better prepared for future health crises.