Pathways to economically viable and sustainable vaccine manufacturing in LMICs

In an effort to improve pandemic preparedness and health security, many low- and middle-income countries (LMICs) have launched initiatives to expand regional vaccine manufacturing. A number of elements relating to vaccine markets, production, value chains, and ecosystems significantly impact the ability to generate economically viable and sustainable vaccine manufacturing in LMICs. This paper provides an overview of vaccine manufacturing characteristics and global vaccine markets dynamics. Establishing vaccine manufacturing is a complex undertaking due to a variety of factors including intense competition, associated uncertainty regarding the ability to capture market share and substantial capital investment requirements. Substantive government commitment and investment are essential to ensure new local entrants compete successfully. In the medium to long run, the role of government should shift from supporting individual firms to strengthening local science ecosystems as this bolsters economic sustainability in three ways. First, investment in science promotes technological advances which can reduce production costs, e.g., through process innovations for vaccine manufacturing. Second, strong science ecosystems help to address the skills gap faced by manufacturers. And third, strong science ecosystems enable research and development of new vaccines that address local unmet needs and open new markets. Furthermore, developing a regional approach to vaccine manufacturing and procurement, with associated regulatory harmonization, is crucial to achieving economically viable and distributed vaccine manufacturing. Importantly, investment in research and development and fostering of regional collaborations drives innovation, feeding into new product discovery and consequently a strong pipeline of new vaccine products, driving economically sustainable regional vaccine manufacturing. This offers the potential to prevent endemic infectious diseases with significant socioeconomic and health burden or to develop therapeutic vaccines, generating regular interpandemic demand for regional vaccine manufacturers, consequently sustaining capacity retention and associated pandemic preparedness.