Regulatory factors affecting sustainable vaccine manufacturing in Asia and the Pacific: Findings from a scoping review and semi-structured interviews

Trends toward regionalised vaccine manufacturing reflect a growing demand to meet regional needs, necessitating a strong regulatory environment. However, data on the regulatory factors needed for sustainable vaccine manufacturing have been sparse, including in resource-limited settings. This study aims to identify the regulatory factors for sustainable vaccine manufacturing in Asia and the Pacific. The five countries selected for this study are Bangladesh, India, Indonesia, Republic of Korea and Singapore, which are member countries of the Asian Development Bank (ADB) with different states of vaccine manufacturing and regulatory capacities. The study comprises a scoping review and semi-structured interviews with key informants from the industry, government policy making authorities and regulatory agencies across these five countries. The scoping review retrieved 71 scientific publications comprising published literature from Pubmed, Embase and grey literature, and the semi-structured interviews included a total of 39 interviews with policymakers (n = 7), regulators (n = 7) and vaccine industry (developers/manufacturers) (n = 25). Content analysis was performed using a positivist, predominantly deductive approach, analysing the regulatory challenges, opportunities and recommendations across the vaccine life cycle. The key regulatory factors for sustainable vaccine manufacturing identified include collaboration, regulatory capacity building, regulatory alignment, strengthened regulatory systems and regulatory agility. These results provide relevant and important evidence to inform regulatory policy as countries globally seek to establish regional vaccine production capabilities for vaccine security. Asian Development Bank (ADB).