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).

The COVID-19 pandemic coupled with recent upheavals in global trade and development assistance funding has disrupted routine immunization programmes and diverted health systems from the targets set in the Immunization Agenda 2030. Regulatory systems are often underappreciated or misunderstood but in fact play a critical role in enabling innovation and facilitating timely access to vaccines for sustained immunization, thereby building vaccine confidence and health system resilience. Regulation is the constant denominator throughout the vaccine life cycle, shaping the pathway from early research and development to approval and market entry and ultimately to equitable distribution and sustained safe use. This paper examines the role of regulation and proposes that regulation be reframed as a function of health system resilience and a structural determinant of immunization sustainability. We synthesize evidence across the vaccine regulatory life cycle, examining innovation facilitation, regional cooperation, public health strengthening and describe the roles of regulation in building health system resilience, namely driving sustainable vaccine access, enabling innovation, supporting regional collaboration and strengthening social acceptance. Without this shift in perspective, regulatory systems strengthening risks being underfunded, reactive, and fragmented; this will perpetuate inequities in vaccine access and undermine the sustainability of immunization programmes.

The COVID-19 pandemic has emphatically underscored the value of vaccines in the control of viral outbreaks. The rapid development of vaccines with potent immunogenicity, production, and global distribution, along with efficiently executed mass vaccination or ring vaccination programmes, are all likely key components of future response to viral outbreaks. Each of these components is a rapidly developing field in its own right; positive developments would not only be relevant for pandemic preparedness but would also benefit the prevention of endemic and childhood diseases. The Coalition for Epidemic Preparedness Innovations (CEPI) has set the target of vaccine discovery and development to be completed within a hundred days to tackle future pandemics. The authors will discuss the regulatory process behind vaccine development, the intellectual property (IP) rights involved, the transfer of liability, and access to vaccines. Issues around vaccine hesitancy will be explored in the next chapter.