Title: Innovation and Complentary Capabilities for Vaccines
Funder: Economic and Social Research Council

Abstract: The global competition to develop vaccines to fight the COVID-19 pandemic has collapsed the typical timescale in which new technologies gain market dominance and leave alternatives behind. While 322 vaccines are in development in 41 countries, only three have been successfully introduced to global markets by seven firms working with six research institutes in five countries. This research studies this natural experiment. We address the question of how the new vaccines that have gained global markets have become dominant. We will do so by investigating the mix, alignment and co-evolution of critical capabilities - innovation, manufacturing and complementary - that enabled the firms, research organisations and regulatory institutions involved in their development to introduce them successfully to markets. We are also interested in understanding the challenges faced by latecomers at different stages, from development, testing and/or manufacturing to market introduction. The empirical evidence will be based on the experience of a selected group of firms and countries with distinctive levels of capabilities and regulatory, cultural and business contexts - Japan, the UK, Germany, India, Brazil, Argentina, Vietnam, and Indonesia. We ask four main questions which will be investigated over the project period: (1) How complementary market-enabling capabilities are built within firms and research institutions, and which kinds of investments and efforts are required for their development? (2) How complementary, political and other market-enabling capabilities, relate to and interact with those required to develop new products (e.g., innovation and manufacturing related efforts) at the firm level in explaining positive outcomes? (3) How do all these different capabilities co-evolve and align for vaccines and products related to the manufacture of pharmaceuticals and other medicinal chemical products? and (4) Which have been the critical alignments and misalignments between firm and regulatory institutions objectives and capabilities that have facilitated or blocked the successful introduction of new vaccines into the global market? Further objectives include: Develop a significant and meaningful collaboration with the researchers of the counterpart country. The fostering of young Japanese researchers.

Lay abstract: The UK has launched the Pandemic Preparedness Partnership which will advise the G7 Presidency how to more quickly develop vaccines through greater global cooperation. £16 million will be invested to support the development of new variant-specific vaccines. But, how can these funds be best invested to reach maximum impact? Where are the main capability bottlenecks in the supply chain? Or more generally: where to invest to improve the capacity of the global system to respond quickly to this and other global crises? This research project contributes to understanding these questions by investigating the recent experience with COVID-19 vaccines, focusing on a specific group of firms, research institutions and countries with distinctive levels of capabilities and regulatory, cultural and business contexts - Japan, the UK, Germany, India, Brazil, Argentina, Vietnam, and Indonesia. In particular, we study the alignments and misalignments between the different kinds of capabilities, at the firm and regulatory level, that have been critical for introducing the new vaccines to the market. We capture three kinds of capabilities: innovation, manufacturing and "complementary market enabling" (i.e. political, regulatory, and those required to manage clinical trials and intellectual property rights), and examine the complementarities and co-evolution of these different capabilities that have enabled (or blocked) the market introduction of the COVID-19 vaccines. We adopt an interdisciplinary and mixed methods design. While our main focus is on COVID-19 vaccines, part of our empirical analysis will extend beyond this particular segment to include evidence related to other vaccines and to closely related sectors like pharmaceuticals and medicinal chemical products. Our approach combines exploratory quantitative empirical analysis and qualitative assessments through context-specific targeted interviews with key stakeholders in selected firms and national and international regulatory institutions. The COVID-19 pandemic saw an unprecedented increase in political (lobbying) activities, with some actors enjoying clear access advantages with experienced and well-funded representatives. However, firms and research institutions with sufficient capabilities to develop or adapt vaccines are also characterised by heterogeneity in the ability to undertake the linked political and other market-enabling strategies. Our empirical analysis will capture this heterogeneity and combine it with the study of production and innovation capabilities. With this approach, we will contribute not only to understanding the current scenario but also identify the main opportunities, challenges and bottlenecks for a positive co-evolution between the different types of capabilities required for addressing global health crises.

Research activity codes: 3.4 VACCINES;3.5 RESOURCES AND INFRASTRUCTURE (PREVENTION)
Health categories: INFECTION