Barriers Influencing Vaccine Development Timelines, Identification, Causal Analysis, and Prioritization of Key Barriers by KOLs in General and Covid-19 Vaccine R&D

Abstract

A frequently mentioned factor holding back the introduction of new vaccines on the market are their prohibitively long development timelines. These hamper their potential societal benefit and impairs the ability to quickly respond to emerging new pathogens. This is especially worrisome since new pathogens are emerging at all-time high rates of over one per year, and many age-old pathogens are still not vaccine preventable.Through interviews with 20 key-opinion-leaders (KOLs), this study identified innovation barriers that increase vaccine development timelines. These innovation barriers were visualized, and their underlying causes revealed by means of qualitative root cause analysis. Based on a survey the innovation barriers were quantitatively ranked based on their relative impact on both regular, and Covid-19 vaccine development timelines. KOLs identified 20 key innovation barriers, and mapping these barriers onto the Vaccine Innovation Cycle model revealed that all phases of vaccine development were affected. Affected by most barriers is the area between the preclinical studies and the market entry. Difficult hand-off between academia and industry, lack of funding, and lack of knowledge of pathogen targets were often mentioned as causes. Quantitative survey responses from 93 KOLs showed that general vaccine development and Covid-19 vaccine development are impacted by distinct sets of innovation barriers. For the general vaccine development three barriers were perceived of the highest impact; limited ROI for vaccines addressing disease with limited market size, limited ROI for vaccines compared to non-vaccine projects, and academia not being able to progress beyond proof of principle. Of highest impact on Covid-19 vaccine development, are lack of knowledge concerning pathogen target, high risk of upscaling unlicensed vaccines, and proof of principle not meeting late-stage requirements. In conclusion, the current study demonstrates that barriers hampering timelines in vaccine development are present across the Vaccine Innovation Cycle. Prioritizing the impact of barriers in general, and in Covid-19 vaccine development, shows clear differences that can be used to inform policies to speed up development in both war and peace time.