Transforming vaccine development

Abstract

The urgency to develop vaccines against Covid-19 is putting pressure on the long and expensive development timelines that are normally required for development of lifesaving vaccines. There is a unique opportunity to take advantage of new technologies, the smart and flexible design of clinical trials, and evolving regulatory science to speed up vaccine development against Covid-19 and transform vaccine development altogether.

Keywords: Adjuvants; COVID-19; Human genetics; Machine learning; Platform technologies; Real world evidence; Regulatory convergence; Smart clinical trials; Systems biology; Vaccine; Vaccine development; Vaccine discovery; Vaccines safety.

Fig. 1

Innovative scientific approaches to accelerate vaccine development, divided by discovery and early development (yellow), late development (red), and implementation (blue). Phase I, Phase II, and Phase III indicate Phase I clinical trials, Phase II clinical trials, and Phase III clinical trials, respectively. EPI = epidemiological studies; CHIM = controlled human infection model studies; H mAbs = human monoclonal antibodies; GMMAs = general modules for membrane antigens; CMC = chemistry and manufacturing controls.

Fig. 2

Net public health benefits versus risk aversion in product development. The relationship between risk aversion by regulators on the x-axis, and the expected net public health benefits on the y-axis. The desire to minimize the likelihood of accepting products with unpredicted product-induced adverse effects drives the request for larger and larger safety data sets. By continuing to move to the right and beyond a ‘sweet spot’ of maximum efficiency, increased risk aversion or requests for more data are anticipated to result in diminishing net public health gains from product research and development. The unintended consequences are false-negative decisions to deny licensure or restrict a product when actual use would result in more good than harm and increased opportunity costs [25].