As an immunologist and biotechnologist, I am frightened and fascinated in almost equal measure by nSARS-CoV-2 and the unique public health and socioeconomic challenges it poses. There is no guarantee that any of the 100+ candidate vaccines currently in development for Covid-19 will be successful in terms of providing effective protection against nSARS-CoV-2 infection. The time-pressures and also scale of material required if we are to approach anything like global herd immunity are unprecedented. So too is the fact that we simply do not yet fully understand this novel virus and therefore lack the advantage of the solid platform of years of research on which fully optimised vaccination strategies are normally built.

It is critical therefore, that significant efforts to develop therapies for nSARS-CoV-2 are being explored in parallel to vaccines. The vast majority of the dozens of therapeutic trials, currently or shortly to be underway worldwide, are for re-purposed medicines as Covid-19 treatments. These are products which suggest a rationale for efficacy in Covid-19 and are already licensed for other conditions or in mid-to-late-stage clinical development; ‘normally’ the mid-way point in the clinical trials process, but now requiring to be tested immediately. We simply do not have time to begin development of novel therapies from first principal if we are to change the trajectory of this pandemic.

Having started the regulatory and manufacturing journey ahead of clinical trials for NovaBiotics’ re-purposed Covid-19 therapy, Nylexa®, I have experienced how the therapeutic development process is being further expedited through managing remotely and fast-tracking the usual regulatory and ethical processes to ensure that potential solutions for this public health emergency are tested in patients as quickly as possible without compromising safety.

The issue remains, however, that whichever vaccine and/or therapy proves successful, no matter how quickly, it must be deployed rapidly across the globe and to billions of people. Science alone will not achieve this, and even the most cutting-edge vaccine or therapy may fail because it isn’t actually a viable solution to a global pandemic: scalable, stable and affordable. Resource must be focused on solutions that can meet these criteria, not solely on the most compelling science.

The success of whichever intervention or interventions eventually become available for Covid-19 will undoubtedly shape the drug discovery process forever. For the better too, as the ability to develop medicines for novel diseases faster, at larger scale and at less cost will hopefully become embedded within the life sciences community. Silver linings from the Covid-19 cloud are set to cast shade for some time to come, until we achieve what would have been deemed the impossible just a few short weeks ago.

Dr Deborah O’Neil OBE, FRSE
CEO of NovaBiotics Ltd