Abstract

Dr. Michael Watson

From haute cuisine to molecular manufacturing – A vaccine
lifers perspective

RNA vaccines responded to COVID-19 so quickly because they can get from concept to scaled production so fast.  RNA isn’t intrinsically better than other vaccine platforms but it is currently the only effective vaccine platform that is fully molecular in its research, development and production.  All other platforms have significant elements of bespoke, haute-cuisine in their development.  RNA vaccines begin with the genetic code of the target antigen and RNA vaccine developers need never touch the pathogen.  Other platforms such as inactivated, or live platforms rely on isolating, culturing and passaging/mutating or inactivating the antigens, often with the need for an adjuvant.   Other platforms must develop bespoke culture, cell lines, inactivation, formulation and adjuvantation whereas RNA vaccines share the same drug substance (the RNA), formulated drug product (the RNA plus LNP) and production process and facility. 

RNA takes days to make, whereas a stable cell line for a recombinant vaccine or master seed for a live attenuated vaccine can take years.  The nucleotide sequence of an RNA vaccine can be sequenced in minutes whereas the structural conformation of a virus or antigen can take weeks or months.  Adjusting the sequence of an RNA vaccine can take days whereas a new protein antigen of viral vaccine strain can take years to develop and bridge to the existing version.   

To achieve this transition from haute-cuisine to molecular manufacturing requires the collaboration of vaccine developers, molecular and structural scientists, process and formulation scientists and regulators as well as investors and funding bodies to name but a few.  It also requires a clear shared vision that simpler, faster and easier is better.

I believe that other platforms can move from haute-cuisine to molecular research, development and production.  This will be more challenging for some platform than others but there is no reason why vaccines such as molecularly engineered subunit vaccines can’t make this transition.  If we can achieve this then not only will we have more pandemic and epidemic preparedness options, we will also kick-start an even more vibrant vaccines sector.  This will allow us to address unmet needs as well as to dramatically improve on the many existing but ageing haute-cuisine vaccines of today.