Abstract
The COVID-19 pandemic demonstrates the ongoing threat of pandemics caused by novel, previously unrecognized, or mutated pathogens with high transmissibility. Currently, vaccine development is too slow for vaccines to be used in the control of emerging pandemics. RNA-based vaccines might be suitable to meet this challenge. The use of an RNA-based delivery mechanism promises fast vaccine development, clinical approval, and production. The simplicity of in vitro transcription of mRNA suggests potential for fast, scalable, and low-cost manufacture. RNA vaccines are safe in theory and have shown acceptable tolerability in first clinical trials. Immunogenicity of SARS-CoV-2 mRNA vaccines in phase 1 trials looks promising, however induction of cellular immunity needs to be confirmed and optimized. Further optimization of RNA vaccine modification and formulation to this end is needed, which may also enable single injection regimens to be achievable. Self-amplifying RNA vaccines, which show high immunogenicity at low doses, might help to improve potency while keeping manufacturing costs low and speed high. With theoretical properties of RNA vaccines looking promising, their clinical efficacy is the key remaining question with regard to their suitability for tackling emerging pandemics. This question might be answered by ongoing efficacy trials of SARS-CoV-2 mRNA vaccines.
Highlights
The coronavirus COVID-19 pandemic demonstrates the threat posed by pandemic pathogens
Yes Acceptable, larger scale clinical trials needed Immunogenicity promising in human studies, potent efficacy in animals – remains to be optimized and confirmed Yes Likely yes, dependent on growing safety database Likely yes, dependent on approach used Likely yes, simple production facilities Likely yes, dependent on formulation and dose Potentially achievable based on animal data Possible in human and animal studies, further optimization of induction of cellular responses needed May be achievable, more investigation needed administered with a single injection vaccine in mice and nonhuman primates (NHPs), which show a very similar disease phenotype and immunity to humans [50]
RNA vaccines fulfil many of the characteristics necessary to be useful to tackle an emerging pandemic and Disease X (Table 3)
Summary
The coronavirus COVID-19 pandemic demonstrates the threat posed by pandemic pathogens. Yes Acceptable, larger scale clinical trials needed Immunogenicity promising in human studies, potent efficacy in animals – remains to be optimized and confirmed Yes Likely yes, dependent on growing safety database Likely yes, dependent on approach used Likely yes, simple production facilities Likely yes, dependent on formulation and dose Potentially achievable based on animal data Possible in human and animal studies, further optimization of induction of cellular responses needed May be achievable, more investigation needed administered with a single injection vaccine in mice and nonhuman primates (NHPs), which show a very similar disease phenotype and immunity to humans [50]. It seems likely that the thermostability of RNA vaccines will improve in the coming years
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