Abstract
Current RNA vaccines against SARS-CoV-2 are limited by instability of both the RNA and the lipid nanoparticle delivery system, requiring storage at −20°C or −70°C and compromising universally accessible vaccine distribution. This study demonstrates the thermostability and adaptability of a nanostructured lipid carrier (NLC) RNA vaccine delivery system for use in pandemic preparedness and pandemic response. Liquid NLC is stable at refrigerated temperatures for ≥ 1 year, enabling stockpiling and rapid deployment by point-of-care mixing with any vaccine RNA. Alternatively, NLC complexed with RNA may be readily lyophilized and stored at room temperature for ≥ 8 months or refrigerated temperature for ≥ 21 months. This thermostable RNA vaccine platform could significantly improve distribution of current and future pandemic response vaccines, particularly in low-resource settings.
One Sentence Summary An RNA vaccine delivery system stable at room temperature for 8+ months and refrigerated for 21+ months.
Competing Interest Statement
C.F. and N.V.H. are co-inventors on patent applications relating to PCT/US2018/37783, Nanostructured Lipid Carriers and stable emulsions and uses thereof. M.A., A.G., and R.K. are co-inventors on U.S. patent application nos. 63/075,032 and 63/107,383, Co-lyophilized RNA and Nanostructured Lipid Carrier. All other authors declare they have no competing interests.
