A Thermostable, Flexible RNA Vaccine Delivery Platform for Pandemic Response

Gerhardt, Alana; Voigt, Emily; Archer, Michelle; Reed, Sierra; Larson, Elise; Van Hoeven, Neal; Kramer, Ryan; Fox, Christopher; Casper, Corey

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.