Nonclinical Safety Assessments of the Next Generation of mRNA Vaccines for SARS-CoV-2 and Other Respiratory Viruses (S12-3)

mRNA-based vaccines hold the promise to be a safe and effective platform and have played a significant role in combatting the COVID-19 pandemic. This presentation will highlight the nonclinical safety considerations for mRNA vaccines including a review of the development of approved SARS-CoV-2 vaccines.  AstraZeneca is developing respiratory virus vaccine candidates using a novel mRNA-based platform delivered in a lipid nanoparticle (LNP) formulation. The nonclinical safety characterization of these products typically includes studies to assess local reactogenicity, biodistribution and systemic toxicity of the components of the vaccine.  The extent of the nonclinical safety program and the battery of tests required depends on the novelty of the lipids used in the LNP formulation, as this can affect the safety attributes of the vaccine candidate.  The IND-enabling regulatory nonclinical safety package for a novel SARS-CoV-2 mRNA vaccine as well as future considerations for the development of mRNA vaccines in a rapidly evolving regulatory landscape and the process to optimize their safety characterization will be described.