S-11-01 Covid19 vaccine toxicology: introduction and CRO experience/perspectives

The pandemic needed the rapid development of a SARsCov2 vaccine, without impacting on safety and despite Covid being a new disease, with limited understanding of the animal models, unknown correlates of protection and challenges of biosafety levels. mRNA vaccines, which were previously in the therapeutic domain, also brought some additional considerations. Despite these challenges, the first person to be vaccinated was just over a year after the first case was identified, on 29th December 2020. This presentation discusses the requirements for a non-clinical program for a SARsCov2 vaccine, linking how vaccines work and addressing potential safety concerns from first in human to license. Woven into the presentation will be a discussion on models and species selection, as well as how we supported speeding development up and kept up with an adapting regulatory environment. We also needed to educate and support new players (both manufacturers and scientists) who were often more familiar with the principles of ICH than the WHO guidelines (the key guidelines for prophylactic vaccine). Finally, we will provide an update on how we are continuing discussions on models and species selection, as well as briefly mentioning the new WHO guidelines for mRNA vaccines.