Main goals of safety evaluation are:
- (1) to support entry into clinical trials (and registration), (2) to identify unexpected toxicities and (3) to identify safety parameters for clinical monitoring.
Nonclinical safety packages for vaccines
According to WHO (2005 & 2013) it should include evaluation of local tolerance, systemic toxicity, and reproductive toxicity.
mRNAs
Nonclinical package prepared according to WHO (2021).
Biodistribution studies are performed on a per-product basis.
Biodistribution studies are performed on a per-product basis.
Toxicology studies need to be conducted in a relevant animal model (immunogenicity to be confirmed), and study designs will be adapted (ie. schedule of administration).
Adjuvanted vaccines
Nonclinical safety package may need to be extended with safety pharmacology studies and genotoxicity assessments for instance.
