This tool was aimed at identifying potential major hurdles or gaps that would need to be addressed during the development of vectored vaccines. The template collects information on the characteristics of the wild type virus from which the vector was derived as well as known effects of the proposed vaccine vector in animals and humans, manufacturing features, toxicology and potency, nonclinical studies, and human use, with an overall adverse effect and risk assessment.
This manuscript uses the BRAVATO template to report the key considerations for a benefit-risk assessment of the coronavirus diseas...