The normal process for the evaluation of a vaccine necessitates that all the required information regarding product safety, efficacy and quality be provided at the time of submission. In other words, all the clinical trial data for safety and efficacy from phase one to three should be provided together with manufacturing information of the product quality.
In an effort to respond to the pandemic, SAHPRA introduced another mechanism to facilitate the review of COVID-19 applications, which is the rolling review process. The rolling review is a mechanism that facilitates the submission of data as it becomes available. This webinar will focus on the vaccine approval processes.
Watch the webinar below: