Stability assessment for vaccines: recent trends & learnings from accelerated scenarios

In recent times, outbreaks and pandemics have prompted the need to consider new paradigms for the stability assessment of vaccines. This article provides an overview of key CMC strategies to support the advancement of stability assessment approaches, including the relevance of product understanding and strong analytical packages, risk-based approaches based on advanced modeling, and increased reliance on prior knowledge. The considerations reported here are based on the current dialogue between Industry and Regulators and need to be assessed on a case-by-case basis; nevertheless, they enable the establishment of a structured path to secure global vaccine access in accelerated scenarios.