mRNA vaccines: immunogenicity and quality characteristics

Abstract

mRNA vaccine technology platform has evolved rapidly in recent years, which has emerged as an important direction in vaccine development. Establishing a quality control platform based on its Critical Quality Attributes (CQAs) is fundamental to ensuring vaccine efficacy and safety. This paper systematically explores the key quality attributes of mRNA vaccines and their impact on vaccine immunogenicity. Additionally, it introduces the technical principles, development status, key quality control items and their significance, as well as immunogenicity indicators of mRNA vaccines, and discusses the critical importance of studying the correlation between CQAs and immunogenicity.