Advances in mRNA vaccine research in the field of quality control

Abstract

In recent years, innovative research and development of mRNA vaccines have made remarkable achievements, especially in the context of pandemic infectious diseases such as the COVID-19 virus, and the need for rapid vaccine development has further fueled the rapid growth of this field. Nevertheless, there are still gaps in our understanding of the working mechanism of mRNA vaccines and their long-term safety, efficacy, and quality control. This article summarizes the development background and production process of mRNA vaccines, outlines existing reference guidelines, quality control projects, and testing methods at home and abroad, and also summarizes the difficulties and future prospects in research and development and quality control. It provides a reference for developing guidelines for mRNA vaccine production, quality control, and preclinical and clinical evaluation.