Research progress and CMC review considerations of MF59 vaccine adjuvant
XU Li
ZHAO Xin
LIU Min
LI Min
Abstract：MF59 is a squalene-based oil-in-water nano-adjuvant.It has been extensively applied in clinical settings,demonstrating excellent safety and adjuvant effects.In the future,it will play a greater role in the development of vaccines for the prevention of emerging infectious diseases.This paper systematically reviews the immunological mechanisms,non-clinical safety studies,and clinical application progress of MF59.Furthermore,it highlights considerations for pharmaceutical research and evaluation of MF59,offering insights into its potential applications in future vaccine development.
Keywords：MF59vaccine adjuvantsqualeneCOVID-19 vaccineinfluenza vaccine
Publication Date：2025-03-30
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：9( 656-664 )