MFDS Establishes Evaluation Guidelines for Preventive mRNA Vaccines

[Asia Economy Reporter Jo In-kyung] The Ministry of Food and Drug Safety (MFDS) distributed vaccine evaluation guidelines on the 27th that provide quality control and non-clinical and clinical trial considerations for preventive messenger ribonucleic acid (mRNA) vaccines.

The guidelines include points that need to be specifically considered in mRNA vaccines, such as mRNA safety affected by the lipid nanoparticle binding state, quality control standards, and precautions during non-clinical and clinical evaluations.

The MFDS explained, "This guideline was prepared as part of the 'Our Vaccine Project,' which supports the entire domestic development process to prepare for new infectious disease crises such as COVID-19."

The mRNA vaccine platform has the advantage of producing vaccines faster than existing methods such as recombinant protein platforms, enabling rapid response in infectious disease crisis situations like COVID-19. Currently, there are two COVID-19 mRNA vaccine candidates in clinical trial stages domestically, both undergoing Phase 1 clinical trials.