The European Medicines Agency (EMA) has created a concept paper that addresses the need to establish a guideline on the quality aspects of messenger RNA (mRNA) vaccines, emphasizing the number of clinical trial applications and marketing authorization applications for mRNA-containing products significantly increasing over the past few years and still growing.
Further, EMA looks to focus on mRNA vaccines because their classification depends on the target and/or whether they are obtained chemically or biologically. New technology for these types of vaccines is not fully accounted for in the existing guidance, which is why a newer guidance is necessary for EMA to highlight specific aspects regarding the manufacturing process, characterization, specifications, and analytical control for mRNA vaccines for the prevention of infectious disease.
According to the company press release, the scope of the guideline will be limited to mRNA vaccines against infectious diseases. Further, mRNA-based therapeutics will be out of scope of the document, and it is not intended to address specific requirements for mRNA vaccines to be used in clinical trials.