mRNA has risen to the surface as a promising solution for addressing future pandemics as well as other infectious diseases such as rabies, Zika, and cytomegalovirus infection. Several mRNA-based products are also in clinical pipelines for cystic fibrosis and various cancers. The COVID-19 pandemic accelerated research and development of this technology as a vaccine platform, leading to mRNA vaccines becoming the first modality to receive emergency use authorization and then approval for SARS-CoV-2 in the U.S.
Analytical Procedures for mRNA Vaccine Quality
We welcome public comments on these draft guidelines.
To build public trust and confidence in innovative products like mRNA-based therapies, they must be of good quality, safe, and effective. Since the successful application of mRNA technology is relatively new, regulatory guidelines and industry standards are still evolving. A common approach for assessing mRNA quality would support developers, manufacturers, regulatory agencies, and national control laboratories worldwide, and provide tools to help accelerate the development of safe and effective mRNA-based products.
