mRNA Clinical Trials: Key Regulatory Considerations

By Daniel Eisenman, PhD, RBP, SM(NRCM), CBSP, Executive Director, Biosafety Services

Over the past two years, Operation Warp Speed brought mRNA-based vaccines into the spotlight, as organizations like Moderna and Pfizer/BioNTech raced to develop a COVID-19 vaccine. While scientists have worked on messenger ribonucleic acid (mRNA) for years, these successes have enabled researchers to use mRNA technology to develop vaccines against a number of other infectious agents, as well as to develop potential therapeutics for a number of other disease indications.

Curious about mRNA technology and the regulatory requirements for its use in clinical trials? You’re not alone—our biosafety team frequently receives questions from study sponsors, contract research organizations (CROs), and sites. Read on as we respond to our most commonly asked questions.