Logistical Considerations in mRNA Vaccine Development

Cancer messenger RNA (mRNA) vaccines have made headlines multiple times in 2023. In February, an mRNA vaccine for cancer received breakthrough therapy designation after demonstrating efficacy in a Phase II trial (1). In May, the National Institutes of Health announced that in a small clinical trial, a personalized mRNA vaccine prevented pancreatic cancer from recurring for about half of trial participants (2). These developments were catalyzed in part by the success of the mRNA vaccine for COVID-19.

Unlike traditional vaccines, the manufacturing process for mRNA vaccines is cell-free and can be performed with synthetic enzymes. This allows for unprecedented speed and scale of mRNA vaccine development and manufacturing, which proved to be pivotal during the COVID-19 pandemic. In turn, the deployment of mRNA COVID-19 vaccines helped forge the robust supply chain for mRNA vaccine manufacturing that had not previously existed. Despite this success, clinical and logistical roadblocks to mRNA cancer vaccine development remain.

This article reviews the therapeutic prospects of mRNA vaccines and considerations for clinical development that could help address present issues with patient recruitment, regulatory compliance, manufacturing, and funding.

Read this article in BioPharm International’s Emerging Therapies 2023 eBook.

About the authors

Andreas Dreps, PhD, is SVP, Drug Development Services at ICON; Martin Lachs, PhD, is VP, Project Management Oncology at ICON.

Article details

BioPharm International
Emerging Therapies 2023 eBook
September 2023
Pages: 18-23

Citation

When referring to this article, please cite it as Dreps, A. and Lachs, M. Logistical Considerations in mRNA Vaccine Development. BioPharm International Emerging Therapies eBook. September 2023.