Codon Optimization in mRNA Vaccines and

Gene Therapies: An Assessment of Protein Misfolding Risks and Regulatory Oversight

A Whitepaper for the Vaccines and Related Biological Products Advisory

Committee.

Created by Ehden Biber, 14th of May, 2025.

Conclusion on Moratorium

Given the mounting evidence of risk and gaps in oversight, a tiered moratorium is recommended.