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Research Advances on the Stability of mRNA Vaccines

Feiran Cheng1,2, Yiping Wang3, Yu Bai1,2

  • 1National Medical Products Administration Key Laboratory for Quality Research and Evaluation of Biological Products, Institute of Biological Products, National Institutes for Food and Drug Control, Beijing 102600, China.

Viruses
|March 30, 2023
PubMed

Insights

Messenger RNA (mRNA) vaccines are unstable, limiting their effectiveness and accessibility. Optimizing mRNA structure, excipients, and manufacturing processes is crucial for developing more stable and globally accessible mRNA vaccines.

Area of Science:

  • Vaccinology
  • Biopharmaceutical Development
  • Drug Delivery Systems

Background:

  • Messenger RNA (mRNA) vaccines exhibit inherent instability due to their properties and lipid nanoparticle (LNP) interactions.
  • This instability poses challenges to vaccine effectiveness, shelf-life, and global accessibility.

Purpose of the Study:

  • To review regulatory guidance on mRNA vaccine stability.
  • To summarize key factors influencing mRNA vaccine stability.
  • To propose research avenues for enhancing mRNA vaccine stability.

Main Methods:

  • Literature review of factors affecting mRNA vaccine stability.
  • Analysis of regulatory guidelines pertinent to vaccine stability.
  • Synthesis of current research and identification of future research directions.

Main Results:

  • mRNA structure, excipients, LNP delivery systems, and manufacturing processes are identified as primary determinants of mRNA vaccine stability.
  • Optimization of these factors presents a viable strategy for improving vaccine stability.

Conclusions:

  • Improving mRNA vaccine stability is essential for enhancing vaccine effectiveness and global accessibility.
  • Further research into optimizing mRNA structure, excipient screening, and manufacturing processes is recommended.
  • Development of thermally stable mRNA vaccines is achievable through targeted interventions.
Keywords:
degradationlipid nanoparticlemRNAstabilityvaccines

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