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Review
. 2025 Apr 28;13(5):473.
doi: 10.3390/vaccines13050473.

Considerations for mRNA Product Development, Regulation and Deployment Across the Lifecycle

John H Skerritt  1
Affiliations
Review

Considerations for mRNA Product Development, Regulation and Deployment Across the Lifecycle

John H Skerritt. Vaccines (Basel). .

Abstract

With the successful deployment of several mRNA vaccines against SARS-CoV-2, an mRNA vaccine against RSV (respiratory syncytial virus) and a large pipeline of mRNA products against other infectious diseases, cancers and rare diseases, it is important to examine the whole product lifecycle. mRNA technology enables product design, testing and manufacturing systems to be rapidly developed, but these advantages can be lost if other factors that determine public access are not closely considered. This review analyzes key aspects of the mRNA product lifecycle including candidate design, manufacturing, quality systems and product safety and storage. Regulatory thinking is well advanced in some countries but not others, but more thought on the regulation of mRNA vaccines outside of a pandemic situation as well as mRNA therapeutics including individual neoantigen therapies and rare disease treatments is needed. Consumer acceptance-the "social license to operate" around mRNA products-is critical for their uptake, particularly outside of a pandemic.

Keywords: lifecycle; mRNA; platform technology; regulation; safety; vaccine development.

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Conflict of interest statement

The author is also an advisor to CEPI (Coalition for Epidemic Preparedness Innovations) on vaccine technologies and regulation.

Figures

Figure 1
Figure 1
Development and administration of mRNA individual neoantigen therapies.
Figure 2
Figure 2
Factors influencing the “Social license to operate” for mRNA vaccines.
See this image and copyright information in PMC

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References

    1. Skerritt J.H., Tucek-Szabo C., Sutton B., Nolan T. The Platform Technology Approach to mRNA Product Development and Regulation. Vaccines. 2024;12:528. doi: 10.3390/vaccines12050528. - DOI - PMC - PubMed
    1. Whitley J., Zwolinski C., Denis C., Maughan M., Hayles L., Clarke D., Snare M., Liao H., Shiou S., Marmura T., et al. Development of mRNA manufacturing for vaccines and therapeutics: mRNA platform requirements and development of a scalable production process to support early phase clinical trials. Transl. Res. 2021;242:38–55. doi: 10.1016/j.trsl.2021.11.009. - DOI - PMC - PubMed
    1. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Harmonised Guideline Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management (Q12) November 2019. [(accessed on 10 January 2025)]. Available online: https://database.ich.org/sites/default/files/Q12_Guideline_Step4_2019_11....
    1. Androsavich J.R. Frameworks for the transformational breakthroughs in RNA-based medicines. Nat. Rev. Drug Discov. 2024;23:412–444. doi: 10.1038/s41573-024-00943-2. - DOI - PubMed
    1. Niu D., Wu Y., Lian J. Circular RNA vaccine in disease prevention and treatment. Sig. Transduct. Target. Ther. 2023;8:341. doi: 10.1038/s41392-023-01561-x. - DOI - PMC - PubMed

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