REVIEW article
Front. Virol.
Sec. Antivirals and Vaccines
This article is part of the Research TopicBridging Gaps in Antiviral Therapy: Innovative Approaches in Drug Discovery and Vaccine DevelopmentView all 3 articles
From COVID-19 to Global Health: Challenges and Opportunities in mRNA Vaccine Manufacturing
Provisionally accepted
- 1Independent Researcher, Quincy, United States
- 2Independent Researcher, Mansfield, United States
- 3Independent Researcher, Peabody, United States
- 4Independent Researcher, Cambridge, United States
- 5University of the Cumberlands, Lebanon, United States
- 6Gyeongsang National University, Jinju, Republic of Korea
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Messenger RNA (mRNA) vaccines have emerged as a powerful tool in combating infectious diseases, including COVID-19, by synthesizing and delivering bioactive mRNA molecules that must remain stable and functional to transcribe target genes and effectively enter host cells. This review provides a brief examination of the synthesis and purification processes of mRNA vaccines, their formulation strategies, production scalability, regulatory frameworks, and global supply chain systems. Several challenges—including molecular instability during synthesis and lipid nanoparticle encapsulation, reliance on specialized equipment, insufficient supply of raw materials and skilled labor, and the need for standardized production quality at scale—are underscored. These concerns are further compounded by fragmented regulatory approval processes and the complexity of maintaining cold chain logistics, particularly in low-resource settings. Addressing these barriers is essential, and emerging solutions include integrating automation and artificial intelligence to enhance manufacturing efficiency and reduce associated costs. Additionally, ongoing research aims to improve the environmental stability of mRNA vaccines, thereby reducing reliance on cold storage and increasing accessibility in developing countries. Prospective developments further encompass the globalization of regulatory standards, the concentration of production capacities, and the application of mRNA technology beyond infectious diseases, including cancer and hereditary disorders. Overall, the review emphasizes that resolving manufacturing and logistical challenges together with international cooperation and supportive policy frameworks is crucial for advancing a new era of mRNA-based therapies accessible to populations worldwide.
Keywords: mRNA vaccines, synthesis and purification, lipid nanoparticle delivery, Cold chain logistics, manufacturing scalability
Received: 23 Oct 2025; Accepted: 01 Dec 2025.
Copyright: © 2025 Choudhary, Mehta, Niaz, Sohoni, Nwagwu and Samad. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
Moazam Niaz
Abdul Samad
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.