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The promise of mRNA vaccines: a biotech and industrial perspective
Open accessAbstract
mRNA technologies have the potential to transform areas of medicine, including the prophylaxis of infectious diseases. The advantages for vaccines range from the acceleration of immunogen discovery to rapid response and multiple disease target manufacturing. A greater understanding of quality attributes that dictate translation efficiency, as well as a comprehensive appreciation of the importance of mRNA delivery, are influencing a new era of investment in development activities. The application of translational sciences and growing early-phase clinical experience continue to inform candidate vaccine selection. Here we review the state of the art for the prevention of infectious diseases by using mRNA and pertinent topics to the biotechnology and pharmaceutical industries.
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“Messenger RNA (mRNA)-based therapy recently emerged as an effective platform for treatment of infectious diseases and cancer (Jackson et al., 2020; Mascola and Fauci, 2020).”
From A thermostable mRNA vaccine against COVID-19 (2020) · cites this paper as Jackson et al., 2020
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
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“mRNA vaccines still suffer from decreased efficacy due to poor RNA stability in solution and in vivo and to limited expression of the payload mRNA; these are all pivotal issues that need to be carefully optimized for preclinical and clinical applications3–6.”
From Combinatorial optimization of mRNA structure, stability, and translation for RNA-based therapeutics (2022) · cites this paper as [4]
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Citations
Cites
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Cited by
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InfluentialmRNA Vaccines against Flaviviruses
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Aldon, Y., McKay, P. F., Herrero, J. M., Vogel, A. B., Lévai, R. F., Maisonnasse, P., Dereuddre‐Bosquet, N., Haas, H., Fábián, K., Grand, R. L., et al. (2021) · Molecular Therapy — Nucleic Acids · doi:10.1016/j.omtn.2021.06.008 · Cited by 34
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“The development of these RNA sequences is comparatively less costly and time-consuming because it avoids the challenging purification processes of proteins (Jackson et al., 2020).”
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Gastrointestinal Delivery of an mRNA Vaccine Using Immunostimulatory Polymeric Nanoparticles
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“Compared to attenuated and live vaccines, the manufacturing of mRNA vaccines is relatively quick and convenient as a diverse set of antigens can be produced with relatively similar fabrication techniques (37).”
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Rapid Development of Analytical Methods for Evaluating Pandemic Vaccines: A Covid-19 Perspective
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Development of mRNA Vaccines/Therapeutics and Their Delivery System
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“RNA-based drugs have recently received significant attention mainly because of the great success of developing mRNA vaccines to cope with the coronavirus disease 2019 (COVID-19) pandemic (Jackson et al., 2020; Kwon et al., 2018; Wang et al., 2020).”
Path towards mRNA delivery for cancer immunotherapy from bench to bedside
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“In general, crafting RNA-based therapeutics involves a complex, multi-step process necessitating precise reaction condition control and meticulous purification (115, 116).”
BackgroundInhalable Dry Powders for Lung mRNA Delivery
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Pressure‐dependent fouling behavior during sterile filtration of mRNA‐containing lipid nanoparticles
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“Although several studies have described the sterile filtration of liposomes (Folmsbee & Moussourakis, 2012; Johnson et al., 2021; Singh et al., 2018; Toh & Chiu, 2013; Zourna et al., 2021), there do not appear to be any published data on the sterile filtration of mRNA‐LNPs or any other LNPs.”
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“B-cells were once the only source for vaccine development; however, computational biology now focuses on histocompatibility complex (MHC) T-cells with the most interacting human leukocyte antigen (HLA) scheme in a new clinical research field called computational biology [44].”
BackgroundMukhtar, M., Wajeeha, A. W., Zaidi, N. U. S. S., & Bibi, N. (2022) · International Journal of Molecular Sciences · doi:10.3390/ijms232213911 · Cited by 31
“To rovide effici nt protection from degr dation by nuclease activity, nature’s fleeting molecule, mRNA, is ack i lipid nanoparticle (LNP) formulations [58].”
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“Therefore, systematic explorations of UTRs may provide broad applicability for mRNA vaccines in response to emerging pathogens such as SARS-CoV-2.”
BackgroundMulti-Epitope Vaccine Design Using an Immunoinformatic Approach for SARS-CoV-2
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“Pathogens 2021, 10, 737. https://doi.org/10.3390/pathogens10060737 https://www.mdpi.com/journal/pathogens Pathogens 2021, 10, 737 2 of 16 Up until now, several therapeutics and vaccines have been used under Emergency Use Authorization for COVID-19 [8].”
BackgroundInfluentialAdvances in mRNA-based drug discovery in cancer immunotherapy
Trani, C. A. D., Fernández-Sendin, M., Cirella, A., Segués, A., Olivera, I., Bolaños, E., Melero, I., & Berraondo, P. (2021) · Expert Opinion on Drug Discovery · doi:10.1080/17460441.2021.1978972 · Cited by 28
“and cost-effectively produced on a large scale [103].”
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“Our hope is this technology will enable further improvements in both transcription and in vitro protein expression to result in better biomedical, biotechnological, and synthetic cell engineering applications [44, 45].”
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Research progress and challenges to coronavirus vaccine development
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“In addition, because there is no mRNA vaccine product in the market, there is no ready‐made experience for mass production and production process of the mRNA vaccine, and large‐scale industrial production also needs to be further explored.(93)”
BackgroundIonizable drug delivery systems for efficient and selective gene therapy
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“However, safe and efficient delivery systems, optimized design and preparation process meeting commercial production standards are still the main factors affecting its clinical application and industrial development for a long time [4].”
BackgroundCurrent Status of Porcine Reproductive and Respiratory Syndrome Vaccines
Wang, H., & Feng, W.-H. (2024) · Vaccines · doi:10.3390/vaccines12121387 · Cited by 26
Nucleic acid functionalized extracellular vesicles as promising therapeutic systems for nanomedicine
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Application of mRNA Technology in Cancer Therapeutics
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Roles of RNA-binding proteins in neurological disorders, COVID-19, and cancer
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Proteoid biodynamers for safe mRNA transfection via pH-responsive nanorods enabling endosomal escape
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Optimizing Messenger RNA Analysis Using Ultra-Wide Pore Size Exclusion Chromatography Columns
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“The production process is cell-free and scalable [6]. mRNA drugs and vaccines are now being widely evaluated for the treatment of rare genetic diseases, several types of cancers, and respiratory and infectious diseases, and they are expected to soon become one of the major class of therapeutic…”
BackgroundmRNA Vaccine: How to Meet the Challenge of SARS-CoV-2
Jin, Y., Hou, C., Li, Y., Zheng, K., & Wang, C. (2022) · Frontiers in Immunology · doi:10.3389/fimmu.2021.821538 · Cited by 24
RNA Therapeutics: A Healthcare Paradigm Shift
Niazi, S. K. (2023) · Biomedicines · doi:10.3390/biomedicines11051275 · Cited by 25
“Typical DNA, pre-mRNA, and mRNA sequences are shown in Figure 3 [34,35].”
BackgroundSafety and efficacy assessment of an mRNA rabies vaccine in dogs, rodents, and cynomolgus macaques
Li, J., Yu, P., Liu, Q., Xu, L., Chen, Y., Li, Y., Zhang, F., Zhu, W., & Peng, Y. (2024) · npj Vaccines · doi:10.1038/s41541-024-00925-w · Cited by 24
“Through a lipid-based delivery system, mRNAvaccine-encodingimmunogensaredeliveredtotargetcellsandelicit vaccine-speci fi c responses 14 . mRNA vaccines are quick and cost-ef fi cient to produce,and have fl exibility in immunogen design 17 – 19 .”
BackgroundRacing to immunity: Journey to a COVID‐19 vaccine and lessons for the future
Fernández, E. C., & Zhu, L. Y. (2020) · British Journal of Clinical Pharmacology · doi:10.1111/bcp.14686 · Cited by 24
In the Era of mRNA Vaccines, Is There Any Hope for HIV Functional Cure?
Esteban, I., Pastor-Quiñones, C., Usero, L., Plana, M., García, F., & Leal, L. (2021) · Viruses · doi:10.3390/v13030501 · Cited by 26
“In studies using unmodified mRNA, the optimization of the coding sequence and mRNA purification has been linked to improved protein production, decreased unwanted inflammatory responses, and enhanced adaptive immune responses [27,35].”
BackgroundCan mRNA Vaccines Turn the Tables During the COVID-19 Pandemic? Current Status and Challenges
Anthony, D. P. S., Sivakumar, K., Venugopal, P., Sriram, D. K., & George, M. (2021) · Clinical Drug Investigation · doi:10.1007/s40261-021-01022-9 · Cited by 23
“The main function of mRNA vaccines is to deliver the gene of interest, encoding the specific target antigen into the host cytoplasm for the production of proteins (including membrane, secretory, or intracellular) [14].”
BackgroundVaccines against SARS-CoV-2 variants and future pandemics
Park, T., Hwang, H., Moon, S., Kang, S. G., Song, S., Kim, Y. H., Kim, H., Ko, E., Yoon, S., Kang, S., et al. (2022) · Expert Review of Vaccines · doi:10.1080/14760584.2022.2110075 · Cited by 23
“pseudouridine and 1-methylpseudouridine [61], allows mRNA molecules to escape the intracellular signaling triggers (TLR7/ 8) [62], resulting in enhanced mRNA translation, antigen expression, and adaptive immune responses [63].”
BackgroundShahrear, S., & Islam, A. B. M. M. K. (2022) · Molecular Diversity · doi:10.1007/s11030-022-10515-4 · Cited by 24
Review: N1-methyl-pseudouridine (m1Ψ): Friend or foe of cancer?
Rubio‐Casillas, A., Cowley, D., Raszek, M., Uversky, V. N., & Redwan, E. M. M. M. (2024) · International Journal of Biological Macromolecules · doi:10.1016/j.ijbiomac.2024.131427 · Cited by 27
Demelenne, A., Servais, A., Crommen, J., & Fillet, M. (2021) · Journal of Chromatography A · doi:10.1016/j.chroma.2021.462283 · Cited by 25
Rethinking Protein Drug Design with Highly Accurate Structure Prediction of Anti-CRISPR Proteins
Park, H.-M., Park, Y., Vankerschaver, J., Messem, A. V., Neve, W. D., & Shim, H. (2022) · Pharmaceuticals · doi:10.3390/ph15030310 · Cited by 21
Distinct dynamics of mRNA LNPs in mice and nonhuman primates revealed by in vivo imaging
Lemdani, K., Marlin, R., Mayet, C., Perkov, V., Pascal, Q., Ripoll, M., Relouzat, F., Dhooge, N., Bossevot, L., Dereuddre‐Bosquet, N., et al. (2024) · npj Vaccines · doi:10.1038/s41541-024-00900-5 · Cited by 25
“LNPs are typically composed of ionizable cationic lipids, phospholipids, cholesterol, and polyethylene glycol (PEG) 5,6 .”
BackgroundTang, Z., Su, T., Jiang, T., Hu, J., Chen, D., Li, X., Lü, J., Lin, J., & Shen, T. (2025) · Journal of Controlled Release · doi:10.1016/j.jconrel.2025.114263 · Cited by 23
Co-Delivery of mRNA and pDNA Using Thermally Stabilized Coacervate-Based Core-Shell Nanosystems
Nasr, S. S., Lee, S., Thiyagarajan, D., Boese, A. S., Loretz, B., & Lehr, C. (2021) · Pharmaceutics · doi:10.3390/pharmaceutics13111924 · Cited by 22
“Many ongoing clinical trials investigate mRNA-based vaccines for rabies, influenza H7N9, influenza H10N8, cytomegalovirus, human metapneumovirus, parainfluenza virus 3, respiratory syncytial virus, and Zika, among others [3].”
BackgroundStudying the Key Intermediate of RNA Autohydrolysis by Cryogenic Gas‐Phase Infrared Spectroscopy
Greis, K., Kirschbaum, C., Taccone, M. I., Götze, M., Gewinner, S., Schöllkopf, W., Meijer, G., von Helden, G., & Pagel, K. (2022) · Angewandte Chemie International Edition · doi:10.1002/anie.202115481 · Cited by 22
Bajoria, S., Kaur, K., Kumru, O. S., Slyke, G. V., Doering, J., Novak, H., Rodriguez‐Aponte, S. A., Dalvie, N. C., Naranjo, C. A., Johnston, R. S., et al. (2022) · Human Vaccines & Immunotherapeutics · doi:10.1080/21645515.2022.2079346 · Cited by 22
mRNA-Based Approaches to Treating Liver Diseases
Cacicedo, M. L., Limeres, M. J., & Gehring, S. (2022) · Cells · doi:10.3390/cells11203328 · Cited by 23
“Recent studies have focused on the development of novel, biocompatible lipid formulations that facilitate cellular uptake, endosomal release, and mRNA expression [34,37].”
BackgroundFiolet, T., Kherabi, Y., MacDonald, C. J., Ghosn, J., & Peiffer‐Smadja, N. (2021) · OSF Preprints (OSF Preprints) · doi:10.31219/osf.io/z4x7t · Cited by 22
Peletta, A., Lemoine, C., Courant, T., Collin, N., & Borchard, G. (2023) · Pharmacological Research · doi:10.1016/j.phrs.2023.106699 · Cited by 21
Advances in the study of LNPs for mRNA delivery and clinical applications
Wang, B., Shen, B., Xiang, W., & Shen, H. (2024) · Virus Genes · doi:10.1007/s11262-024-02102-6 · Cited by 22
“(3) Short development cycle: The mRNA encoding the antigenic protein can be designed as soon as the pathogen's genome sequence is determined [7, 8].”
Cui, T., Fakhfakh, K., Turney, H. N., Güler-Gane, G., Toloczko, A. D., Hulley, M. E., & Turner, R. (2022) · Biotechnology Progress · doi:10.1002/btpr.3301 · Cited by 22
“Increasing attention has been paid to novel mRNA vaccines owing to their high potency, capacity for rapid development as well as their simplified manufacturing procedures and safe administration.(6,7) While two COVID19 mRNA vaccines have been approved from Pfizer-BioNTech and Moderna, many others are in clinical and p…”
BackgroundmRNA Vaccine - A New Cancer Treatment Strategy
Tan, T., Deng, S., Wu, B.-H., Yang, Q., Wu, M., Wu, H., Cao, C., & Xu, C. S. (2023) · Current Cancer Drug Targets · doi:10.2174/1568009623666230222124424 · Cited by 22
The Safety and Effectiveness of mRNA Vaccines Against SARS-CoV-2
Jamous, Y. F., & Alhomoud, D. A. (2023) · Cureus · doi:10.7759/cureus.45602 · Cited by 24
“These steps enable Good Manufacturing Practice (GMP) facilities to produce a new vaccine in a short period of time [19].”
BackgroundKeikha, R., Hashemi-Shahri, S. M., & Jebali, A. (2021) · Scientific Reports · doi:10.1038/s41598-021-00830-5 · Cited by 19
Medjmedj, A., Genon, H., Hezili, D., Loth, A. N., Clemençon, R., Guimpied, C., Mollet, L., Bigot, A., Wien, F., Hamacek, J., et al. (2025) · Molecular Therapy Nucleic Acids · doi:10.1016/j.omtn.2025.102648 · Cited by 19
“1,2 Synthetic mRNA has the same primary structure as mature mRNA molecules, typically consisting of five elements (from 5 ′ to 3 ′ ): a cap structure, a 5 ′ untranslated region (5 ′ UTR), a coding sequence, a 3 ′ UTR, and the poly(A) tail.”
Nanotechnology-Based Nucleic Acid Vaccines for Treatment of Ovarian Cancer
Gildiz, S., & Minko, T. (2022) · Pharmaceutical Research · doi:10.1007/s11095-022-03434-4 · Cited by 19
Nourafkan, E., Kenyon, C., Nair, A., Loveday, K. A., Welbourne, E. N., Tao, M., Ahmed, M., Middleton, J., Dickman, M. J., Brown, S., et al. (2024) · Biotechnology Journal · doi:10.1002/biot.202400473 · Cited by 18
“Establishing a product-and indication-agnostic manufacturing process is highly advantageous [2, 5].”
Antisense oligonucleotide: A promising therapeutic option to beat COVID ‐19
Quéméner, A. M., & Galibert, M. (2021) · Wiley Interdisciplinary Reviews - RNA · doi:10.1002/wrna.1703 · Cited by 18
Physical and chemical advances of synthetic delivery vehicles to enhance mRNA vaccine efficacy
Kim, H. J., Seo, S. K., & Park, H. Y. (2022) · Journal of Controlled Release · doi:10.1016/j.jconrel.2022.03.029 · Cited by 18
Hybrid Lipid Nanocapsules: A Robust Platform for mRNA Delivery
Yadava, S. K., Reddy, B. P. K., Prausnitz, M. R., & Cicerone, M. T. (2024) · ACS Applied Materials & Interfaces · doi:10.1021/acsami.4c00992 · Cited by 18
Roozen, G. V. T., Prins, M. L. M., van Binnendijk, R. S., den Hartog, G., Kuiper, V. P., Prins, C., Janse, J. J., Kruithof, A. C., Feltkamp, M. C. W., Kuijer, M., et al. (2021) · medRxiv · doi:10.1101/2021.07.27.21261116 · Cited by 18
Kremsner, P. G., Guerrero, R. A. A., Arana, E., Aroca Martinez, G. J., Bonten, M. J. M., Chandler, R., Corral, G., De Block, E. J. L., Ecker, L., Gabor, J. J., et al. (2021) · doi:10.2139/ssrn.3911826 · Cited by 17
CircRNA: Unlocking new frontiers in therapeutic and vaccine development
Bahrulolum, H., Rouzbahani, F. N., Hoseini, Z. S., Chaharmahali, M., & Hosseini, S. M. (2025) · Molecular Therapy · doi:10.1016/j.ymthe.2025.10.038 · Cited by 19
Allen, J. D., & Ross, T. M. (2024) · Frontiers in Immunology · doi:10.3389/fimmu.2024.1334670 · Cited by 19
“…antigen design methodology for producing broadly reactive antigens, like COBRA, which utilizes sequence information from in fl uenza surveillance centers to generate antigens that provide immune protection against a broader spectrum of viruses than traditional wild-type vaccine antigens (18, 59).”
BackgroundmRNA vaccine development and applications: A special focus on tumors (Review)
Chen, B., Yang, Y., Wang, X., Yang, W., Lu, Y., Wang, D., Zhuo, E., Tang, Y., Su, J., Tang, G., et al. (2024) · International Journal of Oncology · doi:10.3892/ijo.2024.5669 · Cited by 17
“In vitro transcription (IVT) synthesis eliminates the need for cells and the regulatory barriers that go along with them, making mRNA production unquestionably easier, faster and cleaner than large‑scale protein production and purification (48,49), in contrast to conventional vaccination approaches.”
BackgroundRatner, L. (2022) · Frontiers in Immunology · doi:10.3389/fimmu.2022.953650 · Cited by 17
Photosynthetic Bacteria‐Hitchhiking 2D iMXene‐mRNA Vaccine to Enable Photo‐Immunogene Cancer Therapy
Zhang, S., Yu, J., Liu, Y., Xiong, B., Fang, Y., Zhu, Y., Li, S., Sun, L., Zhou, B., Sun, Y., et al. (2024) · Advanced Science · doi:10.1002/advs.202307225 · Cited by 16
Metadata
- Authors
- Jackson, N. A. C., Kester, K. E., Casimiro, D., Gurunathan, S., & DeRosa, F.
- Affiliations
- Coalition for Epidemic Preparedness Innovations (US)
- Sanofi (United States) (US)
- Translate Bio (United States) (US)
- Corresponding author
- Jackson, Nicholas A. C.
- Venue
- npj Vaccines
- Published
- 2020-02-04
- Volume
- 5
- Issue
- 1
- Pages
- 11-11
- ISSN
- 2059-0105 (ISSN-L)
- PMC
- PMC7000814
- OpenAlex
- W3004539389
- Cited by
- 498
- References
- 68
- Citations by year
- 2026: 39 · 2025: 54 · 2024: 70 · 2023: 76 · 2022: 110 · 2021: 121 · 2020: 28
- FWCI
- 8.02
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Locations
- npj Vaccines (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
- Topics
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › RNA Interference and Gene Delivery
- Health Sciences › Medicine › Infectious Diseases › SARS-CoV-2 and COVID-19 Research
- Life Sciences › Immunology and Microbiology › Immunology › Immunotherapy and Immune Responses
- Keywords
- mRNA vaccines, infectious disease prevention, mRNA delivery, vaccine production, translation efficiency, vaccine development, biotechnology industry, pharmaceutical industry
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