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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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Vaccine development for emerging infectious diseases
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BackgroundCombinatorial optimization of mRNA structure, stability, and translation for RNA-based therapeutics
Leppek, K., Byeon, G. W., Kladwang, W., Wayment-Steele, H. K., Kerr, C. H., Xu, A. F., Kim, D. S., Topkar, V. V., Choe, C., Rothschild, D., et al. (2021) · doi:10.1101/2021.03.29.437587 · Cited by 399
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“The mRNA (encoding RiboNucleic Acid) vaccine encodes a stable prefused form (the form before being fused to the cell membrane of the host cell) of Spike protein (S) (63).”
BackgroundThe interaction of innate immune and adaptive immune system
Wang, R., Lan, C., Benlagha, K., Câmara, N. O. S., Miller, H. E., Kubo, M., Heegaard, S., Lee, P. P. W., Yang, L., Forsman, H. F., et al. (2024) · MedComm · doi:10.1002/mco2.714 · Cited by 395
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“The use of mRNA vaccines for pandemic response has been well described previously in preclinical[12-25] and clinical settings,[16] but this is the first time we have seen the platforms deployed in a real pandemic setting.”
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“In addition, various mRNA engineering methods have been developed to enhance the stability and the translation efficacy of mRNA therapeutics, such as a selection of untranslated regions (UTRs), addition of a poly-A tail, capping, and nucleoside modification [6].”
MethodThe Critical Contribution of Pseudouridine to mRNA COVID-19 Vaccines
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“This technology made possible a fast pace of discovery and manufacturing, critical features that could be fully utilized in a biotech and pharmaceutical setting (Jackson et al., 2020).”
BackgroundCircular RNA vaccine in disease prevention and treatment
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Advances in Lipid Nanoparticles for mRNA-Based Cancer Immunotherapy
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“It has been shown that DNA-dependent RNA polymerases yield abortive initiation products, as well as double-stranded RNA resulting from self-complementary, which can lead to type I IFN and inflammatory cytokines production upon pattern recognition receptors recognition (Jackson et al., 2020).”
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mRNA vaccines in disease prevention and treatment
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“LNP formulations containing novel ionizable cationic lipids are the current leaders in the RNA delivery field with successful application in the delivery of small interfering RNA (siRNA), as well as mRNAs encoding vaccine antigens and therapeutic proteins.(8,9) The work described here utilizes the non replicating mRNA…”
Delivery Strategies for mRNA Vaccines
Ramachandran, S., Satapathy, S. R., & Dutta, T. (2022) · Pharmaceutical Medicine · doi:10.1007/s40290-021-00417-5 · Cited by 191
“Third, mRNAs can be rapidly and inexpensively synthesized with high yield through in vitro transcription reaction and hence are easily scalable to kilogram level quantity [17, 18].”
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Recent Advancement in mRNA Vaccine Development and Applications
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mRNA cancer vaccines: Advances, trends and challenges
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Synthetic biology in the clinic: engineering vaccines, diagnostics, and therapeutics
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“Synthetic biology and biochemical approaches have been used to increase the intracellular stability of vaccine RNAs, reduce cytotoxicity, and enhance protein production (Jackson et al., 2020b; Pardi et al., 2020; Kowalski et al., 2019).”
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Next-Generation TB Vaccines: Progress, Challenges, and Prospects
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Development of multivalent mRNA vaccine candidates for seasonal or pandemic influenza
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Development of mRNA Vaccines: Scientific and Regulatory Issues
Knezevic, I., Liu, M. A., Peden, K., Zhou, T., & Kang, H.-N. (2021) · Vaccines · doi:10.3390/vaccines9020081 · Cited by 114
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From COVID-19 to Cancer mRNA Vaccines: Moving From Bench to Clinic in the Vaccine Landscape
Chakraborty, C., Sharma, A. R., Bhattacharya, M., & Lee, S. (2021) · Frontiers in Immunology · doi:10.3389/fimmu.2021.679344 · Cited by 114
A Review of Pseudorabies Virus Variants: Genomics, Vaccination, Transmission, and Zoonotic Potential
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“A messenger RNA (mRNA)-based vaccine that encodes the immunogenetic antigen of pathogens provides a new vaccine developing platform for multiple viruses [49,50].”
BackgroundAdvances in mRNA non-viral delivery approaches
Ibba, M. L., Ciccone, G., Esposito, C. L., Catuogno, S., & Giangrande, P. H. (2021) · Advanced Drug Delivery Reviews · doi:10.1016/j.addr.2021.113930 · Cited by 107
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Current Developments and Challenges of mRNA Vaccines
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Nanocarrier vaccines for SARS-CoV-2
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“mRNA is labile and prone to degradation primarily from nuclease activity within the cells; hence, efficient protection of the mRNA is critical during administration [285].”
Current and future nanoparticle vaccines for COVID-19
Vu, M. N., Kelly, H. G., Kent, S. J., & Wheatley, A. K. (2021) · EBioMedicine · doi:10.1016/j.ebiom.2021.103699 · Cited by 101
“…minimise opsonization in vivo and various helper lipids and cholesterol to support particle formation. mRNA-LNPs are fully synthetic and manufactured without the requirement of living cells, allowing rapid production of vaccines at scale within weeks after the availability of a viral genome [20].”
Zhang, C., Ma, Y., Zhang, J., Kuo, J. C., Zhang, Z., Xie, H., Zhu, J., & Liu, T. (2022) · Molecules · doi:10.3390/molecules27061943 · Cited by 95
“In addition, the expression of target antigen after translation is much faster than other platforms [256,289,290].”
BackgroundNucleic Acid Vaccines for COVID-19: A Paradigm Shift in the Vaccine Development Arena
Chavda, V. P., Hossain, M. M. M., Beladiya, J., & Apostolopoulos, V. (2021) · Biologics · doi:10.3390/biologics1030020 · Cited by 92
Personalized pancreatic cancer therapy: from the perspective of mRNA vaccine
Huang, X., Zhang, G., Tang, T., Gao, X., & Liang, T. (2022) · Military Medical Research · doi:10.1186/s40779-022-00416-w · Cited by 98
“mRNA can be produced in vitro using a DNA template, ribonucleotide triphosphates, and recombinant enzymes [118, 119].”
BackgroundSARS-CoV-2 vaccines in advanced clinical trials: Where do we stand?
Chakraborty, S., Mallajosyula, V. V. A., Tato, C. M., Tan, G. S., & Wang, T. T. (2021) · Advanced Drug Delivery Reviews · doi:10.1016/j.addr.2021.01.014 · Cited by 90
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“strict cold chain distribution and cryopreservation.[19] For recombinant protein vaccines represented by the receptor binding domain (RBD)”
Clinical development and approval of COVID-19 vaccines
Kalinke, U., Barouch, D. H., Rizzi, R., Lagkadinou, E., Türeci, Ö., Pather, S., & Neels, P. (2022) · Expert Review of Vaccines · doi:10.1080/14760584.2022.2042257 · Cited by 86
“References:[12], [20], [29], [35], [36], [50], [53], [54], [59], [61-63].”
BackgroundA comprehensive comparison of DNA and RNA vaccines
Wang, C., & Yuan, F. (2024) · Advanced Drug Delivery Reviews · doi:10.1016/j.addr.2024.115340 · Cited by 90
Self-Amplifying RNA Vaccine Candidates: Alternative Platforms for mRNA Vaccine Development
Schmidt, C., & Schnierle, B. S. (2023) · Pathogens · doi:10.3390/pathogens12010138 · Cited by 78
“The production of mRNA vaccines is technically simple, fast, cost-effective, cell- and animal-material free, and easy to adapt [3] mRNA vaccines can be produced from linearized plasmid DNA templates or from polymerase chain reaction-based templates by in vitro transcription using phage RNA polymerases such as T7, T3,…”
BackgroundiCodon customizes gene expression based on the codon composition
Diez, M., Medina-Muñoz, S. G., Castellano, L. A., Pescador, G. D. S., Wu, Q., & Bazzini, A. (2022) · Scientific Reports · doi:10.1038/s41598-022-15526-7 · Cited by 71
Influenza Vaccination to Reduce Cardiovascular Morbidity and Mortality in Patients With COVID-19
Behrouzi, B., Campoverde, M. V. A., Liang, K., Talbot, H. K., Bogoch, I. I., McGeer, A., Fröbert, O., Loeb, M. B., Vardeny, O., Solomon, S. D., et al. (2020) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2020.08.028 · Cited by 76
“Although this technology is reported to allow for faster production, it has never led to a licensed vaccine for sale (59).”
BackgroundLipid Nanoparticles as Promising Carriers for mRNA Vaccines for Viral Lung Infections
Asr, M. H., Dayani, F., Segherloo, F. S., Kamedi, A., Neill, A. O., MacLoughlin, R. J., & Doroudian, M. (2023) · Pharmaceutics · doi:10.3390/pharmaceutics15041127 · Cited by 73
“including the prevention of infectious diseases; this is a research area that is currently under intense development [10,28].”
BackgroundThe mRNA Vaccine Revolution: COVID-19 Has Launched the Future of Vaccinology
Ye, Z., Harmon, J., Ni, W., Li, Y., Wich, D., & Xu, Q. (2023) · ACS Nano · doi:10.1021/acsnano.2c12584 · Cited by 72
Influenza and Universal Vaccine Research in China
Li, J., Zhang, Y., Zhang, X., & Liu, L. (2022) · Viruses · doi:10.3390/v15010116 · Cited by 74
“mRNA vaccines are produced by introducing mRNA containing encoded antigenic proteins into the body, which are transcribed and translated to produce the corresponding antigenic proteins and induce a specific immune response [98].”
BackgroundmRNA Therapeutic Modalities Design, Formulation and Manufacturing under Pharma 4.0 Principles
Ouranidis, A., Vavilis, T., Mandala, E., Davidopoulou, C., Stamoula, Ε., Markopoulou, C. K., Karagianni, A., & Kachrimanis, K. (2021) · Biomedicines · doi:10.3390/biomedicines10010050 · Cited by 75
Recent Developments in Vaccine Design: From Live Vaccines to Recombinant Toxin Vaccines
Gupta, S., & Pellett, S. (2023) · Toxins · doi:10.3390/toxins15090563 · Cited by 81
Genito, C. J., Batty, C. J., Bachelder, E. M., & Ainslie, K. M. (2020) · Advanced NanoBiomed Research · doi:10.1002/anbr.202000041 · Cited by 66
“45 Polymeric encapsulation or complexation has been used to deliver mRNA and other nucleic acid vaccines, 46 but complexing it to cationic and ionizable lipids is much more common.”
Hameed, S. A., Paul, S., Dellosa, G. K. Y., Jaraquemada, D., & Bello, M. B. (2022) · npj Vaccines · doi:10.1038/s41541-022-00485-x · Cited by 65
Kavanagh, M. M., Gostin, L. O., & Sunder, M. (2021) · JAMA · doi:10.1001/jama.2021.10823 · Cited by 63
Therapeutic cancer vaccines revamping: technology advancements and pitfalls
Antonarelli, G., Corti, C., Tarantino, P., Ascione, L., Cortés, J., Romero, P. J., Mittendorf, E., Disis, M. L., & Curigliano, G. (2021) · Annals of Oncology · doi:10.1016/j.annonc.2021.08.2153 · Cited by 64
“A key aspect of CV development efforts is the capacity of making early and objective treatment choices in order to select ideal candidates, a specific platform, eventual combinatorial agents, and vaccination schedules.(159) For RNA-based CVs, different aspects still need to be thoroughly assessed to boost their effica…”
Fast-track development of vaccines for SARS-CoV-2: The shots that saved the world
Chavda, V. P., Yao, Q., Vora, L. K., Apostolopoulos, V., Patel, C. A., Bezbaruah, R., Patel, A., & Chen, Z. (2022) · Frontiers in Immunology · doi:10.3389/fimmu.2022.961198 · Cited by 63
Recent advances in immunotherapies against infectious diseases
Ramamurthy, D., Nundalall, T., Cingo, S., Mungra, N., Karaan, M., Naran, K., & Barth, S. (2020) · Immunotherapy Advances · doi:10.1093/immadv/ltaa007 · Cited by 63
“There are currently no licensed RNA vaccines for human application, however, clinical trials are currently underway to develop mRNA vaccines expressing the pre-membrane (prM) and envelope (E) proteins of the Zika virus (ZIKV) (NCT04064905; NCT03014089) [11, 12].”
BackgroundCodonBERT large language model for mRNA vaccinesPreprint
Li, S., Moayedpour, S., Li, R., Bailey, M., Riahi, S., Kogler-Anele, L., Miladi, M., Miner, J. C., Pertuy, F., Zheng, D., et al. (2024) · Genome Research · doi:10.1101/gr.278870.123 · Cited by 66
COVID-19 Vaccines (Revisited) and Oral-Mucosal Vector System as a Potential Vaccine Platform
Ashraf, M. U., Kim, Y., Kumar, S., Seo, D., Ashraf, M., & Bae, Y. (2021) · Vaccines · doi:10.3390/vaccines9020171 · Cited by 62
Knowledge transfer for large-scale vaccine manufacturing
Price, W. N., Rai, A. K., & Minssen, T. (2020) · Science · doi:10.1126/science.abc9588 · Cited by 62
Antigenic characterization of influenza and SARS-CoV-2 viruses
Wang, Y., Tang, C. Y., & Wan, X. (2021) · Analytical and Bioanalytical Chemistry · doi:10.1007/s00216-021-03806-6 · Cited by 62
“As with all vaccine platforms, mRNA vaccines also present challenges that will need to be addressed moving forward which include thermal instability at elevated temperatures, allergic reactions to LNPs, and the unknowns of long-term properties in humans including the effects of repeated administration [417, 456].”
BackgroundSupabphol, S., Li, L., Goedegebuure, S. P., & Gillanders, W. E. (2021) · Expert Opinion on Investigational Drugs · doi:10.1080/13543784.2021.1896702 · Cited by 60
DeFrancesco, L. (2020) · Nature Biotechnology · doi:10.1038/s41587-020-0697-7 · Cited by 55
COVID-19: Insights into Potential Vaccines
Loo, K.-Y., Letchumanan, V., Ser, H., Teoh, S. L., Law, J. W., Tan, L. T., Mutalib, N. A., Chan, K., & Lee, L. (2021) · Microorganisms · doi:10.3390/microorganisms9030605 · Cited by 59
COVID-19 vaccine platforms: Delivering on a promise?
Verdecia, M. A., Kokai‐Kun, J. F., Kibbey, M., Acharya, S., Venema, J., & Atouf, F. (2021) · Human Vaccines & Immunotherapeutics · doi:10.1080/21645515.2021.1911204 · Cited by 57
“Messenger RNA is a noninfectious, non-integrating technology with no potential to cause infections or insertional mutagenesis.(176) mRNA is also easily degraded, and its halflife can be regulated through modifications to the template or delivery method.”
BackgroundCurrent Progress of Severe Fever with Thrombocytopenia Syndrome Virus (SFTSV) Vaccine Development
Kim, D.-K., Lai, C., Cha, I., & Jung, J. U. (2024) · Viruses · doi:10.3390/v16010128 · Cited by 59
Analyzing immune responses to varied mRNA and protein vaccine sequences
Park, H.-J., Bang, Y., Kwon, S. P., Kwak, W., Park, S., Roh, G., Bae, S., Kim, J., Kwak, H. W., Kim, Y., et al. (2023) · npj Vaccines · doi:10.1038/s41541-023-00684-0 · Cited by 53
“…modi fi cation by pseudouridine have shown the potential to overcome these limitations 4,5 . mRNA does not integrate into the host genome, eliminating the need for insertional mutagenesis 6 ; it can be manufactured in a cell-free manner, allowing rapid, scalable, and cost-effective production 7 .”
Barazzone, G. C., Teixeira, A. F., Azevedo, B. O. P., Damiano, D. K., Oliveira, M. P., Nascimento, A. L. T. O., & Lopes, A. P. Y. (2022) · Frontiers in Immunology · doi:10.3389/fimmu.2021.760291 · Cited by 56
Neonatal herpes simplex virus infection: From the maternal infection to the child outcome
Rose, D. U. D., Bompard, S., Maddaloni, C., Bersani, I., Martini, L., Santisi, A., Longo, D., Ronchetti, M. P., Dotta, A., & Auriti, C. (2023) · Journal of Medical Virology · doi:10.1002/jmv.29024 · Cited by 51
Current Vaccine Platforms in Enhancing T-Cell Response
Ura, T., Takeuchi, M., Kawagoe, T., Mizuki, N., Okuda, K., & Shimada, M. (2022) · Vaccines · doi:10.3390/vaccines10081367 · Cited by 56
mRNA vaccines in the prevention and treatment of diseases
Gu, Y., Duan, J., Yang, N., Yang, Y., & Zhao, X. (2022) · MedComm · doi:10.1002/mco2.167 · Cited by 54
Lin, W., Shen, C., Li, M., Ma, S., Liu, C., Huang, J., Ren, Z., Yang, Y., Zhao, M., Xie, Q., et al. (2024) · Advanced Science · doi:10.1002/advs.202408608 · Cited by 47
mRNA Vaccines: Why Is the Biology of Retroposition Ignored?
Domazet‐Lošo, T. (2022) · Genes · doi:10.3390/genes13050719 · Cited by 47
“It was often suggested that the main advantage of mRNA-based vaccines, compared to the more conventional approaches is the possibility of their rapid development and largescale deployment [6,7], which are both desirable properties in pandemic situations.”
BackgroundSchmid, P., & Betsch, C. (2022) · Science Communication · doi:10.1177/10755470221129608 · Cited by 44
“In addition, mRNA vaccines are considered beneficial over conventional vaccines because, among other things, these new types of vaccines allow rapid manufacturing, which is essential for a successful pandemic response (Jackson et al., 2020; Pardi et al., 2018).”
BackgroundShaw, C. A., August, A., Bart, S., Jackson-Booth, P.-G., Knightly, C., Brasel, T., Weaver, S. C., Zhou, H., & Panther, L. (2023) · Vaccine · doi:10.1016/j.vaccine.2023.04.064 · Cited by 48
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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