The clinical progress of mRNA vaccines and immunotherapies
Open accessAbstract
The emergency use authorizations (EUAs) of two mRNA-based severe acute respiratory syndrome coronavirus (SARS-CoV)-2 vaccines approximately 11 months after publication of the viral sequence highlights the transformative potential of this nucleic acid technology. Most clinical applications of mRNA to date have focused on vaccines for infectious disease and cancer for which low doses, low protein expression and local delivery can be effective because of the inherent immunostimulatory properties of some mRNA species and formulations. In addition, work on mRNA-encoded protein or cellular immunotherapies has also begun, for which minimal immune stimulation, high protein expression in target cells and tissues, and the need for repeated administration have led to additional manufacturing and formulation challenges for clinical translation. Building on this momentum, the past year has seen clinical progress with second-generation coronavirus disease 2019 (COVID-19) vaccines, Omicron-specific boosters and vaccines against seasonal influenza, Epstein-Barr virus, human immunodeficiency virus (HIV) and cancer. Here we review the clinical progress of mRNA therapy as well as provide an overview and future outlook of the transformative technology behind these mRNA-based drugs.
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Vaccination is the only approved application of synthetic mRNA.
“Vaccination is the only approved application of synthetic mRNA.2,4”
From Evaluation of synthetic mRNA with selected UTR sequences and alternative poly(A) tail, in vitro and in vivo (2025) · cites this paper as [2]
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- Authors
- Barbier, A. J., Jiang, A. Y., Zhang, P., Wooster, R., & Anderson, D. G.
- Affiliations
- Translate Bio (United States) (US)
- Koch Institute for Integrative Cancer Research At MIT (US)
- Corresponding author
- Anderson, Daniel G.
- Venue
- Nature Biotechnology
- Published
- 2022-05-09
- Volume
- 40
- Issue
- 6
- Pages
- 840-854
- ISSN
- 0733-222X (ISSN-L)
- 1087-0156
- 1546-1696
- OpenAlex
- W4229452462
- Cited by
- 823
- References
- 40
- Citations by year
- 2026: 169 · 2025: 237 · 2024: 210 · 2023: 161 · 2022: 46
- FWCI
- 17.18
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Nature Biotechnology (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Institutes of Health
- National Heart, Lung, and Blood Institute (UH3HL147367, R01HL162564)
- National Institute of Allergy and Infectious Diseases (R61AI161805)
- 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, mRNA therapeutics, COVID-19 vaccines, SARS-CoV-2, influenza vaccination, Epstein-Barr virus, HIV vaccine, cancer immunotherapy, cellular immunotherapy, vaccine production, vaccine formulation, clinical translation
- MeSH terms
- COVID-19, COVID-19 Vaccines, mRNA Vaccines, Herpesvirus 4, Human, Humans, Immunization, Secondary, Influenza Vaccines, RNA, Messenger, Vaccines, Synthetic, Epstein-Barr Virus Infections
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