mRNA vaccines — a new era in vaccinology

Pardi, Norbert; Hogan, Michael J.; Porter, Frederick W.; Weissman, Drew

doi:10.1038/nrd.2017.243

Cited by 4,667RNA Interference and Gene DeliveryImmunotherapy and Immune ResponsesSARS-CoV-2 and COVID-19 Research

mRNA vaccines — a new era in vaccinology

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Pardi, Norbert, Hogan, Michael J., Porter, Frederick W., Weissman, Drew·2018·Nature Reviews Drug Discovery

DOI 10.1038/nrd.2017.243PMC PMC5906799

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Abstract

mRNA vaccines represent a promising alternative to conventional vaccine approaches because of their high potency, capacity for rapid development and potential for low-cost manufacture and safe administration. However, their application has until recently been restricted by the instability and inefficient in vivo delivery of mRNA. Recent technological advances have now largely overcome these issues, and multiple mRNA vaccine platforms against infectious diseases and several types of cancer have demonstrated encouraging results in both animal models and humans. This Review provides a detailed overview of mRNA vaccines and considers future directions and challenges in advancing this promising vaccine platform to widespread therapeutic use.

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mRNA production and lipid nanoparticle formulation are fast and highly scalable, making the technology suitable for rapid vaccine development and supply during pandemics.
“mRNA production and lipid nanoparticle formulation are fast and highly scalable, which renders this technology suitable for the rapid development and supply of vaccines during pandemic scenarios 11,12 .”
From BNT162b2 vaccine induces neutralizing antibodies and poly-specific T cells in humans (2021) · cites this paper as [11]
The Good manufacturing practice production section says mRNA can be produced rapidly in a small facility and is suitable for rapid response to emerging infectious diseases; the Abstract describes its manufacturing as potentially scalable. The Progress in mRNA vaccine delivery section identifies lipid nanoparticles as commonly used delivery tools, but the copy does not establish that their formulation is fast and highly scalable. The GMP section also notes that some production components were available only at limited scale, so rapid pandemic-scale supply is not established. (LLM, conf=0.86)
Experimental — accuracy not yet measured
samRNA vaccines can induce potent immune responses at lower doses due to their ability to amplify antigen production within the body, potentially reducing the risk of adverse reactions.
“samRNA vaccines can induce potent immune responses at lower doses due to their ability to amplify antigen production within the body, potentially reducing the risk of adverse reactions6,44.”
From An Omicron-specific, self-amplifying mRNA booster vaccine for COVID-19: a phase 2/3 randomized trial (2024) · cites this paper as [44]
The “Self-amplifying mRNA vaccines” section says intracellular RNA replication enables substantial antigen production from very small doses and reports potent immune responses at low doses. It does not say this reduces adverse reactions; instead, it warns that SAM vaccines’ inflammatory profile or reactogenicity may be difficult to modulate. (LLM, conf=0.88)
Experimental — accuracy not yet measured
ψ and m1ψ substitutions for U have been widely adopted for mRNA therapeutics and vaccines due to improved in-cell translation and better control of innate immune responses.
“In particular, we focused on ψ and m1ψ, since these substitutions for U have been widely adopted for mRNA therapeutics and vaccines due to improved in-cell translation and to better control of innate immune responses2,3,8,67 through avoidance of recognition by cellular toll-like receptors (TLR7 and TLR8)68, RIG‑I, and PKR69–71.”
From Combinatorial optimization of mRNA structure, stability, and translation for RNA-based therapeutics (2022) · cites this paper as [2]
The 'Modulation of immunogenicity' section (page unavailable) says pseudouridine and 1-methylpseudouridine reduce innate immune sensing and that nucleoside-modified mRNA improves translation. It links these advances to interest in vaccines and protein-replacement therapies, but does not establish that both substitutions were widely adopted for those uses; the vaccine section describes the platform as novel. (LLM, conf=0.86)
Experimental — accuracy not yet measured
Chemical modification is widely believed to be critical to the recent success of mRNA vaccines.
“which is widely believed to be critical to the recent success of mRNA vaccines1,2,10,37,38”
From Algorithm for optimized mRNA design improves stability and immunogenicity (2023) · cites this paper as [10]
BNT162b2, mRNA-1273, and ChAdOx1 nCoV-19 have been shown to induce type I interferon.
“Both BNT162b2 and mRNA-1273, as well as the adenoviral-vectored vaccine ChAdOx1 nCoV-19, have been shown to induce type I interferon, thus potentially inducing pathogen-agnostic protection75–77.”
From Immunological mechanisms of vaccine-induced protection against COVID-19 in humans (2021) · cites this paper as [75]

Non-replicating mRNA vaccines deliver exclusively genetic information coding for the target antigen, containing 5′-cap, 5′ UTR, 3′ UTR, and 3′-poly(A) tail regions.
“Non-replicating mRNA vaccines deliver exclusively genetic information coding for the target antigen, thus containing the 5′-cap, 5′ untranslated region (UTR), 3′ UTR, and 3′-poly(A) tail regions.108”
From Advances in COVID-19 mRNA vaccine development (2022) · cites this paper as [108]
Upscaling of cell-free vaccine production is relatively straightforward, providing a cutting-edge tool for rapid response in epidemics and pandemics.
“Furthermore, the upscaling of cell-free vaccine production is relatively straightforward, thereby providing a cutting-edge tool for rapid response in epidemics and pandemics.4, 5, 6, 7”
From COVID-19 mRNA vaccines: Platforms and current developments (2022) · cites this paper as [5]
mRNA does not integrate into the genome, obviating concerns about insertional mutagenesis.
“Unlike some viral vaccines, mRNA does not integrate into the genome, obviating concerns about insertional mutagenesis5.”
From mRNA vaccines for infectious diseases: principles, delivery and clinical translation (2021) · cites this paper as [5]
The use of modified nucleosides, particularly modified uridine, prevents recognition by pattern recognition receptors, enabling sufficient levels of translation to produce prophylactic amounts of protein.
“The use of modified nucleosides, particularly modified uridine, prevents recognition by pattern recognition receptors, enabling sufficient levels of translation to produce prophylactic amounts of protein5.”
From mRNA vaccines for infectious diseases: principles, delivery and clinical translation (2021) · cites this paper as [5]
Use of mRNA as a source of antigen in vaccination approaches is by far the most popular application.
“although it has been employed for various therapeutic targets, its use as a source of antigen in vaccination approaches is by far the most popular [2]”
From The dawn of mRNA vaccines: the COVID-19 case (2021) · cites this paper as [2]
mRNA has therapeutic potential in viral vaccines, protein replacement therapies, cancer immunotherapies, cellular reprogramming and genome editing.
“mRNA has shown therapeutic potential in a range of applications, including viral vaccines, protein replacement therapies, cancer immunotherapies, cellular reprogramming and genome editing2,4,7–17.”
From Lipid nanoparticles for mRNA delivery (2021) · cites this paper as [4]
mRNA normally contains five structural elements: a 5′ cap, a 3′ poly(A) tail, a protein-coding sequence and 5′ and 3′ untranslated regions.
“mRNA normally contains five structural elements, that is, a 5′ cap, a 3′ poly(A) tail, a protein-coding sequence and 5′ and 3′ untranslated regions (UTRs)2,4,7,13.”
From Lipid nanoparticles for mRNA delivery (2021) · cites this paper as [4]
mRNA is susceptible to degradation and, thus, formulation buffers should be free of any ribonuclease contaminations.
“mRNA is susceptible to degradation and, thus, formulation buffers should be free of any ribonuclease contaminations2,4.”
From Lipid nanoparticles for mRNA delivery (2021) · cites this paper as [4]
These elements can be engineered to improve the stability and translational efficiency of mRNA.
“These elements can be engineered to improve the stability and translational efficiency of mRNA2,4,7,13.”
From Lipid nanoparticles for mRNA delivery (2021) · cites this paper as [4]
Chromatographic purification can remove double-stranded RNA in IVT mRNA preparations, diminishing immune activation and increasing translational efficiency.
“Chromatographic purification can remove double-stranded RNA, an analogue of viral genome, in IVT mRNA preparations, diminishing immune activation and increasing translational efficiency2,4,7,183.”
From Lipid nanoparticles for mRNA delivery (2021) · cites this paper as [4]
Chemical modifications of specific IVT mRNA nucleotides, such as pseudouridine (ψ) and N1-methylpseudouridine (m1ψ), can reduce innate immune sensing of exogenous mRNA translation.
“Chemical modifications of specific IVT mRNA nucleotides, such as pseudouridine (ψ) and N1-methylpseudouridine (m1ψ), can reduce innate immune sensing of exogenous mRNA translation2,4,7,182.”
From Lipid nanoparticles for mRNA delivery (2021) · cites this paper as [4]
Many other lipid nanoparticle-mRNA formulations are in clinical trials for the treatment of infectious diseases, cancer and genetic disorders.
“Many other lipid nanoparticle–mRNA formulations are in clinical trials for the treatment of infectious diseases, cancer and genetic disorders2,4,8,12–14 (Tables 1,2).”
From Lipid nanoparticles for mRNA delivery (2021) · cites this paper as [4]
These features make lipid nanoparticle-mRNA formulations a flexible and on-demand vaccine platform to rapidly respond to emerging infectious pathogens.
“These features make lipid nanoparticle–mRNA formulations a flexible and on-demand vaccine platform to rapidly respond to emerging infectious pathogens4,15,17.”
From Lipid nanoparticles for mRNA delivery (2021) · cites this paper as [4]
Engineering of mRNA molecules and design of lipid nanoparticles have been optimized, contributing to the rapid development and clinical assessment of the two COVID-19 mRNA vaccines.
“To address these concerns, the engineering of mRNA molecules (Box 1) and the design of lipid nanoparticles have been optimized2,4,7–17, which has contributed to the rapid development and clinical assessment15,17 of the two COVID-19 mRNA vaccines, mRNA-1273 (NCT04470427)19,20 and BNT162b2 (NCT04368728)21.”
From Lipid nanoparticles for mRNA delivery (2021) · cites this paper as [4]
Lipid nanoparticle-mRNA formulations have emerged as a potent alternative to conventional vaccine platforms owing to their unique features.
“Since then, lipid nanoparticle–mRNA formulations have emerged as a potent alternative to conventional vaccine platforms, owing to their unique features4,15,17.”
From Lipid nanoparticles for mRNA delivery (2021) · cites this paper as [4]
mRNA-based cellular reprogramming, tissue regeneration and genome editing have shown therapeutic potential in preclinical studies.
“Moreover, mRNA-based cellular reprogramming, tissue regeneration and genome editing have shown therapeutic potential in preclinical studies2,4,8,12–14.”
From Lipid nanoparticles for mRNA delivery (2021) · cites this paper as [4]
mRNA is a non-infective and non-integrating agent with the ability to encode a broad range of antigens.
“First, mRNA is a non-infective and non-integrating agent with the ability to encode a broad range of antigens4,15,17.”
From Lipid nanoparticles for mRNA delivery (2021) · cites this paper as [4]
GMP-grade lipid nanoparticle-mRNA vaccines can be manufactured for specific antigens in a short period of time compared with other vaccine platforms, such as recombinant proteins and inactivated vaccines.
“Finally, GMP-grade lipid nanoparticle-mRNA vaccines can be manufactured for specific antigens in a short period of time, compared with other vaccine platforms, such as recombinant proteins and inactivated vaccines2,4,15,17.”
From Lipid nanoparticles for mRNA delivery (2021) · cites this paper as [4]
Neoantigens are often different between individual patients, allowing the development of personalized vaccines.
“Neoantigens are often different between individual patients, allowing the development of personalized vaccines4,11.”
From Lipid nanoparticles for mRNA delivery (2021) · cites this paper as [4]
Neoantigens, generated by somatic mutations in cancer cells, are usually tumour-specific and have high immunogenicity.
“Neoantigens, generated by somatic mutations in cancer cells, are usually tumour-specific and have high immunogenicity4,11.”
From Lipid nanoparticles for mRNA delivery (2021) · cites this paper as [4]
The sequences of these mRNA structural elements regulate translation initiation, translation termination and post-transcriptional modification of mRNA molecules.
“The sequences of these elements regulate translation initiation, translation termination and post-transcriptional modification of mRNA molecules2,4.”
From Lipid nanoparticles for mRNA delivery (2021) · cites this paper as [4]
To achieve effective translation, mRNA requires five structural elements, including the 5′ cap, 3′ poly(A) tail, protein-coding sequence and 5′ and 3′ untranslated regions.
“To achieve effective translation, mRNA requires five structural elements, including the 5′ cap, 3′ poly(A) tail, protein-coding sequence and 5′ and 3′ untranslated regions (UTRs)2,4.”
From Lipid nanoparticles for mRNA delivery (2021) · cites this paper as [4]
The application of RNA vaccines has been limited by their lack of stability and requirement for a cold chain.
“the application of RNA vaccines has been limited by their lack of stability and requirement for a cold chain”
From A guide to vaccinology: from basic principles to new developments (2021) · cites this paper as [131]
RNA vaccines have exhibited encouraging results in both infection therapy and cancer immunotherapy.
“RNA vaccines, for example, have exhibited encouraging results in both infection therapy and cancer immunotherapy.[6, 7, 11–15]”
From RNA delivery biomaterials for the treatment of genetic and rare diseases (2019) · cites this paper as [12]
mRNA functions as the bridge between DNA and proteins in eukaryotic cells.
“mRNA functions as the bridge between DNA and proteins in eukaryotic cells.[8, 12, 119]”
From RNA delivery biomaterials for the treatment of genetic and rare diseases (2019) · cites this paper as [12]
mRNA does not interact with the genome and only the parts directly required for the encoded protein expression are present in the basic genetic construct.
“The mRNA also does not interact with the genome and only the parts directly required for the encoded protein expression are present in this basic genetic construct (Pardi et al. 2018).”
From Modifications of mRNA vaccine structural elements for improving mRNA stability and translation efficiency (2022) · cites this paper as Pardi et al. 2018
The technique can be easily scaled requiring minimum platform changes during mRNA formulation and production.
“The technique can be easily scaled requiring minimum platform changes during mRNA formulation and production (Pardi et al. 2018).”
From Modifications of mRNA vaccine structural elements for improving mRNA stability and translation efficiency (2022) · cites this paper as Pardi et al. 2018

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Authors: Pardi, N., Hogan, M. J., Porter, F. W., & Weissman, D.
Affiliations: University of Pennsylvania (US)
Duke University (US)
Corresponding author: Weissman, Drew
ORCID: Pardi, Norbert
Hogan, Michael J.
Weissman, Drew
Venue: Nature Reviews Drug Discovery
Publisher: Springer Science and Business Media LLC
Published: 2018-01-12
Volume: 17
Issue: 4
Pages: 261-279
ISSN: 1474-1776 (ISSN-L)
1474-1784
DOI: 10.1038/nrd.2017.243
PMC: PMC5906799
OpenAlex: W2782708334
Cited by: 4,667
References: 218
Citations by year: 2026: 640 · 2025: 683 · 2024: 630 · 2023: 662 · 2022: 801 · 2021: 808 · 2020: 303 · 2019: 90 · 2018: 49
FWCI: 30.60
Type: journal article
Language: en
Open access: bronze
doi.org
Licence: www.springer.com/tdm (tdm)
www.springer.com/tdm (vor)
Locations: Nature Reviews Drug Discovery (publishedVersion)
PubMed (publishedVersion)
Europe PMC (PubMed Central) (acceptedVersion)
PubMed Central (acceptedVersion)
Funders: Bill and Melinda Gates Foundation (OPP1066832, OPP1033102)
National Institutes of Health (AI084860, AI-100645)
Defense Advanced Research Projects Agency (HR0011‐17‐2‐0069)
Advanced Research Projects Agency
National Institute of Allergy and Infectious Diseases (AI-100645, UM1AI100645, R01-AI084860, R01AI050484, R01AI124429, AI124429, U01AI067854, R01AI090788)
Topics: Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › RNA Interference and Gene Delivery
Life Sciences › Immunology and Microbiology › Immunology › Immunotherapy and Immune Responses
Health Sciences › Medicine › Infectious Diseases › SARS-CoV-2 and COVID-19 Research
Keywords: mRNA vaccines, mRNA stability, mRNA delivery, vaccine platforms, cancer vaccines, infectious disease vaccines, vaccine development
MeSH terms: Vaccinology, Animals, Humans, Neoplasms, RNA, Messenger, Vaccines

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