Self-assembled mRNA vaccines

Kim, Jeonghwan; Eygeris, Yulia; Gupta, Mohit; Sahay, Gaurav

doi:10.1016/j.addr.2020.12.014

Cited by 514RNA Interference and Gene DeliverySARS-CoV-2 and COVID-19 ResearchNanoparticle-Based Drug Delivery

Self-assembled mRNA vaccines

Open access

Kim, Jeonghwan, Eygeris, Yulia, Gupta, Mohit, Sahay, Gaurav·2021·Advanced Drug Delivery Reviews

DOI 10.1016/j.addr.2020.12.014PMC PMC7837307

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Abstract

mRNA vaccines have evolved from being a mere curiosity to emerging as COVID-19 vaccine front-runners. Recent advancements in the field of RNA technology, vaccinology, and nanotechnology have generated interest in delivering safe and effective mRNA therapeutics. In this review, we discuss design and self-assembly of mRNA vaccines. Self-assembly, a spontaneous organization of individual molecules, allows for design of nanoparticles with customizable properties. We highlight the materials commonly utilized to deliver mRNA, their physicochemical characteristics, and other relevant considerations, such as mRNA optimization, routes of administration, cellular fate, and immune activation, that are important for successful mRNA vaccination. We also examine the COVID-19 mRNA vaccines currently in clinical trials. mRNA vaccines are ready for the clinic, showing tremendous promise in the COVID-19 vaccine race, and have pushed the boundaries of gene therapy.

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One copy of saRNA produces multiple copies of RNA transcripts by the above-described mechanism to initiate self-amplification of antigen genes in the cell.
“As a result, one copy of saRNA produces multiple copies of RNA transcripts by the above-described mechanism to initiate self-amplification of antigen genes in the cell.35,195,196”
From Advances in COVID-19 mRNA vaccine development (2022) · cites this paper as [35]
The delivery vector employed in saRNA vaccines must allow for higher loading capacity and encapsulation efficiency.
“Hence, the delivery vector employed in saRNA vaccines must allow for higher loading capacity and encapsulation efficiency.35”
From Advances in COVID-19 mRNA vaccine development (2022) · cites this paper as [35]
Tfh cells recognize antigens on the APC surface and help to activate B cells, which in turn produce high-affinity virus-neutralizing antibodies.
“Tfh cells recognize antigens on the APC surface and help to activate B cells, which in turn produce high-affinity virus-neutralizing antibodies.6,55, 56, 57”
From COVID-19 mRNA vaccines: Platforms and current developments (2022) · cites this paper as [56]
Tfh cells further help activate CD8+ cytotoxic T cells that may specifically recognize and eliminate virus-infected cells.
“Tfh cells further help activate CD8+ cytotoxic T cells that may specifically recognize and eliminate virus-infected cells (Figure 1).6,55, 56, 57”
From COVID-19 mRNA vaccines: Platforms and current developments (2022) · cites this paper as [56]
These other lipids can improve nanoparticle properties, such as particle stability, delivery efficacy, tolerability and biodistribution.
“These lipids can improve nanoparticle properties, such as particle stability, delivery efficacy, tolerability and biodistribution7,14,17.”
From Lipid nanoparticles for mRNA delivery (2021) · cites this paper as [17]

Lipid nanoparticle-mRNA formulations typically contain other lipid components, such as phospholipids, cholesterol or PEG-lipids.
“In addition to cationic or ionizable lipids, lipid nanoparticle–mRNA formulations typically contain other lipid components, such as phospholipids (for example, phosphatidylcholine and phosphatidylethanolamine), cholesterol or polyethylene glycol (PEG)-functionalized lipids (PEG-lipids)7,14,17.”
From Lipid nanoparticles for mRNA delivery (2021) · cites this paper as [17]
This structural feature protects mRNA molecules from nuclease degradation and increases nanoparticle stability in physiological fluids.
“This structural feature protects mRNA molecules from nuclease degradation and increases nanoparticle stability in physiological fluids17,46.”
From Lipid nanoparticles for mRNA delivery (2021) · cites this paper as [17]
Lipid nanoparticle-mRNA formulations manufactured by rapid mixing exhibit a stable nanostructure, in which mRNA molecules can be encapsulated in the interior core through electrostatic interactions with the lipids.
“Lipid nanoparticle–mRNA formulations manufactured by rapid mixing exhibit a stable nanostructure17,130,131, in which mRNA molecules can be encapsulated in the interior core through electrostatic interactions with the lipids17,131.”
From Lipid nanoparticles for mRNA delivery (2021) · cites this paper as [17]
Incorporating PEG-lipids further decreases recognition by the MPS and clearance by renal filtration.
“Incorporating PEG-lipids further decreases recognition by the MPS and clearance by renal filtration17,127.”
From Lipid nanoparticles for mRNA delivery (2021) · cites this paper as [17]
This technique allows reproducible and scalable production of lipid nanoparticle-mRNA formulations that show high encapsulation efficiency and homogeneous size distribution.
“This technique allows reproducible and scalable production of lipid nanoparticle–mRNA formulations that show high encapsulation efficiency and homogeneous size distribution17,131.”
From Lipid nanoparticles for mRNA delivery (2021) · cites this paper as [17]
BNT162b2 is stored at −60 °C to −80 °C and requires thawing and dilution by saline before injection.
“mRNA-1273 is stored at −15 °C to −20 °C and is directly injected after thawing17, whereas BNT162b2 is stored at −60 °C to −80 °C and requires thawing and dilution by saline before injection17.”
From Lipid nanoparticles for mRNA delivery (2021) · cites this paper as [17]
mRNA-1273 is stored at −15 °C to −20 °C and is directly injected after thawing.
“mRNA-1273 is stored at −15 °C to −20 °C and is directly injected after thawing17, whereas BNT162b2 is stored at −60 °C to −80 °C and requires thawing and dilution by saline before injection17.”
From Lipid nanoparticles for mRNA delivery (2021) · cites this paper as [17]
The authorized COVID-19 mRNA vaccines are both stored in freezing conditions in the presence of sucrose.
“Of note, the authorized COVID-19 mRNA vaccines are both stored in freezing conditions in the presence of sucrose17.”
From Lipid nanoparticles for mRNA delivery (2021) · cites this paper as [17]
The IVT mRNA molecules used in the mRNA-1273 and BNT162b2 COVID-19 vaccines were prepared by replacing uridine with m1ψ, and their sequences were optimized to encode a stabilized pre-fusion spike protein with two pivotal proline substitutions.
“The IVT mRNA molecules used in the mRNA-1273 and BNT162b2 COVID-19 vaccines were prepared by replacing uridine with m1ψ17,19,21, and their sequences were optimized to encode a stabilized pre-fusion spike protein with two pivotal proline substitutions17,19,21.”
From Lipid nanoparticles for mRNA delivery (2021) · cites this paper as [17]
The clinical-grade COVID-19 vaccine mRNA-1273 was produced within a month after the SARS-CoV-2 genome sequence was available.
“For example, the clinical-grade COVID-19 vaccine, mRNA-1273, was produced within a month after the SARS-CoV-2 genome sequence was available15,17.”
From Lipid nanoparticles for mRNA delivery (2021) · cites this paper as [17]
About 2, 5 and 6 months from sequence availability, clinical trial phases I, II and III were initiated for mRNA-1273, respectively.
“About 2, 5 and 6 months from sequence availability, clinical trial phases I, II and III were initiated, respectively15,17.”
From Lipid nanoparticles for mRNA delivery (2021) · cites this paper as [17]
mRNA-1273 obtained Emergency Use Authorization from the FDA and conditional marketing authorization from the EMA within a year.
“Finally, mRNA-1273 obtained Emergency Use Authorization from the FDA and conditional marketing authorization from the EMA within a year15,17.”
From Lipid nanoparticles for mRNA delivery (2021) · cites this paper as [17]
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 [17]
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 [17]
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 [17]
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 [17]

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[81]Walsh EE, Frenck RW, Falsey AR, Kitchin N, Absalon J, Gurtman A, Lockhart S, Neuzil K, Mulligan MJ, Bailey R, Swanson KA, Li P, Koury K, Kalina W, Cooper D, Fontes-Garfias C, Shi P-Y, Türeci Ö, Tompkins KR, Lyke KE, Raabe V, Dormitzer PR, Jansen KU, Şahin U, Gruber WC, Safety and Immunogenicity of Two RNA-Based Covid-19 Vaccine Candidates, N. Engl. J. Med (2020). 10.1056/NEJMoa2027906. PMC7583697 33053279 · DOI · Paper page

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Authors: Kim, J., Eygeris, Y., Gupta, M., & Sahay, G.
Affiliations: Oregon State University (US)
Corresponding author: Sahay, Gaurav
ORCID: Kim, Jeonghwan
Eygeris, Yulia
Gupta, Mohit
Sahay, Gaurav
Venue: Advanced Drug Delivery Reviews
Publisher: Elsevier BV
Published: 2021-03
Volume: 170
Pages: 83-112
ISSN: 0169-409X (ISSN-L)
DOI: 10.1016/j.addr.2020.12.014
PMC: PMC7837307
OpenAlex: W3119364115
Cited by: 514
References: 318
Citations by year: 2026: 49 · 2025: 119 · 2024: 105 · 2023: 90 · 2022: 98 · 2021: 53
FWCI: 9.08
Type: journal article
Language: en
Open access: green
www.ncbi.nlm.nih.gov
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
www.elsevier.com/legal/tdmrep-license (tdm)
Locations: Advanced Drug Delivery Reviews (publishedVersion)
PubMed Central (publishedVersion)
PubMed (publishedVersion)
Funders: National Eye Institute
Cystic Fibrosis Foundation
National Heart and Lung Institute
National Heart, Lung, and Blood Institute (1R21EY031066, 5R01HL146736, SAHAY19XX0)
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
Physical Sciences › Materials Science › Biomaterials › Nanoparticle-Based Drug Delivery
Keywords: mRNA vaccines, self-assembly, mRNA delivery, lipid nanoparticles, COVID-19 vaccines, route of administration, immune activation, gene therapy, vaccine design
MeSH terms: COVID-19 Vaccines, mRNA Vaccines, Animals, Humans, RNA, Messenger, Vaccines, Synthetic, Drug Design, Gene Transfer Techniques, Nanotechnology, Nanoparticles

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