SARS-CoV-2 mRNA Vaccine Design Enabled by Prototype Pathogen Preparedness
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Abstract
A vaccine for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is needed to control the coronavirus disease 2019 (COVID-19) global pandemic. Structural studies have led to the development of mutations that stabilize Betacoronavirus spike proteins in the prefusion state, improving their expression and increasing immunogenicity 1. This principle has been applied to design mRNA-1273, an mRNA vaccine that encodes a SARS-CoV-2 spike protein that is stabilized in the prefusion conformation. Here we show that mRNA-1273 induces potent neutralizing antibody responses to both wild-type (D614) and D614G mutant 2 SARS-CoV-2 as well as CD8+ T cell responses, and protects against SARS-CoV-2 infection in the lungs and noses of mice without evidence of immunopathology. mRNA-1273 is currently in a phase III trial to evaluate its efficacy.
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Studies of mRNA-1273 in mice show that the structurally defined spike antigen induces robust neutralizing activity and that gene-based delivery promotes Th1-biased responses, including CD8 T cells that protect against virus replication in lung and nose without evidence of immunopathology.
“Studies of mRNA-1273 in mice show that the structurally defined spike antigen induces robust neutralizing activity and that the gene-based delivery promotes Th1-biased responses, including CD8 T cells that protect against virus replication in lung and nose without evidence of immunopathology.32”
From An mRNA Vaccine against SARS-CoV-2 — Preliminary Report (2020) · cites this paper as [32]
Split into 2 atoms — 1 confirmed, 1 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.
Experimental — accuracy not yet measuredAll uridines in the mRNA vaccines were replaced by N1-methylpseudouridine (Ψ).
“To alleviate host cells to attack exogeneous vaccine mRNA as foreign RNA [13,58], all uridines in the mRNA vaccines were replaced by Ψ [2,14].”
From Detailed Dissection and Critical Evaluation of the Pfizer/BioNTech and Moderna mRNA Vaccines (2021) · cites this paper as [2]
The majority of COVID-19 vaccines evoke humoral and cellular immune responses against the SARS-CoV-2 spike protein; these responses may not prevent infection but robustly protect against severe COVID-19 for certain periods of time.
“The majority of COVID-19 vaccines are designed to evoke humoral and cellular immune responses against the SARS-CoV-2 spike protein — responses that may not prevent infection but robustly protect against severe COVID-19, at least for certain periods of time11,150–157.”
From COVID-19 and cellular senescence (2023) · cites this paper as [150]
The two mRNA vaccines show >94% efficacy at preventing COVID-19 illness.
“show >94% efficacy at preventing COVID-19 illness (44–47)”
From mRNA vaccination boosts cross-variant neutralizing antibodies elicited by SARS-CoV-2 infection (2021) · cites this paper as [45]
The COVID-19 vaccine mRNA-1273 developed by Moderna employs the capping enzyme described above.
“Of note, it has been reported that the COVID-19 vaccine mRNA-1273 developed by Moderna employs the capping enzyme described above.28”
From Advances in COVID-19 mRNA vaccine development (2022) · cites this paper as [28]
Many nucleoside-modified mRNA COVID-19 vaccines, including BNT162b2, BNT162b1, BNT162b3, mRNA-1273, TAK919, mRNA-1273.211, mRNA-1273.351, mRNA-1283, ChulaCov19, and PTX-COVID19-B, have been approved for commercialization or entered clinical trials.
“Many nucleoside-modified mRNA COVID-19 vaccines, including BNT162b2, BNT162b1, and BNT162b3 developed by BioNTech27,177; mRNA-1273, TAK919, mRNA-1273.211, mRNA-1273.351, mRNA-1283 developed by Moderna28,178; ChulaCov19 developed by Chulalongkorn University; and PTX-COVID19-B developed by Providence Therapeutics, have been approved for commercialization or entered clinical trials.104”
From Advances in COVID-19 mRNA vaccine development (2022) · cites this paper as [28]
The 2P mutation method is applicable to SARS-CoV-2 and other β-coronavirus viruses.
“The 2P mutation method is applicable to SARS-CoV-2271 and other β-coronavirus viruses,28”
From Advances in COVID-19 mRNA vaccine development (2022) · cites this paper as [28]
These studies enabled Moderna to generate the mRNA-1273 sequence in 2 days and start phase I trials in 66 days.
“These studies enabled Moderna to generate the mRNA-1273 sequence in 2 days and start phase I trials in 66 days127.”
From mRNA vaccines for infectious diseases: principles, delivery and clinical translation (2021) · cites this paper as [127]
Research on MERS-CoV and SARS-CoV suggested that the antigen should be the spike protein and that its amino acid sequence should be slightly modified to lock the protein in its prefusion conformation, maximizing its immunogenicity.
“For example, research on MERS-CoV and SARS-CoV suggested that the antigen should be the spike protein and that its amino acid sequence should be slightly modified to lock the protein in its prefusion conformation, maximizing its immunogenicity127.”
From mRNA vaccines for infectious diseases: principles, delivery and clinical translation (2021) · cites this paper as [127]
mRNA-1273 protected animals from upper and lower airway SARS-CoV-2 infection for at least 3 months after vaccination.
“It also protected the animals from upper and lower airway SARS-CoV-2 infection for at least 3 months after vaccination127.”
From mRNA vaccines for infectious diseases: principles, delivery and clinical translation (2021) · cites this paper as [127]
In a preclinical trial, two 1 μg doses of mRNA-1273 injected into muscle induced robust virus-neutralizing activity and potent CD4+ and CD8+ T cell responses in mice.
“In a preclinical trial, two 1 μg doses of vaccine (a primer dose and a booster) injected into muscle induced robust virus-neutralizing activity as well as potent CD4+ and CD8+ T cell responses in mice127.”
From mRNA vaccines for infectious diseases: principles, delivery and clinical translation (2021) · cites this paper as [127]
mRNA-1273 uses the ionizable lipid SM-102 to formulate lipid nanoparticles that encapsulate an N1-methylpseudouridine-modified mRNA encoding the SARS-CoV-2 spike protein with two proline substitutions that confer the prefusion conformation.
“The vaccine uses the ionizable lipid SM-102 to formulate LNPs that encapsulate an N1-methylpseudouridine-modified mRNA. The sequence encodes the SARS-CoV-2 spike protein with two proline substitutions that confer the prefusion conformation127.”
From mRNA vaccines for infectious diseases: principles, delivery and clinical translation (2021) · cites this paper as [127]
The SARS-CoV-2 mRNA-based vaccine mRNA-1273 entered clinical testing just 2 months after the genetic sequence of SARS-CoV-2 was identified.
“the SARS-CoV-2 mRNA-based vaccine mRNA-1273 entered clinical testing just 2 months after the genetic sequence of SARS-CoV-2 was identified127”
From A guide to vaccinology: from basic principles to new developments (2021) · cites this paper as [127]
The bulk of the mRNA vaccines reported till date have an m7GpppNm cap inserted at the 5′-end during IVT.
“The bulk of the mRNA vaccines reported till date have an m7GpppNm cap inserted at the 5′-end during IVT (Corbett et al. 2020).”
From Modifications of mRNA vaccine structural elements for improving mRNA stability and translation efficiency (2022) · cites this paper as Corbett et al. 2020
All U nucleotides in the mRNA vaccines have been modified to N1-methyl-pseudouridine (Ψ) to reduce immune reaction towards mRNA and to increase protein production.
“However, all U nucleotides in the mRNA vaccines have been modified to N1-methyl-pseudouridine (Ψ) [14] to reduce immune reaction towards mRNA and to increase protein production [2,13,58].”
From Detailed Dissection and Critical Evaluation of the Pfizer/BioNTech and Moderna mRNA Vaccines (2021) · cites this paper as [2]
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Warp Speed for Coronavirus Disease 2019 (COVID-19) Vaccines: Why Are Children Stuck in Neutral?
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- Authors
- Corbett, K. S., Edwards, D. K., Leist, S. R., Abiona, O. M., Boyoglu-Barnum, S., Gillespie, R. A., Himansu, S., Schäfer, A., Ziwawo, C. T., DiPiazza, A. T., Dinnon, K. H., Elbashir, S. M., Shaw, C. A., Woods, A., Fritch, E. J., Martinez, D. R., Bock, K. W., Minai, M., Nagata, B. M., Hutchinson, G. B., Wu, K., Henry, C., Bahl, K., Garcia-Dominguez, D., Ma, L., Renzi, I., Kong, W.-P., Schmidt, S. D., Wang, L., Zhang, Y., Phung, E., Chang, L. A., Loomis, R. J., Altaras, N. E., Narayanan, E., Metkar, M., Presnyak, V., Liu, C., Louder, M. K., Shi, W., Leung, K., Yang, E. S., West, A., Gully, K. L., Stevens, L. J., Wang, N., Wrapp, D., Doria-Rose, N. A., Stewart-Jones, G., Bennett, H., Alvarado, G. S., Nason, M. C., Ruckwardt, T. J., McLellan, J. S., Denison, M. R., Chappell, J. D., Moore, I. N., Morabito, K. M., Mascola, J. R., Baric, R. S., Carfi, A., & Graham, B. S.
- Affiliations
- National Institutes of Health (US)
- Moderna Therapeutics (United States) (US)
- University of North Carolina at Chapel Hill (US)
- Vanderbilt University Medical Center (US)
- The University of Texas at Austin (US)
- Corresponding author
- Graham, Barney S.
- ORCID
- Corbett, Kizzmekia S.
- Edwards, Darin K.
- Leist, Sarah R.
- Abiona, Olubukola M.
- Gillespie, Rebecca A.
- Himansu, Sunny
- Schäfer, Alexandra
- Ziwawo, Cynthia T.
- DiPiazza, Anthony T.
- Dinnon, Kenneth H.
- Elbashir, Sayda M.
- Shaw, Christine A.
- Fritch, Ethan J.
- Martinez, David R.
- Bock, Kevin W.
- Minai, Mahnaz
- Nagata, Bianca M.
- Hutchinson, Geoffrey B.
- Henry, Carole
- Bahl, Kapil
- Garcia-Dominguez, Dario
- Ma, LingZhi
- Renzi, Isabella
- Kong, Wing-Pui
- Schmidt, Stephen D.
- Wang, Lingshu
- Zhang, Yi
- Phung, Emily
- Chang, Lauren A.
- Loomis, Rebecca J.
- Narayanan, Elisabeth
- Metkar, Mihir
- Liu, Cuiping
- Louder, Mark K.
- Shi, Wei
- Leung, Kwanyee
- Yang, Eun Sung
- West, Ande
- Gully, Kendra L.
- Stevens, Laura J.
- Wang, Nianshuang
- Wrapp, Daniel
- Stewart-Jones, Guillaume
- Bennett, Hamilton
- Alvarado, Gabriela S.
- Nason, Martha C.
- Ruckwardt, Tracy J.
- McLellan, Jason S.
- Denison, Mark R.
- Chappell, James D.
- Moore, Ian N.
- Morabito, Kaitlyn M.
- Mascola, John R.
- Baric, Ralph S.
- Carfi, Andrea
- Graham, Barney S.
- Venue
- Nature
- Published
- 2020-08-05
- Volume
- 586
- Issue
- 7830
- Pages
- 567-571
- ISSN
- 0028-0836 (ISSN-L)
- 1476-4687
- PMC
- PMC7581537
- OpenAlex
- W3047091198
- Cited by
- 1,615
- References
- 39
- Citations by year
- 2026: 141 · 2025: 167 · 2024: 190 · 2023: 246 · 2022: 334 · 2021: 432 · 2020: 102 · 2013: 1
- FWCI
- 36.54
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Nature (publishedVersion)
- bioRxiv (Cold Spring Harbor Laboratory) (acceptedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- Carolina Digital Repository (University of North Carolina at Chapel Hill) (submittedVersion)
- PubMed Central (submittedVersion)
- RePEc: Research Papers in Economics (submittedVersion)
- UNC Libraries
- Funders
- U.S. Department of Health and Human Services (AI127521, HHSN261200800001E, 75A50120C00034, HHSN272201700036I)
- Wellcome Trust
- Leidos (HHSN261200800001E)
- National Institutes of Health (#HHSN261200800001E, 5494549, HHSN261200800001C, HHSN272201700036I, Contract HHSN261200800001E, 75N93019F00132, 75A50120C00034, AI100625, AI149644, AI127521)
- Biomedical Advanced Research and Development Authority (75A50120C00034, contract 75A50120C00034)
- NIH Office of the Director (HHSN261200800001E)
- National Cancer Institute (HHSN261200800001E))
- National Institute of Allergy and Infectious Diseases (75N93019F00132, AI100625, U01AI149644, AI149644, U19AI100625, 75A50120C00034, HHSN261200800001E, Z01AI005030, HHSN272201700036I, AI127521, R01AI127521, AI007151, T32AI007151)
- NHLBI Division of Intramural Research (HHSN261200800001E)
- Topics
- Health Sciences › Medicine › Infectious Diseases › SARS-CoV-2 and COVID-19 Research
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › vaccines and immunoinformatics approaches
- Life Sciences › Agricultural and Biological Sciences › Animal Science and Zoology › Animal Virus Infections Studies
- Keywords
- SARS-CoV-2, COVID-19 pandemic, mRNA vaccines, mRNA-1273, spike protein, D614G mutation, neutralizing antibodies, CD8+ T cell responses, vaccine immunogenicity, protective immunity, immunopathology
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