A prefusion SARS-CoV-2 spike RNA vaccine is highly immunogenic and prevents lung infection in non-human primates
Open accessAbstract
To contain the coronavirus disease 2019 (COVID-19) pandemic, a safe and effective vaccine against the new severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) is urgently needed in quantities sufficient to immunise large populations. In this study, we report the design, preclinical development, immunogenicity and anti-viral protective effect in rhesus macaques of the BNT162b2 vaccine candidate. BNT162b2 contains an LNP-formulated nucleoside-modified mRNA that encodes the spike glycoprotein captured in its prefusion conformation. After expression of the BNT162b2 coding sequence in cells, approximately 20% of the spike molecules are in the one-RBD ‘up’, two-RBD ‘down’ state. Immunisation of mice with a single dose of BNT162b2 induced dose level-dependent increases in pseudovirus neutralisation titers. Prime-boost vaccination of rhesus macaques elicited authentic SARS-CoV-2 neutralising geometric mean titers 10.2 to 18.0 times that of a SARS-CoV-2 convalescent human serum panel. BNT162b2 generated strong T H 1 type CD4 + and IFNγ + CD8 + T-cell responses in mice and rhesus macaques. The BNT162b2 vaccine candidate fully protected the lungs of immunised rhesus macaques from infectious SARS-CoV-2 challenge. BNT162b2 is currently being evaluated in a global, pivotal Phase 2/3 trial ( NCT04368728 ).
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Preclinical testing of mRNA-1273 and other SARS-CoV-2 vaccines in advanced clinical evaluation has shown a Th1-skewed vaccine response and no pathologic lung infiltrates.
“Of note, preclinical testing of mRNA-1273 and other SARS-CoV-2 vaccines in advanced clinical evaluation has shown a Th1-skewed vaccine response and no pathologic lung infiltrates. 15,26-28”
From Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine (2021) · cites this paper as [28]
The Results (page unavailable) report a Th1-biased response to BNT162b2 in rhesus macaques and no detectable viral RNA in bronchoalveolar lavage after challenge. The cited paper tests BNT162b2, not mRNA-1273, and the passages in our copy do not establish the claimed absence of pathologic lung infiltrates. (LLM, conf=0.83)
Experimental — accuracy not yet measuredThe 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 [47]
BioNTech uses a segmented poly(A) tail whose two-tail structures are connected in tandem by a 10 bp UGC linker sequence (A30LA70).
“For instance, BioNTech uses a segmented poly(A) tail whose two-tail structures are connected in tandem by a 10 bp UGC linker sequence (A30LA70).27,153”
From Advances in COVID-19 mRNA vaccine development (2022) · cites this paper as [27]
COVID-19 mRNA vaccines BNT162b1 and BNT162b2 developed by BioNTech employ TriLink Cap1 cap analog for co-transcriptional capping.
“Currently, COVID-19 mRNA vaccines BNT162b1 and BNT162b2 developed by BioNTech employ TriLink Cap1 cap analog (m27,3′-O)Gppp(m2′-O)ApG for co-transcriptional capping.27,130”
From Advances in COVID-19 mRNA vaccine development (2022) · cites this paper as [27]
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 [27]
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- Authors
- Vogel, A. B., Kanevsky, I., Che, Y., Swanson, K. A., Muik, A., Vormehr, M., Kranz, L. M., Walzer, K. C., Hein, S., Güler, A., Loschko, J., Maddur, M. S., Tompkins, K., Cole, J., Lui, B. G., Ziegenhals, T., Plaschke, A., Eisel, D., Dany, S. C., Fesser, S., Erbar, S., Bates, F., Schneider, D., Jesionek, B., Sänger, B., Wallisch, A.-K., Feuchter, Y., Junginger, H., Krumm, S. A., Heinen, A. P., Adams-Quack, P., Schlereth, J., Kröner, C., Hall-Ursone, S., Brasky, K., Griffor, M. C., Han, S., Lees, J. A., Mashalidis, E. H., Sahasrabudhe, P. V., Tan, C. Y., Pavliakova, D., Singh, G., Fontes-Garfias, C., Pride, M., Scully, I. L., Ciolino, T., Obregon, J., Gazi, M., Carrion, R., Alfson, K. J., Kalina, W. V., Kaushal, D., Shi, P.-Y., Klamp, T., Rosenbaum, C., Kuhn, A. N., Türeci, Ö., Dormitzer, P. R., Jansen, K. U., & Sahin, U.
- Affiliations
- BioNTech (Germany) (DE)
- Pfizer (United States) (US)
- Texas Biomedical Research Institute (US)
- The University of Texas Medical Branch at Galveston (US)
- ORCID
- Vogel, Annette B.
- Kanevsky, Isis
- Che, Ye
- Swanson, Kena A.
- Muik, Alexander
- Vormehr, Mathias
- Kranz, Lena M.
- Güler, Alptekin
- Maddur, Mohan S.
- Tompkins, Kristin
- Lui, Bonny G.
- Ziegenhals, Thomas
- Eisel, David
- Erbar, Stephanie
- Bates, Ferdia
- Sänger, Bianca
- Wallisch, Ann-Kathrin
- Heinen, André P.
- Hall-Ursone, Shannan
- Griffor, Matthew C.
- Han, Seungil
- Lees, Joshua A.
- Mashalidis, Ellene H.
- Sahasrabudhe, Parag V.
- Tan, Charles Y.
- Fontes-Garfias, Camila
- Pride, Michael
- Scully, Ingrid L.
- Carrion, Ricardo
- Alfson, Kendra J.
- Kaushal, Deepak
- Shi, Pei-Yong
- Kuhn, Andreas N.
- Türeci, Özlem
- Dormitzer, Philip R.
- Jansen, Kathrin U.
- Venue
- bioRxiv (Cold Spring Harbor Laboratory)
- Publisher
- openRxiv
- Published
- 2020-09-08
- OpenAlex
- W3084228540
- Cited by
- 126
- References
- 47
- Citations by year
- 2026: 3 · 2025: 1 · 2024: 7 · 2023: 10 · 2022: 24 · 2021: 72 · 2020: 9
- Type
- posted content
- Language
- en
- Open access
- green
- doi.org
- Locations
- bioRxiv (Cold Spring Harbor Laboratory) (acceptedVersion)
- Funders
- Pfizer
- Instituto Millenium
- Topics
- Health Sciences › Medicine › Infectious Diseases › SARS-CoV-2 and COVID-19 Research
- Life Sciences › Agricultural and Biological Sciences › Animal Science and Zoology › Animal Virus Infections Studies
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › vaccines and immunoinformatics approaches
- Keywords
- BNT162b2, COVID-19 vaccines, mRNA vaccines, lipid nanoparticle formulation, nucleoside-modified mRNA, rhesus monkeys, immunogenicity, neutralizing antibodies, T cell response, COVID-19 pandemic
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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