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BNT162b vaccines are immunogenic and protect non-human primates against SARS-CoV-2

Annette B. Vogel, Isis Kanevsky, Ye Che, Kena A. Swanson, Alexander Muik, Mathias Vormehr, Lena M. Kranz, Kerstin C. Walzer, Stephanie Hein, Alptekin Güler, Jakob Loschko, Mohan S. Maddur, Ayuko Ota-Setlik, Kristin Tompkins, Journey Cole, Bonny G. Lui, Thomas Ziegenhals, Arianne Plaschke, David Eisel, Sarah C. Dany, Stephanie Fesser, Stephanie Erbar, Ferdia Bates, Diana Schneider, Bernadette Jesionek, Bianca Sänger, Ann-Kathrin Wallisch, Yvonne Feuchter, Hanna Junginger, Stefanie A. Krumm, André P. Heinen, Petra Adams-Quack, Julia Schlereth, Stefan Schille, Christoph Kröner, Ramón de la Caridad Güimil Garcia, Thomas Hiller, Leyla Fischer, Rani S. Sellers, Shambhunath Choudhary, Olga Gonzalez, Fulvia Vascotto, Matthew R. Gutman, Jane A. Fontenot, Shannan Hall-Ursone, Kathleen Brasky, Matthew C. Griffor, View ORCID ProfileSeungil Han, Andreas A.H. Su, Joshua A. Lees, Nicole L. Nedoma, Ellene H. Mashalidis, Parag V. Sahasrabudhe, Charles Y. Tan, Danka Pavliakova, Guy Singh, Camila Fontes-Garfias, Michael Pride, Ingrid L. Scully, Tara Ciolino, Jennifer Obregon, Michal Gazi, Ricardo Carrion Jr., Kendra J. Alfson, Warren V. Kalina, Deepak Kaushal, Pei-Yong Shi, Thorsten Klamp, Corinna Rosenbaum, Andreas N. Kuhn, Özlem Türeci, Philip R. Dormitzer, Kathrin U. Jansen, Ugur Sahin
doi: https://doi.org/10.1101/2020.12.11.421008
Annette B. Vogel
1BioNTech, An der Goldgrube 12, 55131 Mainz, Germany
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Isis Kanevsky
2Pfizer, 401 N. Middletown Rd., Pearl River, NY 10965, United States
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Ye Che
3Pfizer, 280 Shennecossett Rd., Groton, CT 06340, United States
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Kena A. Swanson
2Pfizer, 401 N. Middletown Rd., Pearl River, NY 10965, United States
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Alexander Muik
1BioNTech, An der Goldgrube 12, 55131 Mainz, Germany
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Mathias Vormehr
1BioNTech, An der Goldgrube 12, 55131 Mainz, Germany
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Lena M. Kranz
1BioNTech, An der Goldgrube 12, 55131 Mainz, Germany
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Kerstin C. Walzer
1BioNTech, An der Goldgrube 12, 55131 Mainz, Germany
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Stephanie Hein
1BioNTech, An der Goldgrube 12, 55131 Mainz, Germany
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Alptekin Güler
1BioNTech, An der Goldgrube 12, 55131 Mainz, Germany
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Jakob Loschko
2Pfizer, 401 N. Middletown Rd., Pearl River, NY 10965, United States
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Mohan S. Maddur
2Pfizer, 401 N. Middletown Rd., Pearl River, NY 10965, United States
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Ayuko Ota-Setlik
2Pfizer, 401 N. Middletown Rd., Pearl River, NY 10965, United States
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Kristin Tompkins
2Pfizer, 401 N. Middletown Rd., Pearl River, NY 10965, United States
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Journey Cole
4Southwest National Primate Research Center, Texas Biomedical Research Institute, 8715 W. Military Dr, San Antonio, TX 78227, United States
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Bonny G. Lui
1BioNTech, An der Goldgrube 12, 55131 Mainz, Germany
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Thomas Ziegenhals
1BioNTech, An der Goldgrube 12, 55131 Mainz, Germany
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Arianne Plaschke
1BioNTech, An der Goldgrube 12, 55131 Mainz, Germany
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David Eisel
1BioNTech, An der Goldgrube 12, 55131 Mainz, Germany
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Sarah C. Dany
1BioNTech, An der Goldgrube 12, 55131 Mainz, Germany
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Stephanie Fesser
1BioNTech, An der Goldgrube 12, 55131 Mainz, Germany
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Stephanie Erbar
1BioNTech, An der Goldgrube 12, 55131 Mainz, Germany
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Ferdia Bates
1BioNTech, An der Goldgrube 12, 55131 Mainz, Germany
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Diana Schneider
1BioNTech, An der Goldgrube 12, 55131 Mainz, Germany
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Bernadette Jesionek
1BioNTech, An der Goldgrube 12, 55131 Mainz, Germany
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Bianca Sänger
1BioNTech, An der Goldgrube 12, 55131 Mainz, Germany
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Ann-Kathrin Wallisch
1BioNTech, An der Goldgrube 12, 55131 Mainz, Germany
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Yvonne Feuchter
1BioNTech, An der Goldgrube 12, 55131 Mainz, Germany
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Hanna Junginger
1BioNTech, An der Goldgrube 12, 55131 Mainz, Germany
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Stefanie A. Krumm
1BioNTech, An der Goldgrube 12, 55131 Mainz, Germany
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André P. Heinen
1BioNTech, An der Goldgrube 12, 55131 Mainz, Germany
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Petra Adams-Quack
1BioNTech, An der Goldgrube 12, 55131 Mainz, Germany
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Julia Schlereth
1BioNTech, An der Goldgrube 12, 55131 Mainz, Germany
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Stefan Schille
1BioNTech, An der Goldgrube 12, 55131 Mainz, Germany
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Christoph Kröner
1BioNTech, An der Goldgrube 12, 55131 Mainz, Germany
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Ramón de la Caridad Güimil Garcia
1BioNTech, An der Goldgrube 12, 55131 Mainz, Germany
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Thomas Hiller
1BioNTech, An der Goldgrube 12, 55131 Mainz, Germany
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Leyla Fischer
1BioNTech, An der Goldgrube 12, 55131 Mainz, Germany
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Rani S. Sellers
2Pfizer, 401 N. Middletown Rd., Pearl River, NY 10965, United States
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Shambhunath Choudhary
2Pfizer, 401 N. Middletown Rd., Pearl River, NY 10965, United States
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Olga Gonzalez
4Southwest National Primate Research Center, Texas Biomedical Research Institute, 8715 W. Military Dr, San Antonio, TX 78227, United States
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Fulvia Vascotto
7TRON gGmbH – Translational Oncology at the University Medical Centre of the Johannes Gutenberg University, Freiligrathstraße 12, 55131 Mainz, Germany
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Matthew R. Gutman
8VCA SouthPaws Veterinary Specialists and Emergency Center, 8500 Arlington Blvd., Fairfax, VA 22031, USA
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Jane A. Fontenot
9New Iberia Research Center, 4401 West Admiral Doyle Drive, New Iberia, LA, 70560, USA
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Shannan Hall-Ursone
4Southwest National Primate Research Center, Texas Biomedical Research Institute, 8715 W. Military Dr, San Antonio, TX 78227, United States
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Kathleen Brasky
4Southwest National Primate Research Center, Texas Biomedical Research Institute, 8715 W. Military Dr, San Antonio, TX 78227, United States
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Matthew C. Griffor
3Pfizer, 280 Shennecossett Rd., Groton, CT 06340, United States
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Seungil Han
3Pfizer, 280 Shennecossett Rd., Groton, CT 06340, United States
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Andreas A.H. Su
1BioNTech, An der Goldgrube 12, 55131 Mainz, Germany
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Joshua A. Lees
3Pfizer, 280 Shennecossett Rd., Groton, CT 06340, United States
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Nicole L. Nedoma
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Ellene H. Mashalidis
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Parag V. Sahasrabudhe
3Pfizer, 280 Shennecossett Rd., Groton, CT 06340, United States
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Charles Y. Tan
2Pfizer, 401 N. Middletown Rd., Pearl River, NY 10965, United States
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Danka Pavliakova
2Pfizer, 401 N. Middletown Rd., Pearl River, NY 10965, United States
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Guy Singh
2Pfizer, 401 N. Middletown Rd., Pearl River, NY 10965, United States
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Camila Fontes-Garfias
5University of Texas Medical Branch, 301 University Blvd, Galveston, TX 77555, United States
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Michael Pride
2Pfizer, 401 N. Middletown Rd., Pearl River, NY 10965, United States
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Ingrid L. Scully
2Pfizer, 401 N. Middletown Rd., Pearl River, NY 10965, United States
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Tara Ciolino
2Pfizer, 401 N. Middletown Rd., Pearl River, NY 10965, United States
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Jennifer Obregon
2Pfizer, 401 N. Middletown Rd., Pearl River, NY 10965, United States
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Michal Gazi
6Texas Biomedical Research Institute, 8715 W Military Dr, San Antonio, TX 78227, United States
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Ricardo Carrion Jr.
4Southwest National Primate Research Center, Texas Biomedical Research Institute, 8715 W. Military Dr, San Antonio, TX 78227, United States
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Kendra J. Alfson
6Texas Biomedical Research Institute, 8715 W Military Dr, San Antonio, TX 78227, United States
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Warren V. Kalina
2Pfizer, 401 N. Middletown Rd., Pearl River, NY 10965, United States
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Deepak Kaushal
4Southwest National Primate Research Center, Texas Biomedical Research Institute, 8715 W. Military Dr, San Antonio, TX 78227, United States
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Pei-Yong Shi
5University of Texas Medical Branch, 301 University Blvd, Galveston, TX 77555, United States
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Thorsten Klamp
1BioNTech, An der Goldgrube 12, 55131 Mainz, Germany
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Corinna Rosenbaum
1BioNTech, An der Goldgrube 12, 55131 Mainz, Germany
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Andreas N. Kuhn
1BioNTech, An der Goldgrube 12, 55131 Mainz, Germany
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Özlem Türeci
1BioNTech, An der Goldgrube 12, 55131 Mainz, Germany
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Philip R. Dormitzer
2Pfizer, 401 N. Middletown Rd., Pearl River, NY 10965, United States
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Kathrin U. Jansen
2Pfizer, 401 N. Middletown Rd., Pearl River, NY 10965, United States
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Ugur Sahin
1BioNTech, An der Goldgrube 12, 55131 Mainz, Germany
7TRON gGmbH – Translational Oncology at the University Medical Centre of the Johannes Gutenberg University, Freiligrathstraße 12, 55131 Mainz, Germany
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  • For correspondence: Ugur.Sahin@biontech.de
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Abstract

A safe and effective vaccine against COVID-19 is urgently needed in quantities sufficient to immunise large populations. We report the preclinical development of two BNT162b vaccine candidates, which contain lipid-nanoparticle (LNP) formulated nucleoside-modified mRNA encoding SARS-CoV-2 spike glycoprotein-derived immunogens. BNT162b1 encodes a soluble, secreted, trimerised receptor-binding domain (RBD-foldon). BNT162b2 encodes the full-length transmembrane spike glycoprotein, locked in its prefusion conformation (P2 S). The flexibly tethered RBDs of the RBD-foldon bind ACE2 with high avidity. Approximately 20% of the P 2S trimers are in the two-RBD ‘down,’ one-RBD ‘up’ state. In mice, one intramuscular dose of either candidate elicits a dose-dependent antibody response with high virus-entry inhibition titres and strong TH1 CD4+ and IFNγ+ CD8+ T-cell responses. Prime/boost vaccination of rhesus macaques with BNT162b candidates elicits SARS-CoV-2 neutralising geometric mean titres 8.2 to 18.2 times that of a SARS-CoV-2 convalescent human serum panel. The vaccine candidates protect macaques from SARS-CoV-2 challenge, with BNT162b2 protecting the lower respiratory tract from the presence of viral RNA and with no evidence of disease enhancement. Both candidates are being evaluated in phase 1 trials in Germany and the United States. BNT162b2 is being evaluated in an ongoing global, pivotal Phase 2/3 trial (NCT04380701, NCT04368728).

Competing Interest Statement

U.S. and O.T. are management board members and employees at BioNTech SE (Mainz, Germany); K.C.W., B.G.L., D.S., B.J., T.H., T.K. and C.R. are employees at BioNTech SE; A.B.V., A.M., M.V., L.M.K., S.H., A.G., T.Z., F.B., A.P., D.E., S.C.D., S.F., S.E., F.B., B.S., A.W., Y.F., H.J., S.A.K., S.S., A.P.H., P.A., J.S., A.A.H.S., C.K., R.d.l.C.G.G., L.F. and A.N.K. are employees at BioNTech RNA Pharmaceuticals GmbH (Mainz, Germany); A.B.V., A.M., K.C.W., A.G., S.F., A.N.K and U.S. are inventors on patents and patent applications related to RNA technology and COVID-19 vaccine; A.B.V., A.M., M.V., L.M.K., K.C.W., S.H., B.G.L., A.P., D.E., S.C.D., S.F., S.E., D.S., B.J., B.S., A.P.H., P.A. J.S., A.A.H.S., T.H., L.F., C.K., T.K., C.R., A.N.K., O.T. and U.S. have securities from BioNTech SE; I.K., Y.C., K.A.S. J.A.L. M.S.M., K.T., A,O.-S., J.A.F., M.C.G., S.H., J.A.L., E.H.M., N.L.N., P.V.S., C.Y.T., D.P., W.V.K., J.O., R.S.S., S,C., T.C., I.L.S., M.W.P., G.S., and P.R.D., K.U.J. are employees of Pfizer and may hold stock options; C.F.-G. and P.-Y.S. received compensation from Pfizer to perform neutralisation assays; M.R.G. received compensation from Pfizer to read and interpret radiographs and CT scans. J.C., S.H.-U, K.B., R.C., Jr., K.J.A. O.G., and D.K., are employees of Southwest National Primate Research Center, which received compensation from Pfizer to conduct the animal challenge work; M.G. is an employee of Texas Biomedical Research Institute, which received compensation from Pfizer to conduct the RT-qPCR viral load quantification; no other relationships or activities that could appear to have influenced the submitted work.

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BNT162b vaccines are immunogenic and protect non-human primates against SARS-CoV-2
Annette B. Vogel, Isis Kanevsky, Ye Che, Kena A. Swanson, Alexander Muik, Mathias Vormehr, Lena M. Kranz, Kerstin C. Walzer, Stephanie Hein, Alptekin Güler, Jakob Loschko, Mohan S. Maddur, Ayuko Ota-Setlik, Kristin Tompkins, Journey Cole, Bonny G. Lui, Thomas Ziegenhals, Arianne Plaschke, David Eisel, Sarah C. Dany, Stephanie Fesser, Stephanie Erbar, Ferdia Bates, Diana Schneider, Bernadette Jesionek, Bianca Sänger, Ann-Kathrin Wallisch, Yvonne Feuchter, Hanna Junginger, Stefanie A. Krumm, André P. Heinen, Petra Adams-Quack, Julia Schlereth, Stefan Schille, Christoph Kröner, Ramón de la Caridad Güimil Garcia, Thomas Hiller, Leyla Fischer, Rani S. Sellers, Shambhunath Choudhary, Olga Gonzalez, Fulvia Vascotto, Matthew R. Gutman, Jane A. Fontenot, Shannan Hall-Ursone, Kathleen Brasky, Matthew C. Griffor, Seungil Han, Andreas A.H. Su, Joshua A. Lees, Nicole L. Nedoma, Ellene H. Mashalidis, Parag V. Sahasrabudhe, Charles Y. Tan, Danka Pavliakova, Guy Singh, Camila Fontes-Garfias, Michael Pride, Ingrid L. Scully, Tara Ciolino, Jennifer Obregon, Michal Gazi, Ricardo Carrion Jr., Kendra J. Alfson, Warren V. Kalina, Deepak Kaushal, Pei-Yong Shi, Thorsten Klamp, Corinna Rosenbaum, Andreas N. Kuhn, Özlem Türeci, Philip R. Dormitzer, Kathrin U. Jansen, Ugur Sahin
bioRxiv 2020.12.11.421008; doi: https://doi.org/10.1101/2020.12.11.421008
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BNT162b vaccines are immunogenic and protect non-human primates against SARS-CoV-2
Annette B. Vogel, Isis Kanevsky, Ye Che, Kena A. Swanson, Alexander Muik, Mathias Vormehr, Lena M. Kranz, Kerstin C. Walzer, Stephanie Hein, Alptekin Güler, Jakob Loschko, Mohan S. Maddur, Ayuko Ota-Setlik, Kristin Tompkins, Journey Cole, Bonny G. Lui, Thomas Ziegenhals, Arianne Plaschke, David Eisel, Sarah C. Dany, Stephanie Fesser, Stephanie Erbar, Ferdia Bates, Diana Schneider, Bernadette Jesionek, Bianca Sänger, Ann-Kathrin Wallisch, Yvonne Feuchter, Hanna Junginger, Stefanie A. Krumm, André P. Heinen, Petra Adams-Quack, Julia Schlereth, Stefan Schille, Christoph Kröner, Ramón de la Caridad Güimil Garcia, Thomas Hiller, Leyla Fischer, Rani S. Sellers, Shambhunath Choudhary, Olga Gonzalez, Fulvia Vascotto, Matthew R. Gutman, Jane A. Fontenot, Shannan Hall-Ursone, Kathleen Brasky, Matthew C. Griffor, Seungil Han, Andreas A.H. Su, Joshua A. Lees, Nicole L. Nedoma, Ellene H. Mashalidis, Parag V. Sahasrabudhe, Charles Y. Tan, Danka Pavliakova, Guy Singh, Camila Fontes-Garfias, Michael Pride, Ingrid L. Scully, Tara Ciolino, Jennifer Obregon, Michal Gazi, Ricardo Carrion Jr., Kendra J. Alfson, Warren V. Kalina, Deepak Kaushal, Pei-Yong Shi, Thorsten Klamp, Corinna Rosenbaum, Andreas N. Kuhn, Özlem Türeci, Philip R. Dormitzer, Kathrin U. Jansen, Ugur Sahin
bioRxiv 2020.12.11.421008; doi: https://doi.org/10.1101/2020.12.11.421008

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