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Vogel, Annette B; Kanevsky, Isis; Che, Ye; Swanson, Kena A; Muik, Alexander; Vormehr, Mathias; Kranz, Lena M; Walzer, Kerstin C; Hein, Stephanie; Güler, Alptekin; Loschko, Jakob; Maddur, Mohan S; Ota-Setlik, Ayuko; Tompkins, Kristin; Cole, Journey; Lui, Bonny G; Ziegenhals, Thomas; Plaschke, Arianne; Eisel, David; Dany, Sarah C; Fesser, Stephanie; Erbar, Stephanie; Bates, Ferdia; Schneider, Diana; Jesionek, Bernadette; Sänger, Bianca; Wallisch, Ann-Kathrin; Feuchter, Yvonne; Junginger, Hanna; Krumm, Stefanie A; Heinen, André P; Adams-Quack, Petra; Schlereth, Julia; Schille, Stefan; Kröner, Christoph; de la Caridad Güimil Garcia, Ramón; Hiller, Thomas; Fischer, Leyla; Sellers, Rani S; Choudhary, Shambhunath; Gonzalez, Olga; Vascotto, Fulvia; Gutman, Matthew R; Fontenot, Jane A; Hall-Ursone, Shannan; Brasky, Kathleen; Griffor, Matthew C; Han, Seungil; Su, Andreas A H; Lees, Joshua A; Nedoma, Nicole L; Mashalidis, Ellene H; Sahasrabudhe, Parag V; Tan, Charles Y; Pavliakova, Danka; Singh, Guy; Fontes-Garfias, Camila; Pride, Michael; Scully, Ingrid L; Ciolino, Tara; Obregon, Jennifer; Gazi, Michal; Carrion, Jr, Ricardo; Alfson, Kendra J; Kalina, Warren V; Kaushal, Deepak; Shi, Pei-Yong; Klamp, Thorsten; Rosenbaum, Corinna; Kuhn, Andreas N; Türeci, Özlem; Dormitzer, Philip R; Jansen, Kathrin U; Sahin, Ugur
Nature (London), 04/2021, Volume: 592, Issue: 7853Journal Article
A safe and effective vaccine against COVID-19 is urgently needed in quantities that are sufficient to immunize large populations. Here we report the preclinical development of two vaccine candidates (BNT162b1 and BNT162b2) that contain nucleoside-modified messenger RNA that encodes immunogens derived from the spike glycoprotein (S) of SARS-CoV-2, formulated in lipid nanoparticles. BNT162b1 encodes a soluble, secreted trimerized receptor-binding domain (known as the RBD-foldon). BNT162b2 encodes the full-length transmembrane S glycoprotein, locked in its prefusion conformation by the substitution of two residues with proline (S(K986P/V987P); hereafter, S(P2) (also known as P2 S)). The flexibly tethered RBDs of the RBD-foldon bind to human ACE2 with high avidity. Approximately 20% of the S(P2) trimers are in the two-RBD 'down', one-RBD 'up' state. In mice, one intramuscular dose of either candidate vaccine elicits a dose-dependent antibody response with high virus-entry inhibition titres and strong T-helper-1 CD4 and IFNγ CD8 T cell responses. Prime-boost vaccination of rhesus macaques (Macaca mulatta) with the BNT162b candidates elicits SARS-CoV-2-neutralizing geometric mean titres that are 8.2-18.2× that of a panel of SARS-CoV-2-convalescent human sera. The vaccine candidates protect macaques against challenge with SARS-CoV-2; in particular, BNT162b2 protects the lower respiratory tract against the presence of viral RNA and shows no evidence of disease enhancement. Both candidates are being evaluated in phase I trials in Germany and the USA , and BNT162b2 is being evaluated in an ongoing global phase II/III trial (NCT04380701 and NCT04368728).
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