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Abstract

An effective vaccine is needed to halt the spread of the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) pandemic. Recently, we reported safety, tolerability and antibody response data from an ongoing placebo-controlled, observer-blinded phase 1/2 coronavirus disease 2019 (COVID-19) vaccine trial with BNT162b1, a lipid nanoparticle (LNP) formulated nucleoside-modified messenger RNA (mRNA) encoding the receptor binding domain (RBD) of the SARS-CoV-2 spike protein1. Here we present antibody and T-cell responses after BNT162b1 vaccination from a second, non-randomized open-label phase 1/2 trial in healthy adults, 18-55 years of age. Two doses of 1 to 50 µg of BNT162b1 elicited robust CD4+ and CD8+ T-cell responses and strong antibody responses, with RBD-binding IgG concentrations clearly above those in a COVID-19 human convalescent sample (HCS) panel. Day 43 SARS-CoV-2 serum neutralising geometric mean titers were 0.7-fold (1 µg) to 3.5-fold (50 µg) those of the HCS panel. Immune sera broadly neutralised pseudoviruses with diverse SARS-CoV-2 spike variants. Most participants had T helper type 1 (TH1) skewed T cell immune responses with RBD-specific CD8+ and CD4+ T-cell expansion. Interferon (IFN)γ was produced by a high fraction of RBD-specific CD8+ and CD4+ T cells. The robust RBD-specific antibody, T-cell and favourable cytokine responses induced by the BNT162b1 mRNA vaccine suggest multiple beneficial mechanisms with potential to protect against COVID-19.

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Affiliations

  1. BioNTech, An der Goldgrube 12, 55131, Mainz, Germany

    Ugur Sahin, Alexander Muik, Evelyna Derhovanessian, Isabel Vogler, Lena M. Kranz, Mathias Vormehr, Jasmin Quandt, Daniel Maurus, Sebastian Brachtendorf, Verena Lörks, Julian Sikorski, Rolf Hilker, Dirk Becker, Ann-Kathrin Eller, Jan Grützner, Carsten Boesler, Corinna Rosenbaum, Marie-Cristine Kühnle, Ulrich Luxemburger, Alexandra Kemmer-Brück, David Langer, Stefanie Bolte, Katalin Karikó, Tania Palanche, Boris Fischer & Özlem Türeci

  2. TRON gGmbH – Translational Oncology at the University Medical Center of the Johannes Gutenberg, University Freiligrathstraße 12, 55131, Mainz, Germany

    Ugur Sahin

  3. Pfizer, 401 N Middletown Rd., Pearl River, NY, 10960, USA

    John L. Perez, Kena A. Swanson, Jakob Loschko, Ingrid L. Scully, Mark Cutler, Warren Kalina, David Cooper, Philip R. Dormitzer & Kathrin U. Jansen

  4. Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Rd, Tarrytown, NY, 10591, USA

    Alina Baum, Kristen Pascal & Christos A. Kyratsous

  5. University of Texas Medical Branch, Galveston, TX, 77555, USA

    Pei-Yong Shi & Camila Fontes-Garfias

  6. CRS Clinical Research Services Mannheim GmbH, Grenadierstrasse 1, 68167, Mannheim, Germany

    Armin Schultz

  7. Bexon Clinical Consulting LLC, Upper Montclair, NJ, 07043, USA

    Martin Bexon

Corresponding author

Correspondence to
Ugur Sahin.

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Sahin, U., Muik, A., Derhovanessian, E. et al. COVID-19 vaccine BNT162b1 elicits human antibody and TH1 T-cell responses.
Nature (2020). https://doi.org/10.1038/s41586-020-2814-7

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