COVID-19 vaccine BNT162b1 elicits human antibody and TH1 T cell responses
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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 I/II coronavirus disease 2019 (COVID-19) vaccine trial with BNT162b1, a lipid nanoparticle-formulated nucleoside-modified mRNA that encodes the receptor binding domain (RBD) of the SARS-CoV-2 spike protein 1. Here we present antibody and T cell responses after vaccination with BNT162b1 from a second, non-randomized open-label phase I/II trial in healthy adults, 18-55 years of age. Two doses of 1-50 μg of BNT162b1 elicited robust CD4+ and CD8+ T cell responses and strong antibody responses, with RBD-binding IgG concentrations clearly above those seen in serum from a cohort of individuals who had recovered from COVID-19. Geometric mean titres of SARS-CoV-2 serum-neutralizing antibodies on day 43 were 0.7-fold (1-μg dose) to 3.5-fold (50-μg dose) those of the recovered individuals. Immune sera broadly neutralized pseudoviruses with diverse SARS-CoV-2 spike variants. Most participants had T helper type 1 (T H 1)-skewed T cell immune responses with RBD-specific CD8+ and CD4+ T cell expansion. Interferon-γ was produced by a large 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 that it has the potential to protect against COVID-19 through multiple beneficial mechanisms.
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Recognition of T cell epitopes across the entire spike length was one reason BNT162b2 was favoured over BNT162b1.
“T cell recognition of epitopes spread across the entire length of S was one of the reasons to favour BNT162b2 over BNT162b1 14 .”
From BNT162b2 vaccine induces neutralizing antibodies and poly-specific T cells in humans (2021) · cites this paper as [14]
The Article section (page unavailable) says BNT162b2 encodes the full spike protein and was selected to advance, but gives its more favourable systemic tolerability as the reason. It does not report T-cell recognition of epitopes across the spike as a reason; the same section says epitope diversity was not analysed in this study. (LLM, conf=0.86)
Experimental — accuracy not yet measuredTogether with reports of preserved neutralization of SARS-CoV-2 with key B.1.1.7 and B.1.351 spike mutations and of pseudovirus with the full B.1.1.7 spike mutation set, our data indicate broad BNT162b2-elicited immune recognition.
“Together with recent reports of the preserved neutralization of SARS-CoV-2 with key S mutations found in the B.1.1.7 and the B.1.351lineage 39,40 , and neutralization of pseudovirus bearing the full set of mutations of B.1.1.7 S 41 , our data indicate broad BNT162b2-elicited immune recognition 2,13,14 .”
From BNT162b2 vaccine induces neutralizing antibodies and poly-specific T cells in humans (2021) · cites this paper as [14]
The Article section reports that BNT162b1 immune sera neutralized all 17 spike-variant pseudoviruses tested, supporting the general point that vaccination elicited broad recognition. This paper studied BNT162b1, however, not BNT162b2-elicited recognition; the B.1.1.7 and B.1.351 neutralization reports are cited separately in the sentence. (LLM, conf=0.86)
Experimental — accuracy not yet measuredTo allow comparison with previously reported data on BioNTech-Pfizer RNA COVID-19 vaccines, sera for S1- and RBD-binding IgG were analyzed as previously described.
“To enable the comparison of vaccine-induced S1-and RBD-binding IgG responses to previously reported data on the BioNTech-Pfizer RNA vaccines for COVID-19, sera were analysed as previously described 2,13,14 .”
From BNT162b2 vaccine induces neutralizing antibodies and poly-specific T cells in humans (2021) · cites this paper as [14]
The RBD-binding IgG assay section describes how the paper analysed participant sera for RBD-binding IgG, supporting the citation as a previously described method. The passages found do not describe an S1-binding IgG assay, so this source alone does not support that part of the sentence. (LLM, conf=0.86)
Experimental — accuracy not yet measuredThe CleanCap AG trinucleotide cap analog is used in the Pfizer-BioNTech vaccine.
“we also evaluated the translatability of three mRNAs harboring the CleanCap AG trinucleotide cap analog used in the Pfizer-BioNTech vaccine.37,38”
From Evaluation of synthetic mRNA with selected UTR sequences and alternative poly(A) tail, in vitro and in vivo (2025) · cites this paper as [38]
The Manufacturing of RNA section says the Pfizer–BioNTech vaccine candidate BNT162b1 used a TriLink trinucleotide cap 1 analogue with the stated chemical structure. The Article section says a different candidate, BNT162b2, was selected to advance to phase II/III. This paper therefore supports use of a trinucleotide cap in BNT162b1, but does not establish that the marketed Pfizer–BioNTech vaccine uses CleanCap AG; it also does not name the cap as CleanCap AG. (LLM, conf=0.88)
Experimental — accuracy not yet measuredAmong convalescent serum donors, geometric mean neutralizing titers were 90 for symptomatic infections (n=35), 156 for asymptomatic infections (n=3), and 618 for hospitalized individuals (n=1).
“GMTs in subgroups of the donors were as follows: symptomatic infections, 90 (n = 35); asymptomatic infections, 156 (n = 3); hospitalized, 618 (n = 1).”
From BNT162b2 vaccine induces neutralizing antibodies and poly-specific T cells in humans (2021) · cites this paper as [14]
To allow comparison with previously reported data on BioNTech-Pfizer RNA COVID-19 vaccines, sera for neutralizing titers were analyzed as previously described.
“To enable the comparison of vaccine-induced serum neutralizing titres to those previously reported for BioNTech-Pfizer RNA vaccines for COVID-19, sera were analysed as previously described 2,13,14 .”
From BNT162b2 vaccine induces neutralizing antibodies and poly-specific T cells in humans (2021) · cites this paper as [14]
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 [153]
Results from pseudovirus and authentic SARS-CoV-2 neutralization tests correlate very well.
“Although our assays are limited to pseudotyped viruses there is an excellent correlation between pseudotyped and authentic SARS-CoV-2 neutralization assays10.”
From mRNA vaccine-elicited antibodies to SARS-CoV-2 and circulating variants (2021) · cites this paper as [10]
Prior work reports that vaccination generates memory B cells and antibodies that neutralize SARS-CoV-2, including variants like B.1.351.
“Recent studies have documented strong memory B cell and antibody responses post-vaccination that neutralize SARS-CoV-2, including variants of concern (VOCs) such as B.1.351 (Beta) (Goel et al., 2021; Krammer et al., 2021; Sahin et al., 2020; Widge et al., 2021).”
From Rapid induction of antigen-specific CD4+ T cells is associated with coordinated humoral and cellular immunity to SARS-CoV-2 mRNA vaccination (2021) · cites this paper as Sahin et al., 2020
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 [177]
BNT162b2 and mRNA-1273 are composed of 1-methylpseudouridine-modified full-length spike mRNA, with proline substitutions, that is GC rich, codon optimized, and composed of standard mRNA components: cap, 5′ UTR, coding sequence, 3′ UTR, and a poly(A) tail.
“BNT162b2 (BioNTech/Pfizer) and mRNA-1273 (Moderna) are composed of 1-methylpseudouridine-modified full-length spike mRNA, with proline substitutions, that is GC rich, codon optimized, and composed of standard mRNA components: cap, 5′ UTR, coding sequence, 3′ UTR, and a poly(A) tail.”
From COVID-19 mRNA vaccines: Platforms and current developments (2022) · cites this paper as [92]
BNT162b1 induced 8-50-fold higher anti-RBD IgG than convalescent serum.
“8–50-fold higher anti-RBD IgG”
From mRNA vaccines for infectious diseases: principles, delivery and clinical translation (2021) · cites this paper as [27]
In phase I trials of BNT162b1 and BNT162b2, two 30 μg doses delivered 21 days apart induced high antibody and neutralizing titres and a robust CD4+ and CD8+ response with mild to moderate adverse events.
“In phase I trials of the two candidates, two 30 μg doses delivered 21 days apart induced high antibody and neutralizing titres and a robust CD4+ and CD8+ response with mild to moderate adverse events27,28,123,124.”
From mRNA vaccines for infectious diseases: principles, delivery and clinical translation (2021) · cites this paper as [27]
BNT162b1 induced 1.9-4.6-fold higher neutralization titres than convalescent serum.
“1.9–4.6-fold higher neutralization titres than convalescent serum27,123”
From mRNA vaccines for infectious diseases: principles, delivery and clinical translation (2021) · cites this paper as [27]
Antibody quantification was performed using a multiplexed Luminex assay as described previously and confirmed by ELISA.
“Titers of SARS-CoV-2 Spike and RBD IgG, IgA and IgM were quantified in participant sera (N=131), umbilical cord sera (N=10), and breastmilk (N=31) at baseline, 2nd vaccine dose, 2-6 weeks post 2nd vaccine, and delivery by Luminex, and confirmed by ELISA.”
From Coronavirus disease 2019 vaccine response in pregnant and lactating women: a cohort study (2021) · cites this paper as [12]
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- Authors
- Sahin, U., Muik, A., Derhovanessian, E., Vogler, I., Kranz, L. M., Vormehr, M., Baum, A., Pascal, K., Quandt, J., Maurus, D., Brachtendorf, S., Lörks, V., Sikorski, J., Hilker, R., Becker, D., Eller, A.-K., Grützner, J., Boesler, C., Rosenbaum, C., Kühnle, M.-C., Luxemburger, U., Kemmer-Brück, A., Langer, D., Bexon, M., Bolte, S., Karikó, K., Palanche, T., Fischer, B., Schultz, A., Shi, P.-Y., Fontes-Garfias, C., Perez, J. L., Swanson, K. A., Loschko, J., Scully, I. L., Cutler, M., Kalina, W., Kyratsous, C. A., Cooper, D., Dormitzer, P. R., Jansen, K. U., & Türeci, Ö.
- Affiliations
- BioNTech (Germany) (DE)
- Regeneron (United States) (US)
- Bexon Clinical Consulting (United States) (US)
- Clinical Research Services (DE)
- The University of Texas Medical Branch at Galveston (US)
- Pfizer (United States) (US)
- ORCID
- Sahin, Ugur
- Muik, Alexander
- Vogler, Isabel
- Kranz, Lena M.
- Vormehr, Mathias
- Baum, Alina
- Pascal, Kristen
- Quandt, Jasmin
- Maurus, Daniel
- Lörks, Verena
- Hilker, Rolf
- Becker, Dirk
- Boesler, Carsten
- Kühnle, Marie-Cristine
- Luxemburger, Ulrich
- Bexon, Martin
- Karikó, Katalin
- Shi, Pei-Yong
- Fontes-Garfias, Camila
- Swanson, Kena A.
- Scully, Ingrid L.
- Cutler, Mark
- Kyratsous, Christos A.
- Cooper, David
- Dormitzer, Philip R.
- Jansen, Kathrin U.
- Türeci, Özlem
- Venue
- Nature
- Published
- 2020-09-30
- Volume
- 586
- Issue
- 7830
- Pages
- 594-599
- ISSN
- 0028-0836 (ISSN-L)
- 1476-4687
- OpenAlex
- W3090844627
- Cited by
- 1,977
- References
- 13
- Citations by year
- 2026: 96 · 2025: 133 · 2024: 197 · 2023: 274 · 2022: 537 · 2021: 657 · 2020: 77
- FWCI
- 50.71
- Type
- journal article
- Language
- en
- Update notices
- correction (2021-01-19)
- Open access
- bronze
- doi.org
- Licence
- Locations
- Nature (publishedVersion)
- medRxiv (acceptedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- RePEc: Research Papers in Economics (submittedVersion)
- Funders
- Pfizer
- Regeneron Pharmaceuticals
- 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 › Immunology and Microbiology › Immunology › Immune responses and vaccinations
- Keywords
- COVID-19 vaccines, SARS-CoV-2, mRNA vaccines, lipid nanoparticle formulation, spike protein receptor-binding domain, neutralizing antibodies, T cell response, CD4+ T cells, CD8+ T cells, Th1 response, interferon-gamma, pseudovirus neutralization, immune response
- MeSH terms
- COVID-19, COVID-19 Vaccines, Adult, Antibodies, Viral, Female, Germany, Humans, Immunoglobulin G, Male, Middle Aged, Pneumonia, Viral, Viral Vaccines, Cytokines, Coronavirus Infections, CD8-Positive T-Lymphocytes, Th1 Cells, Young Adult, Antibodies, Neutralizing, Pandemics
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