The DOI matches its Crossref record; 26 of the 26 references it cites were found in a registry or an index.
Safety and immunogenicity of the SARS-CoV-2 BNT162b1 mRNA vaccine in younger and older Chinese adults: a randomized, placebo-controlled, double-blind phase 1 study
Open accessPublished version of a preprint
Abstract
An effective vaccine is needed to end the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic. Here, we assess the preliminary safety, tolerability and immunogenicity data from an ongoing single-center (in Jiangsu province, China), parallel-group, double-blind phase 1 trial of the vaccine candidate BNT162b1 in 144 healthy SARS-CoV-2-naive Chinese participants. These participants are randomized 1:1:1 to receive prime and boost vaccinations of 10 µg or 30 µg BNT162b1 or placebo, given 21 d apart, with equal allocation of younger (aged 18-55 years) and older adults (aged 65-85 years) to each treatment group (ChiCTR2000034825). BNT162b1 encodes the SARS-CoV-2 spike glycoprotein receptor-binding domain (RBD) and is one of several messenger RNA-based vaccine candidates under clinical investigation. Local reactions and systemic events were generally dose dependent, transient and mild to moderate. Fever was the only grade 3 adverse event. BNT162b1 induced robust interferon-γ T cell responses to a peptide pool including the RBD in both younger and older Chinese adults, and geometric mean neutralizing titers reached 2.1-fold (for younger participants) and 1.3-fold (for the older participants) that of a panel of COVID-19 convalescent human sera obtained at least 14 d after positive SARS-CoV-2 polymerase chain reaction test. In summary, BNT162b1 has an acceptable safety profile and produces high levels of humoral and T cell responses in an Asian population.
Overview
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Integrity signals
Registry
Cites
Statistics
Verification
Claims the paper makes
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
The source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“In a randomized phase I study on BNT162b1 in younger (18-55 years) and older adults (65-85 years), virus neutralization was lower in the older age group 22 days after the first dose 20 .”
From Age-related immune response heterogeneity to SARS-CoV-2 vaccine BNT162b2 (2021) · cites this paper as [20]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“Thus, the incidence of grade 3 fever of ARCoV was similar to the trial results of another RBD-based mRNA vaccine, BNT162b1.16”
From Safety and immunogenicity of the SARS-CoV-2 ARCoV mRNA vaccine in Chinese adults: a randomised, double-blind, placebo-controlled, phase 1 trial (2022) · cites this paper as [16]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“In phase 1 trials, mRNA-based vaccines (ARCoV, BNT162b1)16 and adenovirus-vector vaccines (ChAdOx1,25 Ad5 vectored COVID-19 vaccine)26 induced a strong T-helper-1-cell response in most participants.”
From Safety and immunogenicity of the SARS-CoV-2 ARCoV mRNA vaccine in Chinese adults: a randomised, double-blind, placebo-controlled, phase 1 trial (2022) · cites this paper as [16]
Experimental — accuracy not yet measuredThe cited source says what the claim attributes to it.
In the citing paper
“The incidence of grade 3 fever of BNT162b1 varied significantly in the same 30 μg group in adults aged 18–55 years, with none (0%) of 12 in the USA,17 one (8%) of 12 in Germany,18 and four (17%) of 24 in China,16 suggesting varying tolerability in different populations.”
From Safety and immunogenicity of the SARS-CoV-2 ARCoV mRNA vaccine in Chinese adults: a randomised, double-blind, placebo-controlled, phase 1 trial (2022) · cites this paper as [16]
In the citing paper
“Till now, all of these candidates have entered clinical trials (Table 5).130,376,377”
From Advances in COVID-19 mRNA vaccine development (2022) · cites this paper as [377]
In the citing paper
“BioNTech and Pfizer collaborated to develop five COVID-19 mRNA vaccine candidates at the beginning of the pandemic, which were based on nucleoside-modified mRNA (BNT162b2, BNT162b1, BNT162b3), non-modified mRNA (BNT162a1) and self-amplifying mRNA (BNT162c2).”
From Advances in COVID-19 mRNA vaccine development (2022) · cites this paper as [377]
In the citing paper
“acceptable safety profile and high levels of humoral and T cell responses in younger (ages 18–55 years) and older adults (ages 65–85 years) in an Asian population83”
From COVID-19 mRNA vaccines: Platforms and current developments (2022) · cites this paper as [83]
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
The self-check needs the paper’s full text.
Citations
Cites
Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China
Huang, C., Wang, Y., Li, X., Ren, L., Zhao, J., Hu, Y., Zhang, L., Fan, G., Xu, J., Gu, X., et al. (2020) · The Lancet · doi:10.1016/s0140-6736(20)30183-5 · Cited by 48,884
Cryo-EM structure of the 2019-nCoV spike in the prefusion conformation
Wrapp, D., Wang, N., Corbett, K. S., Goldsmith, J. A., Hsieh, C.-L., Abiona, O., Graham, B. S., & McLellan, J. S. (2020) · Science · doi:10.1126/science.abb2507 · Cited by 8,897
Structure of the SARS-CoV-2 spike receptor-binding domain bound to the ACE2 receptor
Lan, J., Ge, J., Yu, J., Shan, S., Zhou, H., Fan, S., Zhang, Q., Shi, X., Wang, Q., Zhang, L., et al. (2020) · Nature · doi:10.1038/s41586-020-2180-5 · Cited by 5,983
An mRNA Vaccine against SARS-CoV-2 — Preliminary Report
Jackson, L. A., Anderson, E. J., Rouphael, N. G., Roberts, P. C., Makhene, M., Coler, R. N., McCullough, M. P., Chappell, J. D., Denison, M. R., Stevens, L. J., et al. (2020) · New England Journal of Medicine · doi:10.1056/nejmoa2022483 · Cited by 3,237
RNA-Based COVID-19 Vaccine BNT162b2 Selected for a Pivotal Efficacy Study
Walsh, E. E., Frenck, R., Falsey, A. R., Kitchin, N., Absalon, J., Gurtman, A., Lockhart, S., Neuzil, K., Mulligan, M. J., Bailey, R., et al. (2020) · doi:10.1101/2020.08.17.20176651 · Cited by 2,615
Self-citationmRNA-based therapeutics--developing a new class of drugs
Sahin, U., Karikó, K., & Türeci, Ö. (2014) · Nature Reviews Drug Discovery · doi:10.1038/nrd4278 · Cited by 2,474
Self-citationCOVID-19 vaccine BNT162b1 elicits human antibody and TH1 T cell responses
Sahin, U., Muik, A., Derhovanessian, E., Vogler, I., Kranz, L. M., Vormehr, M., Baum, A., Pascal, K., Quandt, J., Maurus, D., et al. (2020) · Nature · doi:10.1038/s41586-020-2814-7 · Cited by 1,977
Self-citationKarikó, K., Muramatsu, H., Welsh, F. A., Ludwig, J., Kato, H., Akira, S., & Weissman, D. (2008) · Molecular Therapy · doi:10.1038/mt.2008.200 · Cited by 1,930
SARS-CoV-2 mRNA Vaccine Design Enabled by Prototype Pathogen Preparedness
Corbett, K. S., Edwards, D. K., Leist, S. R., Abiona, O. M., Boyoglu-Barnum, S., Gillespie, R. A., Himansu, S., Schäfer, A., Ziwawo, C. T., DiPiazza, A. T., et al. (2020) · Nature · doi:10.1038/s41586-020-2622-0 · Cited by 1,615
Mulligan, M. J., Lyke, K. E., Kitchin, N., Absalon, J., Gurtman, A., Lockhart, S., Neuzil, K., Raabe, V., Bailey, R., Swanson, K. A., et al. (2020) · doi:10.1101/2020.06.30.20142570 · Cited by 1,569
Self-citation
Research works printed but not linked: 2
- Walsh, E. E. et al. Safety and immunogenicity of two RNA-based Covid-19 vaccine candidates. N. Engl. J. Med. 383, 2439–2450 (2020). · DOI · Paper page
- Mulligan, M. J. et al. Phase I/II study of COVID-19 RNA vaccine BNT162b1 in adults. Nature 586, 589–593 (2020). · DOI · Paper page
Cited by
Sorted by citations
Items 101–133 of 133
Tachycardia following Pfizer-BioNTech COVID-19 vaccine
Martins‐Filho, P. R. (2022) · Enfermedades Infecciosas y Microbiología Clínica · doi:10.1016/j.eimc.2022.06.001 · Cited by 4
Gu, Y., Shunmuganathan, B. D. O., Qian, X., Gupta, R., Tan, R. S. W., Kozma, M., Purushotorman, K., Murali, T. M., Tan, N. Y. J., Preiser, P. R., et al. (2022) · medRxiv · doi:10.1101/2022.03.06.22271809 · Cited by 4
Heendeniya, S. N., Chen, S., Bhatti, S. H., Zahra, Q. U. A., Rahimizadeh, K., Poudel, B. H., Wilton, S. D., & Veedu, R. N. (2025) · Experimental Biology and Medicine · doi:10.3389/ebm.2025.10784 · Cited by 3
Side Effects Related to BNT162b2 and CoronaVac Vaccine Requiring Emergency Department Visit
Yavuz, E., Turgut, K., Gülaçtı, U., Aydın, İ., Ozcan, O., SÖNMEZ, C., & Arslan, E. (2022) · Avicenna Journal of Medicine · doi:10.1055/s-0042-1750391 · Cited by 4
Tummolo, A., Dicintio, A., Paterno, G., Carella, R., Melpignano, L., & Giovanni, D. D. (2022) · International Journal of Environmental Research and Public Health · doi:10.3390/ijerph191912227 · Cited by 3
Review of current vaccine development platform to prevent coronavirus disease
Arif, K., Malhotra, S., Mohammad, S., Fatima, S., Farooqui, S., & Saleem, M. (2022) · National Journal of Maxillofacial Surgery · doi:10.4103/njms.njms_454_21 · Cited by 3
Competent immune responses to SARS-CoV-2 variants in older adults following mRNA vaccinationPreprint
Jergović, M., Uhrlaub, J. L., Watanabe, M., Bradshaw, C. M., White, L. M., LaFleur, B., Edwards, T., Sprissler, R. S., Worobey, M., Bhattacharya, D., et al. (2021) · bioRxiv (Cold Spring Harbor Laboratory) · doi:10.1101/2021.07.22.453287 · Cited by 3
Pimenta, P. D. C., Lima, T. C. D. A., Geraldine, V. G. S., Tourinho, F. S., do Nascimento, M. C., Novaes, R. D., & Paranaiba, L. M. R. (2025) · American Journal of Health Promotion · doi:10.1177/08901171251365229 · Cited by 5
mRNA-encoding CD19-targeting T cell engager for refractory immune thrombocytopenia
Wang, M., Liu, T., Dai, Q., Teng, J., Wu, Y., Jia, J., Meng, J., Ma, Y., Shi, H., Cheng, X., et al. (2026) · Cell · doi:10.1016/j.cell.2026.08.039 · Cited by 2
Chavan, P., Dey, R., Castelino, R., Kamble, A., Poladia, P., Bagal, R., Jadhav, M., Shirsat, A., Chavan, A., Dhumal, S. B., et al. (2023) · Drug Metabolism and Personalized Therapy · doi:10.1515/dmpt-2022-0150 · Cited by 2
Capturing adaptive immunity against SARS-CoV-2 in patients with cancer
Luxenburger, H., & Thimme, R. (2021) · Nature Cancer · doi:10.1038/s43018-021-00298-2 · Cited by 2
Tan, A. T., Lim, J. M. E., Bert, N. L., Kunasegaran, K., Chia, A., Qui, M., Tan, N., Chia, W. N., de Alwis, R., Ying, D., et al. (2021) · bioRxiv (Cold Spring Harbor Laboratory) · doi:10.1101/2021.06.29.450293 · Cited by 2
Immunogenicity and Safety of BNT162b2 mRNA Vaccine in Chinese Adults: A Randomized Clinical TrialPreprint
Hui, A., Li, J., Zhu, L., Tang, R., Ye, H., Lin, M., Ge, L., Wang, X., Peng, F., Wu, Z., et al. (2022) · SSRN Electronic Journal · doi:10.2139/ssrn.4114061 · Cited by 2
Self-citationSoegiarto, G., Fajar, J. K., Wulandari, L., Anshory, M., Ilmawan, M., Asmiragani, A., Illiyana, H., Adam, A., Lamadi, S., Sa'adah, U., et al. (2022) · F1000Research · doi:10.12688/f1000research.110281.1 · Cited by 1
Liu, Y., Li, N., Jiang, W., & Geng, Q. (2023) · PubMed Central · doi:10.3779/j.issn.1009-3419.2023.102.02 · Cited by 1
Hannawi, S., Zhang, R., Abuquta, A., Eldin, L. S., Hassan, A., Alamadi, A., Hossain, T., Mostafa, M., Ghoneim, Y., Solo, J., et al. (2023) · Clinical and Translational Medicine · doi:10.1002/ctm2.1387 · Cited by 1
González-Sánchez, Ó. A., Zaldívar, D., Cuevas, E., & González-Ortiz, L. J. (2024) · Vaccines · doi:10.3390/vaccines12010081 · Cited by 1
Roh, G., Lee, J., Park, H., Kwak, W., Park, H., Oh, A., Na, Y., Ha, D., Lee, Y., Bae, S., et al. (2025) · Animal Cells and Systems · doi:10.1080/19768354.2025.2510984 · Cited by 1
COVID-19: VARIANTS, VACCINES, AND ADVERSE REACTIONS
Jolly, A. M., WILSON, S. K., & Thomas, J. (2022) · Innovare Journal of Medical Sciences · doi:10.22159/ijms.2022.v10i3.44723 · Cited by 1
Demaret, J., Corroyer-Simovic, B., Alidjinou, E. K., Goffard, A., Trauet, J., Miczek, S., Vuotto, F., Dendooven, A., Huvent‐Grelle, D., Podvin, J., et al. (2021) · bioRxiv (Cold Spring Harbor Laboratory) · doi:10.1101/2021.07.08.451426 · Cited by 1
Yang, B., Huang, X., Gao, H., Leung, N., Tsang, T. K., & Cowling, B. J. (2022) · Research Square · doi:10.21203/rs.3.rs-1571821/v2 · Cited by 1
Tachycardia following Pfizer-BioNTech COVID-19 vaccine
Martins‐Filho, P. R. (2023) · Enfermedades infecciosas y microbiologia clinica (English ed ) · doi:10.1016/j.eimce.2022.11.013 · Cited by 1
Safety of Pfizer-BioNTech COVID-19 mRNA Vaccine in the ElderlyPreprint
Korzeniowska, K. A., Cieślewicz, A. R., Grabańska-Martyńska, K., & Jabłecka, A. (2021) · Research Square · doi:10.21203/rs.3.rs-1042964/v1
Rubber cast of stomach produced by latex ingestion.
Said, M. Y., & Kay, G. T. (1973) · PubMed
Safety and Immunogenicity of SARS-Cov-2 Vaccine MVC-COV1901– Do Elderly Need a Higher Dose?Preprint
Lien, C.-E., Waits, A., Chen, J., Cheng, W.-H., Yeh, J., Hsieh, S., Chen, C., Janssen, R. S., & Lin, T. (2022) · Research Square · doi:10.21203/rs.3.rs-1850379/v1
Yang, B., Huang, X., Gao, H., Leung, N., Tsang, T. K., & Cowling, B. J. (2022) · Research Square · doi:10.21203/rs.3.rs-1571821/v1
[Progress on the development of the SARS-CoV-2 vaccine and antibody drugs].
Xu, S.-Y., & Tang, D. (2022) · PubMed Central · doi:10.7507/1001-5515.202207063
Razu, M. H., Ahmed, Z. B., Hossain, M. I., Rabby, M. R. I., Akter, F., Karmaker, P., Khan, M. R., Moniruzzaman, M., & Khan, M. (2022) · Heliyon · doi:10.1016/j.heliyon.2023.e17767
Avaliação da resposta imunológica contra SARS-CoV-2 em grupos de risco vacinados com CoronaVac
de Medeiros, G. X. (2023) · Digital Library of Theses and Dissertations (Universidade de São Paulo) · doi:10.11606/t.5.2023.tde-24042024-170719
Identification of novel genetic biomarkers for ChAdOx1 nCoV-19 mediated immunogenicity
Chou, W., Chang, C., Ting, J., Lin, M., Liao, H.-N., Chou, Y.-C., Wei, C.-Y., Chi, H.-H., Ho, S.-Y., Luo, W.-T., et al. (2025) · Frontiers in Immunology · doi:10.3389/fimmu.2025.1622122
Self-citationLi, Y., Wang, L., Ma, J., Geng, W., & Wang, Y. (2025) · Vaccines · doi:10.3390/vaccines13111107
Conformational bias in SARS-CoV-2 Spike CD4+ T-cell epitope dominance
Landry, S. J., Steede, N. K., Tiomkin, Y., Smith, H., Mettu, R. R., Gragert, L. A., Aberle, J. H., Zwezdaryk, K. J., Zheng, C., Kolls, J. K., et al. (2026) · Frontiers in Immunology · doi:10.3389/fimmu.2026.1857103
Wu, H., Weng, R., Gu, S., Wang, J., Ma, X., Li, J., Tie, X., Huang, C., & Chen, K. (2026) · Frontiers in Immunology · doi:10.3389/fimmu.2026.1916788
Self-citation
Metadata
- Authors
- Li, J., Hui, A., Zhang, X., Yang, Y., Tang, R., Ye, H., Ji, R., Lin, M., Zhu, Z., Türeci, Ö., Lagkadinou, E., Jia, S., Pan, H., Peng, F., Ma, Z., Wu, Z., Guo, X., Shi, Y., Muik, A., Şahin, U., Zhu, L., & Zhu, F.
- Affiliations
- Jiangsu Provincial Center for Disease Control and Prevention (CN)
- Fosun Pharma (China) (CN)
- Army Medical University (CN)
- The Affiliated Taizhou People's Hospital of Nanjing Medical University (CN)
- BioNTech (Germany) (DE)
- Corresponding author
- Zhu, Li
- Zhu, Fengcai
- ORCID
- Venue
- Nature Medicine
- Published
- 2021-04-22
- Volume
- 27
- Issue
- 6
- Pages
- 1062-1070
- ISSN
- 1078-8956 (ISSN-L)
- 1546-170X
- OpenAlex
- W3154648093
- Cited by
- 133
- References
- 25
- Citations by year
- 2026: 4 · 2025: 7 · 2024: 7 · 2023: 16 · 2022: 65 · 2021: 33
- FWCI
- 9.60
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Nature Medicine (publishedVersion)
- Research Square (acceptedVersion, cc-by)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Infectious Diseases › SARS-CoV-2 and COVID-19 Research
- Health Sciences › Medicine › Infectious Diseases › COVID-19 Clinical Research Studies
- Life Sciences › Immunology and Microbiology › Immunology › Immune responses and vaccinations
- Keywords
- mRNA vaccines, SARS-CoV-2, COVID-19 vaccines, vaccine safety, immunogenicity, older adults, young adults, spike protein receptor-binding domain, neutralizing antibodies, dose comparison, adverse events, Chinese adults
- MeSH terms
- COVID-19, SARS-CoV-2, COVID-19 Vaccines, mRNA Vaccines, BNT162 Vaccine, Adolescent, Adult, Aged, Aged, 80 and over, Antibodies, Viral, China, Female, Humans, Male, Middle Aged, RNA, Messenger, Vaccines, Synthetic, Young Adult, Antibodies, Neutralizing, Pandemics, Spike Glycoprotein, Coronavirus
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 ›
Are you an author, or do you see a problem with this page? Request a review
