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
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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.
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The incidence of grade 3 fever of ARCoV was similar to the trial results of another RBD-based mRNA vaccine, BNT162b1.
“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]
The Preliminary safety and tolerability data section (article pp. 1062–1070) reports grade 3 fever in BNT162b1 recipients, including 17% of younger and 8% of older participants at the 30 µg dose. The discussion identifies BNT162b1 as an RBD-encoding vaccine. This paper does not report ARCoV's grade 3 fever incidence, so it cannot establish that the two incidences were similar. (LLM, conf=0.86)
Experimental — accuracy not yet measuredIn phase 1 trials, mRNA-based vaccines (ARCoV, BNT162b1) and adenovirus-vector vaccines (ChAdOx1, Ad5 vectored COVID-19 vaccine) induced a strong T-helper-1-cell response in most participants.
“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]
The 'Vaccine-induced T cell responses' section reports significantly stronger BNT162b1-induced T-cell responses than placebo after the boost in both age groups (page not specified). But the study measured IFN-γ responses in bulk peripheral blood mononuclear cells; it does not establish that these were specifically T-helper-1-cell responses or that most individual participants had a strong response. This citation is attached to BNT162b1, not to the other vaccines listed. (LLM, conf=0.84)
Experimental — accuracy not yet measuredThe 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, one (8%) of 12 in Germany, and four (17%) of 24 in China, suggesting varying tolerability in different populations.
“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 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.
“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]
All five BioNTech/Pfizer COVID-19 mRNA vaccine candidates have entered clinical trials.
“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]
BioNTech and Pfizer collaborated to develop five COVID-19 mRNA vaccine candidates at the beginning of the pandemic, based on nucleoside-modified mRNA (BNT162b2, BNT162b1, BNT162b3), non-modified mRNA (BNT162a1) and self-amplifying mRNA (BNT162c2).
“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]
BNT162b1 had an 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 population.
“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]
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- 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
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