Evidence map›Paper›PMID 36120090›Full record

ArticleThe Lancet regional health. Western Pacific2022

Immunogenicity and safety of BNT162b2 mRNA vaccine in Chinese adults: A phase 2 randomised clinical trial.

Ai-Min Hui, Jingxin Li, Li Zhu, Rong Tang, Huayue Ye, Mei Lin, Lei Ge, Xiyuan Wang, Fuzhong Peng, Zhenggang Wu and 22 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in The Lancet regional health. Western Pacific, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04649021 (Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine), which is not on this map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
1.6field-weighted citation impact, top 15% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04649021 phase2completednot on this map

Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine (BNT162b2) in Chinese Healthy Population: A Phase II, Randomized, Placebo-controlled, Observer-blinded Study

TypeinterventionalSponsorBioNTech SERan2020 to 2022Enrolled960ConditionsSARS-CoV-2ArmsBNT162b2, Placebo
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 16 citations in OpenAlex.

  1. Trial
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  3. Observational
  4. Article
  5. Article
  6. A novel and safe SmartCapFrontiers in immunology · 2025
    Article
  7. Review
  8. Article
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  11. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

32 authors at 6 institutions in 3 countries.

Ai-Min HuiFosun Pharma, Boston, MA, USA.
Jingxin LiNHC Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Centre for Disease Control and Prevention, Nanjing, China.
Li ZhuTaizhou People's Hospital, Taizhou, China.
Rong TangNHC Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Centre for Disease Control and Prevention, Nanjing, China.
Huayue YeTaizhou Vaccine Clinical Research Centre, Taizhou, China.
Mei LinTaizhou People's Hospital, Taizhou, China.
Lei GeFosun Pharma, Beijing, China.
Xiyuan WangFosun Pharma, Shanghai, China.
Fuzhong PengTaizhou Vaccine Clinical Research Centre, Taizhou, China.
Zhenggang WuTaizhou People's Hospital, Taizhou, China.
Xiling GuoNHC Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Centre for Disease Control and Prevention, Nanjing, China.
Yunfeng ShiNHC Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Centre for Disease Control and Prevention, Nanjing, China.
Hongxing PanNHC Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Centre for Disease Control and Prevention, Nanjing, China.
Jiahong ZhuLianshui Center for Disease Control and Prevention, Lianshui, China.
Zhizhou SongLianshui Center for Disease Control and Prevention, Lianshui, China.
Jingjun QiuFosun Pharma, Beijing, China.
Wei WangFosun Pharma, Beijing, China.
Jianfei ZhengFosun Pharma, Beijing, China.
Orkun OzhelvaciBioNTech, Mainz, Germany.
Svetlana ShpyroBioNTech, Mainz, Germany.
Meghan BushwayBioNTech, Cambridge, MA, USA.
Evelyna DerhovanessianBioNTech, Mainz, Germany.
Marie-Cristine KühnleBioNTech, Mainz, Germany.
Ulrich LuxemburgerBioNTech, Mainz, Germany.
Alexander MuikBioNTech, Mainz, Germany.
Yoana ShishkovaBioNTech, Mainz, Germany.
Zakaria KhondkerBioNTech, Cambridge, MA, USA.
Simin HuBioNTech, Cambridge, MA, USA.
Eleni LagkadinouBioNTech, Mainz, Germany.
Uğur ŞahinBioNTech, Mainz, Germany.
Özlem TüreciBioNTech, Mainz, Germany.
Fengcai ZhuNHC Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Centre for Disease Control and Prevention, Nanjing, China.
BioNTech (Germany) · DEJiangsu Provincial Center for Disease Control and Prevention · CNFosun Pharma (China) · CNBioNTech (United States) · USNantong University · CNWenzhou Medical University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: BNT162b2, an mRNA vaccine against COVID-19, is being utilised worldwide, but immunogenicity and safety data in Chinese individuals are limited. Methods: This phase 2, randomised, double-blind, placebo-controlled trial included healthy or medically stable individuals aged 18-85 years enrolled at two clinical sites in China. Participants were stratified by age (≤55 or >55 years) and randomly assigned (3:1) by an independent randomisation professional to receive two doses of intramuscular BNT162b2 30 μg or placebo, administered 21 days apart. Study participants, study personnel, investigators, statisticians, and the sponsor's study management team were blinded to treatment assignment. Primary immunogenicity endpoints were the geometric mean titers (GMTs) of neutralising antibodies to live severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and seroconversion rates (SCR) 1 month after the second dose. Safety assessments included reactogenicity within 14 days of vaccination, adverse events (AEs), and clinical laboratory parameters. Randomised participants who received at least one dose were included in the efficacy and safety analyses on a complete case basis (incomplete/missing data not imputed). Results up to 6 months after the second dose are reported. Findings: Overall, 959 participants (all of Han ethnicity) who were recruited between December 5th, 2020 and January 9th, 2021 received at least one injection (BNT162b2, Interpretation: BNT162b2 vaccination induced a robust immune response with acceptable tolerability in Han Chinese adults. However, follow-up duration was relatively short and COVID-19 rates were not assessed. Safety data collection is continuing until 12 months after the second dose. Funding: BioNTech - sponsored the trial. Shanghai Fosun Pharmaceutical Development Inc. (Fosun Pharma) - conducted the trial, funded medical writing. ClinicalTrialsgov registration number: NCT04649021. Trial status: Completed.

Indexed as

BNT162b2 mRNA vaccineCOVID-19Intramuscular injectionMessenger RNANeutralising antibodiesSARS-CoV-2Vaccination

Identifiers

PMID36120090
PMCPMC9472569
OpenAlexW4295812202

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.