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Immunogenicity and Safety of BNT162b2 mRNA Vaccine in Chinese Adults: A Randomized Clinical Trial

35 Pages Posted: 19 May 2022

See all articles by Ai-Min Hui

Ai-Min Hui

Fosun Pharma (USA)

Jing-Xin Li

Jiangsu Provincial Center for Disease Control and Prevention - NHC Key Laboratory of Enteric Pathogenic Microbiology

Li Zhu

Taizhou People’s Hospital

Rong Tang

Jiangsu Provincial Center for Disease Control and Prevention - NHC Key Laboratory of Enteric Pathogenic Microbiology

Huayue Ye

Taizhou Vaccine Clinical Research Center

Mei Lin

Taizhou People’s Hospital

Lei Ge

Fosun Pharma (China)

Xiyuan Wang

Fosun Pharma (China)

Fuzhong Peng

Taizhou Vaccine Clinical Research Center

Zhenggang Wu

Taizhou People’s Hospital

Xi-Ling Guo

Jiangsu Provincial Center for Disease Control and Prevention - NHC Key Laboratory of Enteric Pathogenic Microbiology

Yunfeng Shi

Jiangsu Provincial Center for Disease Control and Prevention - NHC Key Laboratory of Enteric Pathogenic Microbiology

Hong-Xing Pan

Jiangsu Provincial Center for Disease Control and Prevention - NHC Key Laboratory of Enteric Pathogenic Microbiology

Jiahong Zhu

Lianshui Center for Disease Control and Prevention

Zhizhou Song

Lianshui Center for Disease Control and Prevention

Jingjun Qiu

Fosun Pharma (China)

Wei Wang

Fosun Pharma (China)

Jianfei Zheng

Fosun Pharma (China)

Orkun Ozhelvaci

BioNTech (Germany)

Svetlana Shpyro

BioNTech (Germany)

Meghan Bushway

BioNTech (USA)

Evelyna Derhovanessian

Fosun Pharma (China)

Marie-Cristine Kühnle

BioNTech (Germany)

Ulrich Luxemburger

BioNTech (Germany)

Alexander Muik

BioNTech (Germany)

Yoana Shishkova

BioNTech (Germany)

Zakaria Khondker

BioNTech (USA)

Simin Hu

BioNTech (USA)

Eleni Lagkadinou

BioNTech (Germany)

Uğur Şahin

BioNTech (Germany)

Özlem Türeci

BioNTech (Germany)

Feng-Cai Zhu

Jiangsu Provincial Center for Disease Control and Prevention - NHC Key Laboratory of Enteric Pathogenic Microbiology

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Abstract

Background: BNT162b2, an mRNA vaccine against COVID-19, is being utilized worldwide, but immunogenicity and safety data in Chinese individuals are limited.

Methods: In this trial in healthy or medically stable individuals across two clinical sites in China aged 18–85 years, participants were stratified by age (≤55 or >55 years) and randomly assigned (3:1) by an independent randomization 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 neutralizing antibodies to live severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and seroconversion rates (SCR) one month after the second dose. Safety assessments included reactogenicity within 14 days of vaccination, adverse events, and clinical laboratory parameters. Randomized participants who received at least one dose were included in the immunogenicity and safety analyses on a complete case basis (incomplete/missing data not imputed). Results up to one month after the second dose are reported.

Findings: Overall, 959 participants received at least one injection (BNT162b2, n=720; placebo, n=239), recruited between Dec 5th, 2020 and Jan 9th, 2021. The 50% neutralizing GMT was 294·4 (95% CI; 281·1-308·4) in the BNT162b2 group and 5 in the placebo group. SCRs were 99·7% (95% CI; 99%-100%) and 0·8% (95% CI; 0·1%-3·0%) respectively (p<0·001 vs placebo). BNT162b2-elicited sera neutralized SARS-CoV-2 variants of concern. T-cell responses were detected in 58/73 (79·5%) BNT162b2 recipients. Reactogenicity was mild or moderate in severity and resolved within a few days after onset. There were no vaccine-related serious adverse events and unsolicited AEs were uncommon.

Interpretation: BNT162b2 vaccination induced a robust immune response and was well tolerated Chinese adults. However, follow-up duration was short and COVID-19 rates were not assessed. Safety data collection is continuing until 12 months after the second dose.

Trial Registration Details: ClinicalTrials.gov registration number: NCT04649021

Funding Information: BioNTech was the trial sponsor, and Shanghai Fosun Pharmaceutical Development Inc. (Fosun Pharma) conducted the trial, funded medical writing.

Declaration of Interests: U.S. and Ö.T. are management board members and employees at BioNTech SE. E.D., M.K., E.L., U.L., A.M., O.O., S.S., and Y. Shishkova are employees at BioNTech SE. M.B., S.H., and Z.K. are employees at BioNTech US. U.S., Ö.T., and A.M. are inventors on patents and patent applications related to RNA technology and COVID-19 vaccines. M.B., E.D., S.H., M.K., Z.K., E.L., U.L., A.M., O.O., S.S., U.S., and Ö.T. hold securities from BioNTech SE. A.H., L.G., X.W., J.Q., W.W., and J. Zheng, are employees of Fosun Pharma. J.L., L.Z., R.T., H.Y., M.L., F.P., Z.W., X.G., Y.S., H.P., J. Zhu, Z.S., F.Z. declare they have no conflicts of interests.

Ethics Approval Statement: The trial protocol was approved by the Institutional Review Board of the Jiangsu Provincial Center for Disease Control and Prevention (Jiangsu, China). The trial was conducted in compliance with the ethical requirements in the Declaration of Helsinki,9 the Good Clinical Practice guidelines from the International Council for Harmonization, and Chinese laws and regulations related to clinical studies. All participants provided written informed consent.

Keywords: BNT162b2 mRNA vaccine, COVID-19, intramuscular injection, messenger RNA, neutralizing antibodies, SARS-CoV-2, vaccination

Suggested Citation

Hui, Ai-Min and Li, Jing-Xin and Zhu, Li and Tang, Rong and Ye, Huayue and Lin, Mei and Ge, Lei and Wang, Xiyuan and Peng, Fuzhong and Wu, Zhenggang and Guo, Xi-Ling and Shi, Yunfeng and Pan, Hong-Xing and Zhu, Jiahong and Song, Zhizhou and Qiu, Jingjun and Wang, Wei and Zheng, Jianfei and Ozhelvaci, Orkun and Shpyro, Svetlana and Bushway, Meghan and Derhovanessian, Evelyna and Kühnle, Marie-Cristine and Luxemburger, Ulrich and Muik, Alexander and Shishkova, Yoana and Khondker, Zakaria and Hu, Simin and Lagkadinou, Eleni and Şahin, Uğur and Türeci, Özlem and Zhu, Feng-Cai, Immunogenicity and Safety of BNT162b2 mRNA Vaccine in Chinese Adults: A Randomized Clinical Trial. Available at SSRN: https://ssrn.com/abstract=4114061 or http://dx.doi.org/10.2139/ssrn.4114061

Ai-Min Hui (Contact Author)

Fosun Pharma (USA) ( email )

United States

Jing-Xin Li

Jiangsu Provincial Center for Disease Control and Prevention - NHC Key Laboratory of Enteric Pathogenic Microbiology ( email )

Li Zhu

Taizhou People’s Hospital ( email )

Rong Tang

Jiangsu Provincial Center for Disease Control and Prevention - NHC Key Laboratory of Enteric Pathogenic Microbiology ( email )

Huayue Ye

Taizhou Vaccine Clinical Research Center ( email )

China

Mei Lin

Taizhou People’s Hospital ( email )

Lei Ge

Fosun Pharma (China) ( email )

China

Xiyuan Wang

Fosun Pharma (China) ( email )

Fuzhong Peng

Taizhou Vaccine Clinical Research Center ( email )

Zhenggang Wu

Taizhou People’s Hospital ( email )

Xi-Ling Guo

Jiangsu Provincial Center for Disease Control and Prevention - NHC Key Laboratory of Enteric Pathogenic Microbiology ( email )

Nanjing
China

Yunfeng Shi

Jiangsu Provincial Center for Disease Control and Prevention - NHC Key Laboratory of Enteric Pathogenic Microbiology ( email )

Hong-Xing Pan

Jiangsu Provincial Center for Disease Control and Prevention - NHC Key Laboratory of Enteric Pathogenic Microbiology ( email )

Nanjing
China

Jiahong Zhu

Lianshui Center for Disease Control and Prevention ( email )

China

Zhizhou Song

Lianshui Center for Disease Control and Prevention ( email )

China

Jingjun Qiu

Fosun Pharma (China) ( email )

Wei Wang

Fosun Pharma (China) ( email )

Jianfei Zheng

Fosun Pharma (China) ( email )

Orkun Ozhelvaci

BioNTech (Germany) ( email )

Svetlana Shpyro

BioNTech (Germany) ( email )

Meghan Bushway

BioNTech (USA) ( email )

United States

Evelyna Derhovanessian

Fosun Pharma (China) ( email )

Marie-Cristine Kühnle

BioNTech (Germany) ( email )

Germany

Ulrich Luxemburger

BioNTech (Germany) ( email )

Alexander Muik

BioNTech (Germany) ( email )

Yoana Shishkova

BioNTech (Germany) ( email )

Zakaria Khondker

BioNTech (USA) ( email )

Simin Hu

BioNTech (USA) ( email )

Eleni Lagkadinou

BioNTech (Germany) ( email )

Uğur Şahin

BioNTech (Germany) ( email )

Özlem Türeci

BioNTech (Germany) ( email )

Feng-Cai Zhu

Jiangsu Provincial Center for Disease Control and Prevention - NHC Key Laboratory of Enteric Pathogenic Microbiology ( email )

Nanjing
China