Development of an Inactivated Vaccine Candidate, BBIBP-CorV, with Potent Protection against SARS-CoV-2

Hui Wang; Yuntao Zhang; Baoying Huang; Wei Deng; Yaru Quan; Wenling Wang; Wenbo Xu; Yuxiu Zhao; Na Li; Jin Zhang; Hongyang Liang; Linlin Bao; Yanfeng Xu; Ling Ding; Weimin Zhou; Hong Gao; Jiangning Liu; Peihua Niu; Li Zhao; Wei Zhen; Hui Fu; Shouzhi Yu; Zhengli Zhang; Guangxue Xu; Changgui Li; Zhiyong Lou; Miao Xu; Chuan Qin; Guizhen Wu; George Fu Gao; Wenjie Tan; Xiaoming Yang

doi:10.1016/j.cell.2020.06.008

Development of an Inactivated Vaccine Candidate, BBIBP-CorV, with Potent Protection against SARS-CoV-2

Cell. 2020 Aug 6;182(3):713-721.e9. doi: 10.1016/j.cell.2020.06.008. Epub 2020 Jun 6.

Authors

Hui Wang¹, Yuntao Zhang¹, Baoying Huang², Wei Deng³, Yaru Quan⁴, Wenling Wang², Wenbo Xu², Yuxiu Zhao¹, Na Li¹, Jin Zhang¹, Hongyang Liang¹, Linlin Bao³, Yanfeng Xu³, Ling Ding¹, Weimin Zhou², Hong Gao³, Jiangning Liu³, Peihua Niu², Li Zhao², Wei Zhen², Hui Fu¹, Shouzhi Yu¹, Zhengli Zhang¹, Guangxue Xu⁵, Changgui Li⁶, Zhiyong Lou⁷, Miao Xu⁸, Chuan Qin⁹, Guizhen Wu¹⁰, George Fu Gao¹¹, Wenjie Tan¹², Xiaoming Yang¹³

Affiliations

¹ Beijing Institute of Biological Products Company Limited, Beijing, China.
² National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention (China CDC), Beijing, China.
³ National Animal Models for Human Diseases Resources Center, NHC Key Laboratory of Human Disease Comparative Medicine, Beijing Key Laboratory for Animal Models of Emerging and Remerging Infectious Diseases, Institute of Laboratory Animal Science, Chinese Academy of Medical Sciences and Comparative Medicine Center, Peking Union Medical College, Beijing, China.
⁴ National Institute for Food and Drug Control, Beijing, China.
⁵ MOE Key Laboratory of Protein Science & Collaborative Innovation Center of Biotherapy, School of Medicine, Tsinghua University, Beijing, China.
⁶ National Institute for Food and Drug Control, Beijing, China. Electronic address: changguili@aliyun.com.
⁷ MOE Key Laboratory of Protein Science & Collaborative Innovation Center of Biotherapy, School of Medicine, Tsinghua University, Beijing, China. Electronic address: louzy@mail.tsinghua.edu.cn.
⁸ National Institute for Food and Drug Control, Beijing, China. Electronic address: xumiaobj@126.com.
⁹ National Animal Models for Human Diseases Resources Center, NHC Key Laboratory of Human Disease Comparative Medicine, Beijing Key Laboratory for Animal Models of Emerging and Remerging Infectious Diseases, Institute of Laboratory Animal Science, Chinese Academy of Medical Sciences and Comparative Medicine Center, Peking Union Medical College, Beijing, China. Electronic address: qinchuan@pumc.edu.cn.
¹⁰ National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention (China CDC), Beijing, China. Electronic address: wugz@ivdc.chinacdc.cn.
¹¹ National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention (China CDC), Beijing, China. Electronic address: gaofu@chinacdc.cn.
¹² National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention (China CDC), Beijing, China. Electronic address: tanwj@ivdc.chinacdc.cn.
¹³ Beijing Institute of Biological Products Company Limited, Beijing, China. Electronic address: yangxiaoming@sinopharm.com.

Abstract

The coronavirus disease 2019 (COVID-19) pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) threatens global public health. The development of a vaccine is urgently needed for the prevention and control of COVID-19. Here, we report the pilot-scale production of an inactivated SARS-CoV-2 vaccine candidate (BBIBP-CorV) that induces high levels of neutralizing antibodies titers in mice, rats, guinea pigs, rabbits, and nonhuman primates (cynomolgus monkeys and rhesus macaques) to provide protection against SARS-CoV-2. Two-dose immunizations using 2 μg/dose of BBIBP-CorV provided highly efficient protection against SARS-CoV-2 intratracheal challenge in rhesus macaques, without detectable antibody-dependent enhancement of infection. In addition, BBIBP-CorV exhibits efficient productivity and good genetic stability for vaccine manufacture. These results support the further evaluation of BBIBP-CorV in a clinical trial.

Keywords: BBIBP-CorV; SARS-CoV-2; inactivated vaccine.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Animals
Antibodies, Neutralizing / immunology
Antibodies, Viral / immunology
Betacoronavirus / genetics
Betacoronavirus / immunology*
COVID-19
COVID-19 Vaccines
Chlorocebus aethiops
Coronavirus Infections / prevention & control*
Coronavirus Infections / virology
Disease Models, Animal
Drug Evaluation, Preclinical / methods*
Female
Guinea Pigs
Immunogenicity, Vaccine
Macaca fascicularis
Macaca mulatta
Male
Mice
Mice, Inbred BALB C
Pandemics / prevention & control*
Phylogeny
Pneumonia, Viral / prevention & control*
Pneumonia, Viral / virology
Rabbits
Rats
Rats, Wistar
SARS-CoV-2
Vaccines, Inactivated / adverse effects
Vaccines, Inactivated / therapeutic use*
Vero Cells
Viral Vaccines / adverse effects
Viral Vaccines / therapeutic use*

Substances

Antibodies, Neutralizing
Antibodies, Viral
COVID-19 Vaccines
Vaccines, Inactivated
Viral Vaccines