January 16, 2022

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COVID-19: China’s Recombinant Protein Vaccine in Phase 3 Trials

COVID-19: China’s Recombinant Protein Vaccine in Phase 3 Trials

COVID-19: China’s Recombinant Protein Vaccine in Phase 3 Trials.China’s COVID-19 virus recombinant protein subunit vaccine starts preparations for phase III clinical trials, and a total of 29,000 people are planned to be recruited worldwide.

COVID-19: China's Recombinant Protein Vaccine in Phase 3 Trials


Recently, the New Coronavirus recombinant protein subunit vaccine jointly developed by the Institute of Microbiology of the Chinese Academy of Sciences and Chongqing Zhifei Biological Products Co., Ltd. (Zhifei Biological) has begun part of the domestic phase III clinical trial in Xiangtan County, Xiangtan City, Hunan Province.

This clinical trial will be carried out in people 18 years of age and above. It will be a randomized, double-blind, placebo-controlled international multi-center clinical trial. A total of 29,000 people are planned to be recruited worldwide. This trial can be carried out mainly based on the randomized, double-blind, placebo-controlled phase I and II clinical trials that have been carried out in Beijing, Chongqing, and Hunan Province since June. On October 30, the vaccine successfully completed the unblinding of phase I/II clinical trials at the Institute of Microbiology, Chinese Academy of Sciences. The unblinding data showed that the clinical trial results were in line with expectations, and the vaccine showed good safety and immunogenicity.

This recombinant protein subunit vaccine was developed by the scientific research team of the Institute of Microbiology, Chinese Academy of Sciences and has independent intellectual property rights. At present, the Institute of Microbiology of the Chinese Academy of Sciences and Zhifei Biology are actively promoting the Phase III clinical trials of the vaccine in Uzbekistan, Indonesia, Pakistan, and Ecuador.

China’s COVID-19 vaccine production has entered the fast lane: annual production capacity may exceed 600 million doses by the end of the year

On December 2, Sun Chunlan, Vice Premier of the State Council, was investigating the preparations for the development and production of new coronavirus vaccines in Beijing and pointed out that it is necessary to continue scientifically and rigorously to advance the vaccine phase III clinical trials, and to prepare for mass production.

What is the annual production capacity of China’s COVID-19 vaccine? At present, a total of 5 vaccines in China are undergoing phase III clinical trials in accordance with procedures and standards, and all tasks for emergency use and production preparations are proceeding in an orderly manner. A reporter from the Health Times combed the production of these five COVID-19 vaccines and found that by the end of this year, China’s annual production capacity of COVID-19 vaccines may exceed 600 million doses.


SINOPHARM: By the end of the year, the production capacity may reach about 100 million doses

On November 6, Liu Jingzhen, Chairman of Sinopharm Group, revealed at the 3rd Hongqiao International Health Technology Innovation Forum that the construction of the two vaccine production plants has been completed. By the end of this year, the production capacity will reach about 100 million doses. According to national requirements, next year The production capacity should exceed 1 billion doses, “it will be guaranteed to be used by the Chinese people in particular next year.”


Kexing Bio: It can produce about 100 million doses by the end of this year

On October 20th, Gao Qiang, general manager of Beijing Kexing Zhongwei Biotechnology Co., Ltd., stated at a press conference held by the Joint Prevention and Control Mechanism of the State Council that Kexing Zhongwei had fully launched the production of the COVID-19 inactivated vaccine in August. According to the previous production results, the production capacity is about 300 million doses per year, and about 100 million doses of inactivated COVID-19 vaccine (including semi-finished products) can be produced by the end of this year.”

Cansino Bio: The planned production capacity of vaccine is 100~200 million doses

On July 30, Yu Xuefeng, Chairman of the Board of Directors of Cansino Bio, stated at the Science Innovation Board online roadshow that the company’s Phase III clinical trial of the COVID-19 vaccine is under preparation and the plan has not yet been finalized. The current planned production capacity of vaccines is 100 to 200 million doses, and the final annual production capacity depends on factors such as the dose and dosage of the final approved product.

Zhifei Bio: The annual production capacity can reach 300 million doses in the future

On September 29, Zhifei Biological issued the “Announcement on the Change of Pharmaceutical Production License for its Wholly-owned Subsidiary”. The wholly-owned subsidiary Zhifei Longkoma has the production conditions and qualifications for the recombinant new coronavirus vaccine (CHO cell). The developed COVID-19 vaccine has the conditions for industrialization. According to the Securities Times, the filling production line equipment of Zhifeilongkoma recombinant COVID-19 vaccine will begin its first trial operation. In the future, the three production lines will be able to guarantee a daily output of 800,000 doses and an annual production capacity of 300 million doses.

Official response: The annual production capacity may reach 610 million doses by the end of this year

Experts have also responded to the COVID-19 vaccine production capacity that the public has been concerned about. On October 20th, at a press conference held by the Joint Prevention and Control Mechanism of the State Council, Zheng Zhongwei, the leader of the Vaccine R&D Special Team of the Joint Prevention and Joint Control Mechanism of the State Council and Director of the Medical and Health Technology Development Research Center of the National Health Commission, said, ” It is estimated that by the end of this year, the annual production capacity of China’s COVID-19 vaccine will reach 610 million doses. Next year, the annual production capacity of China’s COVID-19 vaccine will be effectively expanded on this basis to effectively ensure the demand for China’s COVID-19 vaccine in China and other countries around the world.”