June 26, 2022

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Chinese COVID-19 Vaccine: Current Status and Product Capacity

Chinese COVID-19 Vaccine: Current Status and Product Capacity

Chinese COVID-19 Vaccine: Current Status and Product Capacity. What is the current progress of Chinese COVID-19 vaccine? How big is the production capacity?

According to Xinhua News Agency, Vice Premier Sun Chunlan and State Councilor Wang Yong were in Beijing on December 2 to investigate the preparations for the development and production of new coronavirus vaccines, and on-site visits to China Food and Drug Administration, Beijing Kexing Company, and Sinopharm Zhongsheng Beijing Company . Sun Chunlan pointed out in the survey that the next step is to prepare for large-scale production of the COVID-19 vaccine.

Chinese COVID-19 Vaccine: Current Status and Product Capacity

Up to now, 5 vaccines in China are undergoing phase III clinical trials, namely: China National Pharmaceutical Group’s “Zhongsheng Wuhan” and “Zhongsheng Beijing” inactivated vaccines, and Beijing Kexing Zhongwei Biotechnology Co., Ltd.’s inactivated vaccines. Live vaccines, the adenovirus vector vaccine developed by the Academy of Military Sciences in conjunction with Cansino, and the COVID-19 recombinant protein vaccine jointly developed by the Institute of Microbiology of the Chinese Academy of Sciences and Anhui Zhifeilongkema.

What is the current progress of Chinese vaccines? What is the R&D and production situation of each company, and can the supply be guaranteed? A reporter from Science and Technology Daily sorted out this.

Current Status of Chinese Vaccines

SINOPHARM Zhongsheng (2 vaccines):

“(The new coronavirus inactivated vaccine developed by Sinopharm Zhongsheng) has been vaccinated in Phase III clinical trials of 50,000 people so far. It should be said that the results will be available soon.” Yang Xiaoming, chairman of Sinopharm Group China Biotech, said recently, including After China approved the emergency use of vaccines, more than 600,000 people of inactivated vaccines from Sinopharm were used urgently. In terms of safety, there is currently no report of the phenomenon of ADE (enhancing the effect of antibody dependence, which will cause serious infections of vaccinators).

Kexing Zhongwei:

Kexing Holding Biotechnology Co., Ltd. Chairman Yin Weidong also said a few days ago that the COVID-19 vaccine Kellyf developed by Beijing Kexing Zhongwei Biotechnology Co., Ltd. is conducting Phase III clinical research in Brazil and is expected to complete the interim analysis in early December.

“We have selected excellent teams of scientists in different countries, followed closely the International Vaccine Phase III clinical specifications, and established a data monitoring committee without Chinese or sponsors, and they will make judgments on our future results. The judgment will be fair and scientific.” Yin Weidong said.

Kang Sino and the team of Academician Chen Wei of the Academy of Military Sciences:

“(Adenovirus vector COVID-19 vaccine) Phase III clinical trials have now enrolled more than 10,000 subjects.” Yu Xuefeng, chairman of Cansino Biological Co., Ltd., introduced that so far, no acute safety incident has been reported. Phase III clinical trials in Pakistan and other places started in September and are currently progressing smoothly.

Anhui Zhifeilong Kema and Institute of Microbiology, Chinese Academy of Sciences:

   Recombinant protein vaccine is a vaccine formed by high-level expression of viral proteins in engineered cells. The vaccine was approved for clinical trials on June 19, Phase I clinical trials were launched on June 23, Phase II clinical trials were launched on July 10, and Phase III clinical trials will be launched in many countries including Uzbekistan in November.

 

How about the production capacity

Previous reports showed that with the support of the Beijing Municipal Government, Sinopharm Zhongsheng took 60 days to build the Beijing COVID-19 Inactivated Vaccine Workshop and passed the on-site assessment by national biosafety experts; another COVID-19 Inactivated Vaccine Workshop located in Wuhan also Completed the expansion and transformation of vaccine production capacity.

According to Zhang Yuntao, vice president of Sinopharm Group China Biotechnology, the actual production capacity of the two workshops is expected to reach 300 million doses, and 100 million doses can be supplied by the end of this year. Sinopharm Zhongsheng is still expanding the production capacity of inactivated COVID-19 vaccines. The annual output of the second phase can reach 1 billion doses, and the total of the first phase and the second phase can reach 1.3 billion doses. The second phase is about 3 months to half a year (can be completed).

At the end of August, the new coronavirus vaccine production line of Kexing Zhongwei has been put into use after evaluation by experts and approval by relevant departments, and mass production has begun. Yin Weidong introduced that the capacity, output, and quality control of the production workshop are world-leading, with an annual production capacity of more than 300 million doses. In the future, it will consider increasing production according to market demand. 100 million doses can be produced by the end of this year.

Regarding the production capacity of adenovirus vector vaccines, Yu Xuefeng said in an interview with the media that the planned production capacity of the COVID-19 vaccine is 100 to 200 million doses. CanSino’s production capacity introduction leaflet also shows that its COVID-19 vaccine production plant is designed and constructed in accordance with China and international GMP requirements, has high-density continuous perfusion cell culture technology, and has an annual production capacity of 100 to 200 million doses.

Regarding the production capacity of recombinant protein vaccines, previous reports showed that based on the current production capacity, once approved, the annual production capacity of Zhifeilongkema’s recombinant subunit COVID-19 vaccine can reach 300 million doses and 150 million doses.

The head of recombinant protein vaccine research and development, Yan Jinghua, a researcher at the Institute of Microbiology of the Chinese Academy of Sciences, said in a report at the first China Health Science and Technology Innovation and Development Conference that the dimer design of the vaccine enables high antigen expression yields and does not require high-level biosafety The laboratory production workshop can realize large-scale industrial production.