4th COVID-19 vaccine was approved in China on March 14

4th COVID-19 vaccine was approved in China on March 14.  This recombinant novel coronavirus vaccine jointly developed by the Institute of Microbiology of the Chinese Academy of Sciences and Anhui Zhifei Longkoma Biopharmaceutical, a wholly-owned subsidiary of Zhifei Biology, has been approved for emergency use in China.

It is worth noting that this is also the first approved internationally. Clinically used recombinant subunit protein vaccine of new coronavirus. Affected by the news, the stock price of Zhifei Biology, a cooperative unit of the Institute of Microbiology of the Chinese Academy of Sciences, rose sharply on March 16. As of the close, Zhifei Biotech’s share price rose nearly 3%.

It is understood that this nCOVID-19 recombinant subunit protein vaccine was developed by the team of Gao Fu, an academician of the Institute of Microbiology of the Chinese Academy of Sciences, and has completed phase I and II clinical trials in October 2020.

The results showed that after the whole course of vaccination of the vaccine, no serious adverse reactions occurred, which conformed to the characteristics of small adverse reactions of subunit vaccines, and the level of neutralizing antibodies produced was equivalent to the current international recombinant protein vaccines and mRNA COVID-19 vaccines, reaching the international advanced level.

According to the current experimental design, this COVID-19 recombinant protein vaccine adopts three doses of vaccination, and the interval between each dose is 1 month.

Since then, the vaccine has started phase III clinical trials in China, Uzbekistan, Pakistan, Ecuador, and Indonesia, starting in November 2020, with 29,000 patients planned to be vaccinated. The current phase III clinical trials are progressing smoothly, especially since they have been highly recognized by Uzbekistan, the country where the first trial was initiated. Previously, Uzbek officials had stated that the first phase of the mass vaccination campaign would cover 4.1 million people.

Tan Yadi, Ph.D. in pharmacology, also said that compared with inactivated and adenovirus vector vaccines, Zhifei biological recombinant protein COVID-19 vaccine may have more potential to participate in global competition. The COVID-19 vaccines in European and American countries are mainly based on three technical routes: mRNA, recombinant and adenovirus vectors. Among them, recombinant vaccines show excellent technical performance, and clinical data are recognized by the medical community.

Despite the difficulty of research and development caused by differences in technical routes, Zhifei Biorecombinant COVID-19 vaccine research and development progress has lagged behind Sinopharm Zhongsheng, Kexing Zhongwei and Kangsino. However, the vaccine also has unique advantages.

According to reports, the research and development of the new coronavirus recombinant protein subunit vaccine is mainly for the development of vaccines against the receptor binding domain (RBD region) on the S protein of the new coronavirus. The production process of recombinant protein vaccine is relatively simple. It does not need to inactivate the intact virus. It only needs to recombinantly express effective antigen fragments in vitro. Therefore, it can be produced in a general-level biosafety laboratory, which significantly reduces the production cost of the vaccine and has a large production capacity. , Storage and transportation are more convenient.

It is worth noting that the vaccine requires 3 injections, which also puts forward higher requirements on the production capacity of Zhifei. As early as March of this year, Zhifei Biological issued an announcement stating that the company has the production conditions and qualifications for the COVID-19 vaccine. Public information shows that Zhifeilongkoma’s current production capacity is 300 million doses. Because of the 3-injection method, it is equivalent to meeting 100 million people’s vaccination.

According to vaccine expert Tao Lina, the bottleneck of the inactivation technology route lies in the original solution, and it is not easy to expand production. The bottleneck of Zhifeilongkoma lies in the sub-assembly link. As long as other vaccine production lines are modified, the production capacity can be easily increased. According to data disclosed by the Institute of Microbiology, Chinese Academy of Sciences, the vaccine’s production capacity can reach 1 billion doses by the end of this year.

Up to now, China has approved 4 COVID-19 vaccines for the market, including 3 COVID-19inactivated vaccines and 1 adenovirus vector vaccine. They are 2 types of Sinopharm Group, 1 type of inactivated vaccines from Beijing Kexing, and 1 type of adenovirus vector vaccine, jointly developed by the team of Kang Xinuo and Academician Chen Wei. Data show that as of March 14, China had received 64.98 million vaccinations against the new coronavirus.

(source:internet, reference only)

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