Sunshine News On May 4, the team of Academician Gao Fu from the Institute of Microbiology of the Chinese Academy of Sciences officially published the results of the recombinant new coronavirus protein vaccine jointly developed with Anhui Zhifeilongkoma Biopharmaceutical Co., Ltd.

Sunshine News (Reporter Zheng Yalei) On May 4, The Institute of Microbiology of the Chinese Academy of Sciences Academician Gao Fu's team officially published the drug jointly developed with Anhui Zhifeilong Kema Biopharmaceutical Co., Ltd. in the top international medical academic journal "New England Journal of Medicine" Phase III clinical trial results of the recombinant novel coronavirus protein vaccine (CHO cell ) (trade name: Zhikweide®). Research shows that the vaccine has good safety and effectiveness. The vaccine can still maintain high protective efficacy six months after being fully vaccinated, and has good durability of immune protection.

The phase III international multi-center clinical trial of the recombinant novel coronavirus protein vaccine (CHO cells) was conducted simultaneously in 31 clinical centers in 24 countries and 1 domestic clinical trial. The center recruited a total of 28,904 subjects over the age of 18, of which 6.4% were elderly people over the age of 60. Its effectiveness and safety were analyzed using randomized, double-blind and placebo-controlled methods.

clinical results show that after the subjects completed the full course of vaccination, the protective efficacy of the vaccine in preventing new coronavirus pneumonia of any severity reached 81.4% (95% CI, 73.3~87.3), and the protective efficacy in severe-critical cases reached 92.9% (95% CI, 52.4 to 99.8); the protective efficacy against deaths reached 100%; among people aged 18 to 59 years, the protective efficacy of the vaccine was 81.2% (95% CI, 72.8 to 87.3); among those over 60 years old In the population, the protective efficacy of the vaccine was 87.6% (95% CI, 2.5 to 99.7). The vaccine has a protection rate of 81.4% (95% CI, 70.1-88.9) against the Delta variant and 92.7% (95% CI, 70.9-99.2) against the Alpha variant.

In the long-term effectiveness analysis 6 months after full vaccination (as of December 15, 2021), the protective efficacy of the vaccine in preventing new coronavirus pneumonia of any severity can still reach 75.7% (95% CI, 71.0~79.8), The protective efficacy against severe-critical cases reached 87.6% (95% CI, 70.6-95.7); the protective efficacy against death cases reached 86.5% (95% CI, 38.9-98.5). The protection rate against the Delta variant was 76.1% (95% CI, 70.0-81.2), and the protection rate against the Alpha variant was 88.3% (95% CI, 66.8-97.0). In terms of the safety of

, the Phase III clinical trial evaluated the safety of the vaccine in tens of thousands of people, and the results showed that the vaccine is safe. The incidence rates of adverse events, and serious adverse events were similar between the vaccine group and the placebo group. There were no vaccine-related deaths. The vast majority (98.5%) of the adverse reactions were mild (grade 1 or 2). Elderly people over 60 years old The adverse event rate is lower and can be cured without treatment or after symptomatic treatment.

The recombinant new coronavirus protein vaccine (CHO cells) was jointly developed by the Institute of Microbiology of the Chinese Academy of Sciences Academician Gao Fu's team and Anhui Zhifei Longkema, a wholly-owned subsidiary of Zhifei Biotech. The vaccine was registered and launched in Uzbekistan on March 1, 2021. It is the first new coronavirus recombinant protein vaccine registered and launched in the world. It was approved for emergency use in China on March 10, 2021; it was approved by the country on February 19, 2022. As a sequential booster vaccine for the new coronavirus inactivated vaccine; it was approved by the state for conditional marketing on March 1, 2022.

Dr. Wang Yuge, who has been engaged in virus research and antiviral drug/vaccine development in the United States, commented on this extremely important article: This is the first domestic vaccine clinical trial published in the world's top medical journal NEJM since the epidemic. Article (Previous clinical trials of Sinopharm, Sinovac and CanSino vaccines were not published on NEJM). Therefore, this vaccine clinical trial study is an important progress in the development of domestic vaccines. In this large three-dose clinical trial of ZF2001, the vaccine showed good protection, which was encouraging data, so the NEJM accepted the study. The recombinant protein vaccine has many advantages, including large output, high protection, good safety, and easy storage. Therefore, this result has guiding significance for China and other countries in formulating vaccination plans.

Editor: Mag