Key Data from Phase III Clinical Trials of the Recombinant COVID-19 Vaccine (CHO Cell)

Chongqing Zhifei Biological Products Co., Ltd (“Zhifei” or “the Company”) and its wholly-owned subsidiary Anhui Zhifei Longcom Biopharmaceutical Co., Ltd (“Zhifei Longcom”) recently received key data from Phase III clinical trial of the Recombinant COVID-19 Vaccine (CHO Cell). The vaccine is developed by Zhifei Longcom in collaboration with the Institute of Microbiology, Chinese Academy of Sciences (IMCAS). Basic information and key data and conclusions are as follows:

 Basic Information

Vaccine Name: Recombinant COVID-19 Vaccine (CHO Cell)

Classification of Registration: Biological Products for Prevention, Class 1

Dosage form: Injection

Indication: For the prevention of COVID-19 infection

Clinical Approval Numbers: 2020L00023, 2020L00024

Technology Platform: Recombinant Protein Subunit

Collaborative Research and Development Unit: IMCAS

Key Data and Conclusions of Phase III Clinical Trial

The international Multi-Regional Phase III clinical trial of the vaccine has been carried out in Hunan Province (China), Uzbekistan, Indonesia, Pakistan and Ecuador since December 12, 2020. A total of 29,000 people aged 18 and above are planned to be enrolled and vaccinated with 3 doses of the vaccine according to the immunization schedule of 0, 1 and 2 month.
By the cutoff date of this data analysis, a total of 28,500 people were enrolled, including 14,251 subjects in the vaccine group and 14,249 subjects in the placebo group. A total of 221 cases were monitored at the primary endpoint after full vaccination, with an efficacy of 81.43%  against any severity of COVID-19. Among them, the efficacy against severe and above COVID-19  cases was 92.87%, and the efficacy against death cases was 100%.

Currently, genotyping of most of the primary endpoint cases has been completed. Preliminary analysis results shows that the efficacy against Alpha variant was 92.68%. The efficacy against Delta variant was 81.38%.

Key data from the completed Phase III clinical trial show that the Recombinant COVID-19 vaccine (CHO Cell) had good safety and vaccine efficacy in patients included in Per Protocol Set (PPS).