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Kexing Announces Phase 3 Clinical Trial Data of COVID-19 Vaccine Kellife
Kexing Announces Phase 3 Clinical Trial Data of COVID-19 Vaccine Kellife. According to news on February 5, Beijing Kexing Zhongwei Biotechnology Co., Ltd. (SINOVAC, hereinafter referred to as Kexing Zhongwei), a subsidiary of Kexing Holding Biotechnology Co., Ltd., has developed a new type of coronavirus inactivated vaccine Kerlaifu Phase III clinical trial Complete preliminary statistical analysis of research data. The relevant situation is announced as follows:
From July 21, 2020, Kexing Zhongwei has selected Brazil and Chile in South America, Indonesia in Southeast Asia, and Turkey in the Middle East to carry out Phase III clinical studies in four countries with different regions and characteristics. These studies used the same batch of vaccines (medium dose 600SU), followed the same immunization procedures (0, 14 procedures), and independently carried out in accordance with the requirements of the drug clinical trial quality management regulations (GCP), and the total number of enrollment reached 25,000.
Phase III clinical studies conducted in Brazil and Turkey respectively evaluated the protective efficacy of Kellyford in high-risk groups (medical staff receiving COVID-19 patients) and the general population. Both countries adopted multi-center, random, and A double-blind, placebo parallel control design, the primary endpoint is the incidence of new coronavirus-caused disease (COVID-19) 14 days after vaccination with 2 doses of vaccine or placebo.
As of December 16, 2020, a total of 12,396 subjects were enrolled in a Brazilian study of medical staff aged 18 and over, and 253 effective cases were obtained during the monitoring period. Following the procedure of 0, 14 days, 2 doses of vaccines have been vaccinated for 14 days. The protective effect is 50.65% against the disease caused by the new coronavirus (COVID-19), the protective effect is 83.70% for the cases requiring medical treatment, and the protection against hospitalization, severe and death cases The protective effect is 100.00%.
The target population of Turkey’s Phase III clinical trial is 18-59 years old at high-risk medical staff (K-1) and the general population at normal risk (K-2). As of December 23, 2020, K-1 cohort was tested 918 subjects were enrolled in the K-2 cohort, 6453 subjects were enrolled in the K-2 cohort, and a total of 7371 subjects were enrolled. Among them, 1322 subjects completed two doses and entered the 14-day observation period after the second dose. Based on the analysis of 29 cases, the protective efficacy against COVID-19 after 14 days of vaccination with two doses of vaccine in the 0,14 day program is 91.25%.
Based on the above results, Kexing Zhongwei has formally submitted a conditional listing application to the China National Medical Products Administration on February 3, 2021 and was accepted. The company will actively promote the registration and application of Kerlaifu in relevant countries and regions, with a view to contributing to the global prevention and control of the COVID-19 pneumonia epidemic and the availability and affordability of the global COVID-19 vaccine.
(source:internet, reference only)