An employee handles trial vaccine samples at a COVID-19 vaccine production base of Sinopharm in Beijing. [Photo/Xinhua]
The world's first inactivated vaccine has shown a 100 percent antibody positive conversion rate, with all subjects producing antibodies according to the latest clinical results from its producer.
China National Biotech Group Co Ltd, Sinopharm's vaccine and bioscience unit, announced on Tuesday the phase-1 and phase-2 clinical trials of its inactivated vaccine had demonstrated good performance in safety and effectiveness on vaccinated volunteers. No subjects showed serious adverse reactions, the company said.
The company said a total of 1,120 volunteers were vaccinated during the phase-1 and phase-2 clinical trials, all of whom produced high-titer antibodies. In the 18-to-59-year-old age group, those who got two doses of vaccine based on the 0-and-28-day procedure demonstrated 100 percent antibody positive conversion rate, while those who got two doses based on the 0-and-14-day procedure and 0-and-21-day procedure showed a 97.6 percent antibody positive conversion rate.
Industry experts said the results were the world's first clinical data on safety and effectiveness collected after two doses of vaccination, offering scientific and measurable support for epidemic prevention and control and emergency use.
Chen Qiaoshan, a medical analyst at Beijing-based market consultancy Analysys, said: "The results of the phase-1 and phase-2 clinical trials of the inactivated vaccine were encouraging. However, the phase-3 clinical trial is critical to the research and development of the vaccine."
According to CNBG, there are a total of three phases of clinical trials, and the company is actively promoting international cooperation on the final stage. It has received cooperation overtures from companies and institutions overseas. Once the inactivated vaccine completes the three trials, it is expected to hit the market by the end of this year or the beginning of next year.
On April 24, CNBG launched phase-2 human trials of its first inactivated vaccine, which was codeveloped by the Wuhan Institute of Biological Products and the Wuhan Institute of Virology under the Chinese Academy of Sciences.
The product, which was approval for clinical trials on April 12, was the first inactivated vaccine worldwide to reach such a developed approval stage. The National Medical Products Administration authorized its phase-1 and phase-2 human trials at the same time that day through a fast-track channel based on solid results from preclinical trial studies.