China firm goes global with vaccine trial
China’s inactivated COVID-19 vaccine candidate has started its phase-3 clinical trial globally in the United Arab Emirates, according to the vaccine developer China National Biotec Group.
The clinical trial was officially initiated after a cooperation agreement was signed on Tuesday, during a videoconference jointly held in Beijing, Wuhan and Abu Dhabi, the company said, adding that it is the first time that China’s self-developed vaccine has carried out phase-3 clinical research internationally.
The CNBG will cooperate with Group 42 (G42), an Abu Dhabi-based artificial intelligence and cloud computing company, for the clinical trial. They will also cooperate in the localized production of the vaccine.
The inactivated vaccine developed by the Wuhan Institute of Biological Products under the CNBG completed its phase 1 and 2 clinical trials in China.
The results showed a good safety record and no severe adverse reactions were found in clinical trials, and vaccine receivers inoculated with two injections in different procedures and doses have all produced high titers of antibodies. For those receiving two injections at an interval of 28 days, the seroconversion rate of neutralizing antibodies reached 100 percent.
Another inactivated COVID-19 vaccine developed by the CNBG’s Beijing Institute of Biological Products has also entered into clinical trials.
To increase its manufacturing capacity, the company has built a large production unit in Beijing that can meet high bio-safety protection requirements. The unit will be able to produce 120 million doses of vaccine per year once mass production begins. Another vaccine production facility in Wuhan is expected to produce 100 million doses after completion.
The clinical research of vaccines is usually divided into three phases. Phase-1 clinical trials mainly evaluate the safety and phase-2 clinical trials evaluate the safety and immunogenicity of the vaccine, as well as the immunization procedures. Phase-3 clinical trials evaluate the safety and efficacy of the vaccine in a larger population.
Liu Jingzhen, chairman of Sinopharm which the CNBG is affiliated to, said the company will accelerate international cooperation in clinical trials and maintain close communication with the World Health Organization.