The world's first international clinical trial (Phase III) of the new crown inactivated vaccine officially launched

On June 23, the launch ceremony of China Pharmaceutical Group China Bionew Crown Inactivated Vaccine (Phase III) United Arab Emirates was held simultaneously by video conference in Beijing, Wuhan, And Abu Dhabi, United Arab EmiratesAt the ceremony, China and Afghanistan signed a relevant clinical cooperation agreement on the spot, marking the world's first new crown inactivated vaccine international clinical trial (Phase III) officially launchedThis is the implementation of President Xi Jinping's speech to the World Health Assembly on "China's new crown vaccine research and development completed and put into use, will be the global public product, to achieve the accessibility and affordability of vaccines in developing countries to make China's contribution" important speech spirit of the stage results, China's original vaccine for the first time in the international phase III clinical research, China's new crown vaccine overseas to carry out the first clinical trial, opened a new chapter of international cooperation, for the early use of the vaccine, for the benefit of mankind, a key stepOn April 12, the new crown inactivated vaccine developed by the Wuhan Biological Products Research Institute in China was the world's first to enter Phase I/II clinical trialsOn April 27,, a new crown inactivated vaccine developed by the China Biological Beijing Biological Products Research Institute also entered Phase I/II clinical trialsA total of 2,240 people were enrolled in phase I/II clinical studies of both vaccinesOn June 16,, the phase i/II clinical trial of Wuhan Institute of Biological Products revealed the results of the phase blinding results: after vaccination safety is good, no serious adverse reactionsAfter different procedures and different doses, the vaccinators in the vaccine group produced high titer antibodiesAfter two doses of the program in 0,28 days, the neutralizing antibody impotence rate reached 100%phase I/II clinical trial results from the Beijing Institute of Biological Products will be released on June 28before, the National Pharmaceutical Group of the four-level enterprise party and government principals, including 180 volunteers took the lead in oculated the new crown inactivated vaccine, volunteer human pre-test showed that the subject antibody has fully reached the level of resistance to the new coronavirus, the protection rate of 100%;While promoting vaccine research and development, SINGroup China Bio is promoting the construction of high-grade bio-safe production facilities at a wartime rateOn April 15th, the Beijing Institute of Biological Products completed the country's first and only high-grade bio-safe production facility, and the new crown vaccine production capacity will reach 120 million doses per yearWuhan Institute of Biological Products, high-grade bio-safe production facilities after the completion of the annual production capacity of up to 100 million dosesClinical studies are usually divided into three phasesIssue I mainly evaluates securityPhase II mainly evaluates vaccine safety and immunogenicity, while exploring immune proceduresPhase III evaluates the safety and effectiveness of vaccines primarily in a larger populationIn view of the effective control of the domestic epidemic, do not have The conditions of Phase III clinical trials, The Pharmaceutical Group of China Biology in a solid domestic I/II clinical trialats at the same time, actively promote phase III clinical overseas cooperation, with a number of countries signed a framework agreement of cooperation with relevant institutionsLiu Jingxuan, chairman of The National Pharmaceutical Group, said that the next step, Chinese biology will be in accordance with the clinical research program, to do a good job in the United Arab Emirates International Clinical (Phase III) trial workSimultaneously accelerate international clinical cooperation with other countries and regionsStrengthen close communication with the World Health Organization, implement the WHO Solidarity Programme, prepare for emergency pre-certification of new crown vaccines, ensure that the vaccine completes clinical trials, and strive to market it at home and abroad as soon as possible, to ensure vaccine availability and affordability.