The new coronavirus inactivated vaccine entered Phase II clinical trials today

new coronavirus inactivated vaccine developed by the Institute of Medical
Medical Biology (hereinafter referred to as the Institute of Medical
Biology) entered phase II clinical trials in Red River County, Yunnan Province on the afternoon of the 20th.
"In the current global epidemic is still serious and complex situation, our efforts for several months, for the global epidemic once again injected a dose of 'strong heart'!" "。 The head
Institute of Medicine and Biology told Science and Technology Daily.
Since the outbreak occurred in January this year, the first Sabin strain polio inactivated vaccine, enterovirus EV71 inactivated vaccine doctor
biological institute, according to the overall deployment of the CPC Central Committee,
, under the leadership of China's medical
, it is duty-bearable to undertake the task of epidemic prevention and control research, the establishment of emergency vaccine research and development team, in emergency vaccine research and development, animal model establishment, virus traceability and transmission mechanism research. Through comprehensive multidisciplinary forces to speed up scientific research, on the basis of adhering to scientific, to ensure safety to speed up the progress of vaccine research and development.
At the beginning of February this year, the Medical
Institute of Biology has started the process of virus isolation and breeding, and in the cell to adapt to generational culture, completed the screening and identification of vaccine production poisons, established a three-level seed bank and passed the China Food and Drug Inspection Research Institute. Using the resource advantages of "National Kunming High-Level Biosecurity Primate Research Center", a model of rhesus monkey animals for evaluation of vaccine safety and protection effectiveness was initially established.
March, a study on the pathogenic mechanism and immunology of SARS-CoV-2 infection was carried out, which laid a solid foundation for vaccine research and development, determined the key production process system of vaccine and the standard system of quality control, and completed the evaluation of the safety, immunogenicity and protection effect of vaccine in non-human primates.
Technology Daily reporter learned that on May 13, Medical
Biology received the "Drug Clinical Trial Approval" issued by the State Drug Administration, approved the implementation of phase I./II. clinical trials. On May 15, the phase I clinical study was officially launched at Huaxi Second Hospital of Sichuan University, using randomized, double-blind and placebo-controlled design, and gradually advancing according to the trial plan. Up to now, nearly 200 healthy adults aged 18 to 59 have been included in the group and phase I clinical trials have been successfully completed.
phase II. First population clinical study, officially launched on June 20, will further evaluate the immunogenicity and safety of vaccination in healthy populations and determine immunization procedures and doses. Phase II clinical studies are organized and implemented by the Vaccine Clinical Research Center of the Yunnan Provincial Center for Disease Control and Prevention, and the screening and selection work is initiated simultaneously at two research sites of the Center for Disease Control and Prevention in Mille City, Yunnan Province, and the Center for Disease Control and Prevention in the old city of Yunnan Province.
against the backdrop of a global pandemic of new crown pneumonia, vaccines are the best hope for an effective solution to the crisis. "As a national public welfare institution, medical
bio practice 'national team' mission, adhering to a rigorous and scientific attitude, relying on the national biosecurity major scientific and technological infrastructure support, make full use of the important technical reserves for major human infectious diseases, and steadily promote the clinical research of the new coronavirus inactivated vaccine." The official said they will do their utmost to provide safe, effective and controlled vaccines to the people at an early time and make new contributions to ensuring people's lives and health, maintaining national public health safety and jointly responding to the outbreak of new coronavirus pneumonia.
Previously, the research on the new coronavirus inactivated vaccine of the Medical
Biological Institute has achieved phased results, while actively carrying out clinical trials, the industrialization of the implementation of the work is also steadily advancing, the Kunming vaccine industry base planning and design with biosecurity protection GMP production workshop, for the industrialization of the new corona inactivated vaccine implementation, is expected to be put into use in the second half of 2020 to ensure the national emergency vaccine supply task.
Institute
has long been engaged in the development and production of viral vaccines. In 1957, gu Fangzhou, an older generation of scientists, was appointed to lead the research team to begin polio research. Medical
has developed and produced live polio vaccine and Sabin strain polio inactivated vaccine for national use, so that hundreds of thousands of children are protected from disability.
According to the Ministry of Science and Technology, health and health committee on June 19, China's scientific research team in accordance with inactivated vaccine, genetic engineering recombinant sub-unit vaccine, adenovirus vector vaccine, anti-virus virus vector vaccine and nucleic acid vaccine and other 5 technical routes, a total of 12 vaccine research and development tasks. At present, clinical trials have been conducted on one adenovirus vector vaccine and four inactivated vaccines, accounting for 40% of the total number of vaccines conducted in clinical trials worldwide.