China has 4 new coronavirus vaccines entering phase III trials
The person in charge of the relevant department said that he is racing against time to promote the vaccine to be launched.
On September 25, the State Council Information Office held a briefing to introduce the progress of the new coronavirus vaccine work. When will the vaccine be available? What is the production capacity? Who can get the vaccine first? These questions are all answered.
11 vaccines have been tested
According to Wu Yuanbin, Director of the Department of Social Development and Science and Technology of the Ministry of Science and Technology, my country’s scientific research team deployed vaccine tasks at the beginning of the epidemic and deployed inactivated vaccines, recombinant protein vaccines, adenovirus vector vaccines, and attenuated influenza virus vector vaccines. Parallel development with 5 technical routes of nucleic acid vaccines. “At present, every technical route has vaccines that have entered the clinical research phase, and 11 vaccines have been in clinical trials, of which 4 vaccines have entered phase III clinical trials. Recombinant protein vaccines, nucleic acid vaccines and attenuated influenza virus vector vaccines are stepping up Carry out Phase I and Phase II clinical trials." Wu Yuanbin said.
Wu Yuanbin said that the four vaccines that have entered phase III clinical trials are currently progressing smoothly, of which three are inactivated vaccines and one is adenovirus vector vaccine. my country's vaccine companies have signed cooperation agreements with institutions in many countries to jointly implement Phase III clinical trials on the basis of compliance with laws and regulations.
Will there be adverse reactions after the new coronavirus vaccination? According to Wang Junzhi, the deputy head of the expert group of the vaccine research and development team of the scientific research group and academician of the Chinese Academy of Engineering, from the information currently available, no ADE phenomenon (a serious adverse reaction) related to the new crown virus vaccine has been found; from the first and second phases According to the results of clinical trials, it is basically a mildly acceptable adverse reaction.
"Any kind of vaccine will produce certain adverse reactions in the clinical stage and large-scale use after the market." Wang Junzhi introduced that the new coronavirus vaccine, as a brand new vaccine, will treat adverse reactions in the first, second, and third phases of clinical trials. The monitoring as an important indicator of safety evaluation. According to the completed Phase I and Phase II clinical results data, they are basically mild adverse reactions. Therefore, the vaccine can successfully enter Phase III clinical trials after completing Phase II clinical trials.
The speed of progress is affected by many factors
“At present, there are 11 new coronavirus vaccines in my country that are in the process of clinical trials. They have not yet obtained marketing authorization and have not been used for vaccination in the general population.” said Yang Sheng, deputy director of the Drug Registration Management Department of the State Drug Administration.
He said that the new crown virus vaccine is used to prevent new crown virus infection in healthy people, and its safety and effectiveness must meet relevant standards. Therefore, it is necessary to complete pre-clinical research, phase I and phase II clinical studies before marketing, and to prove that the corresponding protective effect is achieved through phase III clinical trials, and prove that the safety and effectiveness of the vaccine meet the set standards. It is also necessary to complete commercial-scale production process verification, establish controllable quality standards, and prove that the proposed vaccine has acceptable safety, clear effectiveness, and quality controllability.
As far as phase III clinical trials are concerned, the speed of its progress is affected by many factors, such as the number of subjects, the speed of enrolling subjects, the speed of acquiring infection cases among subjects, and the specific results of the trial.
"We will adhere to the principles of complying with laws and regulations, ensuring safety and effectiveness, and adopting special tasks, optimizing processes, seamless connection, going all out, racing against time, and promoting my country's new crown virus vaccine as soon as possible." Yang Sheng said.
"An answer to the exact protective power of a certain new coronavirus vaccine can only be reached after completing Phase III clinical trials. So far, no R&D team in the world has completed all Phase III clinical trials, and China has entered Phase III. The first echelon of clinical trials, but we also need to be patient." said Zeng Guang, chief epidemiologist of the Chinese Center for Disease Control and Prevention.
Annual vaccine production capacity can reach 610 million doses
According to Zheng Zhongwei, the leader of the vaccine research and development team of the scientific research team and director of the National Health and Health Commission's Medical Science and Technology Development Center, my country has made a careful layout of vaccine production management. Based on current estimates, it is estimated that by the end of this year, my country's annual production capacity of new coronavirus vaccines will reach 610 million doses; by next year, my country's annual production capacity for new coronavirus vaccines will reach 1 billion doses.
Regarding the public concern about the price of the new coronavirus vaccine, Zheng Zhongwei said that the new coronavirus vaccine has the attributes of a public product. Since it is a public product, it must be accessible and affordable. "We will definitely propose a guide price for the new crown vaccine within a range acceptable to the public."
After the vaccines are on the market in the future, who can give priority to vaccination? Zheng Zhongwei said that after the vaccine is launched, vaccinations will be arranged in the order of high-risk groups, high-risk groups, and the general population.
High-risk groups refer to front-line medical and epidemic prevention personnel, border port workers, urban operation guarantee personnel, large-scale agricultural and sideline products and frozen food market workers, and other public place workers; high-risk groups include the elderly, pregnant women, children, People with underlying diseases; others are the general population.