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Original title: Who are the tens of thousands of people in Beijing who receive the new domestically made corona vaccine?
Source: China Economic Weekly
“China Economic Weekly” reporter Jia Xuan | live report of the Services Fair
The ultimate solution to the new coronary pneumonia vaccine, here it comes!
In the public health and epidemic prevention zone of the Trade and Services Fair, three inactivated vaccines of national production for the new crown were exhibited collectively. Two of them are from China Biotechnology Co., Ltd. (hereinafter China Biotechnology), and one is from Kexing Holding Biotechnology Co., Ltd. (hereinafter, Kexing Bio). All three domestic vaccines are reported to have entered the phase III clinical stage.
What stage is the development of the new national corona vaccine headed? Who was vaccinated beforehand? How effective is the vaccine? With these questions in mind, a reporter from China Economic Weekly interviewed Yin Weidong, Chairman, Chairman and CEO of Kexing Biotech, on the site of the services fair.
Ten thousand people in Beijing have been vaccinated against the new crown
“Today, tens of thousands of people in Beijing should have been vaccinated with Kexing Biotech’s new crown vaccine,” said Yin Weidong.
A few days ago, Zheng Zhongwei, director of the Science and Technology Development Center of the National Health Commission and leader of the vaccine research and development team of the Joint Prevention and Control Mechanism of the State Council, said that China has officially launched the emergency use of the new corona vaccine on July 22. Beijing is the first city to launch an emergency vaccination program.
The “Vaccine Administration Act” clearly stipulates that when a particularly important public health event occurs, the National Health Commission will submit an application for the use of emergency vaccines, and the State Food and Drug Administration will organize experts to discuss and agree, and the National Health Commission will establish a certain scope and time limit. Emergency use of vaccines.
Who in Beijing has priority to receive the new crown vaccine?
According to Yin Weidong, there are four main categories of people who have been vaccinated against the new crown. The first category is people related to abroad and key populations who need to go abroad for business; the second category is high-risk populations that will be exposed to the epidemic at work, such as diseases. “Traffic personnel in the control center”; the third category is medical personnel, such as doctors and nurses in fever clinics; Fourth category is related personnel in vaccine research and development and vaccine production companies. “I myself was vaccinated,” Yin Weidong said.
What is the process for prioritizing the new corona vaccine?
“Everyone must sign an informed consent form before vaccination, understand that this vaccine is in clinical research phase III and inform you of the possible risks, and then vaccination can be done after consent,” Yin Weidong said.
It is understood that the new corona vaccine needs to be vaccinated twice, one injection each time.
According to a relevant vaccinator from a core company overseas project, he revealed to China Economic Weekly that after vaccination, he had to measure and report his body temperature every day and there was no physical abnormality.
How is the blind trial phase III clinical trial conducted?
According to Yin Weidong, the protective effect after vaccination must be considered from two aspects.
“Safety is an indicator, if there is fever, what are the adverse reactions, etc., this is safety. The other is effectiveness, which is if antibodies are produced after vaccination.” Yin Weidong said that in phase I and II clinical trials, almost all vaccines all developed antibodies and there were no serious adverse reactions.
It is worth noting that the results of Phase I and II clinical studies show that the vaccine has good safety and immunogenicity, that is, a higher neutralizing antibody titer is produced, but how high a neutralizing antibody titer can prevent the new coronavirus infection. It remains to be answered by phase III clinical studies.
Kexing Biotechnology’s phase III clinical study was launched in Brazil on August 11, and the expected number of inoculations was between 9,000 and 13,000, currently underway. Once the efficacy of the vaccine is demonstrated, the product will be registered in Brazil for use in the prevention and control of the epidemic in Brazil and the Americas.
Speaking about why he chose Brazil for phase III clinical research, Yin Weidong said: “Brazil has a severe epidemic, a large population and a larger market in the future.” Countries and regions such as Indonesia, Turkey and Bangladesh are also huge potential markets for the export of new corona vaccines produced in the country. “In the future, we will fully cooperate with the countries and regions where we are located, not only supplying vaccine products, but also expanding vaccine production capacity through technology transfer.”
How is the phase III clinical study performed?
Yin Weidong further explained that among the 13,000 volunteers, 50% received the vaccine and 50% received a placebo (the placebo contains no effective ingredients and the others are the same as the vaccine). The injections will be numbered in advance. The vaccinators do not know if they are given the vaccine or the placebo and will return to normal life after vaccination.
If there are 100 cases in a certain period of time, the vaccination of these cases was blinded and it is necessary to “take off” at this time. If these 100 cases all appear in the placebo group, the protective effect of the vaccine is 100%. If there are 80 confirmed cases in the placebo group and 20 in the vaccine group, the protective effect is 80%.
Vaccine price prediction: different order sizes at different prices, set at a level of 100 yuan
According to Yin Weidong, the current moment for the vaccine to be finally commercialized depends on the results of phase III clinical trials in Brazil. “If it goes well, it should be available in November or December.”
Regarding the price of vaccines, Yin Weidong said that due to different buyers and different scales of purchase, the price will eventually fluctuate to some extent. “One is national contracting, which must be bulky and the price will be lower; the other is corporate contracting, which is also in bulk, but not as big as the first, and the price is higher; the last is a personal order Because the quantity is relatively small, the price is definitely the highest of these three purchasing methods. ” But the final price, Yin Weidong said, will be at the level of one hundred yuan, not more than one thousand yuan.
Kexing Company reportedly launched the new coronavirus-inactivated vaccine industrialization project in late March 2020, completed preliminary construction procedures in 25 days, and completed construction of the new corona vaccine production workshop and its ancillary facilities in 100 days, forming an annual production of 300 million doses. Above capacity. At the end of August 2020, this new COVID-19 vaccine production line was put into operation after being evaluated by experts and approved by the relevant departments and mass production started.
“In other words, after the results of the third phase of the trial are published, our new corona vaccine can be mass-produced immediately after the corresponding approval by the state,” Yin Weidong said.
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