Chen Wei academician team new crown vaccine patented a vaccine from research and development to the market in a few steps?

As of the beginning of this month, more than 165 vaccines were under study worldwide, 27 of which were in human clinical trials and 6 were in clinical phase III, according to the World Health Organization (WHO). BEIJING, Aug. 17
Xinhua Sun Lujin) According to china Voice News Evening Peak, china's main radio and television station, a new crown vaccine patent application jointly filed by Chen Wei of the Institute of Bioengineering of the Institute of Military Medicine of the Academy of Military Sciences and Consino Bio has been granted a patent right, which is also China's first new crown vaccine patent.
it is understood that the application name of the vaccine is "a human replication defect adenovirus-based recombinant new coronavirus vaccine", is the previous Chen Wei academician team developed adenovirus vector vaccine.
according to the patent abstract, the vaccine has good immunogenicity in both mouse and guinea pig models, and can induce the body to produce strong cellular and body fluid immune responses in a short period of time.
Chen Wei, the team has done a lot of research to ensure the safety of the vaccine going into clinical trials.
" vaccine is for healthy people, so safety comes first, as a drug, to be effective, safe, quality control and mass production;
that although all four elements are the same, the order changes.
the vaccine in the upper body (trial), we have to do a lot of research to verify the minimum clinical safety risk.
" Chen Wei also introduced that the clinical trial team to take a step-by-step approach, starting with the minimum dose, the minimum number of volunteers to start the trial, do more to ensure the safety and effectiveness of the vaccine.
: "In the process, we must have the team's strength, confidence in our own technology and understanding of domestic and foreign regulations."
Actually when we do the candidate vaccine, we are (selecting) three different target genes, there are two parallel groups, each group of the same thing, such as virus packaging to do 5 parallel identical experiments, so you see a vaccine on the clinical (trial), but in fact we may have done 30 vaccine workload.
" in order to combat the epidemic, Chen Wei led the team to develop and reorganize the new crown vaccine, in China and internationally, respectively, the first into Phase I, Phase II clinical trials, to verify the safety of the vaccine and immunogenicity.
the vaccine Phase III international clinical trials are progressing in an orderly manner.
, a member of the Chinese Academy of Engineering and a researcher of the Academy of Military Sciences, was awarded the national honorary title of "People's Hero" on August 11.
to fight the outbreak, she led the team in developing and reorganizing the new crown vaccine.
as of the beginning of this month, more than 165 vaccines were under study worldwide, 27 of which were in human clinical trials and six in Clinical Phase III, according to the World Health Organization.
china's fastest vaccine development process is inactivated vaccines.
all three inactivated vaccines currently in phase III clinical phase are from China.
this number also accounts for half of the clinical vaccine entering Phase III.
does not include the patented vaccine.
Team's vaccine entered Phase I and Phase II clinical trials, respectively, to verify the safety and immunogenicity of the vaccine.
the vaccine Phase III international clinical trials are also progressing in an orderly manner.
, then, does it mean that this new crown vaccine is patented? Does this mean that the research and development process can be accelerated? Will the general public get the vaccine soon? This reporter interviewed The Chinese vaccine expert Tao Lyna.
patent is that it's unique, and we think it's probably better than the existing vaccine, the existing technology, so we're granting it that uniqueness, " says Mr Taurina.
patent is a good thing, but you still have to prove safety and effectiveness, not I gave you a patent, your process can be accelerated, safety and effectiveness or rely on Phase III clinical trials to prove.
" held in the State Council joint prevention and control mechanism of the press conference, the Ministry of Science and Technology, The Director of the Department of Social Development Science and Technology Wu Yuanbin introduced, although the vaccine is an emergency project, but still put special emphasis on scientific, procedural, so china's fastest research and development, such as adenovirus vector vaccine, will be based on the results of clinical trials to determine whether the final use.
Tauliner said that usually after vaccine research and development into Phase III clinical trials, will focus on larger-scale observation and ratio work, "Phase III clinical, usually prescribed to more than 500 people (to participate in the trial), but actually to do thousands or even tens of thousands of people."
Usually there are at least two groups, one of which is vaccinated, and one of which is a placebo group that is very close to the vaccine component, which does not contain the key components of the vaccine, but contains other non-critical components of the vaccine, and we look at whether there is a significant difference between the incidence of the vaccine group and the incidence of the placebo group after the vaccine.
if there is a huge difference, after statistical, mathematical verification, think that there is a protective effect, in the process we will also observe its security.
"What process does it take to get a vaccine into Phase III clinical trials to market?" Tao Lyna introduced that, in general, whether the vaccine can be listed on the market to phase III clinical scale, disease incidence and other related factors for comprehensive study.
"It's going to have to look at the scale of the clinical development, because there's going to be a lot of people, there's a process that's slowly coming in, and it's related to the incidence of the disease, and if you have a high incidence, then you can quickly see that the incidence of the two groups is not consistent, then there are fewer people needed, and there's a short period of time to observe," Taurina said.
each vaccine is different, like cervical cancer, it takes at least 10 years to observe differences in the incidence of cervical cancer in both groups, because cervical cancer is a slow process of development.
Now the new crown (pneumonia) is not the same, the new crown (pneumonia) because of the infection rate is very high, in the United States, Brazil, these countries have a high infection rate, I think it is very likely to do a 5,000 to 10,000 people phase III clinical study, may be after the vaccine, a month can be observed significant incidence differences, and then can be based on this critical results to determine whether the vaccine is protective effect, continue to observe to determine whether the vaccine can be marketed.
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