Will 90% efficiency become the gold standard for the new crown vaccine?

. Medner and Pfizer have both announced the interim results of their phase III clinical trials of the new crown vaccine, which is more than 90% effective. Preliminary results for Phase III, released by the two companies, push the efficiency of the new crown vaccine to a height of 90 percent.
November 17th, Medner announced the interim results of its Phase III clinical trial of the new crown vaccine, with an effective rate of 94.5%.
the same time, Pfizer announced that its co-developed Phase III. phase III clinical trial interim results showed an effective rate of 90%, but then announced on the 18th, its clinical trial final data analysis effective rate of 95%.
the world's first Phase III. preliminary results, both will be efficiency data pushed to a height of 90%, it seems that the efficiency of 90% has become the success of the new crown vaccine gold standard.
the new crown vaccine be effective, really not until 90%?of the 30,000 people who participated in Therena Phase III clinical trials, 95 were infected when the data were published. Five of them were vaccinators, while 90 were placebo vaccinators.
the effectiveness of the vaccine come about? If the incidence rate in the placebo group is 10%, the incidence rate in the vaccine group is 1%, and the immune protection effect of the vaccine is calculated as (10%-1%) ÷10% to 90%.
Zhu Fengcai, deputy director of the Centers for Disease Control and Prevention in Jiangsu Province, explained in an interview with Science and Technology Daily that the protective effectiveness of the new crown vaccine can be assessed by comparing cases of new coronary pneumonia among vaccinated and unvaccinated people.
the end of the test only if a certain number of new coronary pneumonia patients appeared in the subjects. According to the plan announced by the U.S. company Medner, 151 of the 30,000 subjects were infected with neo-coronary pneumonia. The Medner trial has so far seen 95 infected people, and after being blinded, 90 infected people were found in the control group, compared with 5 in the vaccine group, and 11 patients with severe neo-corona pneumonia all occurred in the control group. The current 94.5 per cent efficiency is only the result of a mid-term trial, and Phase III clinical trials will continue until 151 patients infected with neo-coronary pneumonia.
current data, the number of people vaccinated in the placebo group and the vaccine group was the same, with an efficiency of 94.44 percent. However, this result is only phased data, and the final results will be updated after the end of Phase III.
of course, the data processing in clinical studies cannot be so simple, in general, the greater the difference between placebo group infection and vaccine group infection, the more efficient. So, as some reports have mentioned, "none of the patients in Phase III clinical trials are infected" is the basis for the validity of the judgment.Syn't figured out the basic theory, linked to the actual analysis came -
is currently two vaccines published in a row of efficiency are "tested more than 90 points" good results, then all vaccines need to reach 90% to be effective?
Zhongming Li, a former U.S. Food and Drug Administration examiner and vaccine expert, told Science and Technology Daily that vaccines on different technical routes can be different and cannot require all vaccines to be more than 90 percent effective. According to GUIDELINEs issued by the FDA, the new crown vaccine is more than 50% of the time.
the new crown vaccine currently being developed around the world is divided into five different technical routes, such as inactivated vaccine, nucleic acid vaccine, recombinant protein vaccine, adenovirus vector vaccine and detoxifying influenza virus vector vaccine. These technical routes have their own advantages and disadvantages, and efficiency may vary.
inactivated vaccine is the most traditional classical technical route, the preparation method is simple and fast, the safety is relatively high, is the usual means to deal with the spread of acute diseases. However, its disadvantages are large dose, short immunization period, single immunization pathway and so on. The advantages of adenovirus vector vaccine are safe and efficient, resulting in few adverse reactions, the disadvantage is that research and development needs to consider how to overcome the "pre-existing immunity" may bring the problem of insufficient effectiveness. The advantage of nucleic acid vaccine is that it does not need to synthesize proteins or viruses when developed, the process is simple and the safety is relatively high. However, the disadvantage is that there is no global nucleic acid vaccine on the market, has not yet formed a stable and controlled large-scale production supply chain, the effect has yet to be assessed. Recombination protein vaccine is a technical route for large-scale rapid production of vaccines, with the advantage that it is safe, efficient and scalable, but finding a good expression system is difficult. The advantage of influenza virus vector vaccine is that it can prevent two diseases at a time, the number of vaccinations is small, the method of vaccination is simple, the disadvantage is that it takes a long time.
based on past experience with the immune barrier, 'two 60 per cent' is key," he said. Li Zhongming said, "The effectiveness of the new crown vaccine developed by different technologies is good as long as it is more than 60%." In addition, more than 60 per cent of the population should be vaccinated. "
China currently has 4 new crown vaccine research and development in the forefront of the world, but Phase III clinical trials have no further news.
To this end, Li Zhongming explained, on the one hand, this is because China has brought the outbreak to near zero infection, and Phase III clinical trials to be done in the affected areas, the start of the trial subject to foreign cooperation;
In an earlier interview, Zhu Fengcai told Science and Technology Daily that the selection of epidemic areas in Phase III clinical trials is strictly standard, from the local research institutions to the research capacity of the local outbreak, the local outbreak of the study and other factors to consider, these are closely related to the availability of Phase III clinical trial results. Gu Ark invented sugar pills to address the accessability of vaccines, even now that logistics and transportation are highly developed, the storage and transportation of vaccines determine the possible distance it can reach.
mRNA vaccine is a nucleic acid vaccine that must be frozen, with Pfizer's vaccine at minus 80 degrees Celsius and Medner at minus 20 degrees Celsius. In inactivated vaccines, by contrast, only need to be refrigerated (4 degrees Celsius) to be preserved.
effectiveness, safety is also a must for mass vaccination.
"once the number of people vaccinated reaches the millions of orders of magnitude, there is a risk of different serious side effects." Li Zhongming said that people of all kinds of physical fitness in the population have, and Phase III. Phase III clinical trials can only
to tens of thousands of people.
so far, the mRNA vaccine has no qualified products on the market, which can be described as "unprecedented" and it is not possible to predict whether a large number of inoculations will have serious side effects. In contrast, traditional vaccine technology is more mature, clinical use of decades of long-term experience, more secure.
Objectively speaking, after more trial data are available in the future, the new corona inactivated vaccine is likely to achieve an effective rate of about 90%, even if slightly less effective, but in terms of safety, accessability has advantages. Li Zhongming further stressed that a country's use of what immunization strategy in addition to the effectiveness of the vaccine itself to consider a number of other factors, product supply, vaccination coverage of new crown vaccines, pharmaceutical economics, etc. are very important, do not rely on only an efficient number to judge which vaccine is the best.
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