Zhifei Vaccine has performed well, is it trustworthy or is it a misnomer?
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Recently, Zhifei Vaccine has received widespread attention with its dazzling data performance.
On May 4, the Phase III clinical report of Zhifei vaccine was published in the New England Journal of Medicine. From an academic perspective, Zhifei vaccine is stronger than Sinopharm, Kexing or CanSino. Reports are not yet published in such journals.
The Zhifei vaccine is different from most of the current vaccine technologies. There are currently four COVID-19 vaccine technologies in the world :
It is an inactivated technology vaccine represented by Sinopharm and Kexing. I have specifically talked about this technology before;
It is Oxford AstraZeneca, Russia's Satellite, Kangxinuo, Johnson & Johnson, etc., all of which use gland vector technology. I have also talked about the problem of this technology before;
This vaccine from Pfizer, Moderna, and Fosun is the latest mRNA technology. I have also talked about this technology before;
4. It is Zhifei's vaccine, called recombinant protein vaccine, and the Novavax vaccine in the United States is also this technology, which is recombinant spike protein. To put it simply, it is a DNA technology of recombination, that is to say, the receptor tissue on the spike protein of the COVID-19 virus is used as the original version of an antigen, and then re-replicated and assembled using DNA technology, and then the antigen is passed through hydrogen. The adjuvant of alumina stimulates the response of the body's immune system. This technology is used in hepatitis B vaccine.
The Zhifei vaccine was jointly developed by Anhui Zhifei Pharmaceutical and the Institute of Microbiology, Chinese Academy of Sciences. Phase III clinical trials of the vaccine were conducted in some Asian countries, including China, Ecuador, Malaysia, Pakistan, and Uzbekistan.
There are a lot of people selected in the third phase of the clinical trial. The total number of people is 28,904. The ZF2001 in the paper is a code name of Zhifei vaccine. There are 14,453 people in the vaccination group and 14,451 people in the control group, which is almost a 1:1 control. . The average age of clinical participants was 35 years old, and all those who participated in the war were 35 years old, and then 93.6% of them were between 18 and 59 years old, young to middle-aged, and only 6.4% of the elderly over 60 years old. The ratio of males to females is 67.5% for males and 32.5% for females. Most of them are Asians, and Asians account for 80%, including non-Chinese populations in China and other parts of Asia. The underlying disease accounted for 13.2%.
From the perspective of clinical design method and statistical method, it is similar to Pfizer and Moderna. Then two analyses were done. One analysis was on June 30, that is, 7359 people. Almost half of the people who were vaccinated completed three injections. 81.4%, the protection rate for severe disease is 92.9%, and the protection rate for death is 100%.
Then came the second analysis on December 15. The number of people at this time has almost doubled from 7,359 in the previous analysis to 12,625. The result of the analysis at this time was that the protection rate for symptomatic infection became 75.7%, the protection rate for severe cases was 87.6%, and the protection rate for death was 86.5% . These three figures, at least for now, are the best performing data among all our domestic vaccines. Meets the World Health Organization's requirement of 70% efficacy for WHO preference, but a minimum of 50%. The previous Sinovac just passed the minimum tolerance line of the World Health Organization. Then the previous Pfizer was 95%, Moderna was 94.5%, and Oxford-AstraZeneca averaged 70.4%.
For middle-aged people, 18-57 years old, the effective rate after one year of vaccination is 76% by December 15, while the effective rate for the elderly over 60 years old is 67.6%—— The protection for the elderly is still broken. Then they also analyzed different variants. The main analysis in it is Alpha and Delta. By December 15, the effective rate of Delta was 76.1%, and the protection rate of Alpha was 88.3%.
In addition, the researchers also analyzed the protection rate after one injection, that is, the protection rate of one injection of Zhifei vaccine. By December 15, its protection rate was only 55.4%, the severe protection rate was 47.4%, and the death protection rate was 75.7 . This means that the effect of a single injection of Zhifei vaccine is very small, and it also passes the entry pass line of the World Health Organization. Objectively speaking, the gap between Zhifei vaccine and Pfizer and Moderna is still relatively large. After all, the protection rate of Pfizer and Moderna vaccine after one shot is still very high. However , judging from the published data, the side effects of the Zhifei vaccine are better than those of Pfizer and Moderna.
In general, at present, Zhifei vaccine is indeed more effective in domestic vaccines, and has lower side effects. However, there are still problems with the data in this report, and it may be that Zhifei deliberately does not want to make it clear, mainly the following three points:
The first is the effectiveness of the half-year after the vaccination. Despite the report's disclosure result of 75.7%, nearly half of the people were continuously vaccinated within six months. Normally, statistics should be differentiated, that is, the population after half a year of vaccination and the two groups within half a year of vaccination should be counted separately. I believe that Zhifei has this data on hand. As for why not to make a more detailed distinction, there is a high possibility that the validity data after half a year will not look good, so it needs to be combined and counted.
Second, there are problems with clinical testers, which is also the biggest problem. We have seen that the average age of the Phase III clinical testers selected by Zhifei Duo is 35 years old, and they are all people who have been prosperous and prosperous for some years. But the average age for Pfizer Phase 3 is 52, and the average age for Moderna Phase 3 clinical trials is 51. Then the proportion of elderly people is too small, and the proportion of people with underlying diseases is also too small. Basically, these two groups of people who need important protection and vaccination belong to a small number of sample groups that are ignored in the phase III clinical data.
This gives the impression that Zhifei deliberately chooses such a population in order to make safety and efficacy data, which is too far from the population selection of vaccine manufacturers in the United States. Of course, this is much better than other domestic vaccines, such as Sinovac and Sinopharm. Basically, there are no elderly people in the previous clinical reports.
So, as for Kexing and Sinopharm, the answer is already in their clinical reports - what Kexing and Sinopharm were looking for before were almost all healthy people, and even such healthy people were all beaten up All kinds of side effects, then, can these groups that should be protected, the elderly, the weak, the sick, and the disabled, be able to fight? Everyone should have a measure in their hearts.
Third, another problem in Zhifei’s Phase III clinical report is that the population with underlying diseases is low, because the original intention of our vaccine is to protect these immunocompromised people, not to pull these normal healthy people. to vaccinate. In the clinical data of Zhifei, only 13% of the population with underlying diseases, and the age of these people is still relatively low. However, Pfizer's underlying disease accounted for 21% of the population, and Moderna's underlying disease accounted for 22%. The number of clinical samples of Zhifei vaccine is about 10% different, and the proportion of this sample gap is too large. Because in our normal daily life, the population with underlying diseases is about 30%.
To sum up, Zhifei vaccine, first of all, the Phase III clinical data is the best among all vaccines in China. But unfortunately, this clinical data is designed to prove safety. The crowd is looking for young and strong groups. The autoimmunity of these groups has helped improve the efficiency of Zhifei vaccine, as well as the rate of severe disease and mortality. Decline, including weakening of side effects, because the immune system and metabolic system of this group are strong.
What's worse is that the effect of Zhifei vaccine can only be achieved after three injections of Zhifei vaccine. As for one injection, it is very unoptimistic from the report . So for the Zhifei vaccine, it is necessary to return to the original intention of the vaccine as soon as possible to conduct clinical trials, that is, to conduct clinical trials for immunocompromised people and the elderly to see what the protection and side effects are. It is not to find some healthy, young and strong groups to get three injections to achieve such data. It is really incredible that this effect is achieved by three injections of this inoculation.
Of course, the protective effect of Zhifei vaccine on Omicron has not yet been seen. Perhaps this is the reason why Zhifei has been promoting vaccination in various welfare ways recently, hoping to obtain the number of clinical samples for Omicron. However, I still hope that Zhifei will not design samples to prove safety and efficacy data. Really go to those elderly groups with underlying diseases to come to the clinic to see if it is really effective protection, or if something happens accidentally.
Finally, I need to state that this is a research report. I have compared this research report with the United States, as well as with Kexing and Sinopharm in our country. Please treat it scientifically. The US vaccines have already announced some side effects, and the core of mRNA vaccines is based on the spike protein. At present, more and more studies around the world have found that the side effects are very serious.
And the United States is now clearly against the trend of vaccines, and the Novavax vaccine in the United States, which is the recombinant protein vaccine used by Zhifei, the vaccine of this technology is also in the controversy of side effects, so Zhifei The core of the recombinant protein technology is also based on the spike protein. Are we really better than the United States in terms of side effects and effectiveness?
Modern biomedical technology, from research and development to manufacturing, is currently not even in the top ten in the world. Perhaps, facing the current Omicron, we must seriously consider whether there is a need for vaccination.