In an interview with Thepulse.kz one of the developers, a virologist at the Research Institute of Biological Safety Problems Lespek Kutumbetov.
Clinical trials of the third phase of Kazakhstan’s QazCovid-in vaccine should be completed at the end of March 2021. The development of domestic scientists has already received temporary registration in Kazakhstan; a plant is being built in Zhambyl region for mass production of the vaccine. The President of the country Kasymzhomart Tokayev and the Minister of Health Alexey Tsoi have already announced their intention to be vaccinated with the Kazakh vaccine.
Minister of Education and Science Askhat Aimagambetov, without waiting for the completion of research, tested the vaccine on himself last year and, apparently, feels great.
What is the QazCovid-in vaccine, are there any risks when using it, what it consists of, one of the creators of the vaccine, Doctor of Sciences, professor, leading virologist of the Research Institute of Biological Safety Problems Lespek Kutumbetov told The Pulse in an interview.
— Lespek Bekbolatovich, let’s start with the main thing. What is QazCovid-in represents, what is it made of?
— QazCovid-in is one of the five vaccines we are developing against COVID—19 coronavirus infection. Vaccine preparation technologies are different. We have taken up the development of several types of vaccines: inactivated vaccine, subunit vaccine, recombinant (or they are also called vector) vaccines, as well as a “live” vaccine.
In the spring of 2020, we started creating a traditional inactivated vaccine. A biomaterial was delivered to us from a sick person, from there, in laboratory we isolated the causative agent COVID-19 after identification and confirmation of the virus, and after we developed a vaccine.
Why inactivated? Because this is the most reliable, we can say, absolutely harmless type of vaccine. In fact, this is already a traditional direction of creating vaccines, proven for decades. But vector and subunit vaccines are a new generation. In practice, only a few of them have come into widespread use. The difference is that only a certain piece of the virus is taken there, which is transferred to another object. Therefore, the formation of immunity with the help of such vaccines is more difficult.
Preclinical phase I and phase II clinical trials have been conducted and phase III human clinical trials of the inactivated vaccine are nearing completion. So far, in all these trials, the vaccine showed very good positive results.
— And not a single side effect?
– No. Since the third phase is already nearing completion, it is safe to say that the vaccine is safe and effective. Side effects have not been registered in any of the phases of clinical trials. Only standard reactions — possible pain at the injection site, a slight increase in temperature. I want to emphasize that just an increase in temperature indicates a rapid immune response of the body.
— Tell us more about how the clinical trials were conducted?
— In September 2020, the first phase of clinical trials was launched, followed by the second phase. 44 volunteers participated in the first phase. The vaccination scheme is carried out in two stages, with an interval of 21 days. At the same time, in the first phase, half of the volunteers were administered a placebo in comparison. This is mandatory for any such study.
The vaccine is administered in a volume of 0.5 milliliters. That is, such a small amount of the vaccine is injected into the body and it creates immunity in the body.
200 people participated in the second phase. All 200 people received the vaccine, without a placebo. In the second phase, single and double use of the vaccine was tested. And now the third phase of clinical trials is underway, where three thousand volunteers participate.
— Do all participants develop and retain antibodies?
– Yes. After administration of the drug, samples are necessarily taken at the entire stage of the study, blood samples are examined for the presence of cellular and humoral immunity, since both immune components play an essential role in protecting the body. In all cases, all volunteers had both cellular and humoral immunity.
— It was reported that the development scientists tested this vaccine first of all on themselves. You too?
– Of course. It can be said that it is a tradition when developers are vaccinated with their own vaccine. My colleagues and I were vaccinated back in July and, as you can see, we feel great. We still have antibodies today.
— If we compare with studies of vaccines developed in other countries, we get a very small number of volunteers. What is the reason for this? Is this number of research participants enough for an objective picture?
— This is a natural question. You see, human clinical trials are not that simple. First of all, they are all volunteers. Of course, we would like to reach a much larger number at least 10 thousand people. But in order to conduct such tests financial resources, clinical research bases, and even trained specialists are needed because, monitoring in a study is a completely different job for which not everyone even a very good doctor is ready. All test participants must undergo clinical and laboratory tests throughout the entire period, in fact — under almost constant supervision. So, this is a rather complicated process, even organizationally.
So we settled on three thousand people. This is not a little. We believe that this is quite enough. If the vaccine behaves incorrectly, if it is not good, then, of course, it will be immediately clear even with a small number of volunteers. But since our vaccine is inactivated, this is excluded.
— You emphasize that the vaccine is inactivated. Simply put, this is already a “killed” virus, right? Maybe then it is more correct to raise the question of how effective it is?
— No, it’s wrong. The technology of the “killed” virus — inactivation — has been known for a long time, for many decades it has been successfully used in the development of other vaccines that have proven their effectiveness. Among antiviral vaccines polio vaccines can be seen. This is an inactivated vaccine and you know that it is only thanks to vaccination that humanity manages to cope with such a terrible disease as polio.
If we talk about how an inactivated vaccine works, then, in simple words, the scheme is as follows. In laboratory conditions, a live virus accumulates. Then it is chemically inactivated — killed, but at the same time its morphological form practically does not change, so the virus remains in the same morphological form as it was. Then we purify this virus from all side protein and cellular substances so that it acts specifically and remains harmless to the body. Then we mix it, absorb it. By the way, the sorbent is harmless to the body, that is, it will not multiply in the body. And after that, it becomes a vaccine. The protein composition of the vaccine specifically affects the cells of the body and stimulates the formation of immunity. It is very important that inactivated vaccines lead to the development of both cellular and humoral immunity, that is, to a more effective (result — ed.). And, of course, it is administered in certain concentrations necessary for the body’s immune response.
— Will this vaccine work against new strains of the virus?
— All pathogens of the virus in the process of evolution, daily reproduction, undergo genetic changes. But all these changes are to a certain extent transmitted phenotypically, that is, it is like the outer layer of the virus. And if major genetic changes have occurred, then significant changes will occur outside of this pathogen. At this time, the pathogen you are talking about has been aggressed with respect to pathogenicity — it causes a more pronounced infectious process. But there is no information yet that it can bypass the effect of vaccine drugs. This means that the pathogen may be more or less aggressive, but it has not changed its antigenic structure and, therefore, remains vulnerable to the protection that is produced by vaccine preparations. Naturally, if there are significant changes, we will know about it. And then a new vaccine will be created based on new types of virus.
— Does the QazCovid-in vaccine have age restrictions?
— Studies are conducted in the age categories over 18 years old. Since it is inactivated, it has a high harmlessness. Therefore, this vaccine can be recommended from 18 years and older.
In phase two clinical trials, we had people under the age of 70 and there were no side effects. Therefore, everyone can use this vaccine without any fear. As the author of the vaccine, I have no doubts about this. I have used it myself. I am over 60 years old and, as you can see, I feel great.
— If the development is so effective, why is there practically no information about it in international reviews? Even in those streams that many doctors do today on social networks, conducting, in fact, educational program for the population, QazCovid-in does not occur. What is the reason?
— Yes, it really is and, probably, this is our, one might say, omission. We registered the vaccine on the WHO website and started research. The reviews you are talking about include drugs and vaccines after scientific research has been published in special publications. We simply don’t have enough time for this and we would like to get the final results. Even though, we have no doubts about the effectiveness. As soon as we receive them, then we will publish in foreign scientific journals so that the scientific world knows about our results.
https://thepulse.kz/show?slug=chto-predstavlyaet-soboy-vakcina-qazcovid-in&category=detective