In December, the final phase of 3rd clinical trials of the QazCovid-in vaccine has begun in Kazakhstan. 3 thousand volunteers from Almaty and Taraz are taking part in the research.
Kazakhstan holds high hopes for this vaccine. Earlier, the Minister of Health Alexey Tsoi and President Kassym-Jomart Tokayev announced their intention to be vaccinated with the QazCovid-in vaccine.
When will the results of the 3-phase studies be received? How effective and safe is the Kazakh vaccine? And what is the difference between QazCovid-in and other vaccines? We talked about this with Berik Khairullin, professor of the KazSRI of Biological Safety Problems, one of the developers of the Kazakh coronavirus vaccine.
TENGRINEWS:
At what stage is the clinical trial (CT) of Kazakhstan’s QazCovid-in vaccine?
Berik Khairullin:
After the completion of preclinical tests on laboratory animals and 1-2 phases of research, the 3rd phase of clinical trials is currently being conducted.
TENGRINEWS:
When will we know exactly how successful or unsuccessful the kazvaccine trial was?
Berik Khairullin:
After the completion of phase 3 clinical trials. It will be at the end of July approximately, when the results will be received.
TENGRINEWS:
By what criteria were the volunteers selected for the third phase of CT?
Berik Khairullin:
They were selected according to the inclusion/non-inclusion criteria. One of the most important criteria is the absence of antibodies to the SARS-CoV-2 virus. You know, so that a person had not been ill with this infection.
TENGRINEWS:
What were the contraindications to participation in CT?
Berik Khairullin:
Mostly for women, it’s pregnancy. The absence of antibodies was the most important criterion.
TENGRINEWS:
And those who have had cancer and chronic diseases participate in CT?
Berik Khairullin:
We did not include volunteers with chronic diseases in the study.
TENGRINEWS:
The most serious side effects that were detected in volunteers from those three thousand people who were vaccinated?
Berik Khairullin:
We can’t say that yet. According to phase 1 and 2, we can say that the vaccine is safe and does not cause serious undesirable phenomenon. According to the results of our observations, after we were vaccinated, this was a pain at the injection site and a slight increase in temperature.
TENGRINEWS:
So there were no more serious side effects?
Berik Khairullin:
Weren’t.
TENGRINEWS:
Who were sick with Covid from these 3 thousand volunteers, after they were vaccinated?
Berik Khairullin:
This is still confidential information. The data will be available after the full completion of the clinical trial in July.
TENGRINEWS:
What happens if one of those three thousand volunteers dies?
Berik Khairullin:
Well, firstly, as in the whole world, there will be a determination of the reasons why this happened. It will be determined whether the vaccine is the cause of death.
TENGRINEWS:
Will any compensation be paid to the family of the deceased?
Berik Khairullin:
This is confidential information, it is provided under the insurance contract with the insurance company. This is already the prerogative of the insurance company.
TENGRINEWS:
Well, it became known earlier that in the event of the death of a volunteer, an insurance payment of 500 thousand tenge will be provided. How was this amount calculated and will it be revised?
Berik Khairullin:
I repeat myself again. This is confidential information; it is provided for by the insurance contract and depends on the insurance company.
TENGRINEWS:
How long does the protection of the vaccine last, on what day does immunity develop?
Berik Khairullin:
The vaccination is two-fold, and is administered intramuscularly on the first day and 21 days. After 21 days, within 2 weeks, antibodies are formed. A person will not be susceptible to the SARS-CoV-2 coronavirus. Prior to clinical studies with the participation of volunteers, experiments are first conducted on laboratory animals (white mice, guinea pigs, Siberian hamsters, white laboratory rats, monkeys). Only then, after the completion of preclinical studies, it is possible to obtain permission for a clinical trial with the participation of volunteers.
In the first phase, volunteers from 18 to 50 years old participated, in the second phase, people from 18 and older already participated. Volunteers from 18 years and older also participate in the 3rd phase.
TENGRINEWS:
Has everyone developed immunity?
Berik Khairullin:
We have received good data on safety and immunogenicity based on the results of phase 1-2 …
TENGRINEWS:
According to the results of phase 1-2, how much has the vaccine shown its effectiveness?
Berik Khairullin:
Efficiency is not the main goal of Phase 1-2. The effectiveness is finally determined by the 3rd phase. According to the 1st phase, safety is determined, according to the 2nd phase, immunogenicity. The percentage of efficiency at these stages is preliminary. It is calculated definitively in the 3rd phase.
Immunogenicity is the ability of a vaccine to provide immunity and is determined by the level of antibody titers that are produced after vaccination.
While there are intermediate results. I have also been vaccinated since July. The vaccine provides strong immunity against the SARS-CoV-2 virus.
TENGRINEWS:
And what was the titer?
Berik Khairullin:
The titers of antibodies determined after vaccination are comparable to the titers of antibodies observed in volunteers in the study of foreign similar vaccines.
TENGRINEWS:
Good. What result should PCR or rapid test show after QazCovid-in vaccination?
Berik Khairullin:
Firstly, PCR only detects the presence of the virus itself and, accordingly, PCR should not show the presence of the virus after vaccination. And test systems that are adapted to the detection of antibodies after vaccination with our vaccine should show the presence of immunoglobulin G antibodies.
TENGRINEWS:
So this is humoral immunity?
Berik Khairullin:
Yes.
TENGRINEWS:
Where can I view clinical data on the vaccine being developed?
Berik Khairullin:
We send all the research results in the form of a report to the National Center for the Examination of Medicines in the Ministry of Health of the Republic of Kazakhstan, and, accordingly, they have all the data. They control us, and, of course, in the near future our institute will publish data in the open press, but accordingly after obtaining the permission of our Ministry of Health.
TENGRINEWS:
Remind me again, when exactly will we get the results and when can we introduce the vaccine into mass use?
Berik Khairullin:
Mass application will be after its production. When exactly vaccination will begin is decided by our government.
TENGRINEWS:
Are there any approximate deadlines?
Berik Khairullin:
The timing of the use of the domestic vaccine is determined by our government agencies. The most important thing is that our country was able to develop this vaccine independently. Our Research Institute has a very extensive experience in developing vaccines against infectious diseases. This is not the first, but the 6th vaccine of our institute. And the 11th clinical trial. We have conducted more than 40 preclinical studies. And now our country is on the 14th place on the WHO website, as a country that has reached the 3rd phase. This is a very big result! And we have tried to make a vaccine that is not inferior to well-known foreign analogues, so that our country receives immunobiological safety from this dangerous infectious disease.
TENGRINEWS:
Can you briefly tell us what this vaccine consists of?
Berik Khairullin:
This is an inactivated vaccine, purified, concentrated with the addition of an adjuvant — aluminum hydroxide. This is the most proven technology. This technology is more than 70 years old, unlike mRNA technologies, and the same adenovirus vector technology. That is, when people ask about the long-term consequences, this type of vaccine is the most proven. The same technology was once used to create a vaccine against influenza, polio, tick-borne encephalitis, hepatitis, and they have been used for many decades and all the data on the effect on the human body are fully known. And according to this, the most proven technology, this vaccine was developed.
TENGRINEWS:
Can you assure me that this is a really safe vaccine? After all, the most important thing is safety.
Berik Khairullin:
The most important thing of course is safety. Look, first the vaccine goes through a very long study on laboratory animals. Then we, as authors, were the first to be vaccinated twice at the end of July. During the first phase with the participation of 44 people, it was found that the vaccine is safe and areactogenic. Next, phase 2 was carried out with the participation of 200 volunteers, according to the results of which it was determined that the vaccine is immunogenic and safe. And the most important thing is to get to phase 3, you need to go through the whole long way of preclinical trials, as well as phase 1 and 2, in order to obtain permission to conduct extended clinical trials. By the way, many developers from other countries have stopped at phase 1. They couldn’t go any further. So they had some nuances. And we have reached the 3rd phase and our vaccine is completely safe!
TENGRINEWS:
So you are 100 percent sure that your vaccine is safe? Is it so?
Berik Khairullin:
There are no 100 percent safe vaccines, since each person, depending on age have a different state of health and individual immunological protection. However, vaccination is the only way to combat this infection, since eventually every inhabitant of our planet will encounter coronavirus, as it was with well-known social infections such as influenza, measles, which are being fought only with the help of vaccines.
TENGRINEWS:
You say that the vaccine is inactivated. That is, it was alive earlier. You have been working with a live virus. Where did you get it from? Weren’t you afraid of getting infected yourself?
Berik Khairullin:
Only our institute has all the conditions for working with these types of infections. The virus was isolated in Almaty, from patients with confirmed PCR. And then the work was carried out in special conditions that allow not to get infected.
TENGRINEWS:
Did I understand correctly that the vaccine was obtained from a human virus from Almaty? And then you multiplied it, right?
Berik Khairullin:
Yes, a virus was isolated in Almaty, and work began with it on the development of manufacturing technology. Its domestication begins.
TENGRINEWS
Have you been sick with covid yourself?
Berik Khairullin:
No. I was vaccinated.
Anyway, 100 percent of the world’s population will see this virus, and get acquainted with it, figuratively speaking. Some will get over it asymptomatically, they won’t even notice. Some will be seriously ill. And a certain percentage, of course, will die. But even those who get sick – they will have consequences, that is, complications after the disease. This virus affects almost all vital organs. And the complications after this infection are the most serious. Now let’s weigh up – what is better: to be ill asymptomatically, to be ill with medications, or sorry, to die, than to be vaccinated? And in this regard, a choice is being made. Vaccination is the best option.
At the same time, many say, “I will not be vaccinated.” But they should not think only about themselves, but about their grandparents, children. The young organism will imperceptibly get over it, but they can be a carrier of infection.
Still, it is better to be vaccinated in advance, to insure. Yes, there will be a small temperature, yes it will hurt a little. The virus will come anyway. So choose, please. No one will forcibly vaccinate you.
Interviewed by: Ainash Ondiris
https://tengrinews.kz/conference/chego-sdelana-vaktsina-qazcovid-in-naskolko-bezopasna-398/