For approximately 20 years, Russian immunologists have worked on the technology used to create the first vaccine for coronavirus in the world in Russia. This was announced during an interview with RT by Alexander Gintsburg, the director of the N.F. Gamaleya Center. He said that the vaccine had been developed using an accelerated procedure, but without reducing its scope in terms of the number of control studies to prove its safety. Gintsburg reiterated that volunteers on whom the product had been tested did not show any side effects.
“The urgent need for the vaccine, preordained by the crisis and its associated diseases, and tight testing deadlines – this has all elicited criticism from some of our colleagues in other countries. How can we now be sure about its safety and efficiency?”
“Everything done to create this product has been done in strict compliance with Russian legislation, which is what actually regulates the whole process of creating any medical and vaccine products, especially during emergencies. And now we are dealing with an emergency, because we keep on living and have to protect ourselves from infection during this pandemic, when the whole globe has been swept by the infection”.
“As of today, approximately 800,000 people have died from this disease. Unfortunately, there are more and more publications claiming that people suffer serious consequences after going through it, in particular, neurological ones, which over time - as we understand perfectly well - result in a certain incapacity to work or, God forbid, reduce the life spans for those who have had the disease. And people that have been inflicted with a mild form, generally speaking, then have no long-term protection or immunity to this infection”.
“Therefore, based on these prerequisites, this product was created in conformance with, I repeat, Government Resolution No. 441, which permits accelerating many aspects of product development without reducing the number of control study procedures aimed at proving safety in any way, shape, or form.
This Resolution authorizes parallel studies, but by no means abrogates the need for any single one study. Therefore, on one hand, this simple piece of regulation has enabled such acceleration”.
“Meanwhile, as I have said on many occasions, the vaccine has not been developed from scratch. Although it was created in five months, from the time the government issued its statement of work until it was registered, prior to that a whole generation of biotechnologists, virologists, and immunologists - to a large extent under the guidance of Boris Naroditsky, an employee and department director at our institute - has worked for over 20 years to develop the technology used to create this vaccine. And at least six other vaccine products, of which three have been registered, as far as I remember. They have proven to be completely safe."
“Therefore, as of now over 3,500 people in total have been injected with this vaccine product, and without any side effects. Except for the ones that usually occur in the process of any vaccination, namely, a minor rise in body temperature that can be remedied with a paracetamol pill”.
“When you and your team were working on this vaccine, did you have a feeling that you were participating in some kind of racethat you wanted to win?”
“You know, absolutely not. The only feeling was the need to protect ourselves, our relatives, and our people, to fulfill the task for which we were given funds. The only thing was that I had this feeling, like any professional “microbe hunter" that I needed to catch and liquidate this. Yes, I had this feeling”.
“You already started to speak about that: how Russia has managed to outpace other countries in creating and registering a vaccine for COVID-19. You said that you began studies on this before. Don't other countries conduct these kinds of studies? How have we managed to outperform other countries? Is it because our studies were better? Or more complete?
“Naturally, many countries in the world are conducting similar studies. But the Soviet-era and Russian school of immunologists, vaccinologists, and other professionals involved in making vaccines is very high-level. If we take a look, for example, at our center – I am proud of this – four generations of scientists work at our institute now. Therefore, knowledge is transferred not only using paper and electronic media, but it is also passed on by word-of-mouth”.
“Young people often come to me with various questions, and I, since I know all of the scientific personnel at our institute, at the very least, can tell them: "You should go speak with Natalya Kostykova about this issue”. Natalya is 95, and she knows about a tremendous number of infectious disease agents quite well. And who can better than Natalya explain to young people what has been accomplished, and talk about the tiniest nuances and features inherent in a pathogen, and the reactions our body has to it? This is a person who has dedicated her whole life to studying this microbe. No textbook will give you the kind of complete answer that you can get, say, from this employee”.
“The same goes for Felix Ershov. Who can better explain how an immune system will respond to various immunomodulators? He is the person who has created virtually all modern immunomodulators, and knows everything about them. Well, we have another dozen highly respected scientists that work at our institute, not to speak of subsequent generations of professionals.”
“On the other hand, this is an amalgam of very many professions. We have a unique institute. And it is hard to find a center where they simultaneously work on hundreds of bacterial models, and hundreds of viral models, for infectious agents. Meanwhile, the range of interests at our center is quite wide. From mathematic modeling, environmental issues, epidemiology, immunology, and pathogenesis mechanisms to manufacturing various immunobiological products. We have a single platform for all of that. This kind of amalgam forges a team that can handle the most complex tasks”.
“It looks as if Russia is always on the frontline of the struggle against various epidemics, pandemics, and viruses for good reason. Let’s take the example of Ebola, when Russia developed its vaccine. Have you also used the experience gained by developing that vaccine this time around?”
“Yes, of course. The vaccine for Ebola is one of the vaccines created using a universal technology. And that technology formed the foundation used to create the vaccines for COVID-19 as well. And, obviously, the enormous experience behind developing that vaccine has not only been useful, but to a large extent was adapted specifically for the vaccination doses for both animals and for humans. Although everything had certainly already been checked, this time we checked it purposefully. There were no issues that really needed to be explored."
“We already knew what virus concentrations we should inject, starting with mice and monkeysand ending with humans. I mean all the product peculiarities. That means we knew exactly what the necessary composition was that needed to be added to stabilize the product. All the nuances”.
“Therefore, your question is correct, and that helps to explain why it has been possible to create the vaccine by such tight deadlines”.
“But it was not only knowledge about the Ebola virus that helped us. At the time when the COVID-19 pandemic broke out, we were working to create a vaccine for MERS. MERS is also a coronavirus. Meanwhile, its case fatality rate is much higher than in case of COVID-19, it reaches up to 40%. And we had already advanced in work on this development, in fact, we completed stage two for the clinical trials for MERS. And MERS is 80% homologous to COVID-19. Therefore, we already had the whole methodology handy. The required sequence in COVID-19, which differs from MERS by 20%, was to be synthesized and introduced into the same structures and media that we had used to create a MERS vaccine. And we knew all concentrations and dosages perfectly well.”
“It has already been announced that the immunity produced by this vaccine lasts for approximately two years. A vaccine most likely affects each person differently. This figure, two years, how was that determined?”
“For now, that has been established based on the experience working with the Ebola vaccine, where we had the opportunity to observe vaccinated people for two years; this was in the bounds of those same instructions from the government that we received to conduct operations in the Republic of Guinea. And there, for two years, I remember that we were able to observe the effect of the vaccine in 2,000 patients over the course of two years accordingly. And, indeed, the protective antibodies, antibody titers persisted for two years."
“Since the technology platform used both then and now for COVID-19 is, in fact, the same, we also assume that the effect of this vaccine in the booster mode we use will also be for at least two years. After a certain time period we will, of course, monitor that protective immunity level, and report about it and inform a wider audience with your help."
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