"We can cope with the most difficult tasks": director of the Gamaleya center - on the vaccine against COVID-19 and Russian immunologists

- The urgent need for a vaccine, predetermined by the crisis, diseases, a tight deadline for testing - this has caused some criticism from colleagues from some other countries. How confident can we be of its safety and effectiveness at the moment?

- Everything that was done in terms of creating this drug was done strictly in accordance with Russian legislation, which actually regulates the entire process of creating drugs and vaccines, especially in emergency situations. And in this case, the situation is emergency, because we live and must protect ourselves from this infection during a pandemic, when the entire globe is engulfed in this infection.

To date, already about 800 thousand people have died from this disease. Unfortunately, more and more publications appear that say that a person suffers it with serious consequences, in particular, of a neurological nature. Which over time, as we perfectly understand, will lead to a certain lack of ability to work, God forbid, will shorten the life of those who have been ill. And those who have suffered in a mild form, they, as a rule, have long-term protection, there is no immunity to this infection.

Therefore, proceeding from these prerequisites, this drug was created, in accordance with, I repeat, the 441st resolution, which can significantly reduce the time of drug development. Moreover, in no way reducing the number of those control research procedures that are aimed at proving safety.

This decree allows a number of studies to be carried out in parallel, but in no way cancels any of the studies. Therefore, on the one hand, this fact, purely regulatory, made it possible to reduce the creation time.

At the same time, as I have said many times, the vaccine was not created from scratch. Although it was created in five months, from the moment of receiving the state assignment to the moment of registration, before that a whole generation of biotechnologists, virologists, immunologists, largely under the leadership of Boris Savelievich Naroditsky, an employee of our institute, head of the department, has been working for more than 20 years to create the technology with which this vaccine was created. And at least six more vaccine preparations, of which, as far as I remember, three are registered. They showed their complete safety.

Therefore, in total, to date, more than 3.5 thousand residents have received this vaccine preparation, without any side effects. Except for those that usually occur with any vaccination, namely, a slight rise in temperature, which is removed with a paracetamol tablet.

- When you and your team worked on this vaccine, did you have the feeling that you are participating in some kind of race, and did you want to win it?

- You know, there was absolutely no such feeling. The only feeling was the need to protect ourselves, our relatives and our population, to fulfill the task for which we were given the money. The only thing was a certain feeling, like any professional, "microbial hunters", that he needed to be caught and eliminated. Yes, there was this feeling.

- You have already begun to talk about this, how Russia managed to get ahead of other countries in creating, in registering a vaccine against COVID-19. You said that you started research earlier. Do other countries do such research? How did we manage to get ahead of other countries? Because we had better research? Or were they fuller?

- Naturally, in many countries of the world, similar studies are carried out. But the Soviet, domestic school of immunologists, vaccinologists, people who are engaged in the creation of vaccines, it is very serious. If you look at the example of our center, I am proud of this, four generations of scientists are now working at our institute. Therefore, our knowledge is transmitted not only with the help of paper and electronic carriers, they are simply passed from mouth to mouth.

Young people come to me with some question - I, since I know the entire staff, scientific, at least, the institute quite well, I say: approach Natalya Nikolaevna Kostyukova on this issue. Natalya Nikolaevna is 95 years old. But she knows very well the mass of infectious agents. And who better than Natalya Nikolaevna can explain to young people what has already been done, and the slightest nuances and properties of this pathogen, and the reaction of our body to this pathogen? A man who has devoted his whole life to the study of this microbe. And in no textbook you will find such a complete answer that you can get, say, from this employee.

The same thing - Felix Ivanovich Ershov. Who better than him can tell about how the immune system will react to this or that immunomodulator. This is the person who created virtually all modern immunomodulators, and knows everything about them. Well, there are also a dozen very respected scientists who work at our institute. Not to mention the next generations of specialists.

On the other hand, there are many specialties. We have a unique institution. And it is rather difficult to find such a center where hundreds of bacterial models and hundreds of viral models of infectious diseases pathogens are simultaneously working. At the same time, the direction of interests of our center is very broad. Starting from mathematical modeling, ecology, epidemiology, immunology, mechanisms of pathogenesis, and including the production of various immunobiological drugs. All this is on one site. Such an alloy gives birth to the team that can cope with the most difficult tasks. 

- It turns out that it is not without reason that Russia is always at the forefront in the fight against various epidemics, pandemics, viruses. For example, the same example with Ebola, when Russia created a vaccine. Was the experience used to create that vaccine this time?

- Yes, absolutely. The Ebola virus vaccine is one of the vaccines that has been created on the basis of a universal technology. Based on the technology used to create vaccines against COVID-19. And, of course, all the great experience that was used to create that vaccine was not only useful, but in many respects it was transferred. Namely, the doses of immunization, for animals, for humans. Although all this, of course, was checked, but we have already purposefully checked. There weren't any particularly searching moments here.

We already knew the concentrations of the virus that need to be injected, starting from a mouse, a monkey, to a person. So, they knew all the features of the drug. This means that they knew thoroughly the necessary composition, what should be added to stabilize this drug. All the nuances.

Therefore, your question is correct, which also allows you to explain why it was possible to create this in such a short time.

Knowledge about the Ebola virus wasn't the only thing that helped us a lot. The moment the COVID-19 epidemic broke out, we were working to create a vaccine against MERSa. MERS is also a coronavirus. By the way, there is much more mortality than COVID-19, there is up to 40% mortality. And we have advanced in this development, in fact, we have completed the second phase of clinical trials on MERS. And MERS is 80% homologous to COVID-19. Therefore, we had the entire methodological apparatus at hand. The required sequence, which is 20% different from MERS, in terms of COVID-19, is synthesized, and in fact inserted into the same structures, the carriers that we have already used to create the MERS vaccine. And all the concentrations, dosages were already well known to us there.

- It has already been announced that immunity from this vaccine is about two years. The vaccine probably works differently for each person. This figure, in two years, is it determined by what?

- So far, it has been determined by the experience of working with the Ebola virus vaccine, where we had the opportunity to observe the vaccinated for two years, within the framework of the same order of the government, which, in due time, we received for work in the Republic of Guinea. And there, for two years, on two thousand, I remember, patients, we, respectively, could observe the effect of this vaccine. And, indeed, protective protective antibodies, antibody titers persisted for two years.

Since the technological platform that was used then and now for COVID-19 is actually the same, we also assume that the effect of this vaccine, in the booster version in which we use, will also be at least two years. After a certain time, naturally, we will monitor the level of protective immunity, and with your help we will report to the general public, inform it.