— Alexander Leonidovich, is the COVID-19 pandemic over?
– NO. Of course it wasn’t completed. We have been living for almost four years with COVID-19 constantly present in the human population. At the same time, it not only exists, it adapts very well, constantly evolving, changing its antigenic structure. And therefore partially changes its manifestations, that is, the infectious process, the severity of the disease.
— So, has the course of the virus become easier yet?
“It has actually become easier, but the virus still penetrates most human cells as before. And the long-term consequences of COVID-19 remain the same. In other words, there has been no decrease in the number of heart attacks and strokes due to transmission of this virus.
— Can the original Sputnik V, based on the Wuhan variant of the coronavirus, still protect people from the current strain of SARS-CoV-2?
— The original Sputnik V protected you and me from COVID-19 for the first two years, from the time of registration in August 2020 until approximately July 2022. Since mid-summer 2022, when Omicron variants 1, 2 and 3 appeared, Sputnik V’s efficiency has fallen eightfold. And when the “omicron” 4, 5 appeared, the efficiency dropped by 20 times. And when the XBB.1.5 version of the “omicron” (“kraken”) appeared – this was in January 2023 – Sputnik stopped protection altogether. Therefore, last summer the antigenic composition of the vaccine had to be changed.
— As far as I know, clinical trials of the new version of Sputnik V, based on the XBB.1.5 variant, are currently ongoing. Why hasn’t this been done before?
“We had vaccine options ready in the laboratory, we vaccinated our employees, and even in some ways we are uncomfortable; We protected ourselves, but we could not protect the country. But it’s not our fault. All Russian health structures need to be prepared for the fact that vaccine variants will need to be rolled out quickly, even faster than the original Sputnik V.
But we are actually currently running clinical trials of the updated Sputnik based on XBB.1.5 and will complete them on December 10th.
— Does this mean that people can be vaccinated with the new Sputnik on the 11th?
— We receive a registration certificate on December 10, but this does not mean that we can put the vaccine into civil circulation on December 11. We must act in accordance with Federal Law 61. This means that we will develop batches and then start testing on December 11, thus pushing back the date of introduction of the new vaccine into civil circulation by another 2.5 months. So the new Sputnik will enter civilian circulation in March.
– But wait, will a new COVID-19 variant already appear by March 2024?
— Yes, there is a possibility that this vaccine in March will now become very relevant or completely irrelevant. But we have to obey the law, right?
— Well, isn’t it possible to change the law when it is obvious that “omicron” is far ahead of this regulation?
“For me, this is exactly the lesson of the pandemic; We need to learn clearly about this and develop new rules. We certainly cannot be a year behind the ever-evolving virus with our developments.
— Will the vaccine based on XBB.1.5 be nasal?
– But this is also an interesting question. The fact is that after Denis Yuryevich Logunov vaccinated Vladimir Vladimirovich Putin intranasally and the whole country saw it, the President verbally ordered the allocation of money to the Gamaleya Center for comprehensive research of nasal vaccination. This was in November 2021. And just three months ago, we received the good news that there was money from the Ministry of Health and that we needed to prepare an application for a government job. Of course, we prepared and served it quickly. However, by law, all allocated federal money must be approved by the Russian Academy of Sciences. Therefore, the Russian Academy of Sciences wrote that it does not see any interest in this.
– Wait, how is this? Does the Russian Academy of Sciences have no interest in nasal vaccines? Or in this study of a future specific nasal vaccine based on XBB.1.5?
— We’re talking about XBB.1.5. It was the new vaccine mentioned in the application. On September 14, we received a review from the Russian Academy of Sciences, so money for this research has been blocked. However, RAS can also be understood. Of course, there are knowledgeable and educated people who understand very well that nasal vaccination offers fundamentally new opportunities. It provides sterile immunity as it is administered intranasally. This means that the person vaccinated in this way will no longer be a carrier of the pathogen. And the person vaccinated by injection. In other words, it protects itself, but it can release the virus from the nasopharynx and infect others. Therefore, from an epidemiological perspective It is the nasal vaccine that breaks the chain of transmission. This is a fundamental question in epidemiology that has never been resolved. And based on adenovirus, this is now the only technology in the world that allows this to be done.
However, RAS experts also believe that it is not possible to evaluate its effectiveness against coronavirus variants that will circulate in the future by the end of 2024. And the study was designed for 16 months.
— So, did Pfizer and Moderna change the antigenic composition of their vaccines?
– Yes, they changed it a long time ago, of course. But we did it again even earlier; We now propose a second amendment. But we cannot put it into civilian circulation.
– Did they let you out?
– Certainly. Pfizer’s president, Albert Bourla, actually did a great thing: when the American FDA (Food and Drug Administration) banned the old antigenic compound and said that only the new one should be administered to people, Pfizer’s president removed the entire antigenic compound. Old drug stock to Europe. He signed an agreement with the EU and they bought everything from him because the European regulator imposed a ban on the old antigenic compound only 5-6 months later.
From an economic standpoint, I think this is an absolutely great idea. The Nobel Prize in Economics should have been given to this person.
— So there is a second iteration of the vaccine in Europe and the US?
– Yes. And soon perhaps a third will be needed. Let me emphasize that there is nothing fundamentally new in changing the antigenic composition. We change the antigenic composition of the flu vaccine every year and treat it in an absolutely normal way. However, WHO took the main responsibility here; is leading this process. And we must fight COVID-19 domestically. For some reason it suddenly turns out that this is more difficult to do.
— Now the cold season has begun. Now how to get vaccinated against COVID-19?
– It turned out to be nothing. Except for Convasel and Novosibirsk EpiVacCorona. These vaccines have registration documents. We haven’t heard anything about CoviVac for a long time.
— In some clinics in Moscow, as I learned, you can actually be vaccinated with the FMBA vaccine Convasel, which is made on the basis of the N-protein of the coronavirus. Does this make sense?
— The N-protein of the coronavirus has now been thoroughly researched, thousands of articles have been written about it in the world, but in none of them will you find that the antibodies against the N-protein of the coronavirus are viruses. -neutralizing. Yes, antibodies are formed, but they have nothing to do with protection.
— If we turn to the lessons of the epidemic that WHO thought was over, can we look back and say that quarantines were not necessary?
– Of course we need this. In the absence of a vaccine, we are left with nothing but the use of prehistoric methods: self-isolation and masks.
— As far as I remember, the first quarantine was announced in Moscow on April 28, 2020. Is there really no vaccine yet?
— Gamaleya has already gone to the institute. When on April 20, Minister of Health Mikhail Murashko and I first told Vladimir Vladimirovich about our successes, to be honest, at that moment I was already vaccinated. And if we imagine such a fantastic option that we can make the vaccine in 40-45 days, then we can really start general vaccination in April. In this case, there will be no need to declare a curfew; A large amount of money will be saved.
— Is it possible to launch the vaccine in such a short time?
“This is the main lesson of the pandemic and it is now clear what to do when this happens again. As a matter of fact, the time for the vaccine to enter civilian circulation can be reduced to 40-45 days. By the way, the leaders of our country, both Putin and Mishustin, write this in all instructions. Real life demands this from us. What is needed for this? It is necessary to create a vaccine prototype bank against infections transmitted by airborne droplets.
— So, this bank will contain prototypes of drugs using certified technology, and all you have to do is add a new type?
– Yes. For example, the prototypes based on the adenoviral technology we have developed will be stored in the refrigerator as canned food. When you have a microbiological complication of any nature, you do not need to reconstitute the vaccine, you just need to take the right canned product from the refrigerator, open it, develop it and put it into public circulation. This can really be done in 40-45 days.
Why were we the first in the world to make the vaccine? Because we had a vaccine in our refrigerator against MERS – Middle East respiratory syndrome, which is also caused by the coronavirus. Let me remind you that the MERS epidemic occurred in 2013.
— What would it take to create such a vaccine prototype bank?
— To function properly, we need another structure: the National Serum Bank. This bank needs to collect blood samples from citizens across the country. So we see what pathogens are present in the country. This way, we will be able to work without waiting for WHO’s recommendations, which come too late. Once we see antibodies against a new pathogen with epidemic potential in blood samples, we will already know which can to open and which vaccine to give.
Two generations of directors of the Gamaleya Institute tried to convey to the country’s leadership the idea of the need to create a Serum Bank. I’m trying now.