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President of Russia Vladimir Putin: Mr Logunov, first of all, thank you for coming. Today, on your recommendation, and that of your colleagues, I received another jab, this time with Sputnik Light. This is now called re-vaccination. And in connection to this – you and I do not meet very often, but regularly, but in fact I have regular conferences with the management of the institute – today we have a chance to discuss all those topics that worry our people, our citizens. You can share your vision of the situation, whether vaccination and re-vaccination is necessary, and talk about the results of using Sputnik Light both in Russia and abroad. But still, let us begin with the first and foremost question: why and when it is necessary to vaccinate and on what ground the decision to re-vaccinate should be made.

Deputy Director of Gamaleya National Centre of Epidemiology and Microbiology Denis Logunov: Yes, Mr President, this is really the most important question, and, of course, it did not appear out of nowhere. The fact is that there are electronic registers in Russia, exactly like the registers for recording infection rates abroad. I am referring to such leading countries as the US, Europe, and Israel. We can see in these registers that rates are decreasing– both in Russian and foreign ones. It is not a dramatic drop, but a decrease in the effectiveness of vaccinations six to eight months after the first injection. And, naturally, the first impulse of any researcher and of any doctor would be to recommend revaccination with another dose. This is not some new innovation: this route has been used many times during vaccination campaigns.

I can say for sure that according to our and foreign data, as well as international practice, we can see that the introduction of a third dose, introduction of re-vaccination into medical practice, brings the decrease in effectiveness back to its initial level, and even higher, sometimes 1.6 or two times higher than after the first dose. I am referring to the rate of effectiveness. We can see this from the morbidity index. So, this approach, re-vaccination, is working. It has proved its effectiveness, so, of course, it has found its way into the recommendations of the world’s leading regulators, as well as in the Russian Healthcare Ministry.

Vladimir Putin: Do you mean that re-vaccination is required after a certain amount of time after vaccination, six months on average?

Denis Logunov: Yes, correct, six months, and, according to our recommended practice, I believe that re-vaccination should occur after six months under unfavourable epidemiologic conditions. Unfavourable conditions are determined by the Federal Service for the Oversight of Consumer Protection and Welfare and the Chief Sanitary Doctor. Under conditions when we no longer see a pandemic or epidemic spike, vaccination is possible and will be recommended once a year.

Vladimir Putin: Do you mean now or later?

Denis Logunov: Naturally, this will happen later. Right now, we are experiencing an unfavourable period, so at the moment we are talking about six months.

Vladimir Putin: Then the next question is – I know you are also developing a nasal spray vaccine.

Denis Logunov: That’s right.

I would like to say that this is not a new way either. We have extensive experience in the development of vaccines, primarily in our country, and in particular, we know such examples as the polio vaccine. We also know that vaccines administered through parenteral method, or intramuscular injection, are effective, but they have limited ability to induce immunity from so-called breakthrough infection and symptomatic illness. We need to deliver the agent through the mucous membranes to induce barrier immunity.

When it comes to COVID-19, barrier immunity refers to our immune organs located in the nose and the pharynx. To induce barrier immunity, we had to create a vaccine that is delivered nasally. Therefore, we have in fact developed such a nasal agent and we plan to start using it in the near future. It just needs a little finalising, then it will go into clinical tests, and after that, we certainly plan to begin the new vaccine rollout.

This will be an additional barrier. First, it is convenient for vaccination, it is painless, with an absolute minimum of side effects. On top of that, we will achieve the most important thing – first, primary parenteral vaccination will induce systemic immunity, and then the intranasal immunisation will create an additional barrier, mucosal immunity in the upper respiratory tract.

Vladimir Putin: Speaking of painless, I was given a shot just two hours ago, and I do not feel anything, I am feeling normal, everything is fine.

As for this nasal agent – are you still testing its efficacy? Or what are you working on exactly?

Denis Logunov: Mr President, I must confess it is an off-label administration basically, as usual, we are testing it on our employees.

Vladimir Putin: So it is just an experiment.

Denis Logunov: It is.

Vladimir Putin: Can I take part in this experiment?

Denis Logunov: Of course, Mr President.

Vladimir Putin: Alright, we will discuss the details…

Denis Logunov: If you sign an informed consent, you can participate.

Vladimir Putin: Agreed, I will definitely sign it. We can do it today.

People are still concerned about the effectiveness of our vaccine. You actually headed the group of researchers who created Sputnik V. In fact, you and your colleagues are the creators of this medication. Over 50 million people have been inoculated with this vaccine in Russia and many more, over 100 million or more, approximately 120 million people, have received it around the world, in the countries that have recognised and are using it. This amounts to considerable data for analysis. What are its results?

Denis Logunov: Mr President, you are absolutely right, this is exactly how many doses have been used, first of all, thanks to the efforts of the Russian Direct Investment Fund. It is thanks to the RDIF that 71 countries have registered the Sputnik V and Sputnik Light vaccines.

At present, the most important information has come from Argentina, and we also received independent data from San Marino. With the help of our Argentinean colleagues, we have established that the effectiveness of Sputnik Light there is 78 percent, but the Delta strain has not reached the country yet. Therefore, we can gauge the vaccine’s effectiveness against the Delta strain on the example of San Marino, where it is around 80 percent, or 78 percent depending on the analysis set, but we can say confidently that it is around 80 percent, and it is not the immediate effect but effectiveness five months later.

We can make the same conclusion based on Russian studies. We conducted mostly cohort studies on the Delta strain among military personnel deployed in Moscow and the Moscow Region. The effectiveness against this strain is 83 percent.

What does this mean? Yes, we can see a decline from 92–95 percent – the figure was as high as 98 percent in Bahrain – but the vaccine nevertheless remains effective, and its effectiveness is much higher than the 50 percent threshold set for COVID-19 vaccines by the WHO.

At the same time, Mr President, I would like to point out that we continue to keep abreast of the developments, as we discussed it with you the first time, and that we are not satisfied with the figures and achievements, because the virus is changing indeed, and so this is not the time to become complacent.

Of course, we have been working on all of the so-called VOCs, the variants of concern, as translated from the English. We have examined all the required vaccine strains, including the Delta strain. Moreover, we have completed the development and even produced a small batch of the two components: the first one is based on Adenovirus Serotype 26, and the second one relies on Adenovirus Serotype 5. That is to say that if needed, if we discover that the vaccine becomes, all of a sudden, much less effective, we may well use this product as part of clinical trials on the intranasal vaccine.

Vladimir Putin: Mr Logunov, what was the jab I received today? Was it Sputnik Light or simply the first component?

Denis Logunov: You received Sputnik Light. In fact, this is the first component. Let me explain. In our studies and observations, we found that in more than 80 percent of cases one injection was enough to boost immunity, making the second component unnecessary in most cases. Some people have a suppressed immune response, and there are all kinds of conditions that undermine the immune system, and in these instances people need to receive the full Sputnik V vaccine. However, if there are no medical grounds of this kind, Sputnik Light is enough as a booster jab.

Vladimir Putin: Is the jab I got today the same as the first component in terms of volume?

Denis Logunov: Yes, exactly the same.

Vladimir Putin: Mr Logunov, the vaccination of children has been a matter of concern for many people, which is a natural thing. Have you worked on this issue? If we do get a vaccine of this kind, when will this happen?

Denis Logunov: Of course, we are working on this.

We have completed the first two stages in the clinical trials, which demonstrated a high level of tolerance. First, we determined the dose that would be safe for kids. We also discovered that the average immunological potency is much higher in kids compared to adults. As such, we have every reason to believe…

Vladimir Putin: What do you mean by immunological potency? Can you explain in plain language?

Denis Logunov: I am referring to the number of antibodies in the blood samples after receiving the jab. Children have a much higher count compared to adults, while the dosage is lower. Moreover, kids seem to tolerate the vaccine very well.

We reported about this not only to the Healthcare Ministry, but also to the Data Safety Monitoring Board, and we have an independent expert opinion on the safety of this vaccine. For this reason, we expect…

Vladimir Putin: Sorry for interrupting you, but have you changed anything compared to Sputnik V or is this a lower dose of the same vaccine, adjusted for a smaller body weight?

Denis Logunov: You’re right. The dose was adjusted based on patient’s weight, also taking into account the age-specific characteristics of immunity.

Vladimir Putin: So basically, you used the same formula?

Denis Logunov: Absolutely the same, yes, Mr President. Nothing else has changed.

Vladimir Putin: So, in principle, after using it on 120, even 170 million people, this suggests that, if adjusted for patient’s weight, the same formula can be used on children.

Denis Logunov: Yes, certainly.

Vladimir Putin: I see. So you primarily rely on practice, am I right?

Denis Logunov: Absolutely. We now have a huge background and can demonstrate safety based not only on the experience in the Russian Federation, but we also have independent expert opinion from Argentine doctors, and European doctors. This, I think, is very important.

Vladimir Putin: Yes, this is very, very important, indeed. This means it is not some obscure domestic drug, but independent experts in the countries that use it have provided objective information on how it works.

Denis Logunov: More than that, they have published it in independent scientific journals, without any comments or reviews from the Gamaleya Centre or anyone else from the Russian Federation. That is, it is a truly independent appraisal.

Vladimir Putin: Another important question is of course about potential medicines for the treatment of the coronavirus infection.

Denis Logunov: Indeed, Mr President, it is also a very important matter. Because we can keep the infection under control, declare that it is manageable, only if we have not just the preventive treatment schemes, but also have an option for cases when a patient actually has the infection – regardless of whether they might have been given chemotherapy, or have a primary immunodeficiency due to some genetic factors – for this part of the population, we must certainly have medicines, because vaccines will not be able to protect them well enough.

The Gamaleya Centre is working on at least two strategies.

The first is monoclonal antibodies. It is the same type of medication that was used to treat Donald Trump, and its development is almost finished. First of all, we managed to demonstrate in experiments on transgenic animals that it can provide full protection. Clinical trials will begin very soon. I hope we will get authorisation in January. And I hope that in the next three to five months, the medicine will be approved. The Gamaleya Centre is only partially in control as it depends on how soon we can find volunteers for the trial. Still, in the foreseeable future, we will be able to have this treatment registered, as per Government Regulation 441 that specifically addresses COVID-19 medications.

Another area of research is, of course, chemotherapy using chemical substances. Here, we are in the early stages because the funding programme became available and, essentially, the actual possibility to discover a certain class of substances arose relatively recently. We have conducted initial screening and identified the “hits” among compounds (sorry for the lab jargon), the leading compounds that will be improved and tested in further experiments on animals.

This will require more time and I think that by the end of 2022, we will be able to have this medication registered – obviously provided that, the tests on animals and the clinical trials are successful.

Vladimir Putin: When I received my jab about six months ago, they told me I should refrain from getting another vaccine (a flu jab, for example) because the number of COVID-19 vaccines and data on their effectiveness was still insufficient. So, I was told to wait at least a month before getting a flu jab – or vice versa, first flu jab and then, after a month, a COVID-19 jab.

You have analysed how such a vast number of people – 170 million in Russia and all over the world – responded to your vaccine, Sputnik V. Do you think, given the current flu season and high ARVI incidence, that people can get jabbed with one vaccine after another or are they better to wait for a while? After all, the immune system has to first become adapted to just one medicine, does it not?

Denis Logunov: Mr President, actually this is the most difficult question, because it has many aspects.

First, speaking of efficiency, we have made tests and run special experiments. We were administering two vaccines – against COVID-19 and against flu – simultaneously. In this case, there are just two tentative scenarios. Either the vaccines block each other because of their competing antigens, that is, they reciprocally reduce their efficiency, or – and there are also scientific grounds for that – they can both get more effective owing to decussation and the boost that immunity’s helper segment gives to each during vaccination. We have shown that the flu vaccine becomes much more effective if it is administered along with the vaccine against COVID-19, Sputnik V. So, in this sense, there are no restrictions on use.

But there is also a formal aspect related to safety. To determine the degree of safety, all these combinations should be tried and tested under clinical conditions. So far, this has not been done, because there is always a shortage of time for testing all the combinations with regard to all the vaccines. But at this moment, it is enough to wait for two weeks, since, in my opinion, this is the period in which there are primary inflammatory reactions, which are entirely over within two weeks. After two weeks, therefore, we are guaranteed against any complications and this cannot be regarded as a concurrent use.

On the other hand, however, we are clearly aware that one vaccine will not do harm to another.

Vladimir Putin: But still, what is the sequence? First you get jabbed against flu and two weeks later – against COVID-19. Or vice versa. Is that right?

Denis Logunov: Quite right!

Vladimir Putin: Thank you very much.

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