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President of Russia Vladimir Putin: Ms Skvortsova, the Federal Medical-Biological Agency has very many fields of interest and areas of work. All of them are very important for the healthcare system and even for certain large economic sectors, and all of them are highly important and interesting.

I know that you have prepared a report on the Federal Medical-Biological Agency’s 2020 performance results. Please, go ahead.

Head of the Federal Medical-Biological Agency Veronika Skvortsova: Mr President, the Federal Medical-Biological Agency caters for 3.5 million residents of this country, primarily employees of over 700 organisations with extremely hazardous working conditions and risks, their family members, and the population of 20 closed administrative territories, 39 satellite towns and science cities. They are located in 54 Russian regions and at the Baikonur Cosmodrome.

Of course, throughout 2020, the Federal Medical-Biological Agency, just like the entire country, was largely occupied with the novel coronavirus infection.

Our Agency set itself several tasks.

First, we aimed to prevent the infection from spreading and to contain it at the strategic facilities with which the country’s activity is linked and to prevent the infection from spreading on territories for which the Agency is responsible. In addition, the Agency assisted all Russian regions and residents, coordinated the work of the blood donor service, the procurement of anti-COVID blood supplies and also conducted research.

I would like to start by saying that together with our partners, Rosatom, Roscosmos and the Ministry of Industry and Trade, we developed a package of measures to counter the epidemic which allowed us to ensure the uninterrupted operation of all the facilities such as nuclear power plants, to support 15 space launches from our three launch sites and to support the entire scope of search and rescue missions, even during the strict lockdown in Kazakhstan. We were also able to resume training sessions for our country’s national teams in July, without any risks, and avoid spreading the infection across the seven federal bases where the teams trained.

This was primarily due to the fact that we focused on early diagnostics by expanding the network of PCR laboratories on our territories, by 300 percent in the period since March, from 14 to 52 labs. The Rosatom state corporation helped us adopt the technology with which we significantly increased the workflow of each laboratory and reduced test processing times.

As a result, we achieved one of the highest testing rates. Our system had an average figure of 320 per 100,000, and for some strategic facilities over 1,000 per 100,000. That provided for the timely implementation of the entire scope of epidemic control measures and treatments. Consequently, the cumulative mortality rate across all our territories and facilities was only 0.9 percent, which is far lower than the average rate in both Russia and the world in general.

I would like to note that in January, we launched a vaccination campaign. Besides doctors and education workers, we certainly prioritise essential workers at Rosatom, our cosmonaut crews and members of the national sport teams who are to compete in the Olympic Games in July, August and September, in Japan and China.

Our second area of focus is building a COVID-19 relief network. We opened 53 hospitals for coronavirus patients, in almost all our territories. To ensure high quality medical care, we set up a network of reference centres with a headquarters at the Burnazyan Federal Medical and Biophysical Centre, and eight district COVID-19 centres based at our district centres. Each of these district centres has a rapid-response mobile crew that can be sent where needed within two hours and provide methodological, organisational and simply hands-on medical help.

Our combined units of 50–100 people have helped the regions to curb large outbreaks, such as in Yeruda, a village in the Krasnoyarsk Territory. We have collaborated with the Defence Ministry there. Our units supported the healthcare system in Crimea by working several months in Simferopol and Yalta, last summer and autumn. Overall, our combined units have helped 17 constituent entities of the Russian Federation.

Telemedicine has played a huge role. During the epidemic, we conducted more than 105,000 telemedicine consultations, including over 25,000 for patients with the novel coronavirus infection. We evacuated the gravest cases, a total of 900 patients, with more than 200 of them being transported by air ambulance.

Of course, Mr President, our mandate is to coordinate the blood service, so we specifically monitored blood banking and the delivery of the necessary blood components to medical facilities through the integrated database.

Unlike other countries where the number of blood donors and donations has sharply decreased due to the pandemic, we have not experienced any reduction in the volume of blood and components donated, but rather there was an increase of more than 15 percent compared to 2019.

In April 2020, we opened a national coordination centre for the banking and clinical use of immune plasma. The centre has been coordinating this effort across Russia, and it issued methodological recommendations for all regions to follow. We have accumulated more than 22 tonnes of anti-COVID plasma.

Now back to something I actually started with. The Agency’s most important function is, of course, R&D projects. We began working on this at the end of January. The first thing to do was to develop test systems. Our first test system was ready in March. Now there is an entire series of test kits for PCR diagnostics, antigen detection, and isothermal amplification, and enzyme immunoassay for antibodies. Every fifth test now uses a system provided by the Federal Medical-Biological Agency.

Now, we have also developed special technologies, test systems for detecting virus mutations with just an ordinary swab test, in response to concerns regarding the virus variability and the need to detect several of the most significant mutations. The new tests not only confirm the presence of the virus, but also identify the strains that we need to be alert to and that require special attention.

I would like to note the following two new preparations.

First, we have developed a unique preparation hinging on the use of micro-RNA components that block certain RNA virus sites and those sites responsible for copying the virus molecule, or the so-called RNA-polymerase site. We called this preparation Mir-19 because the micro-RNA component is, first of all, completely safe for humans, and it does not affect the human genome or human immunity levels. At the same time, it is extremely effective at destroying the virus. Experiments on animals show that their virus-carrying capacity plunges 10,000-fold. It also prevents the gravest forms of the coronavirus infection, including pneumonitis conditions and acute respiratory distress syndromes against the backdrop of the coronavirus infection.

On December 30, we obtained permission for clinical trials because the entire pre-clinical stage was already over. These clinical trials were launched immediately following New Year celebrations. The new patented molecule is absolutely unique, and we are therefore conducting this phase particularly thoroughly because we have to prove that the preparation is absolutely safe for humans. We will complete the first phase by mid-March and will then start working with patients and also launch the second phase.

If you allow me, I would like to mention the second aspect, namely, the development of a new technological platform for creating next-generation anti-COVID vaccines. We are developing a vaccine for dealing with virus mutations when accumulated mutations in the receptor-binding domain of the S-protein might prevent anti-bodies from bonding. The new vaccine we are developing influences other protein components of the virus, rather than the S-protein. First of all, it helps expand cellular and cytotoxic immunity, rather than humoral immunity through the activation of anti-bodies. As a rule, antibody immunity lasts for months, and cellular immunity lasts several years. Certain experimental projects show that this immunity may last 13 to 17 years.

We have now obtained this medication’s initial formula and are currently getting ready for clinical trials. We hope very much that we will launch clinical trials in the second half of 2021.

This area of focus is currently completely on trend when it comes to international interests. The World Health Organisation meeting on vaccines confirmed the trend of developing next-generation vaccines early in case this virus’s mutation will prevent us from using the vaccines based on antibodies. Therefore, we hope we will be ahead of the game.

Vladimir Putin: Good. If everything goes well, these vaccines will be ready later this year, won’t they?

Veronika Skvortsova: Yes, starting in July.

Vladimir Putin: Are you talking about clinical trials?

Veronika Skvortsova: Yes, clinical trials.

Vladimir Putin: How long do they take?

Veronika Skvortsova: The first and second phase will be combined as currently authorised by the vaccine trial protocol. If we test it on a large pool of patients, the trials will take several months as was the case for Vector’s vaccine and Sputnik V.

Vladimir Putin: As far as I know, all of the test systems used in Russia can rather easily detect the virus regardless of the strain, is that correct?

Veronika Skvortsova: Yes, absolutely. We tested all our systems, including for their ability to detect S-protein mutations. I should mention that the choice of promoters (the active part of our test systems) was so accurate that they essentially disregard mutations and, therefore, work with any strain.

Moreover, the additional test system we developed will allow for selecting the mutations whose carriers require more careful observation because their incidence may be more serious than in others.

Vladimir Putin: It was reported to me that our current vaccines are effective against the strains that seem to be causing dismay in Europe and not only in Europe. The trials of these vaccines against the virus show that our vaccines are effective against these strains.

Veronika Skvortsova: Yes, we found 3,500 mutations in Russian patients. These are single-nucleotide variants which are neutral and do not affect the course of the coronavirus disease. They are represented in single cases, except for seven mutations which were found in more than five percent of our population. Four of these seven mutations were discovered in the spike protein, but neither was found in the receptor domain. This means that the receptor domain in our population is unchanged, and all of our vaccines, both Sputnik V and Vector’s vaccine, are effective because antibodies can bind with this site as normal, without any alterations.

There are also three mutations in deep nucleocapsid protein but it is a completely different story that is unrelated to binding.

Vladimir Putin: Good, thank you.

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