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President of Russia Vladimir Putin: Good afternoon.

What shall we begin with, Ms Skvortsova?

Head of the Federal Medical-Biological Agency Veronika Skvortsova: If I may, Mr President, I’d like to address the participation of the Federal Medical-Biological Agency (FMBA) in the special military operation.

From the very beginning of the operation, FMBA units, comprising combined mobile medical teams, have been actively involved in addressing the medical and sanitary consequences of hostilities in the Donetsk People’s Republic, the Zaporozhye and Kherson regions, as well as sabotage attacks in the Belgorod Region, Crimea, and during emergency situations.

The first months of our work highlighted the urgent need for a significant modernisation of the mobile medical care system and the development of a new specialised medical capability within the agency.

A dedicated department and specialised units were established, incorporating rapid response teams for radiation, chemical, and biological reconnaissance, as well as for identifying hazardous factors and implementing protective measures. Additionally, mobile medical teams composed of experienced specialists were formed to deliver specialised, including high-tech, medical care in combat conditions. These teams are equipped to perform surgical procedures and resuscitation efforts in the field.

To ensure the efficiency of operations, the vehicles underwent comprehensive modernisation. Specialised medical-technical equipment was developed specifically for radiological, toxicological, and biological reconnaissance vehicles, which are fully outfitted with advanced portable digital tools designed by the FMBA’s centre. These devices function within a unified information system, enabling real-time operation.

Notably, armoured ambulances have been introduced, along with specialised ambulances featuring fragmentation protection made from high-density polyethylene and Kevlar. These multilayer materials, developed in the experimental workshops of the FMBA, are used to reinforce vehicles and construct stretchers for safe evacuation of the wounded. They are capable of withstanding damage fragments equivalent up to 110 grammes of TNT. Additionally, KAMAZ-based vehicles have been equipped with built-in operating rooms and resuscitation units, enabling the provision of critical surgical and resuscitation care both during transportation and in field conditions.

Our units operate in close coordination with the Defence Ministry, maintaining direct contact with their medical divisions, and have proven their effectiveness. For instance, on the night of August 7, during an enemy attack on the border areas of the Kursk Region, we swiftly relocated a team of 200 personnel to our medical base in Kurchatov in just four hours. This deployment included 180 highly qualified specialists, 68 surgeons across various specialties, resuscitation experts, radiation, chemical, and biological protection teams, as well as the necessary transport, including armoured vehicles. This enabled our unit to evacuate the wounded or affected individuals directly from the combat zone.

During the first weeks, medical help was provided to 300–400 wounded every day. Up to 60 surgeries were performed daily at six concurrently operating surgical facilities. As of today, in the Kursk Region, over 5,500 patients have received medical help, more than 3,000 surgeries have been performed, and over 2,000 people have been evacuated. We established a mobile hospital with 118 beds located just 35 kilometres from the border areas with ongoing combat operations.

Our medical teams continue to carry out the assigned tasks in five areas and to work closely with the Defence Ministry. To date, medical help has been provided to over 125,000 patients, among them 77,000 servicemen.

Specialised inpatient care is provided at 17 FMBA medical centres, including the one that you opened in Mariupol in late 2023. That centre has been in operation since January.

Vladimir Putin: It turned out to be an excellent, beautiful centre.

Veronika Skvortsova: It is an excellent centre, and it is in high demand. It has already provided help to over 41,000 patients, both civilians and military personnel, with surgical interventions performed on over 2,500 wounded.

I briefly touched on the comprehensive rehabilitation and recovery treatment system for servicemen during the Sports Council meeting. Rehabilitation and recovery services are currently provided at 69 Agency’s facilities.

I would like to note that in October 2023, in collaboration with the Defenders of the Fatherland Foundation and the Ministry of Industry and Trade, we piloted customised prosthetics for the wounded personnel who had lost limbs, integrating it into a continuous rehabilitation cycle. The prosthetics care was provided at the bedside, and this approach proved so successful and so significantly enhanced recovery efficiency and shortened the re-socialisation period, that we decided to scale it up this year. In less than six months, we established a new combined prosthetics and rehabilitation centre in the Moscow Region which will open in January 2025 and will handle both custom prosthetic production and comprehensive rehabilitation.

Last year, in response to the needs primarily arising from the special military operation, we opened a medical and psychological support centre which enjoys high demand. Its specialists provide both emergency assistance and long-term support for servicemen and their families. Importantly, they train specialists. Over the year, 92 specialists were trained for the Defence Ministry hospitals and branches of the Defenders of the Fatherland Foundation. These experts also travel to regional branches of the Foundation upon request to provide assistance, give master classes, and more.

Another important aspect that needs to be taken into account is the growing need for blood and blood components. Since the FMBA is the national coordinator and operator of the blood service, we are currently meeting the demand nationwide, including the Defence Ministry and other military units. Whole blood collection has increased by 49 percent, and plasma and other components by 34 percent.

t is noteworthy that since 2022 we have more than doubled the strategic reserve of blood and its components, ensuring robust protection in emergencies of any magnitude. Following your instruction to achieve national self-sufficiency in blood-derived pharmaceuticals, we have increased the collection of plasma for production purposes twentyfold since 2021, rising from 30,000 litres to 600,000 litres this year.

Vladimir Putin: Twentyfold? That is indeed impressive.

Veronika Skvortsova: Indeed, this volume facilitates the production of essential preparations such as albumin and immunoglobulins. This achievement is largely due to the expansion of the donor movement, with the number of donors rising by 30 percent.

Notably, 99 percent of Russian donors contribute blood voluntarily, motivated by altruism and solidarity with their compatriots, with 81 percent being repeat donors. It is this spirit of donation that has underpinned the transformation and increased supply.

Additionally, as per your instructions, we established the Federal Register of Bone Marrow and Haematopoietic Cell Donors, which has been operational since September 1, 2022, formed through the consolidation of 11 regional registers. At inception, these registers contained 112,000 potential donors, accumulated over a decade.

Vladimir Putin: A fourfold increase?

Veronika Skvortsova: Precisely, in two years, there has been a fourfold enhancement in the efficiency of identifying unrelated donors, now reaching 78 percent, alongside an increase in unrelated transplantations. We aim to expand this to 500,000 next year, thereby providing at least 90 percent of Russians in need with compatible donors domestically, while maintaining all connections with international registries, which actively use our register and we have the opportunity to search theirs.

Mr President, I wish to report on a critical area for our Agency, which is our primary mandate: research, development, and innovation in biotechnology.

In recent years, we have successfully established a robust research cluster comprising 35 R&D centres, including eight strategic enterprises. This infrastructure supports the entire development process, from conceptualisation and foundational research to prototype creation, testing, production transition, and practical application.

Our second achievement is that, on the basis of these centres, we have deployed standardised technological platforms based on advanced, science-intensive technologies. These platforms enable the rapid assembly of specific biotechnological components through developed algorithms, provided they share a unified structure and mode of action.

These two efforts – the establishment of a research cluster and creation of technological platforms – have accelerated the innovation process considerably and enhanced development efficiency. Consequently, from 2020 to 2024, we have not only developed over 100 products, including medicines, diagnostic kits, and medical devices, but also comprehensively tested and registered them for practical use.

Vladimir Putin: Is cancer immunotherapy feasible?

Veronika Skvortsova: Yes, I would like to elaborate further on this topic.

Mr President, if you look at Slide 3, we attach great importance to R&D benefiting our military. After 2022, we developed and introduced new antidotes against chemical warfare agents, new pharmaceutical forms of radiation protectors and drugs that mitigate the effects of ionising radiation, as well as effective antihemorrhagic agents and other means of urgent medical aid that were included in a new kit intended for the Radiological, Chemical and Biological Defence troops, as well as other units of the Defence Ministry and other security and law enforcement agencies.

In parallel, we have created a range of biological hazard identifiers and detectors for all types of dangerous and especially dangerous infections, which can operate in the field and can be handled by operators without any special training. They are designed so effectively that the only requirement is to place the material in a designated tube, insert it into the instrument, and the instrument does the rest. In addition, there are sets of specialised test systems for self-diagnosing and mutual diagnosing among servicemen for all types of especially dangerous infections. This is all that has been created and is being used by soldiers in military units.

In addition, Russian instruments for blood transfusion, plasmapheresis, and sorting formed elements of blood have been developed over the past three years. They are portable, digital, and remotely operated in Wi-Fi mode. We have created preparations of lyophilised (freeze-dried) plasma that is preserved under all temperature conditions and can be transported easily. Universal plasma does not require knowledge of blood groups. It can be infused into any fighter in a combat environment.

I would like to highlight our most important R&D that has gained international recognition and is protected as intellectual property of the Russian Federation. If I may, I will start with the Convacell recombinant protein vaccine against COVID-19. This is the world’s first universal pan-vaccine, whose efficacy does not depend on mutations of the surface S-protein. In 2022, this vaccine was registered and was subsequently issued a permanent registration certificate after large-scale third-phase research earlier this year. This research demonstrated its extremely high efficacy: over 85 percent in the general population and over 92 percent in the context of double-blind, placebo-controlled studies in senior age groups.

It is important to note that no more than one percent of vaccinated individuals – and there are millions of them to date – fall ill. The results of this research were published by the Journal of Infection, a leading international publication. Currently, this drug is used not only in Russia but is also purchased by Nicaragua and several countries in Central and Latin America.

An absolutely innovative drug is the combined allergy vaccine developed by the FMBA’s Institute of Immunology. The vaccine contains two protein fragments of a birch pollen antigen and cross-reactive food antigens containing fruit stones.

This is an experimental vaccine. The experiments took a long time and demonstrated not only safety, lack of toxicity, and good tolerability, but also very high protective efficacy.

Clinical trials are currently underway. The efficacy results will be available after the first season of birch pollen dispersal, from April to June.

Vladimir Putin: Next spring?

Veronica Skvortsova: Yes, we will know the efficacy results by late June. According to the data from all previous experiments, this is a highly effective vaccine with no analogues in the world. The leading international immunology journal, Allergy, published the results of all stages of its testing. This is why the whole world is following this research.

I would like to highlight that for many years, Russia has relied on importing polysaccharide conjugate vaccines for bacterial infections such as pneumococcus, meningococcus, and Haemophilus influenzae, spending a substantial amount – 55 billion rubles over three years. Until recently, we lacked a domestic technological platform for producing these vaccines. However, the St Petersburg Scientific Research Institute of Vaccines and Serums has successfully developed a comprehensive technology, covering the entire process from antigen creation to finished product.

It is worth noting that our St Petersburg Institute of Infectious Diseases is simultaneously identifying the most critical serotypes and strains specific to the Russian population. This enables the development of unique vaccines tailored to the country’s needs.

The first vaccine against Haemophilus influenzae type B, a disease included in the national vaccination schedule, has successfully completed all tests, was registered and launched on the market earlier this year.

The 16-valent pneumococcal vaccine, which includes three unique Russian strains, is currently undergoing clinical trials, and we expect to begin the registration process by the end of next year.

The meningococcal vaccine is particularly unique as it is the first in the world to include serotype B, which accounts for over 30 percent of meningococcal infections in children in Russia. Globally, there has been difficulty conjugating this serotype with the other four, but our team has successfully developed a method to achieve this, a Russian innovation. Preclinical studies have been fully completed, and clinical trials are now underway. We anticipate that this vaccine will be available for use by early 2027.

Vladimir Putin: When will the allergy vaccine be ready for use?

Veronika Skvortsova: If we get positive results next summer, we will report them immediately and we hope to receive approval and registration by the end of next year, 2025.

Vladimir Putin: Millions of people in our country suffer from pollinosis.

Veronika Skvortsova: Yes, there is significant interest in this vaccine abroad as well. I believe we won’t be able to manufacture it using the FMBA capacities alone.

Vladimir Putin: Naturally.

Veronika Skvortsova: We have partnered with the company Generium for production. We have completed the full transfer and have produced the required amount for clinical trials.

If I may, I will very briefly mention cancer vaccines, just a few words.

Vladimir Putin: Of course, that is interesting.

Veronika Skvortsova: The global effort to create personalised medications, including cancer vaccines tailored to an individual’s biological profile, is gaining momentum.

A cluster of four of our centres, led by the Centre for Physico-Chemical Medicine, has developed a technology to identify the mutations that led to a specific person’s tumour. This technology isolates the neoantigens recognised by the individual’s immune system and further identifies the peptide fragments that serve as the precise signal for triggering the immune response in that person.

The second technology involves synthesising these selected peptides, which activate the immune system and guide it towards the tumour.

The development of vaccines that use these peptides as active substances represents the third aspect of our work. We have created several vaccines using various platforms and carriers. This includes peptides incorporated into nanoparticles, those within vector vaccine frameworks, as well as those using adeno-associated viruses and mRNA vaccines.

Why is this so important? The dynamics of activating the immune system vary significantly from person to person. Some individuals require a rapid immune response, while others may need activation over a week or two, with the goal of sustaining this response for three years. This necessitates different approaches and a variety of antigens.

During our experiments with the most aggressive gastrointestinal adenocarcinoma in animals, we observed not only a significant slowdown in tumour growth following the administration of the vaccine, but also, if the tumour is already there, its shrinking by 75–80 percent; as a result, the animals do not die from this tumour but continue to live, allowing us to manage it effectively.

In fact, we have completed a three-year research cycle for this vaccine. Earlier this year, legislation was passed regarding the use of personalised preparations, and we anticipate beginning patient treatments in early 2025. We are also conducting research for other cancer localisations, with melanoma, a type of skin cancer, and glioblastoma, a malignant brain tumour, denoted as No 2 and No 3, respectively.

Mr President, I would like to highlight one final point. I have mentioned mRNA vaccines, and we have achieved a significant breakthrough, positioning ourselves as global leaders in this field. We have developed a unique platform for developing mRNA vaccines that carry a nucleotide code instead of an antigen. This code enters a cell, prompting it to produce the necessary protein.

We have established a platform that facilitates the self-assembly of lipid nanoparticles with a diameter of 200 nanometres, allowing us to encapsulate mRNA containing the biological code inside this particle. Special components attached externally enhance the bio-compatibility and stability of the particles, enabling rapid cell entry and ensuring other distinguishing features.

Our comparative research indicates that this innovation, developed by our scientists, offers a substantial advantage over well-known international counterparts from Moderna and Pfizer. First, our vaccine is 65 percent more effective than Pfizer’s, generating protein using the code delivered inside the cell. It is also 90 percent more effective than Moderna’s vaccine. This data is highly credible.

Secondly, these vaccines faced widespread criticism globally following the COVID-19 pandemic due to numerous systemic side effects.

Vladimir Putin: Are you referring to Moderna and Pfizer?

Veronika Skvortsova: Yes, Moderna and Pfizer, specifically, their mRNA vaccines.

We have successfully modified the administration of this mRNA vaccine using special bioengineering techniques, virtually eliminating all side effects. The vaccine is activated at the injection site, rapidly entering immune cells in the bloodstream and taking effect without affecting other organs and systems.

This platform has also served as the foundation for the cancer vaccine, which, when injected into an animal, reduced the size of the tumour by 80 percent.

Vladimir Putin: How long will it take to complete this work and ensure the vaccine’s practical use?

Veronika Skvortsova: I believe we need approximately 12 more months to ensure it is completely safe, re-evaluating every component and the entire formulation.

Vladimir Putin: Nevertheless, this will be a breakthrough.

Veronika Skvortsova: We are very hopeful.

Vladimir Putin: Thank you.