VLADIMIR PUTIN,PRESIDENT OF RUSSIA:Meeting on increasing vaccine manufacturing and vaccination progress

Vladimir Putin held a videoconference on increasing the manufacturing capacity of COVID-19 vaccines and the progress of vaccination in Russia.
March 22, 2021
16:55
Novo-Ogaryovo, Moscow Region

Meeting on increasing vaccine manufacturing and vaccination progress (via videoconference).

The meeting included Chief of Staff of the Presidential Executive Office Anton Vaino, Deputy Prime Ministers Yury Borisov and Tatyana Golikova, Presidential Aide Maxim Oreshkin, Minister of Industry and Trade Denis Manturov, Healthcare Minister Mikhail Murashko, Minister of Science and Higher Education Valery Falkov, Head of the Federal Service for the Oversight of Consumer Protection and Welfare – Chief State Sanitary Physician Anna Popova, Head of the 48th Central Research Institute of the Defence Ministry Sergei Borisevich, CEO of the Russian Direct Investment Fund (RDIF) Kirill Dmitriev, Director of the Gamaleya Federal Research Centre for Epidemiology and Microbiology of the Healthcare Ministry Alexander Gintsburg, General Manager of the National Immunobiological Company (Nacimbio) of the Rostec State Corporation Andrei Zagorsky, Director General of the Chumakov Federal Scientific Centre for the Research and Development of Immune and Biological Products Aidar Ishmukhametov, General Director of the Vektor State Research Centre of Virology and Biotechnology Rinat Maksyutov, as well as the heads of companies Biocad, Binnopharm Group, Vector-BiAlgam, R-Pharm, Geropharm, Epivac, Generium, Pharmstandard and Nanolek.

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Excerpts from transcript of the meeting on increasing vaccine manufacturing and vaccination progress

President of Russia Vladimir Putin: Good afternoon, colleagues.

Today we will talk about issues related to the production of domestic coronavirus vaccines and the progress of vaccination in Russia.

Our research institutions are creating, as you know, a series of coronavirus vaccines. Three have already been registered in Russia. Two of them – Sputnik V and EpiVacCorona – are produced in large quantities by our pharmaceutical companies and are being used for vaccination. Another one, CoviVac created at the Chumakov Federal Scientific Centre is being prepared for rollout, and the first batches have already been produced. Incidentally, Russia already has three vaccines, which is certainly the result of hard work by thousands of people.

Also, despite the pandemic-related challenges, the domestic pharmaceutical companies, in conjunction with research institutes, have managed to accomplish a multitude of objectives in order to deploy new vaccine production sites in a short amount of time. At many sites, work was carried out almost around the clock. They introduced and calibrated modern and highly efficient equipment and created advanced biotechnological production processes that were unparalleled in our country.

Representatives of the pharmaceutical companies that manufactured the vaccines are here today.

Colleagues, friends, I would like to take this opportunity to thank you and your staff and workers for your truly selfless work and your responsible attitude.

Your efforts, as well as the effective work of our research institutes and the entire healthcare system, have made it possible to stabilise the spread of the coronavirus infection and to protect the life and health of millions of our people.

The implementation of a wide range of preventive measures, including widespread vaccination, has played a significant role in normalising the epidemic situation.

Overall, 6.3 million Russians have taken the first part of the vaccine, of these 4.3 million have been vaccinated in full, that is, they have received both vaccine components.

Today, we can safely say, and the practical results indisputably corroborate, the fact that the Russian vaccines are absolutely safe and dependable. Moreover, no other foreign-made vaccine offers this high degree of protection. To reiterate, this is a great accomplishment for our researchers and specialists.

Our success is recognised abroad as well. The number of countries using the Sputnik V vaccine is expanding fast. Despite deliberate efforts to discredit our vaccine and all kinds of fabrications occasionally bordering on outlandish fantasy, more countries around the world are showing interest in our vaccine with 55 countries having authorised its use.

Contracts with foreign manufacturers – and I want to stress this so that everybody understands what I am talking about: these are foreign manufacturers who will be producing our vaccine on their territory – have been signed for the number of doses needed to vaccinate 700 million people per year. Just today, we signed a contract with an Indian company for doses to vaccinate 100 million people. It is the news of the day.

We are working with 55 countries that have a total population of 1.4 billion. Very shortly, we will expand the number of our partner countries and reach 2.5 billion people.

It should be noted that the government bodies in such countries as Mexico and Argentina analysed the use of our vaccine on their territories, in their countries, and concluded that there are no side effects. It is very important for us because that was an independent assessment.

What is surprising is that right before our meeting I was told that just now, one of the officials in charge from the European Commission declared that they do not need Sputnik V. This is a strange statement. We are not imposing anything on anybody. By the way, many in Europe do not even know that Russia has long applied for registration with the European Medicines Agency. As Ms Golikova reported to me in the morning, the application was filed on January 21, 2021. Only on March 4 did we receive a message that the application review had started.

Here is what I would like to say on the matter. As I just said, we are not imposing anything on anybody. But when we hear such statements from officials, the question arises: whose interests are these people protecting? Is it the interests of certain pharmaceutical companies or the interests of European citizens? What are they up to? Lobbying? And these people are trying to teach us something – and imposing sanctions.

But never mind. Again, it is their choice and they are free to do as they see fit to achieve their goals.

Our pharmaceutical companies must consider the dynamics of the global market and the demand for our vaccine, while expanding their production capacities. But let me emphasise that as before, our domestic needs, supplying Russian citizens with vaccines, must be an absolute priority.

Now our most important task is to continue building up the vaccine production rates in the country. To that end, we must send enough vaccines to the regions, ensure the operation of a broad network of vaccination sites and, of course, continue informing people about where, how and when they can get vaccinated. This entire process must be as accessible and convenient as possible for our people, especially older adults.

I would like to emphasise this once again – our ability to conduct effective vaccination and acquire what specialists, including our colleagues at this meeting, call herd immunity directly affects the speed of our efforts to overcome the pandemic and lift all restrictions. We must reach this goal at all costs and establish this herd immunity.

It is estimated that at least 60 percent of all adults in the country must be vaccinated for complete stabilisation. This will require 69.8 million sets of vaccine doses. We have all the resources for making them. It was reported to me this morning that as of March 17, 20.1 million sets had been produced. Prime Minister Mikhail Mishustin spoke about 20,102,000 sets. At any rate, there are more than 20 million Sputnik V doses. A total of 8.9 million full sets of Sputnik V and over 115,000 sets of EpiVacCorona are already in civilian circulation.

I hope our pharmaceutical companies will not only keep the current pace but will also continue building up production, will ensure reliable and regular vaccine supplies to the regions, and will make good use of the tangible export potential.

Let us discuss today how we plan to address these tasks.

In conclusion, I would like to emphasise that vaccination is certainly a free choice, the personal decision of every individual. By the way, I am going to get vaccinated tomorrow.

Let us start working.

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Minister of Industry and Trade Denis Manturov: I would like to report successively about building up the production of each of the three anti-coronavirus vaccines.

I will start with Sputnik. At present, four companies are producing it at seven sites. I would like to make special mention of the Generium Group and Pharmstandard, which have produced the bulk of the supplied vaccine so far. You have already mentioned the general amount.

There is a daily timetable for presenting labelled vials for control through the Gamaleya Institute and Roszdravnadzor laboratories. This allows us to put new series into civilian circulation very quickly.

Under the plan, 12.5 million sets of the vaccine must be produced in March. The planned figure for April is 17 million. We plan to continue building up production so as to have over 80 million of two-component doses by the first six months.

(The minister went on to describe the new Gererium, Biocad and R-Pharm production sites.)

As you said, all these amounts will be primarily used to vaccinate Russian citizens. To meet the global demand for our vaccine, we are working on transferring technology abroad. We have agreements on this with manufacturers in 10 countries.

Now the EpiVacCorona vaccine. We are consistently reaching an industrial scale of production. Two industrial partners are involved in this: Geropharm in St Petersburg and Vector- BiAlgam in Novosibirsk. As of today, they have produced the first 365,000 double doses and must turn out 5.5 million vaccine sets by July.

Now the CoviVac vaccine from Chumakov Centre: the initial amounts of the vaccine will go into civilian circulation before the end of this month. The centre is capable of producing 775,000 doses in the first half of the year. It plans to expand its plant in April and will be able to produce at least 10 million vaccine doses before the end of the year. We are involving Nanolek in Kirov as an industrial partner to increase vaccine production.

Thus, Mr President, our industry is effectively delivering on the task that only four countries in the world are able to shoulder.

This is largely the result of the intensive development of the pharmaceutical industry that you initiated a decade ago by supporting the comprehensive plan for development. In addition to state investment, over 250 billion rubles of private capital were involved in building production lines and developing medications. A firm technological and research background was established. It made it possible to considerably increase the production of essential medications and start producing complicated preparations for the treatment of oncological, cardio-vascular, orphan and other socially significant diseases. In the last few years, the budget has saved over 240 billion rubles thanks to the consistent replacement of imports with more affordable Russian equivalents in public procurement alone.

The acquired competencies made it possible to produce last year over 30 medications recommended by the Health Ministry for treating and preventing the coronavirus. As was already reported, our companies then scaled up production of these vaccines by investing over 28 billion rubles of their own funds.

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Healthcare Minister Mikhail Murashko: Mr President,

In accordance with the task you have outlined for combating the pandemic, our priority was to make the coronavirus a manageable infection. With this aim in view, we have registered the world’s first novel coronavirus vaccine. Today, three vaccines are available.

I would also like to report that the first batches of the Sputnik V vaccine that can be kept at temperatures between +2 and +8 Celsius, that is, non-frozen which is more convenient logistically, have been delivered to our medical facilities. It is a big step to a more convenient use.

We have also completed the clinical trials of the Sputnik Light vaccine. The documents for its registration are ready.

Relevant organisations keep monitoring the virus’s mutations, including those in Russia. We are analysing the efficiency of medicines for preventing the disease caused by various strains. This work is ongoing continuously and involves several agencies.

Another task is to increase the speed of vaccination. By the end of March, our healthcare facilities will receive over 6.5 million dozes of Sputnik V. We expect that a total of some 30 million dozes will be delivered in April and May.

Our focus is, of course, on people aged over 60, because they are at a higher risk for severe illness. As of now, they account for 46 percent of those who have got the jab. We go directly to the social care facilities and make active use of mobile vaccination teams.

We have managed to synchronise several spheres to ensure the uninterrupted manufacturing of medication by the Ministry of Industry and Trade and have coordinated a management control system with Rostec so as to increase the capacity of vaccination stations almost threefold. As of now, there are 4,500 stationary vaccination stations across Russia, and we continue to increase this figure, as well as over 1,000 mobile stations.

We have established a remote consultation centre whose staff can advise medical personnel on vaccination issues.

We have created vaccine control and safety protocols, which include even minor events. For example, 20 percent of those who received the jab keep vaccination diaries. No other country in the world has such a ramified and serious system for monitoring the quality of medications. Every batch released for use undergoes double control, at the Gamaleya Institute and the producer of EpiVacCorona, as well as at state laboratories.

You have mentioned the European Medicines Agency. We have received a notification that a group of EMA experts will come to Russia on April 10 to establish communication and to monitor our clinical studies.

We are already receiving feedback on the effectiveness of our vaccine and its tolerance. For example, we have received detailed reviews from Argentina.

We have fulfilled your instructions on the development of a pharmaceutical cluster in Yaroslavl. Today we have opened a laboratory for quality control of medications, including immunobiological medicines. It is the largest facility with a floor space of over 8,000 square metres and the most cutting-edge equipment and personnel – chemists, physicists, biologists, virologists and veterinary experts – from all over the country.

Our labs have the prequalification of the World Health Organisation and the European Directorate for the Quality of Medicines, plus US market accreditation, which means that these labs’ conclusions are accepted throughout the world.

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Pharmstandard Chairman of the Board Viktor Kharitonin: We started working with the Gamaleya Research Centre on Sputnik V in August 2020. Over a short period of time, we completed the transfer of laboratory technology, scaled and fine-tuned the manufacturing technology. The first batches of the vaccine that we produced arrived in Russian healthcare facilities in early November.

As of today, our three production sites have produced over 17 million full doses of the vaccine, including 6 million full doses produced over the three weeks of March, which is a record output. Also in March, we released the first 100,000 doses of Sputnik V that do not require freezing and can remain stable at a temperature between +2ºC to +8 ºC. We plan to increase the production volumes further.

I would like to point out that this entire output was secured by our own production capacities. Today we are making this call from our new production facility that will allow us to significantly increase the amount of vaccine produced as soon as in April and reach the production volume of 200 to 300 million doses per year.

It should be specifically pointed out that, thanks to our cooperation with the Russian Direct Investment Fund, we have started supplying the vaccine to foreign markets. We have already transferred the production technology to Kazakhstan and Belarus and continue working with other countries, including India and Italy. In Italy, Sputnik V was highly praised by both scientists and our colleagues from pharmaceutical companies.

I would like to stress that this entire effort would not have been possible without the unique team of scientists and technologists that we have built over the past decade. We hand-picked our experts from all over the world and over 20 percent of our scientists returned from the EU, the United States and Israel at our invitation and are now helping us develop a modern pharmaceutical industry in our country.

Today we can develop and organise production of biotechnology-derived drugs of any level of complexity. At the same time, our entire production is fully up to the international GMP standards, which has been confirmed by numerous inspections from all over the world. In April and May, we are expecting an inspection by the World Health Organisation. We hope we can pass it successfully.

For ten years, Generium has consistently re-invested the major part of its profit into its infrastructure, both production facilities and residential and recreational infrastructure for its workers and their families.

We also scaled up our research infrastructure. I would like to note that modern scientific projects may have a five- to seven-year cycle – sometimes up to ten years.

Thanks to the company team’s high professionalism and the world-class level of research and production infrastructure, Generium took only three months to move from laboratory development to mass production of the vaccine. So far, only four or five companies in the world, including Generium, have successfully tackled such a serious challenge within such a short period of time while maintaining the highest quality. This shows that we are capable of competing with international pharmaceutical giants that have much bigger resources and decades of history.

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Chairman of the Board of the R-Pharm Group Alexei Repik: I am delighted to be welcoming you from Yaroslavl, where at the R-Pharm factory we produce Coronavir for treating mild to moderate cases of coronavirus, Artlegia medication for the treatment of cytokine storm, as well as the Sputnik V vaccine.

It was here at our factory in Yaroslavl that we started working on the vaccine together with the Gamaleya Research Centre, covering the distance between a small laboratory test tube and industrial-scale reactors. As of this moment, we have developed an absolutely stable and reliable technology that complies with the strictest regulatory requirements.

Therefore, our current priority is to transfer our technology to the other platforms we have in Russia and abroad, including in Illertissen, Bavaria, which has attracted considerable interest from our European colleagues.

We have made these achievements above all thanks to our professional team. About a thousand new employees joined us last year, both experienced professionals and young graduates of our partner universities for whom we have created a special training programme.

Our efforts are currently focused on the creation and manufacturing of new forms of the vaccine that will be easier to use and also transport. Our factory is now producing the first registration batches of a promising lyophilic form of the vaccine created by our experts. It has proved stable at temperatures between +2 and +8 C. We are now studying its stability at room temperature. There are grounds to believe that we will succeed. Thanks to more convenient storage requirements, this form will allow us to make the vaccine available in hard-to-reach regions of the country, which is especially important ahead of the spring and summer period.

In addition to this, the lyophilic form will increase the attractiveness of Sputnik on foreign markets, including countries with a hot climate: the Middle East, Africa and Latin America.

We are ready to use the lyophilisation technology on an increasingly large scale at our new flagship factory in the Technopolis Moscow Special Economic Zone. This project is being implemented with active support from the Moscow City Government. We have reached an important strategic agreement on investment support from the RDIF, our long-standing partner and shareholder. It will be the largest biotechnology complex in Eastern Europe for the production of vaccines. Moreover, we have built it very quickly from scratch.

We have purchased the best modern high-tech equipment for this factory, including over 200 bioreactors with different capacities. We hope the factory will be added soon to the registration certificate of Sputnik V and a new product, Sputnik Light, of the Gamaleya Research Centre. We plan to roll out the vaccine already in April or May. The factory’s plans for the second quarter include over 20 million dozes of Sputnik V and tens of millions of Sputnik Light.

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Director of the Gamaleya National Research Centre for Epidemiology and Microbiology Alexander Gintsburg: The Gamaleya Centre also addresses the problem of expanding the production of the Sputnik Light vaccine. In addition, as the holder of the registration certificate, the Centre assumes all responsibility for quality control of this vaccine at all enterprises where it is manufactured in this country and abroad.

Moreover, the Centre is directly involved in launching contractual production that is mostly organised by the Russian Direct Investment Fund. The Centre has prepared the entire package of documents for registering the Sputnik Light vaccine in 55 countries. Considering that each country has its own regulatory system, this is not a fixed package of documents that will apply everywhere; we have to adapt it to every country’s regulatory system.

The Centre is also working on creating various modifications of the Sputnik V vaccine, primarily for different population categories.

The Government’s financial support made it possible for us to quickly and effectively complete the first, second and third stages of clinical trials. The Lancet, a highly prestigious and popular medical journal, published two articles on the results of these trials. This provides important scientific evidence proving the vaccine’s efficacy, and, in our opinion, this has also answered a lot of questions. In any event, this has completely eliminated the Western academic community’ scepticism regarding this vaccine’s quality and efficacy.

My deputy Denis Logunov and I subsequently held numerous meetings with researchers and leading US and European specialists working on similar vaccines, and we proved that our scientific and other approaches were correct, as was the regulatory system that the Russian Government used in these emergency circumstances, during the pandemic, in order to register the vaccine, meaning the procedures stipulated in the Government’s Resolution No. 441 that all Russians are familiar with. Although no one has mentioned this resolution, I would like to note that the entire world now uses its regulatory principles.

Regarding our current plans to further promote this vaccine, I would like to note that major efforts are now underway to prepare the documents that will, hopefully, make it possible to study the effect of Sputnik Light on children, after all formalities with its registration for adults are completed. Clinical and scientific data show that, unfortunately, children also contract COVID-19. Fortunately, they do not always suffer as much as adults, but, nevertheless, the situation is rather disturbing. Today, no one knows what long-term consequences of the infection children may suffer. Consequently, the vaccination of children is a problem that each country and the international community will either face in the near future or is already facing. We are also currently studying the protection that Sputnik Light gives against new strains of the coronavirus.

I would like to inform you that last week the Gamaleya Research Centre held large talks, headed by Russian Ambassador to Italy Sergei Razov, with a leading Italian regulatory institute, the Spallanzani Institute, a counterpart of ours. We have agreed that this week their regulatory bodies will send us through their Ministry of Health a draft memorandum of cooperation between the two institutes, because according to the Spallanzani Institute, it has the largest collection of newly emerged and isolated strains of COVID-19 pathogens in Europe, and this is really so.

If you support this, in just a week the Italians are ready to welcome our employees, who are ready to bring plasma samples from patients vaccinated with Sputnik V, so that the substantial range and number of strains available in the Spallanzani Institute’s collection can be tested for the neutralising activity of the serum obtained from those vaccinated with Sputnik V.

With such cooperation, this work can be done quite quickly. Of course, it not only draws great scientific interest but, I hope, a broad public response, as well as enhances the reputation and promotes our medicine on the global stage in the future.

Once again, thank you very much, Mr President, for supporting all our work at all the development stages and for paying attention to our efforts.

Vladimir Putin: Thank you.

Mr Gintsburg, speaking about children’s vaccination, at what age can it begin today? What do you think?

Alexander Gintsburg: Mr President, it is an appropriate and understandable question. Of course, children must be divided into several age groups. It is necessary to start from the age of 17 and down to 12 or 13. We are now working on this with paediatricians. You see, I am not an expert in paediatric immunology. We have great specialists, and now we are clarifying this.

The next group probably will be those eight years old and up. It is difficult for me to make a prediction for the next one. Perhaps three or four years. Perhaps we will add a lower age group. For this age group – thank you for asking this question – we have developed, patented, and are currently launching clinical trials of Sputnik V’s intranasal form. This is a very gentle and patient-friendly form of vaccination for children, especially little children, who can be traumatised when they see a syringe or when possible side effects arise. The first experiments show that the intranasal form is completely free from any side effects.

Vladimir Putin: How long do you think it will take to receive such a medicine? Approximately. I know, and I do not want to embarrass you, but please give me the approximate timing.

Alexander Gintsburg: I believe this year we will launch and complete clinical trials of the intranasal form. We will do everything to this end.

Vladimir Putin: Okay. Thank you.

Now to international cooperation. We have depoliticised it since the very beginning. Some of our partners see some kind of politicisation on our part. I have already said many times that this is not true, this has never happened. No politicisation. On the contrary, we understand and want our common success to be achieved through joint efforts. Moreover, we believe that it is only possible to develop immunity, not only in our country, but also in other countries, by combining efforts. Therefore, we have always spoken in favour of uniting these efforts, and will work like that. If our Italian partners want, we will gladly work with them.

I have one more question, Mr Gintsburg. I understand that your whole team worked on the anti-coronavirus vaccine but there must be some specific lead developer. Who is this person?

Alexander Gintsburg: Mainly, it is my neighbour here, Denis Logunov and, of course, his young employees. Mr President, should I list their names from memory or do you have them already?

Vladimir Putin: I have them. I would like to give the floor to Mr Logunov with your permission. I would like to see him and I want our entire country to see him.

Mr Logunov, how did this work go and what are the prospects? Your supervisor has just talked about this, but I still want to ask your opinion about any further development of this medication.

Deputy Director for Research at the Gamaleya National Research Centre for Epidemiology and Microbiology Mr President, thank you for this opportunity to say a few words.

I would like to emphasise once again that this is a big team at the Gamaleya Centre. Of course, I am not denying that I was in charge of this, but I would like to highlight that over 400 people were involved in this project.

Naturally, our immediate plans include increasing vaccine production volume. This is the most important challenge we need to resolve. This is our number one task, and of course, this includes transferring the technology abroad. So, this is the production story.

In terms of science, I consider it extremely important to conduct expanded monitoring of the existing virus strains and to assess the efficiency of the vaccine at the screening level. We must at least examine sera screening from vaccinated patient’s reactions to new strains. I consider this very important. The flu virus is also studied in much the same way. A huge number of centres have been established all over the world. I believe similar work must be conducted as regards SARS-CoV-2. We must not miss the important moment when the virus, for one, gets out of control and the existing vaccines may become even potentially ineffective.

In terms of science, I consider this prospect the most important.

Thank you for this opportunity to speak.

Vladimir Putin: Thank you.

You mentioned cooperation with our foreign partners in technology transfer. What do you think, if you have dealt with this, about the level of patent assertion? After all, we are offering something that nobody else offers in the world — we are offering technology transfer.

Denis Logunov: All the patents have been drafted, Mr President. We have submitted the Eurasian patent applications as well. The Gamaleya Centre has done its part regarding patent assertion. The details and technicalities need to be organised by the Russian Direct Investment Fund. They are in charge of a big part of this and are responsible for many things, so if our colleagues are online, perhaps, they might want add something to what I said.

Vladimir Putin: Yes, we have them online. But before I invite them to speak, I want to thank you for your accomplishments, yours and, of course, the entire institute and that large group of your colleagues, researchers, who achieved this result and created the Sputnik V vaccine for our country and our people.

The vaccine enjoys high demand and, as we can see, and you see it too, it gives us the opportunity to resolve numerous other issues that appear unrelated to healthcare, including the economy and the social sphere. Everything turned out to be intertwined, and it strongly influenced everyday life and the economy in our country and other countries – much more in other countries than in Russia – that we could never imagine that this was possible; but it is. And it turned out that your work, the work of your colleagues, you said 400 people were involved in this effort, was very much needed.

I have already had the opportunity to thank Mr Gintsburg, and now I want to thank you personally and everyone who made this possible and achieved this excellent result.

Now, let's put the RDIF Head on. Mr. Dmitriev, are you with us? What can you tell us about patent protection?

CEO of the Russian Direct Investment Fund (RDIF) Kirill Dmitriev: Thank you very much, Mr President.

Our patent protection is very strong. We submitted applications early on, much earlier than other countries, and thus got a headstart. Accordingly, the Gamaleya Institute owns the innovations that are available even at these foreign sites, which include over 20 partner companies in 10 countries.

We believe a US vaccine-maker is most likely infringing on our patents. We have notified this company and want to start a dialogue with them. Clearly, we are not planning to ask them for compensation during the pandemic, but we will certainly be very careful about protecting our intellectual rights.

Mr President, in closing I would like to thank you, because it was your idea to build production partnerships with various countries, and 20 manufacturers from over 10 countries responded. For them, it’s about vaccine safety and independence, and Russia was the only country to have come up with this offer.

Thank you very much. They are very grateful to you for this.

Vladimir Putin: Thank you.

Mr Maksyutov from the Vektor Centre in Novosibirsk, you have the floor.

Director General of the Vektor State Research Centre of Virology and Biotechnology Rinat Maksyutov: Mr President,

We are currently working to expand production of the EpiVacCorona vaccine, which was authorised in the Russian Federation on October 13, 2020.

The vaccine consists of two key components, namely, peptides, short fragments of the new coronavirus’ S-protein, and a carrier protein. We now manufacture two million doses monthly.

The Vektor Centre is located in the unique science town of Koltsovo. This has allowed our research centre to quickly find and engage industrial partners for developing the vaccine and expanding its production. I am talking about the companies EpiVac and Vector-BiAlgam.

Until now, we manufactured vaccine ampoules alone. In early March, we launched a new production line for manufacturing syringe doses, and this will make it possible to more easily vaccinate people at medical facilities.

We are expanding additional vaccine production at a Geropharm facility. Under our production plan, we are set to manufacture 1.5 million doses in April, followed by three million in May. And we are to manufacture five million vaccine doses in the single-dose format from June.

While addressing these production tasks, we have successfully completed clinical trials of the EpiVacCorona vaccine; the trials involved volunteers aged over 60. From March 3, the vaccine can be used for all persons over 18 years old, without any upper limits.

The vaccine’s high safety profile makes it possible to use the preparation for re-vaccinating persons who have already received any COVID-19 vaccine, as well as recovered COVID-19 patients.

The specific technological feature of the vaccine is the use of conservative components of the S protein of the novel coronavirus for the selection of peptides, which ensures the vaccine’s effectiveness against a variety of SARS-CoV-2 strains. Vektor is the only WHO COVID-19 reference laboratory in Russia. It not only conducts the entire range of viral studies of the novel coronavirus, but is also monitoring its genetic mutations across the country on a regular basis.

By now, we have found over 5,300 genetic variations across the genome. In the overwhelming number of cases, the replacement does not change the epidemiological characteristics of the virus. At the same time, we have also found over 50 variations of the British strain, three cases of the South African strain and over 20 unique variations of the virus that must be thoroughly studied.

Vektor is studying these variations of the virus in accordance with a special algorithm. We are studying the virus’s stability on various surfaces; we are also using unique equipment, which has no analogues throughout the world, to study the ability of the virus to be transmitted between living organisms. We have found that the British strain of the novel coronavirus can be effectively neutralised by serum taken from those who had COVID and those vaccinated with Sputnik V or EpiVacCorona.

Vladimir Putin: If I understood you correctly, a vaccine, in this case the vaccine created at your centre, can be effectively used against various strains, new strains of the coronavirus infection?

Rinat Maksyutov: Yes, you are quite right. We are checking this not only theoretically based on the sequences of peptide antibodies selected for the creation of this vaccine, but also based on the entire range of strains circulating in Russia, which we receive and use for relevant studies. The vaccine has proved to be effective against all of them.

Vladimir Putin: I see.

You have mentioned revaccination. Does this mean that your vaccine can be used some time later, when the antibodies disappear?

Rinat Maksyutov: Yes, absolutely. We believe that vaccination will remain effective against the novel coronavirus for a year. But anyway, this vaccine can be used for revaccination as many times as necessary, thanks to its platform which has no extra components. In other words, it can be used again in a year, once a year, or every year, without any limitations, including after the use of any other vaccines, for protection against COVID-19.

Vladimir Putin: Good.

Mr Ishmukhametov, Chumakov Centre, please.

Director General of the Chumakov Federal Scientific Centre for the Research and Development of Immune and Biological Products (Russian Academy of Sciences) Aidar Ishmukhametov: Mr President,

The Chumakov Centre is one of the oldest facilities in the Russian Federation and the oldest vaccine developer in Russia. We remember that in the 1960s, this centre’s achievements helped the country deal with polio. The centre back then developed a unique vaccine that was supplied to the entire world, including the United States, Europe, Japan and many other countries. In fact, now this facility, the Institute of Poliomyelitis, is known around the world.

We are continuing this tradition. As of today, we have developed and produced five vaccines, including for tick-borne encephalitis, rabies and the yellow fever vaccine that is supplied to almost 50 countries, which is perhaps Russia’s biggest export in the pharmaceutical industry.

I am telling you this because I would like you to know about the conditions in which we started on this new job. It was in line with our current work. We did not intend to work exclusively on the coronavirus vaccine. It was important to us to maintain the same production volume and supply vaccines according to the national vaccination calendar as well as deliver on the exports. So we needed to fit this new objective into our existing model. And we succeeded.

How? First of all, thanks to our institute’s structure. The institute consists of departments that focus on fundamental science, applied research, trial production and industrial production itself. We inherited this research and development facility from the Soviet Union where it was a leader in this industry, and we are developing it. We also have a secret advantage, which is our young staff, young boys and girls, as we call them. The average age of our scientists who designed this vaccine is about 30.

Perhaps that – and the understanding that we had to do it – helped us create a whole-virion vaccine. Allow me to remind you that this is a conventional vaccine and we spent exactly one year designing it. I should point out that none of the American or European companies used this type of technology although until recently, before the pandemic, 100 percent of all vaccines were produced with this method.

I think two circumstances prompted this decision. First, our close cooperation with research institutes and timely assistance from the Ministry of Science and Higher Education. Within a very short period of time, we were provided with funds that allowed us to build a team and carry out fundamental research that outlined the structure of the virus and its functional characteristics. This research served as a basis for the practical task of developing a vaccine. Second, we scaled up our research and production facility thanks to our industrial partnership with Nanolek of several years. In this situation, we increased our capacity and we expect to produce up to 10 million [doses] this year. We usually deliver on our obligations.

Mr President, I would like to stress that this type of organisation that has a research and development facility at its core that can outline the task and release a certain number of batches of the vaccine consisting of tens of millions [of doses], on the one hand, and well-coordinated work with research institutes and the search for partners, on the other hand, is a very efficient model. We believe that this model needs further development. We are currently discussing this matter with the ministry. This is not just about a specific vaccine or a specific disease; it is important to us to understand what can happen tomorrow if another disaster or epidemic happens. We need to build a model that can react and adjust to new threats.

Thank you.

Vladimir Putin: I see.

Mr Ishmukhametov, I fully agree with you. We need a stable and reliable model that can protect Russian citizens and the country against scenarios and threats like those that we have dealt with, with the coronavirus. I fully agree with you.

I am glad to hear that you have established a strong relationship with the Russian Academy of Sciences and, as you said, with industrial partners. Certainly, this trio must continue to work efficiently in the future – especially because we know now that the spread of an infection at such a fearful rate is an extremely serious challenge for our country and for the entire world. So the fact that you managed to build up this scientific base is extremely important. Of course, this model needs scaling up in the future.

<…>

CEO of the National Immunobiological Company, Rostec State Corporation, Andrei Zagorsky: As my colleagues have said, vaccine production in the country is growing steadily. We see it from the number of lorries that arrive at our warehouse every day. Once accepted, the products go to a freezer facility, which is right behind me, where they get consolidated and shipped to the regions. This is carried out in close cooperation with the manufacturing sites, the Ministry of Industry and Trade, and the Healthcare Ministry, as well as cargo recipients in the regions. We have no doubt that we will be able to fulfill our tasks on schedule.

Vladimir Putin: Good. Thank you.

As I understand it, you are operating an established system meaning that you are supplying other vaccines, including flu vaccines.

Andrei Zagorsky: Absolutely. Our perimeter includes two companies, including Microgen, which produces about 70 percent of the vaccines on the national immunisation schedule included in the nomenclature. In addition, in late 2020, we completed a deal to consolidate 100 percent of the shares of a company that is Russia’s largest and one of the world's largest manufacturers of flu vaccines. We have been the only supplier and authorised contractor under the national vaccination schedule since 2014.

Vladimir Putin: Mr Zagorsky, you and I understand that the logistics of supplying the vaccines against coronavirus have their own specifics and require fairly low – not really low like Pfizer with its 70 degrees below zero Celsius – but still 20 degrees below zero Celsius, or slightly lower temperatures still must be observed. What can you tell us in this regard?

Andrei Zagorsky: That is true. We monitor the entire production process, especially the temperature, all the way from production, transport, acceptance to a warehouse, storage at the warehouse, to shipment to a recipient region. All products are transported in thermal containers, which can keep temperatures at 18 degrees below zero Celsius for about five days.

Vladimir Putin: I see. Good.

<…>

Deputy Prime Minister Tatyana Golikova: I would like to say a big thank you to our colleagues who are participating or not participating in this meeting, the development teams. To reiterate, in a fairly short time, despite the difficulties, amid the challenging pandemic of 2020, our colleagues accomplished something that seemed almost impossible. Indeed, as you noted, Mr President, they worked 24/7 and made Russia the leader in the production and use of vaccines, primarily, for the public in Russia.

Now, our main challenge is to provide the regions with the necessary amounts of vaccine as soon as possible, because it is being used up quickly. Our goal is to achieve, as quickly and efficiently as possible, the herd immunity numbers that we have set for ourselves. We believe that herd immunity can be achieved in July or August this year; and if production and the vaccination rate pick up the pace, we can get there even sooner.

I would like to take this opportunity to address our citizens. Vacation time is fast approaching, and you will start buying holiday packages soon. Please make sure that health safety comes first, which means go ahead and get vaccinated to make your vacations safe for yourself and your families.

Mr President, please accept my heartfelt thanks for your support and faith in our researchers, our science and our manufacturing industry; your belief that we will rise to the occasion. We really did – and will now be able to accomplish much more.

Thank you.

Vladimir Putin: Thank you very much.

So, we understand in what direction we should be moving. The figures are understandable, and the production scale is also clear.

Therefore, I would like to thank once again the developers for the results of their work. We all hope, the entire country hopes for your help in case a situation similar to the coronavirus outbreak occurs. Judging by what we have heard today, this hope is not idle – we have wonderful research facilities and good personnel. I am referring to the young researchers in this area.

I would like to wish success to the producers – very much now depends on you. It is one thing to produce vaccines for a foreign consumer at foreign sites, and it is another to ensure the required scale of production inside the country. I would like to emphasise over and over again that for us the number one task is to vaccinate our people, to protect our citizens against this infection.

I would like to ask the Healthcare Minister to present proposals on the following matter. I have heard that state decorations have already been conferred on some employees of our research centres who took part in developing these vaccines. But we also heard today that hundreds of people were working on this issue. So, please think it over carefully once again and confer state decorations on all those who did this work. Ms Golikova, I would like you to think, together with the Finance Minister, not only about state decorations but also about material incentives.

Many thanks to everyone. I wish success to all of you.














Συνάντηση για την αύξηση της παραγωγής εμβολίων και την πρόοδο του εμβολιασμού


Ο Βλαντιμίρ Πούτιν πραγματοποίησε τηλεδιάσκεψη για την αύξηση της παραγωγικής ικανότητας των εμβολίων COVID-19 και την πρόοδο του εμβολιασμού στη Ρωσία.
22 Μαρτίου 2021
16:55
Novo-Ogaryovo, Περιφέρεια Μόσχας






Η συνάντηση περιελάμβανε τον Αρχηγό Προσωπικού του Προεδρικού Εκτελεστικού Γραφείου Anton Vaino , τους Αντιπροέδρους της Κυβέρνησης Yury Borisov και την Tatyana Golikova , τον Προεδρικό Βοηθό Maxim Oreshkin , τον Υπουργό Βιομηχανίας και Εμπορίου Denis Manturov , τον Υπουργό Υγείας Mikhail Murashko , τον Υπουργό Επιστημών και Τριτοβάθμιας Εκπαίδευσης Valery Falkov , επικεφαλής της Ομοσπονδιακής Υπηρεσίας για την Εποπτεία της προστασίας των καταναλωτών και Πρόνοιας - Chief State Είδη Ιατρός Άννα Πόποβα , επικεφαλής του 48 ου Κεντρικό Ινστιτούτο Ερευνών του Υπουργείου Άμυνας Σεργκέι Borisevich, Διευθύνων Σύμβουλος της Ρωσικής Άμεση Ταμείο Επενδύσεων (RDIF) Κύριλλος Dmitriev, Διευθυντής του Ομοσπονδιακού Κέντρου Ερευνών Gamaleya για Επιδημιολογία και Μικροβιολογία του Υπουργείου Υγείας Alexander Gintsburg, Γενικός Διευθυντής της Εθνικής Ανοσοβιολογικής Εταιρείας (Nacimbio) της Rostec State Corporation Andrei Zagorsky, Γενικός Διευθυντής του Ομοσπονδιακού Επιστημονικού Κέντρου Chumakov για την Έρευνα και Ανάπτυξη Ανοσοποιητικών και Βιολογικών Προϊόντων Aidar Ishmukhametov, Γενικός Διευθυντής του Κρατικού Κέντρου Ερευνών της Ιολογίας και Βιοτεχνολογίας του Vektor Rinat Maksyutov, καθώς και οι επικεφαλής των εταιρειών Biocad, Binnopharm Group, Vector-BiAlgam, R-Pharm, Geropharm, Epivac, Generium, Pharmstandard και Nanolek.

* * *

Αποσπάσματα από το αντίγραφο της συνάντησης σχετικά με την αύξηση της παραγωγής εμβολίων και την πρόοδο του εμβολιασμού

Πρόεδρος της Ρωσίας Βλαντιμίρ Πούτιν : Καλησπέρα, συνάδελφοι.

Σήμερα θα μιλήσουμε για θέματα που σχετίζονται με την παραγωγή εγχώριων εμβολίων κοραναϊού και την πρόοδο του εμβολιασμού στη Ρωσία.

Τα ερευνητικά μας ιδρύματα δημιουργούν, όπως γνωρίζετε, μια σειρά εμβολίων από κοροναϊούς. Τρία έχουν ήδη εγγραφεί στη Ρωσία. Δύο από αυτά - Sputnik V και EpiVacCorona - παράγονται σε μεγάλες ποσότητες από τις φαρμακευτικές εταιρείες μας και χρησιμοποιούνται για εμβολιασμό. Ένα άλλο, το CoviVac που δημιουργήθηκε στο Ομοσπονδιακό Επιστημονικό Κέντρο Chumakov ετοιμάζεται για διάθεση και έχουν ήδη δημιουργηθεί οι πρώτες παρτίδες. Παρεμπιπτόντως, η Ρωσία έχει ήδη τρία εμβόλια, που είναι σίγουρα το αποτέλεσμα σκληρής δουλειάς χιλιάδων ανθρώπων.

Επίσης, παρά τις προκλήσεις που σχετίζονται με την πανδημία, οι εγχώριες φαρμακευτικές εταιρείες, σε συνεργασία με ερευνητικά ινστιτούτα, κατάφεραν να επιτύχουν πολλούς στόχους προκειμένου να αναπτύξουν νέους χώρους παραγωγής εμβολίων σε σύντομο χρονικό διάστημα. Σε πολλές τοποθεσίες, η εργασία πραγματοποιήθηκε σχεδόν όλο το 24ωρο. Εισήγαγαν και βαθμονομήσουν σύγχρονο και πολύ αποδοτικό εξοπλισμό και δημιούργησαν προηγμένες διαδικασίες βιοτεχνολογικής παραγωγής που ήταν ασύγκριτες στη χώρα μας.

Εκπρόσωποι των φαρμακευτικών εταιρειών που παρήγαγαν τα εμβόλια είναι εδώ σήμερα.

Συνάδελφοι, φίλοι, θα ήθελα να εκμεταλλευτώ αυτήν την ευκαιρία για να σας ευχαριστήσω και το προσωπικό και τους εργαζομένους σας για την πραγματικά ανιδιοτελή εργασία σας και την υπεύθυνη στάση σας.

Οι προσπάθειές σας, καθώς και το αποτελεσματικό έργο των ερευνητικών μας ινστιτούτων και ολόκληρου του συστήματος υγειονομικής περίθαλψης, κατέστησαν δυνατή τη σταθεροποίηση της εξάπλωσης της λοίμωξης από κοροναϊούς και την προστασία της ζωής και της υγείας εκατομμυρίων ανθρώπων μας.

Η εφαρμογή ενός ευρέος φάσματος προληπτικών μέτρων, συμπεριλαμβανομένου του εκτεταμένου εμβολιασμού, έχει διαδραματίσει σημαντικό ρόλο στην εξομάλυνση της επιδημίας.

Συνολικά, 6,3 εκατομμύρια Ρώσοι έχουν λάβει το πρώτο μέρος του εμβολίου, από αυτά τα 4,3 εκατομμύρια έχουν εμβολιαστεί πλήρως, δηλαδή, έχουν λάβει και τα δύο συστατικά του εμβολίου.

Σήμερα, μπορούμε να πούμε με ασφάλεια, και τα πρακτικά αποτελέσματα επιβεβαιώνουν αναμφισβήτητα, το γεγονός ότι τα ρωσικά εμβόλια είναι απολύτως ασφαλή και αξιόπιστα. Επιπλέον, κανένα άλλο αλλοδαπό εμβόλιο δεν προσφέρει αυτόν τον υψηλό βαθμό προστασίας. Για να το επαναλάβω, αυτό είναι ένα μεγάλο επίτευγμα για τους ερευνητές και τους ειδικούς μας.

Η επιτυχία μας αναγνωρίζεται και στο εξωτερικό. Ο αριθμός των χωρών που χρησιμοποιούν το εμβόλιο Sputnik V αυξάνεται γρήγορα. Παρά τις εσκεμμένες προσπάθειες για τη δυσφήμιση του εμβολίου μας και όλων των ειδών κατασκευών που περιστασιακά συνορεύουν με την παράξενη φαντασία, περισσότερες χώρες σε όλο τον κόσμο δείχνουν ενδιαφέρον για το εμβόλιό μας με 55 χώρες που έχουν εγκρίνει τη χρήση του.

Συμβάσεις με ξένους κατασκευαστές - και θέλω να το τονίσω αυτό ώστε όλοι να καταλάβουν τι μιλάω: αυτοί είναι αλλοδαποί κατασκευαστές που θα παράγουν το εμβόλιό μας στην επικράτειά τους - έχουν υπογραφεί για τον αριθμό των δόσεων που απαιτούνται για τον εμβολιασμό 700 εκατομμυρίων ατόμων ανά έτος. Μόλις σήμερα, υπογράψαμε συμβόλαιο με μια ινδική εταιρεία για δόσεις εμβολιασμού 100 εκατομμυρίων ανθρώπων. Είναι τα νέα της ημέρας.

Συνεργαζόμαστε με 55 χώρες με συνολικό πληθυσμό 1,4 δισεκατομμύρια. Πολύ σύντομα, θα επεκτείνουμε τον αριθμό των χωρών εταίρων μας και θα προσεγγίσουμε 2,5 δισεκατομμύρια άτομα.

Πρέπει να σημειωθεί ότι οι κυβερνητικοί φορείς σε χώρες όπως το Μεξικό και η Αργεντινή ανέλυσαν τη χρήση του εμβολίου μας στην επικράτειά τους, στις χώρες τους, και κατέληξαν στο συμπέρασμα ότι δεν υπάρχουν παρενέργειες. Είναι πολύ σημαντικό για εμάς γιατί ήταν ανεξάρτητη αξιολόγηση

Αυτό που προκαλεί έκπληξη είναι ότι ακριβώς πριν από τη συνάντησή μας, μου είπαν ότι μόλις τώρα, ένας από τους αρμόδιους υπαλλήλους της Ευρωπαϊκής Επιτροπής δήλωσε ότι δεν χρειάζονται τον Σπούτνικ Β. Αυτή είναι μια περίεργη δήλωση. Δεν επιβάλλουμε τίποτα σε κανέναν. Παρεμπιπτόντως, πολλοί στην Ευρώπη δεν γνωρίζουν καν ότι η Ρωσία έχει υποβάλει εδώ και πολύ καιρό αίτηση εγγραφής στον Ευρωπαϊκό Οργανισμό Φαρμάκων. Όπως μου ανέφερε η κα Golikova το πρωί, η αίτηση κατατέθηκε στις 21 Ιανουαρίου 2021. Μόνο στις 4 Μαρτίου λάβαμε ένα μήνυμα ότι η επανεξέταση της αίτησης είχε ξεκινήσει.

Να τι θα ήθελα να πω σχετικά με αυτό το θέμα. Όπως μόλις είπα, δεν επιβάλλουμε τίποτα σε κανέναν. Όταν όμως ακούμε τέτοιες δηλώσεις αξιωματούχων, τίθεται το ερώτημα: ποια είναι τα συμφέροντα που προστατεύουν αυτοί οι άνθρωποι; Είναι τα συμφέροντα ορισμένων φαρμακευτικών εταιρειών ή τα συμφέροντα των ευρωπαίων πολιτών; Τι κάνουν; Λόμπυ; Και αυτοί οι άνθρωποι προσπαθούν να μας διδάξουν κάτι - και να επιβάλουν κυρώσεις.

Αλλά δεν πειράζει. Και πάλι, είναι η επιλογή τους και είναι ελεύθεροι να κάνουν όπως κρίνουν κατάλληλο για την επίτευξη των στόχων τους.

Οι φαρμακευτικές εταιρείες μας πρέπει να λάβουν υπόψη τη δυναμική της παγκόσμιας αγοράς και τη ζήτηση για το εμβόλιο μας, ενώ παράλληλα επεκτείνουν την παραγωγική τους ικανότητα. Επιτρέψτε μου όμως να τονίσω ότι, όπως και πριν, οι εγχώριες ανάγκες μας, που παρέχουν στους Ρώσους πολίτες εμβόλια, πρέπει να αποτελούν απόλυτη προτεραιότητα.

Τώρα το πιο σημαντικό καθήκον μας είναι να συνεχίσουμε να αυξάνουμε τα ποσοστά παραγωγής εμβολίων στη χώρα. Για το σκοπό αυτό, πρέπει να στείλουμε αρκετά εμβόλια στις περιοχές, να διασφαλίσουμε τη λειτουργία ενός ευρέος δικτύου τόπων εμβολιασμού και, φυσικά, να συνεχίσουμε να ενημερώνουμε τους ανθρώπους για το πού, πώς και πότε μπορούν να εμβολιαστούν. Όλη αυτή η διαδικασία πρέπει να είναι όσο το δυνατόν πιο προσιτή και βολική για τους ανθρώπους μας, ειδικά για τους ηλικιωμένους.

Θα ήθελα να το τονίσω για άλλη μια φορά - την ικανότητά μας να διεξάγουμε αποτελεσματικό εμβολιασμό και να αποκτούμε αυτό που οι ειδικοί, συμπεριλαμβανομένων των συναδέλφων μας σε αυτήν τη συνάντηση, αποκαλούν την ασυλία των κοπαδιών επηρεάζει άμεσα την ταχύτητα των προσπαθειών μας να ξεπεράσουμε την πανδημία και να αρθούν όλοι οι περιορισμοί. Πρέπει να επιτύχουμε αυτόν τον στόχο με κάθε κόστος και να δημιουργήσουμε αυτήν την ασυλία αγέλης.

Εκτιμάται ότι τουλάχιστον το 60% όλων των ενηλίκων στη χώρα πρέπει να εμβολιαστούν για πλήρη σταθεροποίηση. Αυτό θα απαιτήσει 69,8 εκατομμύρια σύνολα δόσεων εμβολίου. Έχουμε όλους τους πόρους για την παραγωγή τους. Μου αναφέρθηκε σήμερα το πρωί ότι από τις 17 Μαρτίου είχαν κατασκευαστεί 20,1 εκατομμύρια σετ. Ο πρωθυπουργός Μιχαήλ Μισουστίν μίλησε για 20.102.000 σετ. Σε κάθε περίπτωση, υπάρχουν περισσότερες από 20 εκατομμύρια δόσεις Sputnik V. Συνολικά 8,9 εκατομμύρια πλήρεις σειρές Sputnik V και πάνω από 115.000 σετ EpiVacCorona βρίσκονται ήδη σε κυκλοφορία πολιτών.

Ελπίζω ότι οι φαρμακευτικές εταιρείες μας όχι μόνο θα διατηρήσουν τον τρέχοντα ρυθμό αλλά και θα συνεχίσουν να αυξάνουν την παραγωγή, θα διασφαλίσουν αξιόπιστη και τακτική προμήθεια εμβολίων στις περιοχές και θα κάνουν καλή χρήση του απτού δυναμικού εξαγωγών.

Ας συζητήσουμε σήμερα πώς σκοπεύουμε να αντιμετωπίσουμε αυτά τα καθήκοντα.

Εν κατακλείδι, θα ήθελα να τονίσω ότι ο εμβολιασμός είναι σίγουρα μια δωρεάν επιλογή, η προσωπική απόφαση κάθε ατόμου. Παρεμπιπτόντως, θα εμβολιαστώ αύριο.

Ας αρχίσουμε να δουλεύουμε.