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MIL OSI Translation. Region: Russian Federation –

M. Mishustin: “The third vaccine, KoviVac, has been registered. It was developed by the Chumakov Center, and in mid-March the first 120 thousand doses will be launched into civil circulation. “

From the transcript:

Meeting on Circulation of Vaccines to Prevent Novel Coronavirus Infection

Mikhail Mishustin: Good afternoon, dear colleagues!

I would like to start with very good news – today we are announcing that the third vaccine, CoviVac, has been registered. It was developed by the Chumakov Center, and in mid-March the first 120 thousand doses will be launched into civil circulation.

Today Russia is the only country that already has three vaccines to prevent covid infection.

On behalf of the President, at the end of last year, voluntary vaccination of our citizens began throughout the country. Now the Sputnik V vaccine is used more often, but the EpiVacCorona vaccine has already entered civilian circulation. For people who want to get vaccinated, an appointment is organized through the portal of public services. More than 4 thousand vaccination points have been opened in all constituent entities of the Russian Federation. In remote places, mobile posts have been organized, and special transport has been allocated that brings people there.

Let me remind you once again that each region must be fully prepared to receive, store and distribute drugs, so that those who want to get vaccinated do not have any difficulties.

We are constantly increasing the pace of vaccine production. More than 10 million doses of Sputnik V have already been produced, about 80 thousand doses of EpiVacCorona. And in the near future, a line for the industrial production of the third drug, KoviVac, will be launched.

Of course, all necessary requirements must be strictly observed. And I want to draw your attention to the fact that the increase in volumes should in no way affect the quality of the vaccine. I ask you, colleagues, to personally control the entire production process. And so that the reduction in the time required for quality control, for release into civilian circulation, was absolutely scientifically justified and, as I said, did not affect the quality.

At the same time, it is necessary to clearly monitor so that the pricing procedure is transparent and the cost of the drug is reasonable. The main goal is not to get excess profits on such a medicine that is extremely necessary for health, but to help people. We have talked about this more than once. It is also important to set up all logistics and infrastructure chains for three vaccines at once, since it is obvious that the appropriate integration of the portal of public services with manufacturers, with release into civilian circulation, a logistics chain for transportation, storage and then – with medical institutions should work like clockwork.

Let’s discuss all these issues in detail.

I would like to ask the General Director of the Center Chumakov Aidar Ayratovich Ishmukhametov to speak. Please report on how the work with the production and supply of the new vaccine is organized. And of course, I congratulate you on what happened.

A. Ishmukhametov: Thank you. Mikhail Vladimirovich! Dear colleagues!

The vaccine we have developed is the classic whole-virion vaccine. That is, it reflects the entire history of both domestic and world vaccinology. Before the pandemic, 100% of vaccines were produced in this way. It has a clear economy, a clear platform, understandable complications, and, in fact, the situation with it is more predictable. These days it is just one year since we started this work. And this is connected purely with the methodological issues of development.

It was necessary to get a certain pool from patients – a live virus was taken, it was necessary to work it out, teach this virus to cultivate, purify itself, and so on. That is, to go through the entire technological chain and tie the features of this virus to a known platform.

I must say that, probably, the achievement in this case is that none of the six largest global companies that control 100% of the vaccine market in the world and which have always worked in this way have still released whole virion vaccines. This is due exclusively to the methodological issues that I talked about. And this is such an essential question. I am absolutely sure that six months later, maybe earlier, all the same, whole-virion vaccines will dominate in the same way as it happened in other types of vaccines, in other developments.

What allowed us to do this?

First. First of all, this is the management structure of the Chumakov Center. What was laid down in the Soviet Union, what we managed to preserve and help in development somewhere. This is a chain from academic science to production itself. When we started working, we had a clear idea in vitro, imagined what kind of equipment we would need, what kind of people we would need. That is, the simultaneity of today’s registration with the readiness of the site is the most fundamental thing. I believe that this is the most essential factor for the development of the immunobiological industry in general. Because to create something, as it was done in the world in many ways, then try to transpose to other platforms – this is a much more complicated situation.

A few words about development. As you already said, after today’s registration of the vaccine, we need about a month, we are very closely following this, for quality control it takes 28 days. After that, the number of samples you mentioned will go into civil circulation. Further, we assume that we will already produce about half a million a month. And this is a pessimistic scenario. We would just like to test the technology a little (in about two months) at large volumes, and I am sure that we will increase these volumes in the future. Moreover, we are expecting modernization in April. And they used to be responsible for their words. Nevertheless, I believe that this figure can be increased by the end of the year: the 10 million we promised could even double. But so far this way.

The fundamental question, I think, is for development. It is clear that you can approach in several ways. Of course, additional workshops are needed, and they can be created in the Chumakov Center, you can also create a full cycle from the very beginning on another site – by a private investor or … This is a matter of government decision. I will propose the appropriate papers for the leadership; this will be a separate task.

I would like to say a few words about personnel. We sometimes forget about this question, because we believe that we do not have enough hardware. We forget a simple thing: if there is no “iron”, then in general, probably, there are no people who can handle this “iron”.

At one time, we organized the department of development and research at Sechenov University. This is a good breeding ground for attracting new personnel. We think this is probably the most important element for promotion.

And finally, to the issue of further development After satisfying the need – and I hope that within a year we will nevertheless achieve collective immunity by joint efforts – we intend to enter international markets. We are the only company – an institution that is prequalified.

Meeting on Circulation of Vaccines to Prevent Novel Coronavirus Infection

Mikhail Mishustin: Thank you, Aydar Ayratovich.

I would like to thank you once again, the team that worked on the vaccine, and congratulate him on the result. And of course, now it is very important that the entire chain, after the appropriate control procedure has been passed, is built to maximize the production of this vaccine. This, of course, will also require appropriate adjustments to our vaccine distribution system. The main thing is that this does not affect the quality. I would ask Tatyana Alekseevna (Golikova) and colleagues to carefully look at and adjust our respective plans.

You know, we are systematically and literally every day dealing with the production of vaccines and vaccination. I would like Tatyana Alekseevna to report on the current situation. You are welcome.

Tatyana Golikova: Dear Mikhail Vladimirovich! Dear colleagues!

As you already noted in your opening remarks, in accordance with the instructions of the President of the country, mass vaccination has started in the Russian Federation and is gradually gaining momentum.

To date, the first Russian vaccine, Sputnik V, is produced at seven sites. Three additional sites are also expected. As for the second vaccine, EpiVacCorona, there are already two industrial partners here. And we also hope that colleagues from the Chumakov Center will present their proposals on scaling up the vaccine in the near future.

The cumulative total to date produced 11.1 million sets of vaccine doses, which are currently in circulation. Today we plan (I emphasize: just for today) that by the end of the first half of the year the production volume will amount (so far without KoviVac) 88 million sets of doses. The lion’s share – 83 million dose kits – falls on Sputnik V, and 5.4 million kits – EpiVacCorona.

In the first quarter of 2021, we expect the planned volume of vaccine production at the level of 30.5 million dose kits. Based on production plans in the first half of 2021, we estimate that 59 million sets of vaccine doses will be available to citizens for vaccination. To date, 7.9 million vaccine dose kits have been released for use by the population.

Based on the numbers that we determined in connection with the need to achieve herd immunity, Rospotrebnadzor, the Ministry of Health, together with experts, worked out and recommended for use already in industrial operation a mathematical model for achieving herd immunity. It is based on data on the population of different age groups, the epidemiological situation in each region of the country, the number of people who have been ill, the course of vaccination, the load on the corresponding vaccination points, and so on.

Based on this mathematical model, we are planning the parameters for the distribution of vaccines in the constituent entities of the Russian Federation. As I said, this is already in use, in industrial use. We have agreed with colleagues that, depending on the situation, any adjustments to this model can be made once a month, not more often. In any case, in comparison with what it was before, this model shows higher efficiency.

As you have already noted, the number of vaccination points in Russia today is 4129. At the same time, the regions of the Russian Federation are increasing the number of points and the organization of work in this direction. Nevertheless, I would like to once again draw the attention of the regions to the need for special treatment and special attention in the course of vaccination to citizens aged 60+ and patients with chronic diseases. We are also monitoring this situation online in all constituent entities of the Russian Federation. Today, in the Russian Federation as a whole, the proportion of vaccinated citizens over 60 years old is 45%. Nevertheless, we believe these indicators are still insufficient and we ask the regions to increase this position. Every week (this week – twice) we hold meetings with the constituent entities of the Russian Federation on all the nuances of organizing this work, point out the shortcomings, where they are, and the need to correct certain decisions.

As you also noted, in 85 regions of the country, an appointment for vaccination through the EPGU is provided. Feedback from the population is also organized here: citizens can ask questions or inform vaccination organizers about the problems they have with getting vaccinated.

I would also like to draw your attention to the fact that after a complete vaccination with two components is carried out, the corresponding QR code is automatically generated and sent, confirming the vaccination, and the person is issued a vaccinated certificate, including in electronic form.

Dear Mikhail Vladimirovich! Taking into account the fact that we have organized this work, taking into account the prospects that we see today for the production and release into civil circulation of three products registered in the Russian Federation, we believe that the President’s instruction will be fully implemented.

Mikhail Mishustin: Thank you, Tatyana Alekseevna. We are quite successful in vaccination. I want to reiterate that an online system for monitoring the entire vaccination process has been created, in which almost all participants in the process can literally see the situation at any moment. This applies to information on production, and on the appropriate inclusion in civil circulation, and on logistics. But what is very important – now a lot depends on the regions. I would like to draw the attention of the heads of regional authorities: when everything has already been done in our information, when we understand in a planned manner the number of necessary vaccines that will arrive in the regions, so that everything is delivered on time and the process is organized on the ground. I would ask the regional leaders to closely follow this process.

The addition of one more vaccine should not slow down the production of registered vaccines.

EDITOR’S NOTE: This article is a translation. Apologies should the grammar and or sentence structure not be perfect.

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