Universal vaccination is postponed

The coronavirus vaccine has not yet been put into mass production

Irina Pankratova, The Bell

Russian officials are vying to promise that mass vaccination against COVID-19 will begin in the country by the end of the year. But, as The Bell found out, so far no vaccine manufacturer is ready to provide it. Mass – if we understand by it millions and tens of millions of doses – vaccination is unlikely to become even in Moscow by the end of the year.

At the end of September, Health Minister Mikhail Murashko reported to Vladimir Putin about the beginning of scaling up the production of a coronavirus vaccine. In early October, Moscow Mayor Sergei Sobyanin urged Muscovites to hold out for a few more months before the vaccine appeared. Last week, his deputy Anastasia Rakova said that the authorities are preparing to start vaccinating everyone, admitting that the necessary amount of the drug has not yet been received. "As soon as this vaccine arrives, and I think the vaccine will arrive in the next month, we will begin its mass application for all willing Muscovites," she said. Vladimir Putin also let slip about the problems with the launch of the vaccine into mass production last week. "There are certain problems associated with the presence or absence of a certain amount of equipment – hardware, as they say – for the deployment of mass production," the president said at the Russia Calls forum.

The Bell talked to manufacturers and experts who follow the topic about what it all means and when in fact everyone will be able to get vaccinated against coronavirus.

What is the problem with vaccine production

"We cannot achieve stabilization of the vaccine, and so far no one can," admits the businessman, whose company is directly trying to launch the first registered Russian vaccine – developed at the N.F. Gamalei Sputnik V Center – into mass production.

"The stabilization of the vaccine assumes that all doses are the same, correct and clean. It is difficult to ensure such mass production," explains Anton Hopka, general partner and co–founder of the ATEM Capital venture fund, which invests in high-tech companies in the field of biotechnology, medical devices and molecular diagnostics in the United States and Western Europe. 

First, the vaccine is produced in small quantities – the bioreactor is launched at small volumes of about 500 ml, then they should be increased to tens of liters. For mass production, it is necessary to debug the process on large-volume reactors, and so far there are problems with this, admits another interlocutor of The Bell, who is well familiar with how the process is going with manufacturers. According to him, when scaling, the launches of bioreactors are generally unsuccessful. In addition, vaccine series often do not pass quality control at the Gamalei Institute. 

Complex biotechnological production requires calibration, and this process cannot be precisely designed in advance – it needs to be set up experimentally, explains Hopka. It is not known in advance whether the "settings" will work at each stage or not. Often, if they do not work at some of the scaling phases, you need to start the process again. "It usually takes a year to set up such a mass production, but here we are trying to keep within weeks," he says.

All scientific groups are working on the launch of serial production "literally around the clock" and nervously react to incoming reports about the imminent mass production of the vaccine, says one of the interlocutors of The Bell.

The Bell RDIF reported only that "bioreactor launches are going well, the main production task is scaling the production process and using larger bioreactors."

The Moscow authorities are still preparing technological platforms in order to vaccinate everyone, a source in the mayor's office told The Bell, "but the volume of production is not our forecasts." The Department of Health also forwarded a request for production volumes to the Ministry of Health. Manufacturers really promise a vaccine by the end of November, but for how long the available production volume will be enough to vaccinate everyone.

Vaccination within the framework of "post–registration tests" on 30 thousand volunteers is now carried out from volumes manufactured by the developer - the Gamalei Center, but its production capacity is quite small. "By the end of this year, we should reach millions of vaccines per year. From 3 to 5 million doses per year," Denis Logunov, a vaccine developer, said in an interview with Medusa in June. They refused to answer The Bell's questions about the current production volumes at the Gamalei Center, redirecting the request to the Ministry of Health. They didn't answer it there.

What kind of production is considered mass

What is considered mass production is also a question. "It is assumed that we want to vaccinate about half of the country's population, which means that tens of millions of doses of vaccine are needed," Hopka says. The dynamics of morbidity will still be calculated by epidemiologists, taking into account quarantines and other non-pharmaceutical measures, and perhaps the percentage of vaccination required for the formation of population immunity will be less than 50%, he notes. But in any case, we are talking about tens of millions of doses of the vaccine per month.

The estimated production volumes of the COVID-19 vaccine are virtually unprecedented, the expert notes. There is no sufficient capacity today in principle – all countries of the world are experiencing the same difficulties now.

What volume of production was promised

Back in the summer, the RDIF stated that by the end of the year, 30 million doses will be released in Russia for the domestic needs of the country. But already in mid-October, Industry Minister Denis Manturov, in an interview with Bloomberg, called these promises "nonsense." "The main task now is to scale production," he said. – It is impossible to produce 30 million doses by the end of the year."

"With the successful scaling of the already launched production technologies, Russia can reach the production of about 7-10 million doses of vaccines per month in December," a representative of the RDIF shared with The Bell an updated forecast last week. "And under the most conservative scaling scenario, this volume will be reached in January." But manufacturers have not yet confirmed their readiness to produce the vaccine in millions of doses at such a time and give much more cautious forecasts. By the end of the year, hundreds of thousands of vaccines will be produced in Russia, but not even a million, all the interviewees interviewed by The Bell believe.

• "Now there is a process of transfer to production, this means scaling up to the production of industrial volumes," Dmitry Morozov, CEO of Biocada, told The Bell. – By December we plan to complete this process, and before that we can only talk about our plans and expectations: we have set ourselves the task of producing about 2 million doses per month. We will find out how much we will get in fact when the transfer process is completed." According to Morozov, from the technical side, the company did not encounter difficulties when launching the bioreactor, but "the process is not fast: if you try to explain in simple words, now every company that plans to produce Sputnik-V has its conditional recipe, but production is different for everyone, so it needs to be adapted to individual characteristics equipment to receive a stable quality drug at the output." There is no single solution here, and as a result – the difficulties and time costs that are observed in all participants of the process, explains Morozov.

• Binnopharm's capacities are potentially designed to produce about 1.5 million doses of vaccine per year, Rustem Muratov, head of Alium (pharmaceutical holding AFK Sistema, VTB and RDIF, which includes the Binnopharm plant), said in an interview with RBC last week. So far, Binnopharm, according to him, is also busy adapting the technology of the creator of the vaccine to production. "There is no competition between vaccine manufacturers now, rather, with the active participation of the Ministry of Health and the Ministry of Industry, we are helping each other to develop scaling technology – the needs of the state far exceed the current production capabilities of any of the manufacturers," he admitted.

• The R-Pharm plant in Yaroslavl in September announced the imminent release of 8 million doses per month, but the exact timing was not specified. The company, in response to a request from The Bell, reported that they are expanding existing and creating new biovaccine production facilities in the Yaroslavl region and in Moscow. The total area of the new plants will be about 50 thousand square meters, about 200 bioreactors will be installed there. The capacity of the plants "will allow the production of tens of millions of doses of vaccines per year," the company says. It is planned that the main part of them will be launched in January 2021. R-Pharm did not say how long it would take to debug and reach the design capacity.   

• Generium promised to produce from 60 to 100 million doses of vaccine per year when reaching full capacity, but the company also did not give forecasts for the timing. They did not respond to The Bell's request there.

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