By Kester Kenn Klomegah
President Vladimir Putin has praised the entire healthcare system, and particularly the hard-working team of scientists and specialists from different institutions for their efforts at research and creating a series of coronavirus vaccines for use against the coronavirus both at home and abroad. Three vaccines already registered in Russia, two of them – Sputnik V and EpiVacCorona – are produced in large quantities by Russian pharmaceutical companies and are currently used for vaccination. It is additionally planned to rollout another one – CoviVac.
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, Putin said during a videoconference meeting focused on increasing the manufacturing capacity of COVID-19 vaccines and the progress of vaccination in Russia.
Unreservedly made reference to staff qualities such as consistent and effective hard-work, truly selfless work and responsible attitude, and further urged them to continue making relentless efforts in stabilising the spread of the coronavirus infections and in protecting the life and health of millions of people in the country.
Putin further noted that 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.
“We can safely say, and the practical results indisputably corroborate, the fact that the Russian vaccines are absolutely safe and dependable. Our success is recognised abroad as well. The number of countries using the Sputnik V vaccine is expanding fast, more countries around the world are showing interest in our vaccine with 55 countries having authorised its use,” he told the meeting.
In addition, Russia now has a number of contracts with foreign manufacturers, – 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. The latest, it has signed a contract with an Indian company for doses to vaccinate 100 million people. Indisputably, working with 55 countries means a total population of 1.4 billion. There are plans to expand the number of partner countries and that will reach estimated 2.5 billion people.
While Russia and its pharmaceutical companies are considering the dynamics of the global market and the demand for Russian-made vaccines, and expanding their production capacities, it equally places emphasis on domestic needs, supplying and vaccinating Russian citizens with vaccines, is an absolute priority. It is estimated that at least 60 percent of all adults in the country must be vaccinated for complete stabilisation. This requires 69.8 million sets of vaccine doses. At any rate, there are more than 20 million Sputnik V doses, according to Russian president, quoting his Prime Minister Mikhail Mishustin.
In his contribution at the meeting, Minister of Industry Denis Manturov informed that under the plan, 12.5 million sets of the vaccine must be produced in March. The planned figure for April is 17 million. It is planned to continue building up production so as to have over 80 million of two-component doses by the first six months.
According to him, all these amounts will be primarily used to vaccinate Russian citizens. In order to meet the global demand for Russian vaccines, his ministry is working on scaling up production of vaccines and on transferring technology abroad. It already has comprehensive agreements on this with manufacturers in 10 countries.
Healthcare Minister Mikhail Murashko informed the meeting about organisations that 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,” he said, and further mentioned the need 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. As of now, there are 4,500 stationary vaccination stations across Russia, and plans to increase this figure, as well as over 1,000 mobile stations.
Participating in the meeting, Pharmstandard Chairman of the Board Viktor Kharitonin also discussed production capability of the vaccine and pointed to the successful completion of the transfer of laboratory technology, scaled and fine-tuned the manufacturing technology abroad.
“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,” added Kharitonin.
Taking his turn, Chairman of the Board of the R-Pharm Group Alexei Repik talked about efforts that are currently focused on the creation and manufacturing of new forms of the vaccine that will be easier to use and also to transport. He noted that it will increase the attractiveness of the vaccines on foreign markets, including countries with a hot climate: the Middle East, Africa and Latin America.
“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. 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,” informed Alexei Repik.
Director of the Gamaleya National Research Centre for Epidemiology and Microbiology Alexander Gintsburg also highlighted a few aspects of the vaccine production and about documents for registration. According to him, the Gamaleya Research 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, therefore it has to adapt it to every country’s regulatory system.
He further spoke about The Lancet, a highly prestigious and popular medical journal, that published two articles on the results of scientific data and clinical trials. This provides important scientific evidence proving the vaccine’s efficacy, this has completely eliminated the Western academic community’ scepticism regarding the vaccines’ quality and efficacy.
Alexander Gintsburg explained a little about children’s vaccination. According to him, children must be divided into several age groups. Russian experts and specialists in paediatric immunology are working in this direction. He said that a vaccine has been 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.
CEO of the Russian Direct Investment Fund (RDIF) Kirill Dmitriev stressed patent protection and about protecting intellectual rights for Russian made vaccines and other medical products. “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,” he told the meeting.
On foreign cooperation, “Mr President, 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,” Kirill Dmitriev said in appreciation.
Director General of the Vektor State Research Centre of Virology and Biotechnology Rinat Maksyutov discussed various research operations. 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,” he said.
According to Rinat Maksyutov, the Research Centre 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,” he told the meeting.
Director General of the Chumakov Federal Scientific Centre for the Research and Development of Immune and Biological Products (Russian Academy of Sciences) Aidar Ishmukhametov spoke about their engagement and involvement in research and production of medical products, tracing its roots to the Soviet Union.
The Chumakov Centre is one of the oldest facilities in the Russian Federation and the oldest vaccine developer in Russia. That in the 1960s, this centre’s achievements helped the country deal with polio. The centre back then developed a unique vaccine that 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 well-known around the world.
It is continuing this tradition. As of today, it has 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.
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 one hand, and well-coordinated work with research institutes and the search for partners, on the other hand, is a very efficient model.
“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. We inherited this research and development facility from the Soviet Union where it was a leader in this industry, and we are developing it,” he underlined the importance of his institution at the meeting.
CEO of the National Immunobiological Company, Rostec State Corporation, Andrei Zagorsky, however, noted that vaccine production is growing steadily. He highlighted the question of warehousing (storage), freezer facility and shipping to the regions. This is carried out in close cooperation with the manufacturing sites, as well as cargo recipients in the regions. These tasks are fulfilled on schedule, he said.
“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,” he added, speaking at the meeting.
Deputy Prime Minister Tatyana Golikova concluded with high appreciation. The meeting ended with clear understanding in what direction should be moving to overcoming the coronavirus pandemic and at the same time, extend assistance to foreign countries that are in need. She, however, reiterated that, in a fairly short time, despite the difficulties and amid the challenging pandemic of 2020, all her colleagues have indeed accomplished something that seemed almost impossible, worked 24/7 and made Russia the leader in the production and use of vaccines, primarily, for the public in Russia.
Kester Kenn Klomegah is a versatile researcher and a passionate contributor, most of his well-resourced articles are reprinted elsewhere in a number of reputable foreign media.