Russia’s RDIF & Prominent Government Lab Progress COVID-19 Vaccine: Production Facility Readied in the Moscow Region

Jun 10, 2020 | COVID-19, Russia, Vaccine, Vaccine Development, Vaccine Manufacturing

Russia’s RDIF & Prominent Government Lab Progress COVID-19 Vaccine Production Facility Readied in the Moscow Region

Russia’s sovereign wealth fund known as the Russian Direct Investment Fund (RDIF), instrumental in forming a partnership with a Russian drug development company to develop the first approved use of an antiviral for COVID-19 treatment (Avifavir), has teamed with a $10 billion conglomerate called Sistema PJSFC and a government research laboratory called Gamaleya National Research Institute of Epidemiology and Microbiology to develop a major COVID-19 vaccine production facility. Not well reported in the Western press, RDIF has supported the development of a Russian COVID-19 vaccine that is scheduled to commence clinical trials by mid-June 2020 and enter production by the fall. With vaccine trial voluntary and participant enrollment underway, this Russian vaccine is the result of a partnership between Gamaleya and another Russian defense-focused research lab.

TrialSite News offers brief breakdown of this situation; the vaccine, players and timelines as reported by the RDIF supported by ongoing background research and discussions.

Who is the RDIF?

The Russian Direct Investment Fund, which has operated in an impressive manner since the advent of COVID-19. That Russia has an approved drug (Avifavir) that helps its people with COVID-19 symptoms can largely be attributed to the RDIF. Established in 2011 to make investments in leading high-growth companies in Russia and attract foreign direct investment, they have approximately $10 billion of capital under management. It has been reported that RDIF efforts have led to over $40 billion of foreign capital infusion into the Russian economy

Vaccine Background

According to RDIF, the Russian COVID-19 vaccine was developed by the same government labs that developed what is claimed “an effective against the Ebola virus, as well as a vaccine against the MERS virus (Middle East respiratory syndrome).” From 2015-2019, Gamaleya National Research Institute of Epidemiology and Microbiology was actively targeting research and development-related vaccine work, which purportedly has been now leveraged for the novel coronavirus vaccine.

The vaccine is alleged to reduce the time taken for the actual development of immunity to SARS-CoV-2, the virus behind the COVID-19 pandemic. Lead developer, the government-backed Gamaleya National Research Institute of Epidemiology and Microbiology, reports that the first vaccination leads to humoral cellular immunity and once a second vaccine is administered, a key feature of this vaccine kicks in—memory cells are formed.

With a tinge of nationalistic edge (common nowadays among many countries during the COVID-19 pandemic), RDIF claims that this was one of the first nations worldwide to have a batch of the preclinical vaccine completed.  Purporting to have successful ongoing preclinical animal research (hamsters and monkeys) confirm safety and effectiveness, the vaccine now will be tested in humans.

Stanford (BA) and Harvard (MBA) educated Kirill Dmitriev, CEO of RDIF, commented: “Creating an effective vaccine against coronavirus infection is one of the priorities in the fight against the virus. The Russian research base for vaccine development is one of the best globally, and we expect that the Russian vaccine will be one of the first in the world ready to be used. RDIF alongside Sistema and the Gamaleya National Research Institute of Epidemiology and Microbiology are actively working on one of the most promising coronavirus vaccines in the world. Following the completion of clinical trials of the vaccine, RDIF and Alium are ready to launch mass-production for the fastest possible vaccination of Russian citizens. This continues the series of RDIF investments in production of drugs for the treatment of any form of coronavirus infection: mild, moderate and severe.”

What group is behind the development of the vaccine?

RDIF behind the scenes provides money and support to facilitate partnerships, including that with Gamaleya National Research Institute of Epidemiology and Microbiology  (“Gamaleya”) and the Central Research Institute of the Radiation, Chemical and Biological Defense Troops (“Central Research Institute”).

Gamaleya is an elite government-financed research and development lab in Siberia and the Central Research Institute is a military/defense based research operation.

When is the vaccine scheduled to progress into clinical trials in humans?

According to a recent statement by Russian Defense Minister Sergei Shoigu, the Russian COVID-19 vaccine will be completed by June 1, hence why the recent flurry of press out of Russia. The experiment vaccine it is claimed by Russian authorities will move into clinical trials by the end of July.

When does Volunteer Participant recruitment commence?

Now. There has been recent press out of Russia announcing the identification of volunteer participants for forthcoming vaccine clinical trial. 

Who are the voluntary participants?

According to Tass, two groups of volunteers were selected out of  a pool of military personnel and civilians. The Russian Defense Ministry told the Russian press that 50 “servicemen,” including 10 medical workers, would be placed on a 14-day quarantine on June 4 and 9. The military personnel participants are between the ages of 25 to 50 years. As part of their protocol, the participants must go through a quarantine to exclude the potential of transmitting the infection to other participants and medical personnel.

Where are the Clinical Trials being conducted?

The military personnel volunteers will be tested at the 48th Central Research Institute of the Russian Defense Ministry. This happens to be where Russian health and government authorities tested vaccines for Ebola and Middle East Respiratory Syndrome (MERS) and a universal flu vaccine.

At least for a group of civilian volunteers, the vaccine investigational site is the Burden Main Military Clinical Hospital in Moscow. The military investigational team will monitor the participants on a daily basis.

When is Russia planning on launching mass production of the vaccine?

They are purporting to be ready by autumn 2020.

Who is organizing and developing the vaccine production facility?

A partnership including RDIF, Sistema PJSFC and the Gamaleya National Research Institute of Epidemiology and Microbiology.

Where is the vaccine going to be mass produced?

The aforementioned vaccine manufacturing partnership collaborates now to develop the production site at the “Alium plant” in Zelenograd in the metropolitan area of Moscow “for the large-scale production of the first vaccine for the prevention of coronavirus infection in Russia,” reported RDIF.

What are some more details of the “Alium”?

As it turns out, this is actually a facility that belongs to Alium holding, established in October 2019 due to the merger of two Russian pharmaceutical companies including Obolenskoe and Binnopharm. Post-merger, Alium is now one of Russia’s top ten pharmaceutical companies. This new large company has over 200 drugs in its portfolio across therapeutic areas from respiratory and central nervous system and gastrointestinal to cardiology and infectious diseases.

Who owns the new Alium holding?

The merger was supported by shareholder conglomerate Sistema PJSFC, a publicly-traded diversified Russian holding company serving over 150 million customers in sectors ranging across sectors. The company generated nearly $10 billion in revenues in 2019.

Sistema PJSFC Chairman Comments on Vaccine Production

Vladimir Chekhov, President of Sistema PJSFC commented on the efforts to date: “portfolio assets evolved into something of an “umbrella” giving the nation full-cycle protection from the virus. For example, Meds Otradnoye has been repurposed into an infectious disease hospital. Sistema BioTech moved fast to develop two diagnostic kits to test for COVID-19. Other assets produce personal protection equipment, while the pharmaceutical manufacturers Alium and Sintez provide Russians with affordable medications to treat COVID-19 and its comorbidities. Producing a coronavirus vaccine is yet another step for Sistema. Our production plant in Zelenograd is poised to start preparing for the production of a pilot batch of a vaccine developed by the National Gamaleya National Research Centre for Epidemiology and Microbiology, an initiative backed by the Russian Direct Investment Fund. If successful, the project will serve to fast-track the vaccination of at-risk groups.“

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