Production of Russias First Coronavirus Vaccine Will Be at the Alium Plant

15 June 2020

GMP News

The Russian Direct Investment Fund (RDIF), Russia’s sovereign wealth fund, Sistema PJSFC and the Gamaleya National Research Institute of Epidemiology and Microbiology have agreed to cooperate to organise a production site at the Alium plant in Zelenograd in the Moscow region, for the large-scale production of the first vaccine for the prevention of coronavirus infection in Russia.

A distinctive characteristic of the vaccine is its ability to reduce the time taken for the development of immunity to the virus. According to the Gamaleya National Research Institute of Epidemiology and Microbiology, the first vaccination leads to humoral cellular immunity, and after the second one, memory cells are formed – one of the key features of a vaccine. The first clinical trials of the vaccine are expected to begin in mid-June 2020. The launch of mass production of the vaccine is anticipated by autumn 2020.

The Alium holding was established in October 2019 as a result of a merger between the pharmaceutical companies Obolenskoe and Binnopharm. Following the merger, Alium is among Russian’s top-10 pharmaceutical companies.

The Gamaleya National Research Institute of Epidemiology and Microbiology completed preclinical studies of an experimental sample of a vaccine against coronavirus and was one of the first to do so, not only in Russia but globally. The results of preclinical studies on monkeys and hamsters confirm the effectiveness and safety of the drug.

In 2015-2019, the Gamaleya National Research Institute of Epidemiology and Microbiology created an effective vaccine against the Ebola virus, as well as a vaccine against the MERS virus (the Middle East respiratory syndrome).

Kirill Dmitriev, CEO of the Russian Direct Investment Fund, said:

“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.”

Vladimir Chirakhov, President of Sistema PJSFC, said:

“From the first days of the epidemic, Sistema has been on the forefront of the coronavirus fight. Our portfolio assets evolved into something of an “umbrella” giving the nation full-cycle protection from the virus. For example, Medsi 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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