Production of Russian Sputnik V Vaccine against Coronavirus Launched in Kazakhstan

22 December 2020

GMP News

The Russian Direct Investment Fund (RDIF, Russia’s sovereign wealth fund) announce the launch of production of Sputnik V, the world’s first registered vaccine against coronavirus, – in Kazakhstan.

A validation batch was produced today at the Karaganda pharmaceutical complex. The batch will be sent for verification to the developer of the vaccine – the Gamaleya National Center. The Karaganda pharmaceutical complex is an innovative biotechnology production facility with necessary equipment and qualified personnel, in compliance with international standards. Thus the production of the vaccine was organized in an unprecedented short period of time. RDIF and the Gamaleya Center are providing any necessary assistance to facilitate technology transfer.

The vaccine is produced under the agreement between RDIF and the Ministry of Health of Kazakhstan signed on December 4, 2020. On December 13, materials required for the production of the first batch of the vaccine were delivered to Kazakhstan. At least 2 million doses of the Sputnik V vaccine will be produced in the country.

On December 14, RDIF and the Gamaleya Center announced the final control point data analysis of the Phase III post-registration clinical trials of the Sputnik V vaccine in Russia, which demonstrated the Sputnik V vaccine efficacy rate of 91.4%.

Calculation was based on the analysis of data of volunteers (n = 22 714) who received both the first and second doses of the Sputnik V vaccine or placebo at the third and final control point of 78 confirmed cases in accordance with the Phase III clinical trials protocol.

The vaccine demonstrated 100% efficacy against severe coronavirus cases. There were 20 severe cases of coronavirus infection among confirmed cases in the placebo group and no severe cases in the vaccine group.

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

“We are grateful to the Ministry of Health of Kazakhstan for their support in organizing the production of a vaccine in one of our key partner states in such a short time. The deployment of full-scale production of Sputnik V in Kazakhstan brings us closer to achieving our common goal of ensuring sufficient quantities of a safe and effective vaccine to protect the population from coronavirus infection. We are currently in cooperation with the Ministry of Health and the National Center for Expertise of Medicines and Medical Devices which is responsible for vaccine assessments, to obtain registration of the vaccine in Kazakhstan”.

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