First batch of the Sputnik V vaccine produced in Belarus for validation

First batch of the Sputnik V vaccine produced in Belarus for validation

Moscow, February 26, 2021 – The Russian Direct Investment Fund (RDIF, Russia’s sovereign wealth fund), Generium, a high-end Russian pharmaceutical company, and Belmedpreparaty, the leading pharmaceutical manufacturer in the Republic of Belarus, are preparing to begin production of the world’s first registered vaccine against coronavirus, Sputnik V.

The first batch of the Gam-COVID-Vak (Sputnik V) vaccine developed by the Gamaleya National Center has been produced for validation at Belmedpreparaty production facilities, utilizing technology transferred by the Russian company Generium. Upon obtaining the results of the stability study for the first batch of Sputnik V, preparations will begin for mass production. RDIF and its partners are also working on testing the full-cycle technology used for Sputnik V production at facilities in the Republic of Belarus. Production of Sputnik V at Belmedpreparaty sites will meet 100% of vaccine requirements in Belarus in order to protect its citizens against COVID-19.

To establish production, RDIF has transferred the required vaccine production technology and provided comprehensive support to its partners in Belarus, including the documentation and necessary biological material for the vaccine’s production. RDIF also assisted in equipment selection and procurement of any necessary consumables required in the process.

Belarus became the second country in the world after Russia to officially register Sputnik V. The registration certificate for the vaccine was issued on December 21, 2020. Furthermore, the first foreign clinical trials Sputnik V began in Belarus in October 2020. The volunteers were vaccinated as part of a double-blind, randomized, placebo-controlled clinical trial in eight clinics selected as research centers. The delivery of the first batch and the start of the Sputnik V vaccination programme in Belarus took place on December 29, 2020.

Denis Manturov, Minister of Industry and Trade of the Russian Federation, said:

“The joint production of the Sputnik V vaccine is an important step in cooperation between our countries. Industrial cooperation and development of partnership allow implementing important joint projects for a more effective protection of the population of Belarus. Our countries have also reached an agreement to start working on the improvement and modernization of Belarus’s laboratory base. In addition, we are discussing the possibility to launch full-scale production of the Russian vaccine there. This may happen in late March or early April of 2021. The Gamaleya Institute, Generium company and RDIF are assisting with the technology transfer.”

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

“RDIF and its partners are assisting in facilitating the production of the vaccine in Belarus, which will fully meet the needs of the country. Belarus was the first foreign country to start clinical trials of Sputnik V, register the vaccine and begin vaccinating the country’s population. The launch of vaccine production in the country will significantly increase the scale of vaccination with no additional logistics costs.”

Sputnik V has a number of key advantages:

·        Efficacy of Sputnik V is 91.6% as confirmed by the data published in the Lancet, one of the world's oldest and most respected medical journals; it is one of only three vaccines in the world with efficacy of over 90%; Sputnik V provides full protection against severe cases of COVID-19.

·        The Sputnik V vaccine is based on a proven and well-studied platform of human adenoviral vectors, which cause the common cold and have been around for thousands of years.

·        Sputnik V uses two different vectors for the two shots in a course of vaccination, providing immunity with a longer duration than vaccines using the same delivery mechanism for both shots.

·        The safety, efficacy and lack of negative long-term effects of adenoviral vaccines have been proven by more than 250 clinical studies over two decades.

·        The developers of the Sputnik V vaccine are working collaboratively with AstraZeneca on a joint clinical trial to improve the efficacy of the AstraZeneca vaccine.

·        There are no strong allergies caused by Sputnik V.

·        The storage temperature of Sputnik V at +2+8 C means it can be stored in a conventional refrigerator without any need to invest in additional cold-chain infrastructure.

·        The price of Sputnik V is less than $10 per shot, making it affordable around the world.