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Bolivia has registered Sputnik V vaccine based on Russian clinical trial data

Bolivia has registered Sputnik V vaccine based on Russian clinical trial data

Sputnik V has been registered under the emergency use authorization procedure

Moscow, January 6, 2021 – The Russian Direct Investment Fund (RDIF, Russia’s sovereign wealth fund) announces the registration of the Russian Sputnik V vaccine against coronavirus by State Agency for Medicines and Health Technologies (Agencia Estatal De Medicamentos Y Tecnologías En Salud, AGEMED) of the Plurinational State of Bolivia.

The vaccine was registered under the emergency use authorization procedure and was approved by AGEMED based on the results of Phase III clinical trials in Russia, without additional trials in Bolivia. Sputnik V was registered by Argentina’s regulator ANMAT under the same procedure on December 23, 2020.

Phase III clinical trial data obtained in Russia was also accepted by regulators in Serbia and Belarus to register Sputnik V and begin the vaccination of the population. In Serbia the vaccination started on January 6, 2021 and in Belarus – on December 29, 2020. 

On December 30, 2020 RDIF and the Health Supply Centre (Central de Abastecimiento y Suministros de Salud, CEASS) of Bolivia announced the agreement to supply the country with 5.2 million doses of Sputnik V sufficient to vaccinate 2.6 million people. Supplies of the vaccine to Bolivia will be facilitated by international partners of RDIF in India, China, South Korea and other countries. The agreement will make it possible for more than 20% of Bolivia’s population to access the vaccine.

The efficacy of the vaccine is 91.4% according to the results of the third and final control point analysis of Russian Phase III clinical trials data obtained 21 days after administering the first dose to volunteers. 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.

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

“Registration of Sputnik V in Bolivia will help save many lives and prevent the spread of coronovirus using a safe and effective vaccine based on proven human adenoviral vectors platform. We appreciate our partnership with Bolivia's regulators and expect more countries in Latin America and other parts of the world to register the vaccine under emergency use authorization procedure soon”.

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Last Updated: 07-Jan-2021