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Russia's RDIF Says Bolivia Registered Sputnik V Vaccine Based on Trial Results in Russia

© Sputnik / Georgy Zimarev / Go to the mediabankSputnik V Vaccine
Sputnik V Vaccine - Sputnik International
MOSCOW (Sputnik) - Bolivia has registered the Sputnik V coronavirus vaccine based on Russia's clinical trial data, the Russian Direct Investment Fund (RDIF) said on Wednesday.

"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," the statement said.

The view shows an ampoule component 1 of the two-component vector vaccine the Sputnik-V against coronavirus infectionin the city polyclinic No. 4 in Volgograd, Russia - Sputnik International
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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 coronavirus 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".

The Sputnik V vaccine was registered by the Argentinean regulator, ANMAT, on December 23, 2020 under the same procedure.

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. The 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.

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