Bolivia registers Russia’s Sputnik V COVID-19 vaccine
pharmafile | January 7, 2021 | News story | | COVID-19, Vaccine
Bolivia’s state agency for medicines and health technologies (AGEMED) has registered Russia’s Sputnik V COVID-19 vaccine under emergency use authorisation.
The approval was based on the results of Phase III clinical trials in Russia, without additional trials in Bolivia.
On December 30, the Russian Direct Investment Fund and AGEMED announced the agreement to supply Bolivia with 5,200,000 doses of Sputnik V, enough to vaccinate 2,600,000 people. Supplies of the jab 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.
According to Phase III trial data obtained 21 days after the first dose was administered to volunteers, the efficacy of the Sputnik V vaccine is 91.4%.
Calculation was based on the analysis of data of volunteers who received both the first and second doses of the Sputnik V vaccine or placebo at the 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 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 authorisation procedure soon”.
Darcy Jimenez
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