The Russian Direct Investment Fund (RDIF) has announced that the National Administration of Drugs, Foods and Medical Devices of Argentina (ANMAT) has registered the Sputnik V vaccine against Covid-19.
With this latest development, Argentina became the first Latin American country to officially register Sputnik V.
Based on the data from Phase III clinical trials in Russia and without further trials in Argentina, the vaccine was registered under the emergency use authorisation procedure and was authorised by ANMAT.
RDIF and the Government of Argentina entered into a contract earlier this month for the supply of ten million doses of the vaccine to the country.
The representatives of the regulator examined various vaccine production sites that will supply Sputnik V to Argentina.
Global partners of RDIF in India, China, South Korea and other countries, will assist in the supplies of Sputnik V vaccine to Argentina.
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Last week, the Gamaleya Center and RDIF reported that data from the third and final control point analysis obtained 21 days after giving the first dose to volunteers showed vaccine efficacy of 91.4%.
The vaccine demonstrated to be highly effective, at a rate of above 90%, at each of the three control points of the trials.
In addition, it showed 100% efficacy against severe Covid-19 cases.
The RDIF noted that a single dose of Sputnik V vaccine costs less than $10 for global markets.
The vaccine’s lyophilised (dry) form that can be stored at a temperature of 2-8 °C aids in easy distribution in global markets.
Russian Direct Investment Fund CEO Kirill Dmitriev said: “Registration of the Sputnik V vaccine in Argentina without additional clinical trials in the country is a testament to Russian regulatory standards and the quality of clinical trials.”
The first shipment of the vaccine is expected to reach Argentina soon.
In October, the RDIF submitted applications for accelerated registration under emergency use listing and prequalification of its Sputnik V vaccine against Covid-19, to the WHO.