Argentina grants emergency use authorisation for Sputnik V vaccine

Supplies to be facilitated by international partners of RDIF in India, China, South Korea and other countries

Argentina became the first country in Latin America to officially register Sputnik V, under the emergency use authorisation procedure by The National Administration of Drugs, Foods and Medical Devices of Argentina (ANMAT) based on the results of Phase III clinical trials in Russia.

On December 10, the Russian Direct Investment Fund (RDIF) and the Government of Argentina signed a contract for the supply of 10 million doses of Sputnik V vaccine to the country. ANMAT representatives inspected a number of vaccine production sites that will supply Sputnik V to Argentina.

Supplies of the vaccine to Argentina will be facilitated by international partners of RDIF in India, China, South Korea and other countries.

On December 14, the Gamaleya National Center and RDIF announced the results of the third and final control point analysis of data obtained 21 days after administering the first dose to volunteers. The efficacy of the vaccine is reportedly 91.4 per cent.

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 was confirmed to be highly effective, at a rate of above 90 per cent, at each of the three control points of the clinical trials (20, 39 and 78 confirmed cases of novel coronavirus infection among volunteers both in the placebo group and in the group that received the vaccine).

The vaccine demonstrated 100 per cent efficacy against severe coronavirus cases. There were 20 severe cases of coronavirus infection among confirmed cases in the placebo group and no severe cases in the vaccine group.

Sputnik V is based on the traditional platform of human adenoviral vectors. As per a RDIF release, the cost of one dose is less than $10 for international markets and the production of the lyophilised (dry) form of the vaccine, which is stored at a temperature of +2 to +8 degrees Celsius, enables the vaccine to be easily distributed to international markets.

Kirill Dmitriev, CEO of the Russian Direct Investment Fund, commented, “With ANMAT approval, Sputnik V will become an important part of Argentina’s national coronavirus vaccine portfolio and will make a significant contribution to ensuring public safety against the pandemic. We expect that the first shipment of the vaccine will arrive in Argentina very soon and will make good news for Christmas.”