Argentina registers Sputnik V vaccine based on Russian clinical trial data

Moscow, Dec 24 : The Russian Direct Investment Fund, the country's sovereign wealth fund, announced that Argentina has registered the Russian coronavirus vaccine, Sputnik V.

Argentina is the first country in Latin America to officially register Sputnik V.

The vaccine was registered under the emergency use authorisation procedure and was approved by the regulator, National Administration of Drugs, Foods and Medical Devices of Argentina (ANMAT), based on the results of Phase 3 clinical trials in Russia, without additional trials in Argentina.

On December 10, RDIF and the Argentine government 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.

RDIF 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.

We are ready to develop cooperation on the vaccine with other Latin American countries and we hope that they will take ANMAT's decision into account."

"The Russian vaccine is based on a well-studied platform of human adenoviral vectors with no long-term negative effects, which has been proven in more than 250 clinical trials over decades.

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."



Source: IANS