Registering the vaccine based on the data from clinical trials in Russia confirms ANMAT’s high confidence in Russian regulatory standards
MOSCOW, Russia – The Russian Direct Investment Fund (RDIF) Russia’s sovereign wealth fund announced the registration of the Russian Sputnik V vaccine against coronavirus by The National Administration of Drugs, Foods and Medical Devices of Argentina (ANMAT).
Argentina was the first country in Latin America to officially register Sputnik V. The vaccine was registered under the emergency use authorization procedure and was approved by the regulator, ANMAT, based on the results of Phase III clinical trials in Russia, without additional trials in Argentina.
On December 10, RDIF and the government of Argentina signed a contract for the supply of ten 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 91.4 percent.
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 was confirmed to be highly effective, at a rate of above 90 percent, 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 percent 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 has a unique set of parameters, making it one of the most competitive vaccines globally. The efficacy rate is over 90 percent and the vaccine is based on a safe and well-studied platform of human adenoviral vectors. The cost of one dose is less than $10 for international markets and the production of the lyophilized (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, chief executive officer of the Russian Direct Investment Fund, commented: “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.”
