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Covid-19: Russia’s Sputnik V vaccine confirms 91.4% efficacy

Our Bureau Mumbai | Updated on December 15, 2020

Data to be submitted for accelerated registration internationally

Russia’s Sputnik V vaccine has demonstrated an efficacy of over 90 percent, according to the Gamaleya Center and the Russian Direct Investment Fund.

“Evaluation of efficacy was carried out among volunteers 21 days after receiving the first dose of the vaccine or placebo upon reaching the third and final statistically significant representative control point of the trial, in compliance with the Phase III clinical trial protocol of the Sputnik V vaccine. The data analysis at the final control point of the trials demonstrated a 91.4 percent efficacy rate,” they said.

Kirill Dmitriev, RDIF’s Chief Executive, said that the data will be used to submit applications for accelerated registration of the Russian vaccine in other countries. “We also see high interest from international pharmaceutical companies in the Gamaleya Center vaccine, since the use of Sputnik V components in combination with other vaccines can significantly increase their efficacy,” it added.

India’s Dr Reddy’s Laboratories is conducting clinical trials on the vaccine here, while Hetero Biopharma has an alliance to make 100 million doses of the vaccine. Global supplies are being produced by RDIF’s international partners in India, Brazil, China, South Korea and other countries, Russia’s sovereign wealth fund said.

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‘100% effective against severe cases’

The analysis of the Sputnik V vaccine efficacy at the final control point was carried out on the basis of 78 confirmed cases identified in the placebo group (62 cases) and in the vaccine group (16 cases), RDIF said.

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,” it added.

As of December 14, more than 26,000 volunteers were vaccinated at 29 medical centres in Russia as part of the ongoing clinical trials. Currently, Phase III clinical trials are approved and are ongoing in Belarus, the UAE, Venezuela and other countries, as well as Phase II-III in India, the note said.

Till date, no unexpected adverse events were identified as part of the research, it added. Some of those vaccinated had short-term minor adverse events such as pain at the injection point and flu-like symptoms including fever, weakness, fatigue, and headache.

The price of one dose of Suptnik V has been pegged at less than $10 for international markets while the production of the lyophilized (dry) form of the vaccine, which is stored at a temperature of +2o to +8o Celsius, enables easier distribution of the vaccine in international markets, the note added.

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Published on December 15, 2020

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