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A press release from Sputnik V said the parties intend to start the production of the vaccine at the beginning of next year.
The Gamaleya Center and RDIF announced on November 24 positive results obtained during the second interim data analysis of the largest double-blind, randomised, placebo-controlled Phase III clinical trials in Russia’s history involving 40,000 volunteers.
Interim trial results have once again confirmed the high efficacy of the Sputnik V vaccine, based on a well-studied platform of human adenoviral vectors.
Evaluation of efficacy was carried out among volunteers 28 days after receiving the first dose (7 days after the second dose) of the vaccine or placebo upon reaching the second control point of the trial in compliance with the clinical trial protocol, the press release said.
The analysis demonstrated a 91.4 percent efficacy rate for the Sputnik V vaccine.
The uniqueness of the Russian vaccine lies in the use of two different vectors based on the human adenovirus, which allows for a stronger and longer-term immune response as compared to vaccines using one and the same vector for two doses.
Preliminary data on volunteers on the 42nd day after the first dose (equivalent to 21 days after the second dose), when they have already formed a stable immune response, indicates the efficacy rate of the vaccine is above 95 percent, according to the official website of Sputnik V vaccine.
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.
Requests for more than 1.2 billion doses of Sputnik V vaccine came from more than 50 countries. The vaccine supplies for the global market will be produced by RDIF’s international partners in India, Brazil, China, South Korea and other countries, it said.
The safety of vaccines based on human adenoviruses has been confirmed in more than 75 international publications and more than 250 clinical trials conducted during the past two decades, the press release said.
“We are delighted to announce the agreement between RDIF and Hetero that will pave the way to production of the safe and highly effective Sputnik V vaccine on Indian soil,” said
Kirill Dmitriev, CEO of the Russian Direct Investment Fund.
“The vaccine’s interim clinical trial results show 95 percent efficacy on the 42nd day after the first dose. I am confident that Sputnik V should become an integral part of the national vaccine portfolio of every country willing to protect its population from the coronavirus,” Dmitriev said.
He hoped that with the cooperation of Hetero, they will be able to significantly increase production capacity and provide people of India with an efficient solution.
Murali Krishna Reddy, Director of International Marketing at Hetero Labs, said they are pleased to collaborate with RDIF as a manufacturing partner for the most anticipated Sputnik V vaccine for the treatment of Covid-19.
“While we look forward to the clinical trial results in India, we believe that manufacturing the product locally is crucial to enable swift access to patients. This collaboration is another step towards our commitment in the battle against Covid-19 and realizing the objective of ‘Make-in-India’ campaign as envisioned by our Hon’ble Prime Minister of India,” he said.
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