RDIF, Hetero to produce over 100 mn doses of Sputnik V vaccine

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.

Hyderabad: The Russian Direct Investment Fund (RDIF, Russia’s sovereign wealth fund), and Hetero, Hyderabad-based generic pharmaceutical company through its biologics arm Hetero Biopharma, have agreed to produce in India over 100 million doses per year of the world’s first registered vaccine against the novel coronavirus infection – Sputnik V. The partners intend to start the production of Sputnik V in the beginning of 2021.

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.

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Interim trial results show efficacy of the Sputnik V vaccine, based on a well-studied platform of human adenoviral vectors. Evaluation of efficacy was carried out among 18,794 volunteers for 28 days after receiving the first dose (seven 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 analysis demonstrated a 91.4 per cent efficacy rate for the Sputnik V vaccine.

Vaccine efficacy

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. So, 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 per cent.

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.

When the Sputnik V vaccine is used, the coronavirus itself does not enter the body as the vaccine only contains genetic information about part of its outer protein coat, the so-called “spikes” forming its crown. This completely eliminates the possibility of getting infected as a result of vaccination while also causing the body’s stable immune response.

Key collaboration

Kirill Dmitriev, CEO of the Russian Direct Investment Fund, said, “The vaccine’s interim clinical trial results show 95 per cent 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.”

“Thanks to our cooperation with Hetero, we will be able to significantly increase production capacity and provide people of India with an efficient solution in this challenging period of the pandemic,” he added.

Murali Krishna Reddy, director, International Marketing, Hetero Labs, said, “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 realising the objective of ‘Make-in-India’ campaign as envisioned by our Prime Minister of India.”

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