Hyd-based Hetero Biopharma to produce 100 million doses of Sputnik V vaccine

At present, phase III clinical trials have been approved and are being conducted in India, Belarus, the UAE, Venezuela, and other countries. The company said over 50 countries have requested more than 1.2 billion doses of Sputnik V. The vaccine supplies for the global market will be produced by RDIF's international partners in India, Brazil, China, South Korea, and other countries.

The Gamaleya Center and RDIF announced on 24 November that the analysis demonstrated a 91.4 per cent efficacy rate for Sputnik V. The results were obtained during the second interim data analysis of the largest double-blind, randomised, placebo-controlled phase III clinical trials in Russia involving 40,000 volunteers. "Interim trial results have once again confirmed the high efficacy of the Sputnik V vaccine, the world's first registered vaccine against coronavirus based on a well-studied platform of human adenoviral vectors. Evaluation of efficacy was carried out among volunteers (n=18,794) 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," said RDIF.

B. Murali Krishna Reddy, the director of international marketing, Hetero Labs Limited, said, "We 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."

Kirill Dmitriev, the CEO of the DIF, said, "We are delighted to announce the agreement between RDIF and Hetero that will pave the way to production of safe and highly effective Sputnik V vaccine in India. I am confident that Sputnik V will become an integral part of the national vaccine portfolio of every country willing to protect its population from the novel 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."

The RDIP claimed that 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 that use only one vector for two doses. Some 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.

RDIF also said that the safety of vaccines based on human adenoviruses have been confirmed in more than 75 international publications and more than 250 clinical trials conducted during the past two decades, while the history of the use of human adenoviruses in vaccine development started in 1953. Adenovirus vectors are genetically modified viruses of the regular flu that cannot reproduce in a human body. When the Sputnik V vaccine is used, the novel 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.