The Russian Direct Investment Fund (RDIF, Russia’s sovereign wealth fund), and Hetero, one of India’s leading generic pharma companies (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 parties plan 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.
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 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. 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 with vaccines using one and the same vector for two doses.