The Russian Direct Investment Fund (RDIF), and Hetero, one of India’s leading generic pharmaceutical 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, QİA.AZ reports citing RDIF.
The parties intend to start the production of Sputnik V at 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, randomized, 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 (n = 18,794) 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 analysis demonstrated a 91.4% 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. 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%.
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.
Russian Direct Investment Fund (RDIF) is Russia’s sovereign wealth fund established in 2011 to make equity co-investments, primarily in Russia, alongside reputable international financial and strategic investors.
Hetero is one of India’s leading generic pharmaceutical companies and the world’s largest producer of anti-retroviral drugs. Backed by 25 years of expertise in the pharmaceutical industry, Hetero’s strategic business areas spread across APIs, Global Generics, Biosimilars, Custom pharmaceutical services.