The Gamaleya National Research Center of Epidemiology and Microbiology and the Russian Direct Investment Fund (RDIF) said on Tuesday that interim results published in The Lancet, a peer-reviewed medical journal, have confirmed the efficacy of the Sputnik V vaccine at 91.6 per cent in phase 3 trial. RDIF's India partner, Dr Reddy's Laboratories, which is also conducting the clinical trials here, has said that it would apply for emergency approval in March and that it aims to launch the vaccine in the same month.
Based on the human adenoviral (flu virus) vector platform, Sputnik V showed higher efficacy in the elderly group (over 60 years) at 91.8 per cent, RDIF said in a statement. In the interim efficacy analysis, data from 19,866 volunteers were included. Of these, 14,964 received the vaccine and 4,902 were given the placebo.
RDIF added that the vaccine has shown good safety profile. Most adverse events (about 94 per cent) were mild and included flu-like symptoms, injection site reactions, headache and asthenia (weakness or lack of energy). No serious adverse events associated with vaccination were reported nor were any events of allergies or anaphylactic shock.
Alexander Gintsburg, director, Gamaleya Research Institute of Epidemiology and Microbiology, said, “The publication of internationally peer reviewed data on Sputnik V’s clinical trial results is a great success in the global battle against the Covid-19 pandemic... Several vaccines have already been created based on human adenoviruses and this tool is one of the most promising for development of new vaccines in the future.”
For India, supplies of 125 mn patient doses (each patient needs two jabs) have been lined up over the next 12 months. While most of these doses would come from Indian manufacturers, some will arrive from Russia.
Sputnik V is already registered in 16 countries: Russia, Belarus, Serbia, Argentina, Bolivia, Algeria, Palestine, Venezuela, Paraguay, Turkmenistan, Hungary, UAE, Iran, Republic of Guinea, Tunisia and Armenia.
"The data published by The Lancet proves that not only is Sputnik V the world’s first registered vaccine, it is also one of the best," RDIF CEO Kirill Dmitriev said. "It fully protects against severe Covid-19, according to data which has been independently compiled and reviewed by peers and then published in The Lancet."
"Sputnik V," he added, "is one of only three vaccines in the world with efficacy of over 90 per cent but outperforms them in terms of safety, ease of transportation due to storage requirements of +2 to +8 degrees (Celsius) and a more affordable price.”