The Gamaleya National Research Center of Epidemiology and Microbiology of the Ministry of Health of the Russian Federation and the Russian Direct Investment Fund (RDIF, Russia's sovereign wealth fund) announce that The Lancet, one of the world's oldest and most respected medical journals, has published interim results of a Phase III clinical trial of Sputnik V, confirming the vaccine's high efficacy and safety. Sputnik V, which is based on a well-studied human adenoviral vectors platform, is the world's first registered vaccine against coronavirus.
In the interim efficacy analysis of the randomized, double-blind, placebo-controlled clinical trial, where data on 19,866 volunteers were included in the efficacy analysis (14,964 of whom received the vaccine and 4,902 the placebo), the two-dose treatment of Sputnik V administered 21 days apart demonstrated efficacy of 91.6% against COVID-19. The calculation is based on the analysis of 78 confirmed cases of COVID-19 identified in the placebo group (62 cases) and in the vaccine group (16 cases). Sputnik V generated a robust humoral and cell mediated immune response.
Alexander Gintsburg, Director of the 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. The Russian vaccine's safety and high efficacy are shown by the hard scientific data presented and I congratulate the entire team of Gamaleya National Research Center for this monumental achievement. 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."
Kirill Dmitriev, CEO of the Russian Direct Investment Fund, commented: "This is a great day in the fight against the COVID-19 pandemic. The data published by The Lancet proves that not only Sputnik V is the world’s first registered vaccine, but also one of the best. 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 is one of only three vaccines in the world with efficacy of over 90% but outperforms them in terms of safety, ease of transportation due to storage requirements of +2 to +8 degrees and a more affordable price. Sputnik V is a vaccine for all mankind."
Hildegund C.J. Ertl, M.D., Professor, Vaccine & Immunotherapy Center, The Wistar Institute, USA, said: "The vaccine is 100% effective in preventing serious disease or death, which in the end is the most crucial parameter; we can all deal with the sniffles as long as we stay out of the hospital or the graveyard. Even after a single dose of this prime-boost regimen protection against disease was at 87.6%. Sputnik V is thus more effective than the AstraZeneca or Johnson&Johnson. Sputnik V, which, unlike the equally efficacious RNA vaccines of Pfizer and Moderna, can be stored in the fridge, will be of tremendous value to combat the global COVID-19 pandemic."
Cecil Czerkinsky, PhD, M.D., Research Director, National Institute of Health and Medical research (Inserm), France, said: "The interim results of the phase 3 clinical trial of Sputnik V COVID adenovirus vector vaccine are fairly impressive. This vaccine appears to be highly efficacious and immunogenic across age groups. This is clearly good news as this dual formulation vaccine is comparatively easy to manufacture and to deploy amid the anticipated global shortage of vaccines and logistical problems in vaccination roll-out of temperature-sensitive vaccines recently authorized for emergency use."
Omar Sued, President of the society of infectologists, Argentina, said: "The paper, published in The Lancet, confirms successful results and provides additional information about the efficacy and the safety of this vaccine in different subgroups. From the public health's point of view, the efficacy of the vaccine was very high. The safety profile was very good. The dissemination of this information is vital for informing the scaling up and rollout of t...
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