Moscow: Russian Sputnik vaccine demonstrated an efficacy of 91.6 per cent against COVID-19, the disease caused by the novel coronavirus (SARS-CoV-2), according to an interim analysis of a phase 3 clinical trial published in the journal The Lancet. The vaccine also has been deemed to offer complete protection against severe cases of COVID-19.
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) announced on Tuesday that the Lancet, one of the world’s oldest and most respected medical journals, has published interim results of a phase 3 clinical trial of Sputnik V, confirming the vaccine’s high efficacy and safety.
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 per cent 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.
“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 the development of new vaccines in the future,” said Alexander Gintsburg, Director of the Gamaleya Research Institute of Epidemiology and Microbiology.
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.”
According to the peer-reviewed study results, the vaccine provides full protection against severe cases of the novel coronavirus infection. Among the confirmed severe cases of COVID-19, 20 were recorded in the placebo group, while none were recorded in the vaccine group. Due to the time needed for the immune response to develop, in the first week after vaccination, there was no significant difference in protection against severe cases of COVID-19 between the vaccine and placebo groups, while in the period from 7 to 14 days the vaccine’s efficacy rose to 50 per cent, in the period from 14 to 21 days to 74.1 per cent, and to 100 per cent from the 21st day, giving full protection against severe cases of the coronavirus.
Importantly, the study included 2,144 volunteers over 60 years old with the maximum ages of 87 years (vaccine group) and 84 years (placebo group), showing great safety results for the elder age strata. The vaccine’s efficacy for the elderly was shown at 91.8 per cent and did not differ statistically from the group of 18-60 years old, also demonstrating great safety and immunogenicity results.
Sputnik V has also demonstrated an excellent safety profile: 70 episodes of serious adverse events (SAE) not related to COVID-19 were recorded in 68 study participants – in 45 volunteers from the vaccine group and 23 volunteers from the placebo group. None of these events were associated with the vaccination as confirmed by Independent Data Monitoring Committee. Most adverse events (94 per cent) were mild and were limited to flu-like syndromes, injection site reactions, headache and asthenia.
Sputnik V is one of only three vaccines in the world to have demonstrated the efficacy of over 90 per cent. Sputnik V is based on a well-studied human adenoviral vectors platform and is the world’s first registered vaccine against coronavirus. The vaccine uses two different vectors – based on human adenovirus serotypes Ad5 and Ad26 – in two separate shots, allowing for a more effective defense against the coronavirus than vaccines using the same vector for both shots. By deploying two different vectors, Sputnik V avoids a possible neutralising effect and generates a durable and longer-lasting immune response.