Russia’s Sputnik COVID-19 vaccine has 91.4% efficacy after 28 days, new interim data show
pharmafile | November 24, 2020 | News story | Manufacturing and Production, Research and Development | COVID-19, Sputnik V, Vaccine
The National Research Center for Epidemiology and Microbiology and the Russian Direct Investment Fund (RDIF) have released a statement saying the Sputnik V vaccine for COVID-19 has a 91.4% efficacy after 28 days, and over 95% efficacy 42 days after the first dose.
Kirill Dmitriev, CEO at the RDIF, said: “The Gamaleya Center has developed one of the most efficient vaccines against coronavirus in the world with an efficacy rate of more than 90%. The uniqueness of the Russian vaccine lies in the use of two different human adenoviral vectors which allows for a stronger and longer-term immune response as compared to the vaccines using one and the same vector for two doses.”
These results come from a double-blind, randomised, placebo-controlled Phase 3 trial which involves 40,000 volunteers. The interim research data will be published in a peer-reviewed journal upon completion, in which Gamaleya said they will provide access to the full trial report.
The second interim analysis of the Sputnik V vaccine efficacy was carried out on the basis of 39 confirmed cases in the patient population, with 31 cases identified in the placebo group and eight cases in the vaccine group. The ratio of the placebo group to the vaccinated group is one to three.
Alexander Gintsburg, Gamaleya Center Director, said: “It is very important that the second interim efficacy analysis of Sputnik V has confirmed our findings from the first stage and shown its efficacy at 91-92%. Let me stress that the second analysis was conducted a week after volunteers got the second dose, meaning that their bodies have partially reacted to both doses. We expect the efficacy rate to be even higher based on the data three weeks after the second immunisation when the body’s strongest and most stable response is achieved.
“We plan to conduct the third interim data analysis after 78 confirmed coronavirus cases among volunteers and we have every reason to believe that the results will exceed our initial expectations. The drug’s final efficacy assessment will be made available after Phase 3 clinical trials are concluded.”
Russia was the first country to approve a coronavirus vaccine, but it came with much controversy. Titled Sputnik V, it was developed by the Gamaleya Institute and approved by the government on 11 August after an early trial was conducted on 76 participants.
Conor Kavanagh
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