Final control point analysis shows 90% efficacy for Russia’s Sputnik V COVID-19 vaccine
pharmafile | December 15, 2020 | News story | Manufacturing and Production, Research and Development | COVID-19, Sputnik V, Vaccine
Efficacy data have been revealed from the final control point data analysis for Russia’s Sputnik V COVID-19 vaccine, showing the candidate to have an efficacy exceeding 90%, according to the Russian Direct Investment Fund (RDIF) and the National Research Center for Epidemiology and Microbiology, known as the Gamaleya Center.
The double-blind, randomised, placebo-controlled Phase 3 study evaluated 22,714 participants in total – 17,032 received the vaccine, while 5,682 received placebo.
The analysis was based on the identification of 78 confirmed cases of COVID-19 in the study population, 62 of which occurred in the placebo group and 16 in the vaccine group. Given the case split and 3:1 ratio of vaccine patients to placebo patients, the researchers noted that the vaccine presented an efficacy rate of 91.4%.
Additionally, 20 severe cases of COVID-19 infection were identified in the placebo group, and no severe cases identified in the vaccine group, which the researchers said suggested an efficacy rate of 100% for the vaccine in preventing severe infections.
The study evaluated the vaccine at three key thresholds: once 20 cases of COVID-19 had been identified in participants, the candidate’s efficacy was evaluated to be 92%, while its efficacy stood at 91.4% at 39 confirmed cases, and 91.4% again at 78 cases.
“The data analysis at the third and final control point of the Sputnik V vaccine clinical trials confirmed the efficacy of the vaccine of over 90%. Clinical trials have proven this in the three consecutive statistically important points described in trials protocol,” commented Kirill Dmitriev, CEO at the RDIF. “The data obtained will lay a basis for a report that will be used to submit applications for accelerated registration of the Russian vaccine in other countries. We also see high interest from international pharmaceutical companies in the Gamaleya Center vaccine, since the use of Sputnik V components in combination with other vaccines can significantly increase their efficacy.”
The vaccine has shown comparable levels of efficacy to those seen in candidates from Moderna and Pfizer/BioNTech, but costs just $10 per dose in international markets and can be stored at temperatures between 2°C and 8°C.
Matt Fellows
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