Sputnik V over 91% effective in final analysis, shows data

In India, the developers have tied up with Dr Reddy’s Laboratories for trials and regulatory approvals and, if approved, RDIF will supply 100 million doses of the vaccine to Dr Reddy’s for distribution

The developers of Russia’s Sputnik V vaccine said on Monday that it had shown an efficacy of 91.4% based on the final analysis of data from clinical trials, and a report is being prepared for accelerated registration of the vaccine in various countries.

A view shows boxes containing vials with Gam-Covid-Vac, also known as Sputnik-V, vaccine against the coronavirus disease (Covid-19) at a production facility of BIOCAD biotechnology company in Saint Petersburg, Russia. (Reuters File Photo)

The Gamaleya National Research Center for Epidemiology and Microbiology and the Russian Direct Investment Fund (RDIF) said the calculation was based on analysis of the data of volunteers who received the first and second doses of the Sputnik V vaccine or a placebo at “the third and final control point of 78 confirmed cases in accordance with the Phase III clinical trials protocol”.

In India, the developers have tied up with Dr Reddy’s Laboratories for trials and regulatory approvals and, if approved, RDIF will supply 100 million doses of the vaccine to Dr Reddy’s for distribution. Dr Reddy’s recently began phase II and III clinical trials after getting requisite clearance.

Separately, RDIF recently finalised a deal with Hetero Biopharma to manufacture 100 million doses a year in India starting 2021.

“The Sputnik V vaccine efficacy against severe cases of coronavirus was 100%. Among the confirmed cases of coronavirus infection, 20 severe cases were recorded in the placebo group, while no severe cases were recorded in the vaccine group,” the two developers of the Russian vaccine said in a statement.

The research data is expected to be published by the Gamaleya Center team in an international peer-reviewed medical journal.

More than 26,000 volunteers were vaccinated as part of double-blind, randomised, placebo-controlled phase III post-registration clinical trials of Sputnik V in Russia. “No unexpected adverse events were identified as part of the research,” the statement said. The analysis of Sputnik V’s efficacy at the final control point was carried out on the basis of 78 confirmed cases, including 62 cases identified in the placebo group and 16 cases in the vaccine group.

Besides India, phase III clinical trials of Sputnik V are underway in Belarus, the UAE, Venezuela and other countries.

Russia’s health minister Mikhail Murashko said: “The new data on efficacy of the Gamaleya Center vaccine is extremely encouraging.”