The developers of Russian vaccine Sputnik V announced Monday that it had shown 91.4% effectiveness based on the final analysis of data from clinical trials. A report is being prepared for accelerated registration of the vaccine in different countries.
The National Epidemiology and Microbiology Research Center in Gamaleya and the Russian Direct Investment Fund (RDIF) said the calculation was based on analysis of data from volunteers who received the first and second dose of the Sputnik V vaccine or a placebo at the “third and final checkpoint.” of 78 confirmed cases under the Phase III Clinical Trial Protocol ”.
Also read | Covid-19: What You Need To Know Today
In India, the developers worked with Dr. Reddy’s Laboratories have partnered to obtain studies and regulatory approvals, and if approved, RDIF Dr. Reddy’s will deliver 100 million doses of the vaccine for distribution. Dr. Reddy recently started Phase II and III clinical trials after receiving the required approval.
According to Deepak Sapra, CEO of API and Pharmaceutical Services at Dr. Reddy, Sputnik V-doses distributed in India will be a combination of Indian and Russian vaccines.
Separately, RDIF recently signed a contract with Hetero Biopharma to manufacture 100 million doses per year in India from 2021.
“The effectiveness of the Sputnik V vaccine against severe cases of coronavirus was 100%. Among the confirmed cases of coronavirus infection, 20 severe cases were registered in the placebo group while no severe cases were registered in the vaccine group, “the two developers of the Russian vaccine said in a statement.
The research data is expected to be published in an international journal by the Gamaleya Center team.
More than 26,000 volunteers were vaccinated in double-blind, randomized, placebo-controlled Phase III clinical trials following the registration of Sputnik V in Russia. “The investigation did not identify any unexpected adverse events,” the statement said. The analysis of the effectiveness of Sputnik V at the final control point was performed on the basis of 78 confirmed cases, including 62 cases identified in the placebo group and 16 cases in the vaccine group.
In addition to India, Phase III clinical trials with Sputnik V are currently ongoing in Belarus, the United Arab Emirates, Venezuela and other countries.
Russia’s Health Minister Mikhail Murashko said: “The new data on the vaccine effectiveness against the Gamaleya Center are extremely encouraging.”