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Opinion

Sputnik V more than 91% effective in final analysis, shows data

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

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

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In India, developers have partnered 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 obtaining the necessary authorization.

According to Deepak Sapra, CEO of Dr Reddy’s API and Pharmaceutical Services, the Sputnik V doses distributed in India will be a combination of Indian and Russian-made vaccines.

Furthermore, RDIF recently finalized an agreement with Hetero Biopharma to manufacture 100 million doses per year in India from 2021.

“The efficacy of the Sputnik V vaccine 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 Centro Gamaleya team in an international peer-reviewed medical journal.

More than 26,000 volunteers were vaccinated as part of post-registration, double-blind, randomized, placebo-controlled phase III clinical trials of Sputnik V in Russia. “No unexpected adverse events were identified as part of the investigation,” the statement said. Analysis of the efficacy of Sputnik V at the endpoint checkpoint 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.

In addition to India, phase III clinical trials of Sputnik V are underway in Belarus, the United Arab Emirates, Venezuela, and other countries.

Russian Health Minister Mikhail Murashko said: “The new data on the efficacy of the vaccine from the Gamaleya Center is extremely encouraging.”

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