A Subject Expert Committee of the Central Drug Standards Control Organisation is scheduled to meet on Wednesday to discuss Dr Reddy’s application seeking emergency use approval for the Sputnik V Covid-19 vaccine candidate.
Dr Reddy’s Laboratories Ltd had last week applied to the Drugs Controller General of India (DCGI) for an emergency licence for the Russian vaccine. It had partnered with the Russian Direct Investment Fund (RDIF) in September 2020 to conduct clinical trials for Sputnik V.
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The lab is currently conducting a phase 2 and 3 bridging study with around 1,500 participants, aimed at proving that the vaccine provides protection in the Indians.
A phase 3 study in Russia, published in The Lancet, showed the vaccine had an efficacy of 91.6%. The trial had included data on 19,866 volunteers, who had received both the first and second doses of the vaccine.
The vaccine’s less effective than those developed by Pfizer and Moderna, but significantly higher than that of the jab developed by the University of Oxford and AstraZeneca. The Oxford vaccine is manufactured in India by Serum Institute of India under the Covishield brand.
The vaccine received approval in Indian in January, along with harat Biotech International’s Covaxin. Bharat Biotech chairman and managing director Krishna Ella has said that he expects efficacy data to be out by March.
The two-dose Sputnik V vaccine was originally developed by Russia’s Gamaleya National Research Institute of Epidemiology and Microbiology and is being commercialized globally by Russian Direct Investment Fund (RDIF).
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