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, which have efficacy of 95% and 94%, 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 the Russian Direct Investment Fund (RDIF).
RDIF had in September signed a pact with Dr Reddy’s, wherein the Indian drugmaker would conduct the bridging study and distribute doses to 100 million people if it were granted a licence. This was later increased to 125 million.
India’s Hetero Biopharma is also contracted to manufacture the vaccine—with a capacity of 100 million doses per annum through another pact with RDIF. The Russian sovereign fund is also in advanced talks with Panacea Biotec for manufacturing the vaccine. RDIF plans to manufacture 300 million doses of the vaccine in India.