Coronavirus | Expert committee to rule on Sputnik V on April 1

Vials of the Sputnik V COVID-19 vaccine.   | Photo Credit: Getty Images

A decision on India approving a third COVID-19 vaccine is likely soon, with a subject expert committee (SEC) set to take up Dr. Reddy’s Laboratories application seeking emergency use authorisation for Russia’s Sputnik V vaccine on April 1.

The meeting of the SEC is scheduled for Thursday, sources in the pharma major confirmed. It will be the second time the application will go before the committee that advises the Drugs Controller General of India (DCGI). Last month, the committee had sought more data on Sputnik V vaccine trials from Dr. Reddy’s. The firm should submit immunogenicity and safety data of Phase II and III trial as per approved protocol for further consideration. “Further, the firm is requested to present its data with more clarity,” it had said at the February 24 meeting.

Dr. Reddy’s has since submitted additional data before the committee. The dosing of the volunteers under Phase III trials has also been completed. The trial data is being analysed and findings likely to be ready early April, sources said. The Russian Direct Investment Fund (RDIF) has a partnership with Dr. Reddy’s for the clinical trials and distribution of the vaccine, developed by Gamaleya National Research Institute of Epidemiology and Microbiology, in India.

If approved, Sputnik will join the indigenous Covaxin, developed by Bharat Biotech, and Covishield or the vaccine developed by AstraZeneca with University of Oxford that is manufactured by Serum Institute of India. These two vaccines are being used in the immunisation programme launched on January 16. In the run-up to the trials and authorisation, RDIF has got into manufacturing partnerships for Sputnik V with four vaccine makers in India for at least 750 million doses a year. Three of the firms, Hetero Biopharma, Gland Pharma and Virchow Biotech, are based in Hyderabad, while Stelis Biopharma is in Bengaluru.

As per data published in the Lancet, Sputnik V has an efficacy of 91.6%. The vaccine is based on a platform of human adenoviral vectors and uses two different vectors for the two shots in a course of vaccination. Approved for use in 58 countries, the vaccine was the first to be registered globally against COVID-19 in August, according to RDIF.

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Printable version | May 11, 2021 11:38:57 PM |

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