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Still Without Sputnik V Approval, SEC Asks Dr. Reddy for More Vaccine Data | India News


NEW DELHI: The Subject Matter Experts Committee (SEC) of India’s drug regulator, tasked with examining the Covid-19 vaccine proposals, sought additional data on the Russian Covid-19 vaccine ‘Sputnik V’ while deciding on its emergency use authorization, a senior government official said Thursday.
In September 2020, Dr. Reddy’s partnered with the Russian Direct Investment Fund (RDIF) to conduct the Sputnik V clinical trials and for its distribution rights in India. The company had conducted phase 2 trials in India with 1,500 participants. Phase three trials are underway.
The leading Hyderabad-based pharmacist had applied for its emergency license on February 19. The committee reviewed D. Reddy’s request on Thursday. Sputnik V has yet to receive the emergency use authorization, as the SEC has sought additional data, according to top sources.
In February, the committee had asked the drug company to provide immunogenicity data. The approval, if granted, would make Sputnik V the third coronavirus vaccine to be administered in India.
Russia had recorded Sputnik V in August, ahead of large-scale clinical trials, which had raised concerns among many experts about the accelerated process. However, subsequent reviews have shown that the vaccine is safe and effective in preventing Covid-19.
The efficacy of Sputnik V is 91.6%, as confirmed by data published in The Lancet. The vaccine is based on human adenoviral vectors, which cause the common cold. It uses two different vectors for the two injections in a vaccination course, providing immunity with a longer duration.
RDIF had previously announced four manufacturing agreements with Indian pharmaceutical manufacturers: Virchow Biotech Private Limited, Gland Pharma Private Limited, Stelis Biopharma and Hetero Biopharma.
So far, more than six crore doses of the corona vaccine have been administered in the country since the campaign began on January 16 after the approval of ‘Covishield’ and ‘Covaxin’.

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