Russian trials data of Sputnik Light next week | Hyderabad | Live Newspaper Hyderabad

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HYDERABAD: Final data from the Russian trials of single-dose vaccine Sputnik Light is expected to be available by next week after which Dr Reddy’s Laboratories will approach the SEC (subject expert committee) for approval. Meanwhile, local manufacturing of the two-dose Sputnik V is expected to begin by September-October.
“We are now in the process of receiving data on Sputnik Light. We should be going to SEC with the updated data once we receive the full and final clinical data maybe in about a week’s time and that’s something that could ensure better availability of the vaccine,” M V Ramana, CEO branded markets (India & emerging markets), Dr Reddy’s Laboratories, said on Tuesday.
The company said it would be leveraging the Russian Phase-3 trials data of Sputnik Light for its India filing as per the SEC recommendation. Sputnik Light comprises the first adenoviral vector – Ad26 – which has shown an interim efficacy of 79.4% in Russian trials.
SEC, which advises the Indian drug regulator Drugs Controller General of India (DCGI), had observed that as Sputnik Light is the same as component-1 of the two-dose Sputnik-V, for which the safety and immunogenicity data had already been generated in the country, there was no need to conduct a separate trial in India.
Deepak Sapra, CEO of API & services, Dr Reddy’s Labs, said the local manufacturers of Sputnik V are currently in the process of technology absorption and scaleup. “We expect that from the September-October timeframe we are likely to have locally manufactured Sputnik available,” he said during a virtual media interaction on the sidelines of the Q1 results for financial year 2021-22.


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Author: sidnaz pro