Dr Reddy’s to launch Sputnik V under EUA by March
The bridging phase II and phase III study on 1,600 subjects in India is assessing immunogenicity and safety.
Hyderabad: Hyderabad-based Dr Reddy’s Laboratories, which is currently carrying out phase III trials of Russia’s Covid-19 vaccine Sputnik V vaccine, expects it to apply for Emergency Use Authorisation (EUA) in India by March and subsequently launch it.
The bridging phase II and phase III study on 1,600 subjects in India is assessing immunogenicity and safety. Phase II trial has been completed, met primary end points and safety has been established. The company expects 100 per cent dosing as part of the phase III to complete in February 2021.
Deepak Sapra, CEO of API and Pharmaceutical Services, Dr Reddy’s said, “After that we expect to compile the data and submit for Emergency Use Authorisation, make the request to the DCGI with our dossier. And based on the approval from the DCGI, we believe that we should be in a position to launch the vaccine through a EUA in the month of March 2021.”
The EUA for the vaccine has been obtained in 12 countries including Europe, Asia, Latin America and Africa. Dr Reddy’s had earlier partnered with Russian Direct Investment Fund (RDIF) to carry out clinical trials of the Sputnik V vaccine and for its distribution rights in India.
As per the arrangement with RDIF, the company will be able to supply 125 million patient doses (250 million jabs), vaccinating approximately nine per cent of the population in the country. The product will be initially made in Russia and gradually prodution will start in India.
“We are progressing well on the phase 3 clinical trials for Sputnik V vaccine in India. We continue to focus on enhancing our product offerings to our patients to serve them better,” Dr Reddy’s Laboratories co-chairman and MD GV Prasad said.
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