Hyderabad-based Dr Reddy's Laboratories said it expects to roll out Russia's Sputnik V COVID-19 vaccine in India in March via emergency use authorisation (EUA). Sputnik V is undergoing Phase-3 trials in India currently which is expected to be completed by February.
After the completion of the ongoing trials, Dr Reddy's would approach the Drug Controller General of India (DCGI) for EUA, based on which the vaccine will be launched in March. "The Phase 3 trial of currently ongoing. We are dosing patients and we expect to complete the dosing as part of the Phase 3 by February. After that we expect to compile the data and submit for Emergency Use Authorisation, make the request to the DCGI with our dossier," DRL's CEO of APIs and pharmaceutical services Deepak Sapra told reporters. Sapra further stated, "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 in India."
He added Dr Reddy's has tied up with Russian Direct Investment Fund (RDIF) for 125 million doses for India and is in discussions with the Indian government and private companies for vaccine supply. The interim efficacy of 22,000 of the volunteers was showing a result of 91.1 per cent. Sapra said, "In addition to the efficacy, safety, immunogenicity criteria have also been met as part of this ongoing Phase 3 as part of the interim result. We expect the full results of 33,760 subjects to come in the month of February."
Dr Reddy's has teamed up with RDIF to distribute the Gamaleya National Research Institute of Epidemiology and Microbiology-developed vaccine in India. Sputnik V became the world's first registered COVID-19 vaccine which is based on the established human adenoviral vector platform.
With PTI inputs; by Mehak Agarwal
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