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Dr.Reddy's says Sputnik V Covid-19 vaccine found to be safe in mid-stage trial
The company has submitted the mid-stage trial safety data to India's drug regulator for review and approval to continue late-stage trial. Last September Dr. Reddy’s and the Russian Direct Investment Fund entered into a partnership covering clinical trials of the vaccine and its distribution in India
An independent board in India has found Russia's Sputnik V Covid-19 vaccine safe in a mid-stage trial and recommended progressing to late-stage trials, Indian drugmaker Dr. Reddy's Laboratories Ltd said on Monday.
Last September Dr. Reddy’s and the Russian Direct Investment Fund (RDIF) entered into a partnership covering clinical trials of the Sputnik V vaccine and the rights for its distribution in India.
The mid-stage trial safety data has been submitted to India's drug regulator for review and approval to conduct late-stage trials, Dr.Reddy's said in a regulatory filing.
India's Hetero Biopharma has already announced a deal with the RDIF to make more than 100 million doses of Sputnik V, whose efficacy has been found to be more than 91% in trials done outside India.
Outside Russia, where authorities say over a million people have now been inoculated with the Sputnik V vaccine, which has been approved for emergency use by regulators in Algeria, Argentina, Bolivia, Serbia and in the Palestinian self-ruled territory.
India on Monday also signed a purchase order with vaccine producer Serum Institute to procure AstraZeneca's Covid-19 vaccine, a source said, in the first step toward joining one of the world's largest vaccination programmes against the novel coronavirus.
India's drug regulator has given emergency use approval to vaccines from AstraZeneca and Bharat Biotech.
In addition to Sputnik V, Zydus Cadila's ZyCoV-D vaccine is also undergoing trials in India.
India aims to secure 600 million doses of vaccine to inoculate 300 million citizens over the next six to eight months. The programme is expected to begin on January 16.
