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Dr Reddy’s gets nod for bridging trials of Sputnik Light vaccine

Our Bureau New Delhi | Updated on September 15, 2021

RDIF, in partnership with Dr Reddy’s Labs, to distribute first 250 million doses of Sputnik in India

Dr Reddy’s Laboratory has received the green signal from the drug regulator to conduct Phase 3 bridging trials of the single-dose Covid vaccine, Sputnik Light.

The subject expert committee of the Central Drugs Standard Control Organisation had, in August, recommended the grant of permission to conduct Phase 3 immune-bridging clinical trials in India.

Distribution of vaccines

It is to be noted that the Russian Direct Investment Fund (RDIF), in partnership with the Dr Reddy’s Labs, will distribute the first 250 million doses of the Sputnik V vaccine in India, and also conduct trials for necessary regulatory approvals.

It may be recalled that the committee had, in July, denied the approval for emergency-use authorisation of the Sputnik V vaccine. However, the panel, in August, noted that the firm has presented the safety and immunogenicity, along with the longevity of the antibodies, which gives a measure of the persistence of antibodies in participants.

Meanwhile, India reported 27,176 fresh Covid cases on Wednesday with 284 deaths in the last 24 hours till 8:00 am, according to Health Ministry data. The daily infections have been less than 30,000 for the last 4 days. It’s a big respite for India as the Covid situation in the US is dire, according to reports.

In India, the active caseload declined to 3.5 lakh on Sunday, constituting 1.05 per cent of the total cases. Besides this, none of the States, except Mizoram, registered more than 100 active cases on Wednesday. A spike in active cases was noticed in 13 States/UTs, including Assam, Delhi and Jammu and Kashmir. Also, there were 38,012 recoveries in the last 24 hours and with this the recovery rate stood at 97.62 per cent. The cumulative recoveries stood at 3.25 crore.

It is to be noted that the weekly positivity rate was at 2 per cent, less than 3 per cent for the last 82 days, and the daily positivity rate stood at 1.69 per cent, less than 3 per cent for the last 16 days.

Also, the country conducted 16.10 lakh tests during the previous day aggregating to 54.60 crore tests done so far, as per the data. In addition, India administered 58.41 lakh vaccinations till 7:00 pm on Wednesday, taking a total to 76.47 crore vaccinations provided so far.

Published on September 15, 2021

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