Expert panel reviews EUA application for Sputnik V vaccine; seeks immunogenicity, safety data
India
Updated: Wednesday, February 24, 2021, 22:12 [IST]
New Delhi, Feb 24: An expert panel of India s Central Drug Authority which reviewed the application of Dr Reddy s Laboratories seeking emergency use authorisation for the COVID-19 vaccine Sputnik V on Wednesday recommended that the firm present immunogenicity and safety data, sources said.
Dr Reddy s Laboratories on February 19 said it had approached drugs regulator DCGI for emergency use authorisation (EUA) for the Russian vaccine. The Subject Expert Committee (SEC) on COVID-19 of the CDSCO which discussed the application by Dr Reddy s Laboratories seeking emergency use authorisation for COVID-19 vaccine Sputnik V on Wednesday asked the firm to submit immunogenicity and safety data as per the protocol approved by the CDSCO. Once it submits these data, its EUA application will be considered, a source said.
India News: As the country gears up to inoculate its “priority population” of 50-plus people in the third phase of Covid vaccination starting next month, Pune-bas.
Updated Feb 23, 2021 · 05:17 pm A health worker takes a swab sample of a woman for conducting RT-PCR test in Chennai on February 22. | Arun Sankar/ AFP
India on Tuesday registered 10,584 new coronavirus cases, taking the overall count to 1,10,16,434. Seventy-eight more deaths pushed the country’s toll to 1,56,463.
The number of active cases stood at 1,47,306, while the number of recoveries reached 1,07,12,665. As many as 1,17,45,552 health care and frontline workers have been vaccinated against the coronavirus so far. Of these, 6,28,696 were inoculated on Monday.
India is using two vaccines, the Oxford University/AstraZeneca vaccine produced by the Serum Institute in Pune, and a government-backed vaccine developed by Hyderabad-based Bharat Biotech whose efficacy is not entirely yet known.
Covaxin is one of two vaccines being administered as part of India’s Covid vaccination drive. It was given conditional emergency-use nod in absence of complete Phase 3 trial data.