An expert panel of India's central drug authority has recommended permission for conducting a phase-3 clinical trial of single-dose COVID-19 vaccine 'Sputnik Light' as a booster dose, official sources said on Saturday.
Govt Panel Recommends Permission For Phase 3 Trial Of Sputnik Light Vaccine As Booster Dose
Hyderabad-based Dr. Reddy's Laboratories had presented its proposal to DCGI for conducting?the phase-3 trial of Sputnik?Light vaccine as booster dose.
Sputnik light vaccine as booster. (representational image)
Sputnik light vaccine as booster. (representational image)
The recommendations have been sent to the Drugs Controller General of India (DCGI) for final approval. The DCGI had on February?4 granted emergency use permission to Sputnik Light vaccine in India, subject to certain regulatory provisions.
Hyderabad-based Dr Reddy's Laboratories had presented its proposal to DCGI for conducting?the phase-3 trial of Sputnik?Light vaccine as a booster dose. Sputnik Light?is the same as component-1 of?Sputnik?V.?
"The?Subject?Expert?Committee?(SEC) on COVID-19 of the CDSCO, which reviewed the application on Friday after detailed deliberation, recommended granting permission for the phase-3 clinical trial with the condition?to initiate the trial with Sputnik Light vaccine for which the firm is holding emergency use authorisation permission in the country subject to certain regulatory provisions,"??an official source said. Sputnik?Light?vaccine is approved in 29 countries, including Argentina and Russia.
With PTI inputs.
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