Sputnik Light: SEC recommends permission for phase 3 trial as booster dose

An expert panel of India’s central drug authority has recommended the permission for conducting phase-3 clinical trial of single-dose COVID-19 vaccine ‘Sputnik Light’ as a booster dose, official sources said on Saturday.

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 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 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.

(Only the headline and picture of this report may have been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)

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