Expert Committee on COVID-19 recommends phase 3 trial of Sputnik Light vaccine as booster dose
A government panel has recommended permission for phase three trial of Sputnik Light vaccine as booster dose. 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.
The Subject Expert Committee (SEC) on COVID-19 of the CDSCO, reviewed the application after detailed deliberation. It 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.
Sputnik Light vaccine is approved in 29 countries, including Argentina and Russia.