An expert panel of India’s central drug authority has recommended the permission for conducting phase-III clinical trial of single-dose COVID-19 vaccine ‘Sputnik Light’ as a booster dose, official sources said recently.
The recommendations have been sent to the Drugs Controller General of India (DCGI) for final approval.
The DCGI had on 4th February 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-III 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 after detailed deliberation, recommended granting permission for the phase-III clinical trial with the condition to initiate the trial with Sputnik Light vaccine for which the firm is holding Emergency Use Authorisation (EUA) 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.
Edits by EP News Bureau