Government recommends permission for trial of Sputnik Light as booster dose

Sputnik Light vaccine tested in a phase 3 trial!

On Saturday, official sources said that, an expert panel of India’s central drug authority has recommended permission to conduct a phase-3 clinical trial of the single-dose of Covid-19 vaccine ‘Sputnik Light’ as a booster dose.

An official source said, "The Subject Expert Committee [SEC] on Covid-19 of the Central Drugs Standard Control Organization [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 authorization permission in the country subject to certain regulatory provisions."

Meanwhile, the recommendations have been sent to the Drugs Controller General of India (DCGI) for final approval.

On February 4, the DCGI had granted emergency use permission for the Sputnik Light vaccine in India, subject to certain regulatory provisions. Hyderabad-based Dr Reddy’s Laboratories had proposed to DCGI to conduct a phase-3 trial of the Sputnik Light vaccine as a booster dose.

Developed by Russia’s Gamaleya Center, Sputnik Light is built on a human adenovirus vector platform where instructions are sent through a proxy and a harmless virus to trigger an immune reaction.

Sputnik Light is the same as component-1 of the Russian two-dose Sputnik V vaccine that has been used in India’s vaccination drive.

Official sources said, an expert panel of the country's central drug authority has recommended granting emergency use authorization (EUA) to Serum Institute of India's Covid-19 vaccine Covovax for the 12-17 age group also now.