Government panel recommends permission for Sputnik Light vaccine to be tested in a phase 3 trial as a booster dose
As per official sources, an expert panel of India’s federal drug regulator has recommended authorization to undertake a phase-3 clinical study of the single-dose Covid-19 vaccine ‘Sputnik Light’ as a booster dose.
According to an official source, the Central Drugs Standard Control Organization’s [CDSCO] Subject Expert Committee [SEC] on Covid-19, which reviewed the application on Friday after extensive deliberation, recommended granting permission for the phase-3 clinical trial with the condition that the trial begins with the Sputnik Light vaccine, for which the company has emergency use authorization in the country subject to certain regulatory provisions.
Meanwhile, the suggestions have been forwarded to India’s Drugs Controller General (DCGI) for final clearance.
The DCGI granted emergency use clearance for the Sputnik Light vaccine in India on February 4, subject to certain regulatory conditions. Dr Reddy’s Laboratories, located in Hyderabad, had submitted to DCGI a phase-3 study of the Sputnik Light vaccine as a booster dosage.
Sputnik Light, developed by Russia’s Gamaleya Center, is based on a human adenovirus vector platform in which instructions are conveyed through a proxy and a harmless virus to induce an immunological response.
Sputnik Light is the same as component-1 of the Russian two-dose Sputnik V vaccine utilised in India’s immunisation campaign.