India's Central Drugs Standard Control Organisation (CDSO) has granted permission to recommend conducting a Phase-3 clinical trial of the single-dose COVID-19 vaccine ‘Sputnik Light’ as a booster dose, an official source said.
India's Hyderabad state-based drugmaker Dr. Reddy’s Laboratories, which is a licensed manufacturer and distributor of the Sputnik V vaccine for coronavirus, had proposed to conduct a Phase-3 trial of the 'Sputnik Light' vaccine as a booster dose.
"The Subject Expert Committee (SEC) on Covid-19 of the Central Drugs Standard Control Organisation (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.
According to the study published on medRxiv, a Sputnik Light booster demonstrated high virus neutralising activity (VNA) against the Omicron variant and is also proven to increase the effectiveness of vaccines other than Sputnik V.
Sputnik Light as a booster shot has been registered in over 20 countries including Argentina, Bahrain, the UAE, San Marino, and the Philippines.
Developed by Russia’s Gamaleya Centre, Sputnik Light is built on a human adenovirus vector platform.