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Indian Government Recommends Permission for Phase 3 Trial of Sputnik Light Vaccine as Booster Dose
Indian Government Recommends Permission for Phase 3 Trial of Sputnik Light Vaccine as Booster Dose
Sputnik International
Last month, the Drugs Controller General of India (DCGI) granted emergency use permission for the single-dose 'Sputnik Light' COVID vaccine in the country. A... 06.03.2022, Sputnik International
2022-03-06T07:21+0000
2022-03-06T07:21+0000
2022-10-19T20:02+0000
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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.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.
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Indian Government Recommends Permission for Phase 3 Trial of Sputnik Light Vaccine as Booster Dose
07:21 GMT 06.03.2022 (Updated: 20:02 GMT 19.10.2022) Last month, the Drugs Controller General of India (DCGI) granted emergency use permission for the single-dose 'Sputnik Light' COVID vaccine in the country. A study has revealed that the coronavirus vaccine Sputnik Light is expected to provide a high level of protection against severe disease and hospitalisation in the face of the Omicron strain.
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.
