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DCGI nod for Sputnik Light bridging trials in India

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Mallika Soni    16 September 2021

The single-dose Sputnik Light COVID-19 vaccine has received permission from the Subject Expert Committee (SEC) of the Drugs Controller General of India (DCGI) to carry out phase 3 bridging trials in India.

In 2020, Dr Reddy′s Laboratories had collaborated with the Russian Direct Investment Fund (RDIF) to carry out phase 3 trials of the vaccine. As the company presented safety, immunogenicity and efficacy data, permission was granted for carrying out the trials in India, mentioned the Central Drugs Standard Control Organisation in a statement.

In July, the expert committee had refused to give emergency use authorization for Sputnik Light vaccine, and had ruled out phase 3 trials. The committee had stated that there was no scientific rationale for the trials to be conducted.

Makers of Sputnik Light vaccine have stated that the vaccine has an efficacy of 79.4%. The vaccine has been approved in Russia for individuals aged above 60 years. 

Source: NDTV

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