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17-10-2020

In a significant development related to the coronavirus vaccine, India is likely to resume phase 2 clinical trials of the Russian COVID-19 vaccine, Sputnik V, said sources. An expert panel at the Central Drugs Standard Control Organisation (CDSCO) on Friday recommended granting permission to Dr Reddy's Laboratories for conducting phase 2 clinical trials of the vaccine.

Notably, the Hyderabad-based pharmaceutical firm had on October 13 reapplied to the Drugs Controller General of India (DCGI) seeking permission to conduct combined phase 2 and 3 human clinical trials of the vaccine in the country.

After suffering a setback on the earlier trial, the firm has now come up with a revised protocol that stated that the Phase II trial would include 100 subjects, while the Phase III trials would involve 1,400 volunteers, as reported.

"Following deliberation, the SEC has recommended the grant of permission for the phase 2 clinical trial of the potential vaccine first. After they submit the safety and immunogenicity data of the first phase, they then would be allowed to proceed for phase 3 of the trials," said.