Hetero gets SEC approval for phase 3 trials of Sputnik V

The Subject Expert Committee (SEC) under India’s drug controller has given a go-ahead to Hetero Biopharma to start phase 3 trials for Sputnik V, the Russian Covid-19 vaccine in India. The SEC has asked the company to study and monitor the vaccine's immunogenicity on days 21, 24, and 48 of the trial. The company was also asked by the panel to “study and assess neutralising antibodies and gamma interferon,” says the minute of the meeting.

Earlier on April 13 the expert committee had given its approval for the emergency use of Sputnik V. Sputnik V is developed by the Gamalaya Institute with the help of the Russian Direct Investment Fund (RDIF).

Hetero Biopharma is one among many other local drug manufacturers that the RDIF has partnered with in order to produce Sputnik V in large numbers in India.