Sputnik Light gets DCGI nod for Phase -3 trial

The single-dose version of Sputnik V is be tested in Indians to establish that it generates a similar immune response to trials in Russia

The Drug Controller General of India (DCGI) has recommended that the single-dose version of the Sputnik V vaccine—Sputnik Light—be tested in Indians to establish that it generates a similar immune response to trials in Russia.

On June 30, the Hyderabad-based Dr. Reddy’s Laboratories licensed to manufacture the vaccine, presented updated safety, immunogenicity and efficacy data of Phase III clinical trial of the single-dose version conducted in Russia along with the proposal to conduct a Phase III clinical trial.

In a meeting on August 5, the expert committee of the DCGI permitted the trial with the condition that the vaccine’s efficacy also be evaluated on the 42nd, 90th and 180th day following the second dose. “... Interim analysis can be conducted at day 42 as this data was not generated during the Sputnik V trial in India after first dose, which was stated to be available up to day 21 only,” read the minutes of the meeting made public on Wednesday.