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.

Not expected to evaluate efficacy.

A phase-3 trial normally involves testing the efficacy of the vaccine in thousands. This Sputnik trial, however, is not expected to evaluate efficacy.

The two-dose version of the vaccine was approved for ‘emergency use’ by the DCGI in April, though few doses have been practically available in a landscape dominated by Covishield and, to a lesser extent, Covaxin. The former comprises over 85% of the over 75 crore vaccines administered in India.

Sputnik Light is the first dose of the original two-dose composition but differs from other two-dose vaccines in that the vector, carrying the spike protein, in the first dose differs from the vector in the second dose. Trials in Russia show a single dose efficacy of 79%.

In July, Russian Direct Investment Fund (RFID), the promoters of the vaccine developed at the Gamaleya Research Institute, announced a production tie-up with the Serum Institute of India to produce 300 million doses annually. Earlier, it had entered into similar pacts with Hetero, and Gland Pharma, among others. Only about 31 lakh doses of the first component of the vaccines and 4.5 lakh doses of the second have been available from RFID, Dr. Reddy’s said in a statement late August. Local production of the vaccine was to have begun in September.

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