Sputnik Light gets nod for phase III clinical trial

Drug Controller General of India’s expert committee suggests interim analysis too.

A view shows samples of Sputnik Light vaccine against the coronavirus disease (COVID-19) developed by the Gamaleya Research Institute of Epidemiology and Microbiology, in this still image taken from video released May 6, 2021 by the Russian Direct Investment Fund (RDIF)

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 observed in trials in Russia.

The Hyderabad-based Dr. Reddy’s Laboratories, which is licensed to manufacture the vaccine, had presented updated safety, immunogenicity and efficacy data of Sputnik Light phase III clinical trial conducted in Russia, along with the proposal to conduct a Phase III clinical trial here.

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

A phase III 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 available in a landscape dominated by Covishield and, to a less extent, Covaxin. The former comprises over 85% of the over 75 crore vaccines administered in India.

First component

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, the 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.