DCGI Turns Down Dr Reddy's Application To Conduct Phase 3 Trials On Russia-Made Single Dose Sputnik Light Vaccine

Dr Reddy’s Laboratories application seeking permission to conduct phase-3 trials on the Russian vaccine Sputnik Light in India has been turned down by the Drugs Controller General of India (DCGI).

Apparently, the Subject Expert Committee (SEC) did not see any ‘scientific rationale’ in permitting the company to carry out the phase-3 trials of the single-dose vaccine.

The Russian Ministry of Health along with the Russian Direct Investment Fund (RFID) and the Gamaleya National Research Centre of Epidemiology have jointly developed Sputnik Light that was launched back in May.

One of the sources quoted in a report by the Economic Times claimed that Sputnik Light is just the first dose of Sputnik V, which has already been authorized for use in India. Dr Reddy’s reportedly wanted to test the former’s immunogenicity and sought the DCGI’s go-ahead for the same.

“As a result of the earlier trials on Sputnik V, the immunogenicity data on both the doses (components) was seen. The data with single dose vaccine was not so great and hence the SEC did not find any rationale to conduct the trial again,” the source added.

Actually, Sputnik Light is formed of recombinant adenovirus 26 or Ad26, which is the first dose of the Sputnik V vaccine. Sputnik V’s second dose, made of the component adenovirus 5 or Ad5, is only a booster shot which has been excluded from the Sputnik Light inoculation.