Indian Drug Regulator approves Single Dose Sputnik for Phase III Trial
The Drugs Controller General of India (DCGI) has approved the conducting of the Phase III bridging trials of Sputnik Light on the Indian population. The Sputnik Light is a single-dose Covid-19 vaccine of the Russian vaccine Sputnik.
The nod comes after a recent study published in the medical journal The Lancet said that Sputnik Light showed 78.6 to 83.7 per cent efficacy against Covid-19, significantly higher than most two-shot vaccines.
The Subject Expert Committee of the Central Drugs Standard Control Organisation (CDSCO) in July had refused to grant emergency-use authorisation to Sputnik-Light, ruling out the need for the conduct of the phase III trial of the Russian vaccine in the country.
The committee had noted that Sputnik Light was the same as component-1 of Sputnik V and its safety and immunogenicity data in the Indian population was already generated in a trial.
The study was conducted on at least 40,000 elderly people in Argentina. Sputnik Light also reduced hospitalizations among the target population at 82.1-87.6 per cent, the study said.
The Russian Direct Investment Fund (RDIF) last year partnered with Dr Reddy’s Laboratories to conduct the phase III trials of Sputnik V vaccine in India. In April, Sputnik V received an emergency use authorisation in India. Reddy’s administered the first dose of the vaccine in Hyderabad under a limited pilot on May 14.
Last year, Hyderabad-based Dr Reddy's Laboratories had partnered with the Russian Direct Investment Fund (RDIF) to conduct phase 3 trials of the vaccine. After the company submitted safety, immunogenicity and efficacy data, the SEC granted permission for conducting the trials in India, a statement by the Central Drugs Standard Control Organisation said.
"The committee noted that the firm has now presented the safety and immunogenicity along with the longevity of the antibodies which gives a measure of persistence of antibodies in the participants," the statement added.
In May, Dr Reddy's CEO Deepak Sapra told a news channel that the company will have discussions with the government and the regulator in June for an immediate launch. But in July, the expert committee had refused to grant emergency-use authorisation for Sputnik Light, ruling out third phase trials for the vaccine developed by Russia's Gamaleya Institute. The committee had said it did not find any "scientific rationale" for the trials to be conducted.
According to Sputnik Light makers, the vaccine has shown an efficacy of 79.4 per cent. If the jab is approved in India, Sputnik Light could be the first single-dose vaccine to be used in the country.