The single-dose COVID-19 vaccine Sputnik Light received approval from the Subject Expert Committee (SEC) of the Drugs Controller General of India (DCGI) today to conduct phase 3 bridging trials in India.
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 NDTV that the company will have discussions with the government and the regulator in June for an immediate launch. But in July, the expert committee 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.
In Russia, the vaccine has been approved for people above 60 years old. The pharma firm has said the vaccine does not cause serious adverse effects.