Govt Will Accept Sputnik Light’s Russian Safety Data, No need for Phase 3 Trials: Dr Reddy’s

·2-min read

In a move that could potentially speed up the rollout of single-dose Sputnik Light Covid-19 vaccine in India, Dr Reddy’s on Thursday said the government panel has told the Hyderabad-based pharma firm that it doesn’t need to conduct Phase 3 trials and only require to submit Russian safety data for approval in India.

The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) said Dr ready doesn’t need to do a separate Phase 3 trial of Sputnik Light in India. Dr Reddy’s is now required to submit only the Russian Phase 3 immunogenicity, safety and efficacy data for approval in India.

The announcement comes hours after it was reported that Dr Reddy’s had been denied approval for the trial in the country.

The Sputnik Light vaccine has been developed by Russian Ministry of Health, the Gamaleya National Research Centre of Epidemiology and Microbiology and the Russian Direct Investment Fund (RDIF). According to real-world data collected by the Ministry of Health of the Buenos Aires province (Argentina), the RDIF had said that the Sputnik Light vaccine has demonstrated 78.6 per cent to 83.7 per cent efficacy among the elderly.

As per the data from over 1,86,000 people aged 60-79, more than 40,000 of whom received a shot of Sputnik Light (first dose of Sputnik V) as part of the mass-scale civil vaccination program, the infection rate between 21st and 40th day from the date of receiving the first dose was only 0.446 per cent.

Dr Reddy's had conducted a Phase-II/III study for its two-dose Sputnik V jab on 1,600 volunteers in India before it was granted an emergency use authorisation in mid-April.

If approved, the Sputnik Light jab would be the first single-dose vaccine to be used in India’s vaccination drive.

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