COVID-19: India approves phase 3 trial of Russia’s Sputnik Light

Russia‘s Sputnik Light has been approved for phase 3 bridging trials in India. The single-dose COVID-19 vaccine received approval from the Subject Expert Committee (SEC) of the Drugs Controller General of India (DCGI) Wednesday after Hyderabad-based Dr Reddy’s Laboratories submitted safety, immunogenicity and efficacy data. “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,” Central Drugs Standard Control Organisation said in a statement.

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Dr Reddy’s Laboratories had partnered with the state-run Russian Direct Investment Fund (RDIF) to conduct phase 3 trials of Sputnik Light in India. Earlier, the SEC had refused to grant emergency-use authorisation for Sputnik Light, saying it did not see any “scientific rationale” for allowing the third phase trials to be conducted in India.

Russia’s Gamaleya Research Institute of Epidemiology and Microbiology, which has developed the Sputnik Light, claims an efficacy of 79.4% for the vaccine. If approved, Sputnik Light could be the first single-dose vaccine to be used in India.

The DCGI has already approved the Sputnik’s two-dose version for ‘emergency use’, though availability has been an issue. India has largely relied on the two India-made vaccines approved for emergency use by the DCGI: Pune-based Serum Institute of India’s Covishield and Bharat Biotech’s Covaxin, with the former comprising over 85% of the over 75 crore vaccines administered nationwide

Sputnik Light’s Russian promoter RFID announced in July a production tie-up with the Serum Institute of India to produce 300 million doses annually after similar pacts with other Indian pharma companies such as Hetero and Gland Pharma. However, RFID has only provided about 31 lakh doses of the first component of the vaccines and 4.5 lakh doses of the second, Dr. Reddy’s said in a statement late August.