Will India Approve Single-dose Sputnik Light Vaccine?

Dr Reddy's Laboratories, based in Hyderabad, announced on Thursday that the single-dose Sputnik Light vaccine can submit Russian safety data for approval in India. Sputnik Light is a single-dose Covid-19 vaccine developed by the same company that created Sputnik V.

The Subject Expert Committee (SEC) met on Wednesday to discuss Dr Reddy's request for marketing authorization for Sputnik Light in India. Interim safety and efficacy data from the phase I/II clinical trial of Sputnik Light in Russia, as well as a clinical trial protocol for a phase III trial of Sputnik Light in India, were presented to the SEC.

Sputnik Light is the first dose component of Sputnik V, and Dr. Reddy's has already provided safety and immunogenicity data on the first dose component in India through its clinical trial.

Sputnik Light is currently undergoing a phase III efficacy trial in Russia, and the SEC has recommended that Dr Reddy's submit safety, immunogenicity, and efficacy data from the phase III clinical trial in Russia to the SEC for consideration of Sputnik Light Marketing Authorisation in India.

"Furthermore, the SEC noted that, in light of the safety and immunogenicity data already generated by Dr Reddy's in India on the first dose component of Sputnik V (in other words, Sputnik Light), there was no need for a separate phase III trial of Sputnik Light in India," according to a statement from Dr Reddy's.

The company's clarification comes amid reports that the SEC has denied Dr Reddy's permission to conduct phase 3 trials in India of Russia's Covid-19 vaccine Sputnik Light.

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