Dr Reddy's on July 1 said that the Subject Expert Committee (SEC) asked the company to submit safety, immunogenicity and efficacy data from the phase III clinical trial of Sputnik V in Russia to the SEC for its consideration of Marketing Authorisation of Sputnik Light in India.
"The SEC observed that in view 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," the company said.
On Wednesday (June 30), the SEC deliberated on the submission for Marketing Authorisation of Sputnik Light in India from Dr Reddy’s.
The company said it has presented to the SEC, interim safety and efficacy data from the Phase I / II clinical trial of Sputnik Light in Russia, along with a clinical trial protocol for a Phase III trial of Sputnik Light in India.
Dr Reddy's is the brand custodian of the Sputnik V vaccine in India and has the sole distribution rights for the first 250 million doses of the vaccine in India as per its agreement with Russian sovereign fund RDIF.
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