DCGI seeks Russian Sputnik Light trial data
The Hindu
‘No need for separate Phase 3 trial’
A Subject Expert Committee that advises the Drugs Controller General of India has asked Dr. Reddy’s Laboratories to submit data from Phase III clinical trial of Sputnik Light being carried out in Russia for grant of Marketing Authorisation (MA) of the single dose vaccine against COVID-19. The panel said this observing that there was no need for a separate Phase III trial of Sputnik Light in India since the safety and immunogenicity data has been generated during the two-dose Sputnik V trial in India. Sputnik Light is the first component of Sputnik V and its efficacy is said to be 79.4%. “The firm should present the safety, immunogenicity and efficacy data of Phase III clinical trial of Sputnik Light that is being carried out in Russia for considering the proposal for grant of MA in the country,” the SEC meeting on Wednesday recommended to Dr. Reddy’s Laboratories.
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