Drug panel seeks data from Russia trials for Sputnik Light decision

“After detailed deliberation, the committee recommended that the firm should present the safety,” stated the Subject Expert Committee (SEC) looking into DRL’s proposal on Wednesday.

An expert panel of India’s top drug regulator has sought more information from Dr Reddy’s Laboratories to decide whether to recommend marketing authorisation for Sputnik Light — the single-dose version of the Sputnik V Covid-19 vaccine.

“After detailed deliberation, the committee recommended that the firm should present the safety, immunogenicity and efficacy data of the phase 3 clinical trial of Sputnik Light that is being carried out in Russia for considering the proposal for grant of marketing authorization in the country,” stated the Subject Expert Committee (SEC) looking into DRL’s proposal on Wednesday. Sputnik Light is essentially the first dose of Sputnik V, which was developed by the Gamaleya Research Institute of Epidemiology and Microbiology in Moscow.

In a separate development, the SEC also refused to back Serum Institute of India’s request to test Covovax on children between the ages of 2 and 17 years until it perused data from the adult trials. “The committee noted that the vaccine is not approved in any country,” stated minutes of the SEC’s meeting on Wednesday.

“After detailed deliberation, the committee recommended that the firm should submit the safety and immunogenicity data from the ongoing clinical trial in adults for considering conduct of clinical trial in children.”

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