Hyderabad: In a significant development that could accelerate the rollout of a single-dose Russian vaccine artificial satellite Prakash in India, Subject Expert Committee (seconds) of Central Drugs Standard Control Organization (CDSCO) has told Dr Reddy’s Laboratories that it does not need to conduct a separate Phase III trial in India for the vaccine as data from Russian Phase III trials alone is sufficient for marketing authorisation.
“After detailed deliberations, the Committee recommended that the firm consider the proposal for grant of marketing authorization in the country for the safety, immunogenicity and efficacy of the Phase III clinical trial of Sputnik Lite being conducted in Russia. data must be presented.” Minutes of the SEC meeting held on June 30 which were uploaded on Thursday.
The SEC, advising the Drugs Controller General, said, “Since the safety and immunogenicity data of component-1 in the Indian population has already been generated in another trial in the country, there seems to be insufficient data and justification in conducting a separate trial. ” of India (DCGI).
The Committee noted that Sputnik Lite is similar to Component-1 of Sputnik V. In addition, the firm has already produced Component-1 protection and immunity in the country. The Committee also noted that the third in Russia Phase I efficacy trial is underway and efficacy data is yet to be generated,” the minutes of the meeting said.
Dr Reddy’s, which is the Indian partner of RDIFhad submitted a proposal for the grant of market authorization of Sputnik Lite, component-1 of Sputnik V, along with interim safety and efficacy data resulting from a phase-I/II clinical trial in Russia and Had a stage-III clinical presentation. Testing protocol before the SEC.
Sputnik Lite is a single-dose version of the two-dose Russian COVID-19 vaccine Sputnik V that contains only component-1 of the vaccine, the adenoviral vector Ad26. In Sputnik V, a second adenoviral vector Ad5 is administered 21 days after the first dose.
The single-shot jab has shown an interim efficacy of 79.4%, according to its developers the Gamleya Institute and Russian Direct Investment Fund (RDIF). The two-dose version has shown an efficacy of 97.6%, as stated by its developers according to real-world data, compared to 91.6% in trials.
Dr Reddy’s conducted a bridging Phase-II/3 study on 1,600 volunteers in India before being granted emergency use authorization for the two-dose jab Sputnik V in mid-April this year.
The company has already started a soft pilot for two-dose jab in multiple cities in 26 cities across the country, but a full commercial rollout is still awaited.
“After detailed deliberations, the Committee recommended that the firm consider the proposal for grant of marketing authorization in the country for the safety, immunogenicity and efficacy of the Phase III clinical trial of Sputnik Lite being conducted in Russia. data must be presented.” Minutes of the SEC meeting held on June 30 which were uploaded on Thursday.
The SEC, advising the Drugs Controller General, said, “Since the safety and immunogenicity data of component-1 in the Indian population has already been generated in another trial in the country, there seems to be insufficient data and justification in conducting a separate trial. ” of India (DCGI).
The Committee noted that Sputnik Lite is similar to Component-1 of Sputnik V. In addition, the firm has already produced Component-1 protection and immunity in the country. The Committee also noted that the third in Russia Phase I efficacy trial is underway and efficacy data is yet to be generated,” the minutes of the meeting said.
Dr Reddy’s, which is the Indian partner of RDIFhad submitted a proposal for the grant of market authorization of Sputnik Lite, component-1 of Sputnik V, along with interim safety and efficacy data resulting from a phase-I/II clinical trial in Russia and Had a stage-III clinical presentation. Testing protocol before the SEC.
Sputnik Lite is a single-dose version of the two-dose Russian COVID-19 vaccine Sputnik V that contains only component-1 of the vaccine, the adenoviral vector Ad26. In Sputnik V, a second adenoviral vector Ad5 is administered 21 days after the first dose.
The single-shot jab has shown an interim efficacy of 79.4%, according to its developers the Gamleya Institute and Russian Direct Investment Fund (RDIF). The two-dose version has shown an efficacy of 97.6%, as stated by its developers according to real-world data, compared to 91.6% in trials.
Dr Reddy’s conducted a bridging Phase-II/3 study on 1,600 volunteers in India before being granted emergency use authorization for the two-dose jab Sputnik V in mid-April this year.
The company has already started a soft pilot for two-dose jab in multiple cities in 26 cities across the country, but a full commercial rollout is still awaited.
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