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Expert panel reviews EUA application for Sputnik V vaccine; seeks immunogenicity, safety data

Expert panel reviews EUA application for Sputnik V vaccine; seeks immunogenicity, safety data India Updated: Wednesday, February 24, 2021, 22:12 [IST] New Delhi, Feb 24: An expert panel of India s Central Drug Authority which reviewed the application of Dr Reddy s Laboratories seeking emergency use authorisation for the COVID-19 vaccine Sputnik V on Wednesday recommended that the firm present immunogenicity and safety data, sources said. Dr Reddy s Laboratories on February 19 said it had approached drugs regulator DCGI for emergency use authorisation (EUA) for the Russian vaccine. The Subject Expert Committee (SEC) on COVID-19 of the CDSCO which discussed the application by Dr Reddy s Laboratories seeking emergency use authorisation for COVID-19 vaccine Sputnik V on Wednesday asked the firm to submit immunogenicity and safety data as per the protocol approved by the CDSCO. Once it submits these data, its EUA application will be considered, a source said.

Andhra pradeshNew delhiMadhuri adnalSimran kashyapGamaleya national research institute of epidemiologySerum institute of indiaExpert committeeIndia central drug authorityMinistry of health russia onRussian direct investment fundCentral drug authoritySubject expert committeeHyderabad based bharat biotechDrugs controller generalBharat biotechSerum institute

Coronavirus | Dr Reddy s initiates Emergency Use Authorisation process for Sputnik V

Sputnik V is one of only three vaccines in the world with an efficacy of 91.6% and has most authorisations granted with 26 countries globally, says company.

Gamaleya national research institute of epidemiologyReddy laboratories ltdMinistry of health russia onRussian direct investment fundDrugs controller generalEmergency use authorisationManaging directorGamaleya national research instituteCorona virusLockdown extensionSingle day spik eCovid 19 vaccineHealth ministryIndian council for medical researchCoronavirus vaccineRisk of deaths

Dr Reddy s initiates process for emergency use authorisation of Sputnik V-ANI

Hyderabad (Telangana) [India], Feb 19 (ANI): Dr Reddy s Laboratories said on Friday it has initiated the process with the Drugs Controller General of India (DCGI) for emergency use authorisation of human adenoviral vector-based platform vaccine candidate Sputnik V. As part of the review process, Dr Reddy s will present the safety profile of phase two study and interim data of phase three study which is expected to complete by February 21. The efficacy of Sputnik V was reported to be 91.6 per cent by the Lancet, which is an impressive development in the fight against Covid-19, said Co-chairman and Managing Director G V Prasad.

Gamaleya national research institute of epidemiologyMinistry of health russia onRussian direct investment fundDrugs controller generalGamaleya national research instituteDr reddy 39s laboratoriesCo chairman and managing directorgv prasadSputnik vDrugs controller general of india dcgiEmergency use authorisationRussian direct investment fund rdifAdenoviral vaccinesஅமைச்சகம் ஆஃப் ஆரோக்கியம் ரஷ்யா ஆன்ரஷ்ய நேரடி முதலீடு நிதிமருந்துகள் கட்டுப்படுத்தி ஜநரல்ஸ்பட்நிக் வ்

Dr Reddy s initiates process for EUA of Sputnik V

Dr Reddy s initiates process for EUA of Sputnik V
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Gamaleya national research institute of epidemiologyMinistry of health russia onRussian direct investment fundDrugs controller generalGamaleya national research instituteஅமைச்சகம் ஆஃப் ஆரோக்கியம் ரஷ்யா ஆன்ரஷ்ய நேரடி முதலீடு நிதிமருந்துகள் கட்டுப்படுத்தி ஜநரல்

Dr Reddy s initiates process for EUA of Sputnik V - The Hindu BusinessLine

Dr. Reddy’s Laboratories has initiated the process with the Drugs Controller General of India (DCGI) for Emergency Use Authorization (EUA) of the human adenoviral vector-based platform Covid-19 vaccin

Gamaleya national research institute of epidemiologyMinistry of health russia onRussian direct investment fundDrugs controller generalEmergency use authorizationManaging directorGamaleya national research instituteEua of sputnik vEmergency use sputnik vCo vidCovid vaccineஅமைச்சகம் ஆஃப் ஆரோக்கியம் ரஷ்யா ஆன்ரஷ்ய நேரடி முதலீடு நிதிமருந்துகள் கட்டுப்படுத்தி ஜநரல்அவசரம் பயன்பாடு அங்கீகாரம்நிர்வகித்தல் இயக்குனர்

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