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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. ....

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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. ....

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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. ....

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Dr Reddy's initiates process for EUA of Sputnik V

Dr Reddy's initiates process for EUA of Sputnik V
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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 ....

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