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No COVID Vaccine Approval Yet, Drug Regulator Analysing SII and Bharat Biotech Data

No COVID Vaccine Approval Yet, Drug Regulator Analysing SII and Bharat Biotech Data by Iswarya on  December 31, 2020 at 12:24 PM Vaccine makers Serum Institue of India (SII) and Bharat Biotech, who are expecting a nod for approval of emergency use, the Central Drug Standard Control Organisation s (CDSCO) Subject Expert Committee on Wednesday stated that it was still doing the analyses of the additional data and information submitted by SII and Bharat Biotech. The next meeting of the drug regulator will take place on January 1. The Subject Expert Committee met on Wednesday to consider the Emergency Use Authorisation (EUA) request of Pfizer, SII, and Bharat Biotech Private Ltd.

India continues to mull over SII and Bharat Biotech s COVID-19 vaccine candidates

India continues to mull over SII and Bharat Biotech s COVID-19 vaccine candidates IANSDec 31, 2020, 08:19 IST Clinical trials of the Oxford-AstraZeneca COVID-19 vaccine, which will be manufactured by SII in IndiaBCCL The analysis of the additional data and information submitted by Serum Institute of India (SII) and Bharat Biotech is still being conducted by regulator Central Drug Standard Control Organisation s (CDSCO) Subject Expert Committee and their next meeting will be held on January 1. The Subject Expert Committee met on Wednesday to consider the Emergency Use Authorisation (EUA) request of Pfizer, SII and Bharat Biotech Private Ltd. Further time was requested on behalf of Pfizer, while the additional data and information presented by the SII and Bharat Biotech was perused and analysed by the SEC.

AstraZeneca Serum Institute covishield Bharat Biotech covaxin vaccine emergency approval drug regulator DCGI analysing

URL copied A medical worker, right, prepares a vaccine shot. (Representational image) Vaccine makers Serum Institue of India (SII) and Bharat Biotech, who are expecting a nod for approval of emergency use, the Central Drug Standard Control Organisation s (CDSCO) Subject Expert Committee on Wednesday said that it was still doing the analyses of the additional data and information submitted by SII and Bharat Biotech. The next meeting of the drug regulator will take place on January 1. SII, Bharat Biotech awaits emergency approval | Key points The Subject Expert Committee met on Wednesday to consider the Emergency Use Authorisation (EUA) request of Pfizer, SII and Bharat Biotech Private Ltd.

COVID-19 vaccine in India: Emergency use authorisation still not approved; SEC to reconvene on Jan 1

PM Narendra Modi reviewed the development of COVID-19 vaccine candidate ZyCOV-D in Ahmedabad. The analysis of the additional data and information submitted by Serum Institute of India (SII) and Bharat Biotech is still being conducted by regulator Central Drug Standard Control Organisation s (CDSCO) Subject Expert Committee and their next meeting will be held on January 1. The Subject Expert Committee met on Wednesday to consider the Emergency Use Authorisation (EUA) request of Pfizer, SII and Bharat Biotech Private Ltd. Further time was requested on behalf of Pfizer, while the additional data and information presented by the SII and Bharat Biotech was perused and analysed by the SEC.

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