Expert Panel Gives Nod To Bharat Biotech’s Covaxin For Restricted Emergency Use

The development comes a day after the SEC gave approval to Bharat Biotech’s Covaxin for restricted emergency use.

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New Delhi: In what comes as a significant relief for India, the Subject Expert Committee (SEC) on Saturday gave nod to the Bharat Biotech’s vaccine candidate 'Covaxin' for restricted emergency use. The development comes a day after the SEC gave approval to Oxford-Astrazeneca vaccine candidate for restricted emergency use. The Drug Controller General of India (DCGI) will give the final approval to both the vaccine candidates. After getting approval by DCGI, Covaxin will be the first indigenous vaccine developed by Bharat Biotech in collaboration with Indian Council of Medical Research and National Institute of Virology. The committee of experts assessing Coronavirus vaccines had called Hyderabad-based Bharat Biotech for a meeting in the afternoon today, a day after the firm was asked to present more data to get a nod, a  source close to news agency IANS on Saturday.

#COVID19Update

Subject Expert Committee (SEC) of @CDSCO_INDIA_INF makes recommendations in respect of accelerated Approval Process request of @SerumInstIndia, @BharatBiotech & Phase-III Trials of M/s Cadila Healthcare Ltd.https://t.co/hwNyTYqSJM pic.twitter.com/9uLOrjV7cQ — Ministry of Health (@MoHFW_INDIA) January 2, 2021

On Friday, the Subject Expert Committee of the Central Drug Standard Control Organisation (CDSCO) had held that the data provided by Bharat Biotech for its Coronavirus vaccine is not sufficient for grant of emergency use approval and asked for more information. The expert committee, tasked with vetting Covid-19 vaccine proposals, had convened a meeting to take a call on emergency use authorisation sought by the Serum Institute of India and Bharat Biotech for their respective vaccine candidates. Notably, the panel recommended emergency licensure for the Serum Institute of India-manufactured 'Covishield'. It become the first vaccine to secure recommendation for emergency use in India. The nod of the DCGI is, however, awaited on the recommendation. The Pune-based Serum Institute has partnered with Oxford-AstraZeneca for conducting clinical trials and manufacturing 'Covishield' while Bharat Biotech has collaborated with the Indian Council of Medical Research (ICMR) for 'Covaxin'. Meanwhile, the government has planned to vaccinate as many as 30 crore people in the first phase of vaccination drive. It will be offered to one crore healthcare workers, along with 2 crore frontline and essential workers and 27 crore elderly above the age of 50 years most of whom have co-morbidities.