Bharat Biotech seeks emergency use authorisation for Covid-1
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After Pfizer and Serum Institute, Hyderabad-based pharmaceutical firm Bharat Biotech applied to the central drug regulator seeking emergency use authorisation for its COVID-19 vaccine Covaxin, official sources said.

Covaxin is being indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).

The Hyderabad-based firm is conducting phase-3 clinical trial of its vaccine in around 25 places, including Delhi, Mumbai, Patna and Lucknow. The firm, while applying for the phase-3 trial, had stated that the vaccine was well-tolerated in all dose groups and no serious adverse events have been reported. The most common adverse event was transient pain at the injection site, a source said.

The Drugs Controller General of India (DCGI) had on October 23 granted permission to the firm for conducting phase-3 clinical trial of Covaxin after assessing the safety and immunogenicity data of phase 1 and 2 trials.

An expert committee of the Central Drugs Standard Control Organisation (CDSCO) will meet on 9 December to review applications of Pfizer, Serum Institute of India and Bharat Biotech seeking emergency use authorisation for their COVID-19 vaccine candidates.

Source: https://www.timesnownews.com/health/article/bharat-biotech-seeks-emergency-use-authorisation-for-indian-covid-19-vaccine-covaxin/691747
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