March 30, 2023

ocugen: USFDA lifts clinical hold on Ocugen’s IND application for Covaxin paving way for its evaluation for US market | India News – Times of India

HYDERABAD: Ocugen Inc, Bharat Biotech‘s partner for US and Canada, said the US drug regulator, US Food & Drug Administration (USFDA), has lifted the clinical hold on the submission of its investigational new drug (IND) application for India’s first indigenously developed Covid-19 vaccine Covaxin (BBV152).
The move paves the way for the evaluation of Covaxin as a Covid-19 vaccine candidate for the US market. “Covaxin will be evaluated as a Covid-19 vaccine candidate in the United States,” Bharat Biotech tweeted on Saturday.
“We are pleased to be able to move our clinical programme for Covaxin forward, which we hope will bring us closer to offering an alternative Covid-19 vaccine,” said Dr Shankar Musunuri, chairman, CEO & co-founder, Ocugen.
“We firmly believe that managing this pandemic requires more than one approach to vaccines, so we are heartened to be able to continue developing our vaccine candidate,” he added.
Ocugen Inc is co-developing Bharat Biotech’s Covaxin vaccine candidate for Covid-19 in the USA and Canada. Covaxin, is a whole-virion inactivated Covid-19 vaccine that uses the same vero cell manufacturing platform that has been used in the production of polio vaccines for decades.
Over 27.65 crore doses of the vaccine have already been administered in India to adults as well as children in the 15-18 years age bracket. The vaccine received the Emergency Use Listing nod from the World Health Organisation in November 2021

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