Home / Companies / News /  Covaxin clinical trials to resume in the US as FDA lifts halt
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US FDA has finally lifted the pause on 2/ 3 clinical trials of Bharat Biotech's COVID-19 vaccine Covaxin in the USA, Ocugen Inc, Bharat Biotech’s partner for the jab in the USA and Canada, said in a statement. US Food and Drug Administration in April decided to halt the clinical trials temporarily after the WHO observed deficiencies in Covaxin manufacturing plants in India.

"We're extremely pleased that we can proceed with our clinical trials for Covaxin our whole virus inactivated COVID-19 vaccine candidate. The need for delivering an additional, differentiated vaccine option, we believe, remains a priority," Dr Shankar Musunuri, Chairman, CEO and Co-Founder, Ocugen Inc said.

"Thank you to our clinical trial partners and site collaborators for their ongoing support. Ocugen will now work with study sites to fully resume this clinical development program immediately," he further said.

WHO had earlier suspended the supply of Covaxin through US procurement agencies, after its inspections. Sources close to the Hyderabad-based firm, however, confirmed that it had not supplied the Covid vaccine to any UN agency and no impact of the suspension would be felt. 

After WHO inspection, Bharat Biotech had said it is temporarily slowing down production of Covaxin across its manufacturing units for facility optimisation as it has already completed its supply obligations to procurement agencies and foresees a decrease in demand. 

The company further said after the recent WHO post-Emergency Use Listing (EUL) inspection, it is working on further improvements and upgrades to ensure that the production of Covaxin continues to meet ever-increasing global regulatory requirements.

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