FDA lifts hold on Covaxin’s clinical trials in US

The US Food and Drug Administration which has put on hold the phase 2/ 3 clinical trials of Bharat Biotech’s COVID-19 vaccine Covaxin, in USA, has lifted the pause, according to a statement issued by Ocugen Inc, Bharat Biotech’s partner for the jab in USA and Canada.

“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.

The FDA’s earlier decision, in April, to put on hold the trials was based on the US firm’s decision to voluntarily implement a temporary pause in dosing participants of the jab, following the World Health Organisation’s observations on Covaxin manufacturing plants in India.

“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 inspectors identified GMP (good manufacturing practice) deficiencies in the Bharat Biotech’s manufacturing plants.

Sources had said the city-based firm however, had not supplied the Covid vaccine to any UN agency and no impact of the suspension would be felt. OCU-002 is Ocugen’s Phase 3 immuno-bridging study of Covaxin.

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 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.