USFDA lifts clinical hold on Phase 2, 3 trials of Covaxin in US

Naga Sridhar | Updated on: May 23, 2022


Need to deliver an additional, differentiated vaccine option remains a priority: Ocugen

Hyderabad, May 23 The US Food and Drug Administration (FDA) has lifted the clinical hold on Phase 2, 3 clinical trials of Bharat Biotech’s Covid vaccine, Covaxin (BBV152), in the US.

This was announced by Ocugen Inc, partner of Bharat Biotech for Covaxin in the US on Monday.  “We’re extremely pleased that we can proceed with our clinical trials for Covaxin, our whole virus inactivated Covid vaccine candidate. The need for delivering an additional, differentiated vaccine option, we believe, remains a priority,” said Shankar Musunuri, Chairman, CEO and Co-Founder, Ocugen Inc, in a release.

“Ocugen will now work with study sites to fully resume this clinical development program immediately,’‘ he added. 

Following deficiencies detected in the manufacturing process by WHO during the inspection of a Bharat Biotech facility recently, the US regulator paused trials of Covaxin.

With more than 350 million doses having been administered to adults outside the US, Covaxin is currently approved for adults in India and authorised under emergency use in 25 countries. 

“Applications for emergency use authorisation are pending in more than 60 other countries. Covaxin is listed by the WHO as authorised for emergency use. And, as many as 110 countries have agreed to mutual recognition of Covid vaccination certificates with India that includes vaccination using Covaxin,’‘ said the release. 

The trade name, Covaxin, has not been evaluated by the USFDA, it added. 

Published on May 23, 2022
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