The US FDA Placed a Clinical Hold on the Ocugen’s IND Application for Covaxin (BBV152) to Treat COVID-19
Shots:
- The US FDA has issued a clinical hold on the Ocugen’s IND application to evaluate the COVID-19 vaccine i.e., Covaxin (BBV152) in the P-III trial for COVID-19 patients. The vaccine was developed by Bharat Biotech in collaboration with ICMR - NIV
- The purpose is to identify the specific deficiencies and provide information to address those deficiencies The US FDA will issue a formal written communication along with additional information to Ocugen
- The company plans to closely work with the US FDA to resolve the partial clinical hold shortly. In the P-III trial, Covaxin showed 77.8% overall efficacy, 63.6% & 65.2% efficacy against asymptomatic disease & Delta variant
Ref: Globenewswire | Image: Ocugen
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