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