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The US FDA Placed a Clinical Hold on the Ocugen’s IND Application for Covaxin (BBV152) to Treat COVID-19

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The US FDA Placed a Clinical Hold on the Ocugen’s IND Application for Covaxin (BBV152) to Treat COVID-19

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  • 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

Click here to­ read the full press release 

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This content piece was prepared by our former Senior Editor. She had expertise in life science research and was an avid reader. For any query reach out to us at connect@pharmashots.com

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