US rejects Covaxin for emergency use, asks for more data

 

The US Food and Drug Administration has rejected the emergency use authorization proposal for Bharat Biotech's Covaxin put forward by its US partner Ocugen, per Mint.

  • The FDA has reportedly sought more data on the vaccine's trials and performance before it can grant approvals, per The Times of India.
  • The company will now apply for a "Biologics Licence Application (BLA), which is a full approval," in the US, after submitting the requisite data. 
  • Ocugen chief executive officer (CEO) Dr. Shankar Musunuri said "While this will extend our timelines, we are committed to bringing Covaxin to the US," per MoneyControl.

Of note: The company recently secured exclusive rights to market Covaxin in Canada too.

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