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.