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Tuesday, September 28, 2021

Ocugen-Partnered Covaxin's WHO Clearance Delayed Further

 

  • The World Health Organization (WHO) has further delayed the emergency use authorization (EUA) for Covaxin, a COVID-19 vaccine developed in India. Ocugen Inc (NASDAQ: OCGN) is the U.S. partner for the vaccine.

  • According to sources, the global body has sent more technical queries to its manufacturer Bharat Biotech.

  • Without EUA, Covaxin would not be considered an accepted vaccine by most countries around the world. WHO's queries for Bharat Biotech come despite the drugmaker asserting that it has submitted all data required for clearance.

  • The indication of a delay comes merely days after the Union Health Ministry hinted that the global body was likely to give its nod anytime soon.

  • According to Bharat Biotech, Phase 3 trials of Covaxin had demonstrated an efficacy rate of 77.8%.

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