FDA Removes Clinical Hold On Ocugen's COVID Vaccine Trial

  • The FDA has lifted the clinical hold on Ocugen Inc's OCGN Phase 2/3 trial, OCU-002, for Covaxin (BBV152), a whole virus inactivated COVID-19 vaccine candidate. 
  • In April, the agency paused the trials of the shot, Covaxin, after an inspection of a Bharat Biotech facility by the World Health Organization (WHO) revealed deficiencies in the manufacturing process.
  • Related: FDA Places Clinical Hold On Ocugen's Late-Stage COVID-19 Vaccine Trial.
  • "Ocugen will now work with study sites to fully resume this clinical development program immediately," Chairman and Chief Executive Officer Shankar Musunuri said.
  • Ocugen is responsible for conducting trials and commercializing the vaccine in the U.S. under a partnership with Bharat Biotech.
  • With more than 350 million doses administered to adults outside the U.S., Covaxin is approved for adults in India and authorized for emergency use in 25 countries and has received an emergency use listing from the WHO.
  • Price Action: OCGN shares are up 2.24% at $2.28 during the premarket session on the last check Monday.
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