OcugenPartner Bharat Shares Phase 3 Results Demonstrating 77.8% Protection against Overall Disease

 

• Efficacy analysis demonstrates COVAXIN™ to be 93.4% protective against severe symptomatic COVID-19
  
  

• Efficacy data demonstrates 65.2% protection against the SARS-CoV-2, B.1.617.2 Delta variant
  
  

• Adverse events reported were similar to placebo, with 12.4% of subjects experiencing commonly known side effects and less than 0.5% of subjects feeling serious adverse events
  

Ocugen, Inc. (NASDAQ: OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19, today announced that its co-development partner, Bharat Biotech, shared positive results of its Phase 3 study of COVAXIN™, a whole virion inactivated COVID-19 vaccine candidate. COVAXIN™ demonstrated a vaccine efficacy in mild, moderate, and severe COVID-19 disease of 77.8% with efficacy against severe COVID-19 disease alone of 93.4%.

“As we brace ourselves for the potential next wave of COVID-19 outbreaks from the Delta variant, reporting of the final efficacy analysis from this Phase 3 study comes at a crucial time. We expect these efficacy and safety outcomes, along with demonstrated efficacy against emerging variants of concern, will support our initiatives to bring COVAXIN™ to the US and Canadian markets,” said Dr. Shankar Musunuri, Chairman of the Board, Chief Executive Officer and Co-Founder of Ocugen.

“With the Delta variant becoming a dominant strain of COVID-19 in the United States, we believe that the Phase 3 efficacy results reported by Bharat Biotech demonstrate that COVAXIN™ has the potential to become an important option to expand protection against this emerging variant. Combining these data with the only Delta-variant results from a controlled Phase 3 clinical trial, evidence continues to support a favorable benefit-risk profile for COVAXIN™,” said Dr. Bruce Forrest, Acting Chief Medical Officer and a member of the vaccine scientific advisory board of Ocugen.

https://finance.yahoo.com/news/ocugen-covid-19-vaccine-co-214200360.html