• Armed with new data from its development partner Bharat Biotech, Ocugen Inc (NASDAQ: OCGN) plans to press ahead with plans to file for approval of their COVID-19 vaccine, Covaxin, in the U.S. and Canada.
• Covaxin has already been approved for restricted emergency use in India, getting the green light in January months before the final results from the trial were available.
• New data from the 25,800-patient Phase 3 trial show that the shot has an overall protective efficacy of 77.8% and 65.2% against the highly transmissible delta (B.1.617.2) variant.
• The two-dose vaccine based on an inactivated form of the virus formulated with an immune-boosting adjuvant showed to be 93.4% protective against severe symptomatic COVID-19.
• Adverse events reported were low, with 12.4% of subjects experiencing commonly known side effects and less than 0.5% of subjects feeling serious adverse events.
• Ocugen recently announced that it will pursue submission of a Biologics License Application (BLA) for its COVID-19 vaccine candidate in the U.S. and has initiated discussions with Health Canada for regulatory approval.
• Price Action: OCGN shares are up 14.3% at $8.33 during the premarket session on the last check Tuesday.