Ocugen Preps US Filings For COVID-19 Vaccine As New Data Shows Overall Efficacy Of Around 79%

Armed with new data from its development partner Bharat Biotech, Ocugen Inc 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.