The COVID-19 vaccine developed by Ocugen's Indian partner, Bharat Biotech, has been found to be 93.4% effective against severe cases of COVID-19 in a late-stage trial, the U.S. drug developer said on Friday.
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%. "In the Phase 3 trial conducted by Bharat Biotech, subjects vaccinated with Covaxin achieved greater protection against emerging B.1.617.2 (delta) and B.1.351 (beta) variants than those who had previous natural infections. Results showed an efficacy rate of 65.2%," Ocugen said in a statement.
“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.
“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.
Bharat Biotech’s Phase 3 clinical trial enrolled 25,798 participants across 25 sites and between 18-98 years of age in India, including 2,750 over the age of 60 and 7,065 with comorbidities. The primary endpoint of the Phase 3 clinical trial is based on the first occurrence of PCR-confirmed symptomatic (mild, moderate, or severe) COVID-19 with onset at least 14 days after the second study vaccination in serologically negative (to SARS-CoV-2) adult participants at baseline.
“The safety and efficacy readouts from Phase III clinical trials present a comprehensive data package for Covaxin. This has been a great journey of science leading to translational product development to combat this deadly pandemic,” added Dr. Krishna Ella, Chairman & Managing Director, Bharat Biotech. “We continue our efforts towards additional studies on variants of concern. Our commitment to data transparency has been sustained with 10 publications within the past year, and we will share our findings with regulators worldwide.
Ocugen recently announced that it will pursue submission of a Biologics License Application (BLA) for its COVID-19 vaccine candidate, Covaxin in the United States and has initiated discussions with Health Canada for regulatory approval.
