COVAXIN COVID-19 Vaccine Shows Positive Results in Phase 3 Data
The therapy demonstrated an efficacy of 65.2% against the Delta variant.
Ocugen, a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies, recently announced positive results from a phase 3 study of their COVID-19 vaccine, COVAXIN.
The therapy was co-developed with Bharat Biotech, a vaccine and bio-therapeutics research and product development company based in Hyderabad, India.
“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,” Shankar Musunuri, chairman of the board, chief executive officer and co-founder of Ocugen said. “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.”
The phase 3 clinical trial included 25,798 participants between the ages of 18 and 98 years old across 25 sites. The primary endpoint was 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 adult participants at baseline.
The whole virion inactivated COVID-19 vaccine candidate demonstrated an overall efficacy of 77.8%, as well as an efficacy of 93.4% against severe, symptomatic disease. Additionally, the therapy demonstrated an efficacy of 65.2% against the emerging Delta variant.
There were a low number of adverse events reported, with 12.4% experiencing commonly known side effects and less than 0.5% experiencing serious adverse events.
Ocugen stated that they soon plan on applying for a Biologics License Application (BLA) in the United States.
“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,” Bruce Forrest, acting chief medical officer and a member of the vaccine scientific advisory board of Ocugen said. “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.”