Covaxin maker Bharat Biotech’s partner in the U.S. Ocugen Inc on January 9 said phase 2/3 immuno-bridging and broadening study of the COVID-19 vaccine candidate in the United States has delivered positive results.
“The study met both co-primary endpoints with robust immune responses. Covaxin was found to be well-tolerated in vaccine-naive individuals and in individuals previously vaccinated with mRNA vaccines in the U.S., with no vaccine-related serious adverse events, thrombotic events, or cases of myocarditis or pericarditis,” Ocugen said in a release.
“The data add to the body of evidence that Covaxin, an adjuvated whole SARS-CoV-2 virus inactivated vaccine, has been demonstrated to be well-tolerated and effective against COVID-19 disease,” the Nasdaq listed firm said.
“Given that a portion of the public remains hesitant to receive mRNA vaccines, this investigational COVID-19 vaccine candidate, which relies on a well-established approach to vaccine development and manufacturing, may provide an important additional vaccine option,” Chairman and CEO Shankar Musunuri said.
“The topline data from the immuno-bridging and broadening study will be critical to support Ocugen’s future plans for the development of Covaxin in the U.S.,” the firm said.
The study enrolled 419 U.S. adult participants that were randomized 1:1 to receive two doses of Covaxin or placebo, 28 days apart. Immunogenicity results from Covaxin-vaccinated participants in the U.S. were compared with results in the vaccinated participants in Bharat Biotech’s Phase 3 study in India.
