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maker of covaccine Bharat Biotech’US partner Ocugen Inc said on January 9 that the Phase 2/3 immuno-bridging and comprehensive study of its COVID-19 vaccine candidate in the United States has produced positive results.
“The study met both co-primary endpoints with robust immune responses. Covaxin was well tolerated in vaccine-naive individuals and in individuals previously vaccinated with mRNA vaccines in the US, with no vaccine There were no -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 adjuvant whole SARS-CoV-2 virus inactivated vaccine, has been demonstrated to be well tolerated and effective against COVID-19 diseasethe Nasdaq listed firm said.
“Given that a segment of the public is hesitant to receive mRNA vaccines, this investigational COVID-19 vaccine candidate, which relies on a well-established approach to vaccine development and manufacture, provides an important additional vaccine option.” Can do,” said President and CEO Shankar Musunuri.
“The topline data from the immuno-bridging and comprehensive study will be critical to support Ocugene’s future plans for the development of Covaxin in the US,” the firm said.
The study enrolled 419 US adult participants, who were randomized 1:1 to receive two doses of Covaxin or placebo, 28 days apart. The immunization outcomes of Covaxin-vaccinated participants in the US were compared with the outcomes of vaccinated participants in Bharat Biotech’s Phase 3 study in India.