Ocugen announced positive results from a phase two/three study of Covaxin, its COVID-19 vaccine candidate developed by Bharat Biotech.
A release said that Covaxin has been demonstrated in clinical trials to generate a broader immune response “against the whole virus, covering important antigens such as S-protein, RBD, and N-protein, whereas currently approved vaccines in the US target only the S-protein antigen.”
Additionally, in contrast to other inactivated vaccines, clinical trials have demonstrated that TLR7/8 agonist adjuvant in COVAXIN generates a Th1-biased immune response that induces robust long-term memory B- and T-cell responses, the release said.
“The successful completion of this study represents an important milestone to the ongoing management of COVID-19,” said Dr. Shankar Musunuri, Chairman, Chief Executive Officer, and Co-Founder of Ocugen.
“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,” Dr. Musunuri said.
The study enrolled 419 US adult participants that were randomized 1:1 to receive two doses of Covaxin or placebo, 28 days apart.
“It 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 United States with no vaccine-related serious adverse events, thrombotic events, or cases of myocarditis or pericarditis,” the release said.
These data add to the body of evidence that Covaxin, an adjuvanted whole SARS-CoV-2 virus inactivated vaccine, has been demonstrated to be well-tolerated and effective against COVID-19 disease,” the release added.
“These positive data represent an important step in the management of the ever-evolving COVID-19 pandemic,” said Dr. Eric Feigl-Ding, epidemiologist and health economist, Chief of COVID Task Force at the New England Complex Systems Institute.
“The need for different vaccine approaches to COVID-19 has become critically apparent with the continued emergence of variants to the SARS-CoV-2 virus.”
The top-line data from the immuno-bridging and broadening study will be critical to support Ocugen’s future plans for the development of Covaxin in the US, the release said.