 "Bharat Biotech, Covaxin")
Ocugen on Monday announced positive results from the phase two/ three study of its COVID-19 vaccine candidate, Covaxin, which has been 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 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.
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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 adjuvated 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.
(Only the headline and picture of this report may have been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)
