Ocugen announces positive data for Bharat Biotech's Covaxin in US trials

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.

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.