Bharat Biotech’s Covaxin inching closer to US launch plan?

Bharat Biotech’s Covaxin

Indian vaccine maker Bharat Biotech’s partner for Covaxin in the USA, Ocugen, on January 9 announced positive data from phase 2, 3 immuno-bridging and broadening clinical study of its COVID-19 vaccine.

The company said that Covaxin, an inactivated virus vaccine has been demonstrated in clinical trials to generate a broader immune response against the whole virus covering important antigens whereas currently approved vaccines in the US target only S-protein antigen.

In contrast to other inactivated vaccines, clinical trials have demonstrated that the vaccine generates more robust immune response that induces robust long-term memory B- and T-cell responses.

“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.”

This study enrolled 419 adult participants in the USA that were randomised 1:1 to receive two doses of Covaxin or placebo, 28 days apart.

Blinded safety results and preliminary unblinded immunogenicity results are available through Day 56, one month following the second vaccination. Immunogenicity results from Covaxin vaccinated participants in the US were compared with results in the vaccinated participants in the Bharat Biotech-sponsored phase 3 study in India.

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Approximately 24 percent of tested participants in the US were vaccine-naïve, while all participants in the Bharat Biotech phase 3 study were vaccine-naïve.

“Both co-primary immunogenicity endpoints were met,” said the company, adding that there were no deaths or related adverse events of special interest during the trials.

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 firm has said.