Bharat Biotech's partner says Covaxin shows positive results in Phase 2/3 study in US

Ocugen Inc., Bharat Biotech's partner for US and Canada for COVID-19 vaccine Covaxin (BBV152) on Monday said it got positive results from the Phase 2/3, observer-blind, immuno-bridging and broadening study of the jab in US.

A press release from the US biopharmaceutical company said the study enrolled 419 US adult participants that were randomized 1:1 to receive two doses of Covaxin or placebo, 28 days apart.

''The successful completion of this study represents an important milestone to the ongoing management of COVID-19. 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,'' Shankar Musunuri, Chairman and CEO of Ocugen said.

Immunogenicity results from Covaxin-vaccinated participants in US were compared with results in Covaxin-vaccinated participants in the Bharat Biotech-sponsored Phase 3 study in India.

Approximately 24 per cent of tested participants in US were vaccine-naive while all participants in the Bharat Biotech Phase 3 study were vaccine-naïve, it said.

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 US, the release added.

(This story has not been edited by Devdiscourse staff and is auto-generated from a syndicated feed.)