Bharat Biotech’s Partner Ocugen Inc Says COVID-19 Vaccine ‘Covaxin’ Shows Positive Results in Phase 2/3 Study in US
Hyderabad, January 9: 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. Covaxin Regulatory Approval Was Rushed Due to Political Pressure? Government Terms Media Reports About COVID-19 Vaccine ‘Misleading and Fallacious’.
“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. COVID-19 in India: Bharat Biotech’s ‘Covaxin’ Gets Emergency Use Authorisation for Children Between 6-12 Years.
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.
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